Priority in Public Health PDF

Public Health Ethics Analysis 3
Series Editor: Michael J. Selgelid
Drue H. Barrett · Leonard W. Ortmann

Angus Dawson · Carla Saenz
Andreas Reis · Gail Bolan Editors
Public Health
Ethics: Cases
Spanning the Globe
Public Health Ethics Analysis
Volume 3
Edited by
Michael J. Selgelid
Monash University, Melbourne, Australia
During the 21st Century, public health ethics has become one of the fastest growing
subdisciplines of bioethics. This is the first book series dedicated to the topic of
public health ethics. It aims to fill a gap in the existing literature by providing
thoroughgoing, book-length treatment of the most important topics in public health
ethics—which have otherwise, for the most part, only been partially and/or
sporadically addressed in journal articles, book chapters, or sections of volumes
concerned with public health ethics. Books in the series will include coverage of
central topics in public health ethics from a plurality of disciplinary perspectives
including: philosophy (e.g., both ethics and philosophy of science), political science,
history, economics, sociology, anthropology, demographics, law, human rights,
epidemiology, and other public health sciences. Blending analytically rigorous and
empirically informed analyses, the series will address ethical issues associated with
the concepts, goals, and methods of public health; individual (e.g., ordinary citizens’
and public health workers’) decision making and behaviour; and public policy. Inter
alia, volumes in the series will be dedicated to topics including: health promotion;
disease prevention; paternalism and coercive measures; infectious disease; chronic
disease; obesity; smoking and tobacco control; genetics; the environment; public
communication/trust; social determinants of health; human rights; and justice. A
primary priority is to produce volumes on hitherto neglected topics such as ethical
issues associated with public health research and surveillance; vaccination;
tuberculosis; malaria; diarrheal disease; lower respiratory infections; drug resistance;
chronic disease in developing countries; emergencies/disasters (including
bioterrorism); and public health implications of climate change.
More information about this series at http://www.springer.com/series/10067

Drue H. Barrett • Leonard W. Ortmann
Angus Dawson • Carla Saenz • Andreas Reis
Gail Bolan
Editors
Public Health Ethics:

Cases Spanning the Globe
Editors
Drue H. Barrett Leonard W. Ortmann
Office of Scientific Integrity, Office of the Office of Scientific Integrity, Office of the
Associate Director for Science, Office of Associate Director for Science, Office of
the Director the Director
Centers for Disease Control and Prevention Centers for Disease Control and Prevention
Atlanta, GA, USA Atlanta, GA, USA
Angus Dawson Carla Saenz

Center for Values, Ethics and the Law in Regional Program on Bioethics
Medicine, Sydney School of Public Health Office of Knowledge Management,
The University of Sydney Bioethics, and Research
Sydney, Australia Pan American Health Organization
Washington, DC, USA
Andreas Reis
Global Health Ethics Gail Bolan
Department of Information, Evidence Division of STD Prevention
and Research National Center for HIV/AIDS, Viral
World Health Organization Hepatitis, STD and TB Prevention
Geneva, Switzerland Centers for Disease Control and Prevention
Atlanta, GA, USA
ISSN 2211-6680 ISSN 2211-6699 (electronic)

Public Health Ethics Analysis
ISBN 978-3-319-23846-3 ISBN 978-3-319-23847-0 (eBook)
DOI 10.1007/978-3-319-23847-0
Library of Congress Control Number: 2015960197
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Disclaimer
The contents of this casebook represent the opinions, findings, and conclusions of
the authors and do not necessarily reflect the official position, views, or policies of
the editors, the editors’ host institutions, or the authors’ host institutions.
v
Preface
Public health ethics can be seen both as the application of principles and norms to
guide the practice of public health and as a process for identifying, analyzing, and
resolving ethical issues inherent in the practice of public health. Public health ethics
helps us decide what we should do and why. Although the practice of public health
has always considered ethical issues, the emergence of public health ethics as a
discipline is relatively new. Although rooted in bioethics and clinical and research
ethics, public health ethics has many characteristics that set it apart. The defining
characteristics are its focus on achieving social goods for populations while respect-
ing individual rights and recognizing the interdependence of people.
Currently there are few practical training resources for public health practitio-
ners that consider ethical issues and dilemmas likely to arise in the practice of pub-
lic health. In public health ethics training, we have found it advantageous to use
cases to illustrate how ethical principles can be applied in practical ways to decision
making. The use of cases encourages reflection and discussion of ethics, reinforces
basic ethical concepts through application to concrete examples, highlights practi-
cal decision making, allows learners to consider different perspectives, and sensi-
tizes learners to the complex, multidimensional context of issues in public health
practice. The case-based approach (known as casuistry) contrasts with the theoreti-
cal approach to considering moral principles, rules, and theories. By describing
scenarios, cases allow the learner to use ethical principles in the context of a realis-
tic situation that sheds light on ethical challenges and illustrates how ethical prin-
ciples can help in making practical decisions.
This casebook comprises a broad range of cases from around the globe to high-
light the ethical challenges of public health. For those new to public health ethics,
Section I introduces public health ethics. Chapter 1, “Public Health Ethics: Global
Cases, Practice, and Context” by Ortmann and colleagues, summarizes basic
concepts and describes how public health ethics differ from bioethics, clinical
ethics, and research ethics. The chapter also includes an approach for conducting an
ethical analysis in public health. In Chap. 2, “Essential Cases in the Development of
Public Health Ethics,” Lee, Spector-Bagdady, and Sakhuja highlight important
vii
viii Preface
events that shaped the practice of public health and explain how practitioners
address and prevent ethical challenges.
Section II is organized into chapters that discuss the following public health
topics:
• Resource allocation and priority setting
• Disease prevention and control
• Chronic disease prevention and health promotion
• Environmental and occupational public health
• Vulnerability and marginalized populations
• International collaboration for global public health
• Public health research
We have invited some of the leading writers and thinkers in public health ethics
to provide an overview of the major ethical considerations associated with each
topic. The topic overviews offer the authors’ perspectives about applicable ethical
theories, frameworks, and tools and draw attention to the cases that follow. The
cases are meant to highlight the ethical issues in practice. Each represents the work
of authors from around the globe who responded to a solicitation from the U.S.
Centers for Disease Control and Prevention. We worked with the authors to ensure
that each case included a concise articulation of a public health situation that raises
ethical tensions, challenges, or concerns that require decisions or recommendations
from public health officials or practitioners. The cases are presented in a standard
format that includes a background, case description, discussion questions, and ref-
erences. However, we also allowed for variation in the amount of detail provided in
each section and the approach used to set up the case. Our goal was to include just
enough contextual information to orient the reader who is not an expert in the case
topic. We include the case setting, population, or intervention in question, legal or
regulatory landscape, and questions to stimulate discussion on core ethical issues.
Each case—although fictionalized—is as realistic as possible to reflect the ethical
challenges that public health practitioners face daily. Sometimes the cases were
based on actual or composite events. In these instances, the case details were modi-
fied to exclude identifying information that could be considered private, sensitive,
or disputable by others involved in the case.
We deliberately did not attempt to provide a resolution or solution for the cases.
Often in public health practice, there is no single correct answer. Instead, ethical
analysis in public health is a process to identify the ethical dimensions of the options
available and to arrive at a decision that is ethically justifiable, through deliberation
and consideration of relevant facts, values, and contexts.
The cases and other writings in this book represent the opinions, findings, and
conclusions of the authors and do not necessarily reflect the official position, views,
or policies of the editors, the editors’ host institutions, or the authors’ host institu-
tions. We decided which topic category to place the case in to best distribute the
cases across chapters. However, you may note that some cases cross topic areas and
could just as easily have been included in another chapter.
Preface ix
This casebook is written for public health practitioners, including frontline work-
ers, field epidemiology trainers and trainees, and managers, planners, and decision
makers with an interest in learning about how to integrate ethical analysis in their
day-to-day public health practice. However, the casebook will also be useful to
instructors in schools of public health and public health students as well as to aca-
demic ethicists who can use the book to teach public health ethics and distinguish it
from clinical and research ethics.
Our hope is that the casebook will increase awareness and understanding of pub-
lic health ethics and the value of ethical analysis in public health practice in all of its
forms. This includes applied public health research; public health policy develop-
ment, implementation, and evaluation; and public health decision making in national
and international field settings and training programs. By emphasizing prospective
practical decision making, rather than just presenting a theoretical academic discus-
sion of ethical principles, we hope this casebook will serve as a useful tool to sup-
port instruction, debate, and dialogue about the nature of ethical challenges
encountered in public health practice and how to resolve these challenges. We rec-
ommend discussing the cases in small groups and using the discussion questions,
the ethical framework described in Chap. 1, and the information provided in the
topic area overview sections as a starting place for exploring the ethical issues
reflected in the cases. The ultimate goal of case-based learning is to develop skills
in ethical analysis and decision making in daily public health practice. The ethical
framework provides a convenient tool for putting our ideas into practice.
Atlanta, GA, USA Drue H. Barrett, PhD

Atlanta, GA, USA Leonard W. Ortmann, PhD
Sydney, Australia Angus Dawson, PhD
Washington, DC, USA Carla Saenz, PhD
Geneva, Switzerland Andreas Reis, MD
Atlanta, GA, USA Gail Bolan, MD
Contents
Section I Introduction to Public Health Ethics

1 Public Health Ethics: Global Cases, Practice, and Context .................. 3
Leonard W. Ortmann, Drue H. Barrett, Carla Saenz,
Ruth Gaare Bernheim, Angus Dawson, Jo A. Valentine,
and Andreas Reis
1.1 Introduction .................................................................................... 3
1.2 Public Health .................................................................................. 5
1.3 Ethics.............................................................................................. 9
1.4 Public Health Ethics ....................................................................... 19
1.5 Ethical Frameworks ....................................................................... 27
1.6 A Three-Step Approach to Public Health Decision Making.......... 28
References ................................................................................................... 33
2 Essential Cases in the Development of Public Health Ethics ................ 37
Lisa M. Lee, Kayte Spector-Bagdady, and Maneesha Sakhuja
2.1 Introduction .................................................................................... 37
2.2 Case Study: Jacobson v. Massachusetts ......................................... 39
2.3 Case Study: U.S. Public Health Service Research on Sexually
Transmitted Disease: Alabama and Guatemala ............................. 44
2.4 Case Study: The New York City A1C Registry ............................... 50
2.5 Conclusions and Implications ........................................................ 54
References ................................................................................................... 55
Section II Topics in Public Health Ethics

3 Resource Allocation and Priority Setting................................................ 61
Norman Daniels
3.1 Resource Allocation in Public Health ............................................ 61
3.2 Collective Lessons from the Cases ................................................ 62
3.3 Specific Ethical Issues in Resource Allocation .............................. 65
xi
xii Contents
3.4 Decision-Making Process .............................................................. 69

References ................................................................................................... 70
3.5 Case 1: Priority Setting and Crisis of Public
Hospitals in Colombia.................................................................... 71
References ................................................................................................... 74
3.6 Case 2: Intersection of Public Health and Mental
Health: Meeting Family Needs ...................................................... 74
References ................................................................................................... 79
3.7 Case 3: Public-Private Partnerships: Role of Corporate
Sponsorship in Public Health ......................................................... 80
References ................................................................................................... 83
3.8 Case 4: Black-White Infant Mortality: Disparities,
Priorities, and Social Justice .......................................................... 84
References ................................................................................................... 86
3.9 Case 5: Priority Setting in Health Care: Ethical Issues.................. 87
References ................................................................................................... 89
3.10 Case 6: Critical Care Triage in Pandemics .................................... 90
References ................................................................................................... 93
4 Disease Prevention and Control ............................................................... 95
Michael J. Selgelid
4.1 Introduction .................................................................................... 95
4.2 Mandatory Treatment and Vaccination .......................................... 95
4.3 Disease Screening and Surveillance .............................................. 97
4.4 Stigma ............................................................................................ 98
4.5 Access to Care................................................................................ 99
4.6 Health Promotion Incentives .......................................................... 100
4.7 Emergency Response ..................................................................... 101
4.8 Conclusion ..................................................................................... 102
References ................................................................................................... 103
4.9 Case 1: Mandatory Vaccination in Measles Outbreaks.................. 103
References ................................................................................................... 107
4.10 Case 2: Public Health Approaches to Preventing
Mother-to-Child HIV Transmission ............................................... 108
References ................................................................................................... 111
4.11 Case 3: Newborn Bloodspot Screening: Personal Choice
or Public Health Necessity? Storage and Ownership
of Newborn Bloodspots.................................................................. 111
References ................................................................................................... 114
4.12 Case 4: Decoding Public Health Ethics and Inequity
in India: A Conditional Cash Incentive
Scheme—Janani Suraksha Yojana ................................................. 116
References ................................................................................................... 119
4.13 Case 5: HIV Criminalization and STD
Prevention and Control .................................................................. 120
References ................................................................................................... 124
Contents xiii
4.14 Case 6: Ethics of Administering Anthrax Vaccine to Children ..... 125

References ................................................................................................... 128
4.15 Case 7: Non-adherence to Treatment in Patients
with Tuberculosis: A Challenge for Minimalist Ethics.................. 129
References ................................................................................................... 132
4.16 Case 8: Mass Evacuation ............................................................... 132
References ................................................................................................... 135
5 Chronic Disease Prevention and Health Promotion .............................. 137
Harald Schmidt
5.1 Introduction .................................................................................... 137
5.2 Individuals ...................................................................................... 140
5.3 Formal and Informal Health Workers ............................................ 141
5.4 Governments (At Different Levels) ............................................... 144
5.5 Corporate Entities .......................................................................... 147
5.6 Case Studies ................................................................................... 149
References ................................................................................................... 151
5.7 Case 1: Municipal Action on Food and Beverage
Marketing to Youth ........................................................................ 153
References ................................................................................................... 157
5.8 Case 2: Obesity Prevention in Children: Media
Campaigns, Stigma, and Ethics...................................................... 158
References ................................................................................................... 161
5.9 Case 3: Obesity Stigma in Vulnerable
and Marginalized Groups ............................................................... 162
References ................................................................................................... 166
5.10 Case 4: Water Fluoridation: The Example of Greece .................... 167
References ................................................................................................... 170
5.11 Case 5: The Prohibition of Smoking in Public
Places in Bulgaria........................................................................... 172
References ................................................................................................... 175
6 Environmental and Occupational Public Health ................................... 177
Bruce Jennings
6.1 Environment and Workplace: Key Venues for Public Health ........ 177
6.2 Population Benefits, Individual Rights, and Ethically
Acceptable Risk ............................................................................. 180
6.3 Systems and Power: The Ethical Importance
of Ecological and Social Context ................................................... 183
References ................................................................................................... 185
6.4 Case 1: Assessing Mining’s Impact on Health
Equity in Mongolia ........................................................................ 186
References ................................................................................................... 190
6.5 Case 2: Exceptions to National MRSA Prevention Policy
for a Medical Resident with Untreatable MRSA Colonization ..... 191
References ................................................................................................... 194
xiv Contents
6.6 Case 3: Safe Water Standards and Monitoring

of a Well Construction Program..................................................... 195
References ................................................................................................... 198
6.7 Case 4: Implementation of Global Public Health Programs
and Threats to Personal Safety ....................................................... 199
References ................................................................................................... 201
7 Vulnerability and Marginalized Populations.......................................... 203
Anthony Wrigley and Angus Dawson
7.1 Introduction .................................................................................... 203
7.2 Different Approaches to the Concept of Vulnerability .................. 204
7.3 Concerns Surrounding Approach (V2): Universal Condition ........ 205
7.4 Concerns Surrounding Approach (V3): Specific Attributes,
Contexts, or Groups ....................................................................... 206
7.5 Concerns Surrounding Approach (V4):
Overarching Concepts .................................................................... 207
7.6 Simplifying the Concept of Vulnerability (V5):
The Moral-Marker Approach ......................................................... 208
References ................................................................................................... 210
7.7 Case 1: Reducing Sudden Infant Death Syndrome
in a Culturally Diverse Society: The New Zealand Cot
Death Study and National Cot Death Prevention Programme ....... 211
References ................................................................................................... 215
7.8 Case 2: Medical Tourism and Surrogate Pregnancy:
A Case of Ethical Incoherence ....................................................... 216
References ................................................................................................... 220
7.9 Case 3: Compulsory Treatment for Injection Drug Use
after Incarceration .......................................................................... 220
References ................................................................................................... 224
7.10 Case 4: Unanticipated Vulnerability: Marginalizing
the Least Visible in Pandemic Planning ......................................... 226
References ................................................................................................... 229
7.11 Case 5: Can Asylum Seeking Be Managed Ethically? .................. 230
References ................................................................................................... 233
7.12 Case 6: Tuberculosis Screening, Testing, and Treatment
among Asylum Seekers .................................................................. 235
References ................................................................................................... 239
8 International Collaboration for Global Public Health .......................... 241
Eric M. Meslin and Ibrahim Garba
8.1 Introduction .................................................................................... 241
8.2 The Rise of Globalization and Global Health ................................ 242
8.3 Ethics Frameworks for Global Health............................................ 246
8.4 Summary ........................................................................................ 253
References ................................................................................................... 253
8.5 Case 1: The Ethics of HIV Testing Policies ................................... 256
References ................................................................................................... 259
Contents xv
8.6 Case 2: Just Allocation of Pre-exposure Prophylaxis

Drugs in Sub-Saharan Africa ......................................................... 260
References ................................................................................................... 262
8.7 Case 3: Drug Trials in Developing Countries ................................ 263
References ................................................................................................... 265
8.8 Case 4: Ethical Issues in Responding to International
Medication Stock-Outs .................................................................. 266
References ................................................................................................... 269
8.9 Case 5: Transmitting Cholera to Haiti ........................................... 270
References ................................................................................................... 274
8.10 Case 6: Perilous Path to Middle East Peace:
The Sanctions Dilemma ................................................................. 274
References ................................................................................................... 278
8.11 Case 7: Advancing Informed Consent and Ethical Standards
in Multinational Health Research .................................................. 279
References ................................................................................................... 283
9 Public Health Research ............................................................................ 285
Drue H. Barrett, Leonard W. Ortmann, Natalie Brown,
Barbara R. DeCausey, Carla Saenz, and Angus Dawson
9.1 Introduction .................................................................................... 285
9.2 What Is Different About Public Health Research? ........................ 287
9.3 Ethical Considerations for Protecting the Public
during Health Research .................................................................. 289
9.4 How Ethical Challenges Can Arise in Public Health
Research: Lessons Learned from Cases ......................................... 296
9.5 Conclusions .................................................................................... 297
References ................................................................................................... 298
9.6 Case 1: To Reveal or Not to Reveal Potentially
Harmful Findings: A Dilemma for Public Health Research .......... 300
References ................................................................................................... 303
9.7 Case 2: Ethical Challenges in Impoverished Communities:
Seeking Informed Consent in a Palestinian Refugee
Camp in Lebanon ........................................................................... 305
References ................................................................................................... 309
9.8 Case 3: Improving Review Quality and Efficiency
of Research Ethics Committees to Enhance Public
Health Practice in Africa ................................................................ 310
References ................................................................................................... 313
9.9 Case 4: Internet-Based HIV/AIDS Education
and Prevention Programs in Vulnerable Populations:
Black Men Who Have Sex with Men ............................................ 314
References ................................................................................................... 317
Index ................................................................................................................. 319

Contributors
Rima Afifi, PhD, MPH Department of Health Promotion and Community Health,
Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon
Waleed Al-Faisal, PhD Department of Family and Community Medicine, Faculty
of Medicine, Damascus University, Damascus, Syrian Arab Republic
Primary Health Care, Dubai Health Authority, Dubai, United Arab Emirates
Silviya Aleksandrova-Yankulovska, MD, PhD, DSc Faculty of Public Health,
Department of Public Health Sciences, Medical University of Pleven, Pleven,
Bulgaria
Aikaterini A. Aspradaki, PhD, MA, DDS Joint Graduate Programme in Bioethics,
University of Crete, Crete, Greece
Drue H. Barrett, PhD Office of Scientific Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease Control and
Prevention, Atlanta, GA, USA
Michael T. Bartenfeld, MA Children’s Preparedness Unit, Disability and Health
Branch, Division of Human Development and Disability, National Center on Birth
Defects and Developmental Disabilities, Centers for Disease Control and Prevention,
Atlanta, GA, USA
Carrie Bernard, MD MPH CCFP FCFP Department of Family and Community
Medicine, University of Toronto, Toronto, ON, Canada
Department of Family Medicine McMaster University, Hamilton, ON, Canada
Ruth Gaare Bernheim, JD, MPH Department of Public Health Sciences,
University of Virginia, Charlottesville, VA, USA
Divya Kanwar Bhati, BSc, MSc, MBA World Health Organization Collaborating
Centre for District Health System Based on Primary Health Care, Indian Institute of
Health Management Research University, Jaipur, Rajasthan, India
xvii
xviii Contributors
Dhrubajyoti Bhattacharya, JD, MPH, LLM Department of Population Health

Sciences, School of Nursing and Health Professions, University of San Francisco,
San Francisco, CA, USA
Erika Blacksher, PhD Department of Bioethics and Humanities, University of
Washington, Seattle, WA, USA
Karin Johansson Blight, RGN, MSc, PhD The Policy Institute, Kings College
London, London, UK
Gail Bolan, MD Division of STD Prevention, National Center for HIV/AIDS,
Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention,
Atlanta, GA, USA
Renaud F. Boulanger, BA Biomedical Ethics Unit, McGill University, Montréal,
QC, Canada
Andrew Boyd, MD Department of Medicine, Section of Hospital Medicine,
Columbia University, New York, NY, USA
Natalie Brown, MPH Human Research Protections Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the Director,
Centers for Disease Control and Prevention, Atlanta, GA, USA
Cynthia H. Cassell, PhD Birth Defects Branch, Division of Birth Defects and
Developmental Disabilities, National Center on Birth Defects and Developmental
Disabilities, Centers for Disease Control and Prevention, Atlanta, GA, USA
Paul Christopher, MD Department of Psychiatry and Human Behavior, Warren
Alpert Medical School, Brown University, Providence, RI, USA
Brian Cook, PhD Toronto Food Strategy, Toronto Public Health, Toronto, ON,
Canada
Maite Cruz-Piqueras, BA Andalusian School of Public Health, Granada, Spain
Norman Daniels, PhD Department of Global Health and Population, Harvard
T.H. Chan School of Public Health, Boston, MA, USA
Colleen Davison, MPH, PhD Clinical Research Centre and Department of
Emergency Medicine, Kingston General Hospital, Kingston, ON, Canada
Department of Public Health Sciences, Queen’s University, Kingston, ON, Canada
Angus Dawson, PhD Center for Values, Ethics and the Law in Medicine, Sydney
School of Public Health, The University of Sydney, Sydney, Australia
Barbara R. DeCausey, MPH, MBA Clinical Research Branch, Division of
Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD,
and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA
M. Gabriela Doberti, MD Hospital Padre Hurtado, Facultad de Medicina, Clínica
Alemana–Universidad del Desarrollo, Santiago, Chile
Contributors xix
Dora M. Dumont, PhD, MPH Division of Community, Family Health and Equity,
Rhode Island Department of Health, Providence, RI, USA
Ewout Fanoy, MD Department of Infectious Disease Control, Municipal Health
Service Utrecht, Zeist, The Netherlands
National Institute for Public Health and the Environment, Centre for Infectious
Disease Control, Bilthoven, The Netherlands
Sherry Fontaine, PhD Department of Management, University of Wisconsin-La
Crosse, La Crosse, WI, USA
Joseph B.R. Gaie, PhD Department of Theology and Religious Studies, University
of Botswana, Gaborone, Botswana
Ibrahim Garba, MA, JD, LLM Indiana University Center for Bioethics,
Indianapolis, IN, USA
Public Health Law Program, Office of State, Tribal, Local, and Territorial Support,
Rachel M. Glassford, BS School of Public Health and Health Services, George
Washington University, Falls Church, VA, USA
Daniel S. Goldberg, JD, PhD Department of Bioethics and Interdisciplinary
Studies, Brody School of Medicine, East Carolina University, Greenville, NC, USA
M. Inés Gómez, MD, Masters of Bioethics Centro de Bioética Facultad de
Medicina, Clínica Alemana–Universidad del Desarrollo, Santiago, Chile
Susan D. Goold, MD, MHSA, MA Department of Internal Medicine and
Department of Health Management and Policy, Center for Bioethics and Social
Sciences in Medicine, University of Michigan, Ann Arbor, MI, USA
María del Pilar Guzmán Urrea, PhD Department of Community Medicine,
El Bosque University, Bogotá, Colombia
Riripeti Haretuku, MEd Maori SIDS and Research, MauriOra Associates,
Auckland, New Zealand
Alison Hayward, MD, MPH Department of Emergency Medicine, Yale School of
Medicine, Yale University, New Haven, CT, USA
Uganda Village Project, Iganga, Uganda
Margaret Henning, MA, PhD International Health Systems Program, Harvard
T. H. Chan School of Public Health, Boston, MA, USA
Health Science, Keene State College, Keene, NH, USA
Ildefonso Hernández-Aguado, MD, PhD Department of Public Health, History
of Science and Gynecology, Universidad Miguel Hernández and CIBER de
Epidemiología y Salud Pública, San Juan, Alicante, Spain
xx Contributors
Sylvia Hoang, MPH Social and Epidemiological Research Department, Centre for
Addiction and Mental Health, Toronto, ON, Canada
Matthew R. Hunt, PT, PhD School of Physical and Occupational Therapy, McGill
University, Montréal, QC, Canada
Centre for Interdisciplinary Research on Rehabilitation, Montréal, QC, Canada
Hamid Hussain, MD, PhD Faculty of Medicine, University of Baghdad,
Baghdad, Iraq
Dubai Residency Training Program and Public Health Consultant, Dubai Health
Authority, Dubai, United Arab Emirates
Carel IJsselmuiden, MD, MPH Council on Health Research for Development,
Geneva, Switzerland
School of Applied Human Sciences, South African Research Ethics Training
Initiative, University of KwaZulu-Natal, Pietermaritzburg, South Africa
Craig Janes, PhD School of Public Health and Health Systems, University of
Waterloo, Waterloo, ON, Canada
Bruce Jennings, MA Center for Biomedical Ethics and Society, Vanderbilt
University, Nashville, TN, USA
Kipton E. Jensen, PhD Department of Philosophy and Religion, Morehouse
College, Atlanta, GA, USA
Monique Jonas, PhD School of Population Health, Faculty of Medical and Health
Sciences, The University of Auckland, Auckland, New Zealand
Amar Kanekar, PhD, MPH, MB, MCHES, CPH Department of Health, Human
Performance and Sport Management, University of Arkansas at Little Rock,
Little Rock, AR, USA
Mary Kasule, PhD Office of Research and Development, University of Botswana,
Gaborone, Botswana
Carla Kessler, MA Ethics Institute, Utrecht University, Utrecht, The Netherlands
Sarah A. Kleinfeld, MD Department of Psychiatry, Medstar Georgetown
University Hospital, Washington, DC, USA
Sarah Ann Kotchian, JD Education and Early Childhood Policy, Holland
Children’s Movement and the Holland Children’s Institute, Omaha, NE, USA
Maria Kousis, PhD, MSc Center for Research and Studies in Humanities, Social
Sciences and Pedagogics, University of Crete, Crete, Greece
André Krom, PhD Technology Assessment, Rathenau Institute, The Hague,
The Netherlands
Contributors xxi
Juan Laguna-Sorinas, MD, MPH Department of Epidemiological Surveillance,

Provincial Office of Health and Social Welfare of Granada
Department of Health and Social Welfare–Regional Government of Andalusia,
Granada, Spain
Lory Laing, PhD School of Public Health, University of Alberta, Edmonton, AB,
Canada
Drew E. Lee, MD, MA Department of Family Medicine, Advocate Lutheran
General Hospital, Park Ridge, IL, USA
Lisa M. Lee, PhD, MA, MS Presidential Commission for the Study of Bioethical
Issues, Washington, DC, USA
Justin List, MD, MAR, MSc Robert Wood Johnson/VA Clinical Scholars
Program, University of Michigan, Ann Arbor, MI, USA
Oyunaa Lkhagvasuren, MD, MPH, MEd Leading Researchers, Ulaanbaatar,
Mongolia
Lorna Luco, MD, Master of Bioethics Centro de Bioética, Facultad de Medicina,
Clínica Alemana–Universidad del Desarrollo, Santiago, Chile
Blanca Lumbreras, PhD Department of Public Health, History of Science and
Gynecology, Universidad Miguel Hernández and CIBER de Epidemiología y Salud
Pública, San Juan, Alicante, Spain
Catherine L. Mah, MD, FRCPC, PhD Faculty of Medicine, Memorial University,
St. John’s, NL, Canada
Jihad Makhoul, DrPH, MPH Department of Health Promotion and Community
Health, Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon
Isabel Marin-Rodríguez, MD, MPH Provincial Office of Health and Social
Welfare of Granada, Department of Health and Social Welfare–Regional Government
of Andalusia, Granada, Spain
Christopher W. McDougall, MA Institute of Health Policy, Management and
Evaluation, and Joint Centre for Bioethics, University of Toronto, Toronto, ON,
Canada
Eric M. Meslin, PhD Indiana University Center for Bioethics, Indianapolis, IN,
USA
Jennifer Milburn, MHA Newborn Screening Ontario, Children’s Hospital of
Eastern Ontario, Ottawa, ON, Canada
Joseph Millum, PhD Clinical Center Department of Bioethics and Fogarty
International Center, National Institutes of Health, Bethesda, MD, USA
xxii Contributors
Raquel de Mock, MD Adult Health Program, Ministry of Health, University of

Panama, Panama City, Panama
Boitumelo Mokgatla, BMedSc, MSc (Bioethics) Africa Office for Council on
Health Research for Development, Gaborone, Botswana
Mapping African Research Ethics Review and Medicines Regulatory Capacity,
Gaborone, Botswana
Indira Nair, MSc, PhD Department of Engineering and Public Policy, Carnegie
Mellon University, Pittsburgh, PA, USA
Rima Nakkash, DrPH, MPH Department of Health Promotion and Community
Health, Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon
Stuart G. Nicholls, MSc, MRes, PhD School of Epidemiology, Public Health and
Preventive Medicine, University of Ottawa, Ottawa, ON, Canada
Lloyd Novick, MD, MPH Brody School of Medicine, East Carolina University,
Greenville, NC, USA
Leonard W. Ortmann, PhD Office of Scientific Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease Control and
Georgina Peacock, MD, MPH, FAAP Division of Human Development and
Disability, National Center on Birth Defects and Developmental Disabilities,
Anastas Philalithis, AKC, MBBS, PhD, MRCP, MS Department of Social
Medicine, Faculty of Medicine, University of Crete, Crete, Greece
Daryl Pullman, MA, PhD Division of Community Health and Humanities,
Faculty of Medicine, Memorial University, St. John’s, NL, Canada
Andreas Reis, MD, MSc Global Health Ethics, Department of Information,
Evidence and Research, World Health Organization, Geneva, Switzerland
Christy A. Rentmeester, PhD AMA Journal of Ethics, American Medical
Association, Chicago, IL, USA
Josiah D. Rich, MD, MPH Department of Medicine, Warren Alpert Medical
School, Brown University, Providence, RI, USA
Jorge Rodríguez, MD Sexual and Reproductive Health, Ministry of Health,
Panama City, Panama
Panamanian Family Medicine Association, Panama City, Panama
Miguel Angel Royo-Bordonada, MD, MPH, PhD National School of Public
Health, Madrid, Spain
Contributors xxiii
Babette Rump, MD Department of Infectious Disease Control, Municipal Health

Service Utrecht, Zeist, The Netherlands
Carla Saenz, PhD Regional Program on Bioethics, Office of Knowledge
Management, Bioethics, and Research, Pan American Health Organization,
Washington, DC, USA
Maneesha Sakhuja, MHS Presidential Commission for the Study of Bioethical
Issues, Washington, DC, USA
Harald Schmidt, MA, PhD Department of Medical Ethics & Health Policy,
Center for Health Incentives and Behavioral Economics, University of Pennsylvania,
Philadelphia, PA, USA
Michael J. Selgelid, MA, PhD Centre for Human Bioethics, Monash University,
Melbourne, Australia
Kasturi Sen, BA, Dip Soc Pol, PhD Global Public Health, Wolfson College
(Common Room), University of Oxford, Oxford, UK
Pablo Simón-Lorda, MD, PhD Primary Health Care Centre Chauchina, UGC
Santa Fe, Granada, Spain
Department of Health and Social Welfare–Regional Government of Andalusia,
Granada, Spain
Maxwell J. Smith, MS Dalla Lana School of Public Health and the Joint Centre
for Bioethics, University of Toronto, Toronto, ON, Canada
Jeremy Snyder, PhD Faculty of Health Sciences, Simon Fraser University,
Burnaby, BC, Canada
Daniel M. Sosin, MD, MPH, FACP Office of Public Health Preparedness and
Response, Centers for Disease Control and Prevention, Atlanta, GA, USA
Kayte Spector-Bagdady, JD, M Bioethics Presidential Commission for the Study
of Bioethical Issues, Washington, DC, USA
Maribel Tamayo-Velázquez, PhD Andalusian School of Public Health, Granada,
Spain
Emily Taylor, MA Dalla Lana School of Public Health, University of Toronto,
Toronto, ON, Canada
Olinda Timms, DA, PGDMLE, PGDB Department of Health and Humanities,
St. Johns Research Institute, Bangalore, Karnataka, India
Ioannis Tzoutzas, DDS, Dr. Odont., FIADR, FASM School of Dentistry,
National and Kapodistrian University of Athens, Athens, Greece
xxiv Contributors
Jo A. Valentine, MSW Division of STD Prevention, National Center for HIV/

AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and
Jim van Steenbergen, MD, PhD National Institute for Public Health and the
Environment, Centre of Infectious Disease Control, Bilthoven, The Netherlands
Leiden University Medical Centre, Centre for Infectious Diseases, Leiden,
The Netherlands
Claude Vergès, MD, EdD, MA (Bioethics, Law) Children’s Hospital, University
of Panama, Panama City, Panama
Marcel Verweij, PhD Department of Social Sciences, Communication, Philosophy
and Technology: Centre for Integrated Development, Wageningen University,
Wageningen, The Netherlands
A.M. Viens, PhD Centre for Health, Ethics and Law, Southampton Law School,
University of Southampton, Southhampton, UK
Meghan Wagler, MPH Faculty of Health Sciences, Simon Fraser University,
Burnaby, BC, Canada
Frank Wagner, MA, MHSc Department of Family and Community Medicine,
Faculty of Medicine, University of Toronto, Toronto, ON, Canada
Toronto Central Community Care Access Centre and the University of Toronto Joint
Centre for Bioethics Toronto, ON, Canada
Douglas Wassenaar, PhD South African Research Ethics Training Initiative,
School of Applied Human Sciences, University of KwaZulu-Natal, Pietermaritzburg,
South Africa
Marjan Wassenberg, MD, PhD Department of Medical Microbiology, Utrecht
University Medical Centre, Utrecht, The Netherlands
Anthony Wrigley, PhD Centre for Professional Ethics, Keele University,
Staffordshire, UK
Susan Zinner, MSJ, MHA, JD School of Public and Environmental Affairs,
Indiana University Northwest, Gary, IN, USA
Section I
Introduction to Public Health Ethics
Chapter 1
Public Health Ethics: Global Cases, Practice,
and Context
Leonard W. Ortmann, Drue H. Barrett, Carla Saenz, Ruth Gaare Bernheim,

Angus Dawson, Jo A. Valentine, and Andreas Reis
1.1 Introduction
Introducing public health ethics poses two special challenges. First, it is a relatively
new field that combines public health and practical ethics. Its unfamiliarity requires
considerable explanation, yet its scope and emergent qualities make delineation dif-
ficult. Moreover, while the early development of public health ethics occurred in a
Western context, its reach, like public health itself, has become global. A second
challenge, then, is to articulate an approach specific enough to provide clear
The opinions, findings, and conclusions of the authors do not necessarily reflect the official posi-
tion, views, or policies of the editors, the editors’ host institutions, or the authors’ host
institutions.
L.W. Ortmann, PhD (*) • D.H. Barrett, PhD
Office of Scientific Integrity, Office of the Associate Director for Science,
Office of the Director, Centers for Disease Control and Prevention, Atlanta, GA, USA
e-mail: lortmann@cdc.gov
C. Saenz, PhD
Regional Program on Bioethics, Office of Knowledge Management, Bioethics, and Research,
Pan American Health Organization, Washington, DC, USA
R.G. Bernheim, JD, MPH
Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA
A. Dawson, PhD
Center for Values, Ethics and the Law in Medicine, Sydney School of Public Health,
The University of Sydney, Sydney, Australia
J.A. Valentine, MSW
Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA
A. Reis, MD, MSc
Global Health Ethics, Department of Information, Evidence and Research,
World Health Organization, Geneva, Switzerland
© The Author(s) 2016 3

D.H. Barrett et al. (eds.), Public Health Ethics: Cases Spanning the Globe,
Public Health Ethics Analysis 3, DOI 10.1007/978-3-319-23847-0_1
4 L.W. Ortmann et al.
guidance yet sufficiently flexible and encompassing to adapt to global contexts.

Broadly speaking, public health ethics helps guide practical decisions affecting
population or community health based on scientific evidence and in accordance
with accepted values and standards of right and wrong. In these ways, public health
ethics builds on its parent disciplines of public health and ethics. This dual inheri-
tance plays out in the definition the U.S. Centers for Disease Control and Prevention
(CDC) offers of public health ethics: “A systematic process to clarify, prioritize, and
justify possible courses of public health action based on ethical principles, values
and beliefs of stakeholders, and scientific and other information” (CDC 2011).
Public health ethics shares with other fields of practical and professional ethics both
the general theories of ethics and a common store of ethical principles, values, and
beliefs. It differs from these other fields largely in the nature of challenges that pub-
lic health officials typically encounter and in the ethical frameworks it employs to
address these challenges. Frameworks provide methodical approaches or proce-
dures that tailor general ethical theories, principles, values, and beliefs to the spe-
cific ethical challenges that arise in a particular field. Although no framework is
definitive, many are useful, and some are especially effective in particular contexts.
This chapter will conclude by setting forth a straightforward, stepwise ethics frame-
work that provides a tool for analyzing the cases in this volume and, more impor-
tantly, one that public health practitioners have found useful in a range of contexts.
For a public health practitioner, knowing how to employ an ethics framework to
address a range of ethical challenges in public health—a know-how that depends on
practice—is the ultimate take-home message.
We learn new things more readily when we can relate them to familiar things,
and we understand complex things by breaking them into their components.
Accordingly, throughout this introductory chapter, we will relate public health eth-
ics to more familiar concepts and better-known related fields, while the immediately
following section will explore the components of public health ethics that derive
from its parent disciplines of public health and ethics. After describing public
health’s core activities, goals, and values, we will explain why ethical concepts like
the right to health, social justice, and health equity directly follow as central con-
cerns of public health. After defining ethics broadly in everyday terms, we will
examine the complementary roles facts and values play in public health. This exam-
ination is important because the respective bases of the two parent disciplines differ
considerably; public health science rests on the logic of scientific discovery, whereas
ethics rests on the logic of right action and good decision making. We will then
contrast the more familiar, everyday understanding of morality with the formal dis-
cipline of ethics as a prelude to considering three well-known ethical theories rele-
vant to public health. Because both laws and ethical rules establish parameters for
public health practice, their similarity and difference need to be clarified. This
extended account, first of parent disciplines, then of kindred concepts, and finally of
family resemblances between the related fields of clinical ethics, bioethics, and
research ethics, will culminate in an effort to characterize what is distinctive about
public health ethics.
1 Public Health Ethics: Global Cases, Practice, and Context 5
1.2 Public Health
There are many definitions of public health. They often begin as descriptions of cur-
rent practice but once established become prescriptions for subsequent practice. It
is important, then, to consider definitions, because they shape not only public health
practice, but also how we conceive of public health ethics (Dawson and Verweij
2007). The same logic applies to how we think about the individual concepts of
health and the public. Defining health as the absence of disease or symptoms, for
example, more readily fits allopathic medicine, which focuses on negating symp-
toms to treat disease. But it hardly fits public health’s emphasis on preventive mea-
sures that address root causes rather than symptoms. Nor does it cover public
health’s promotion of health and well-being across a range of interventions. In this
regard, the World Health Organization (WHO) offers a definition of health more
suitable to public health: “A state of complete physical, mental, and social well-
being and not merely the absence of disease or infirmity” (WHO 2006). But even
this more holistic definition does not sufficiently clarify the meaning of “public” in
public health. Dawson and Verweij (2007) identify two primary meanings of “pub-
lic” in public health, each of which they break down into three senses. Public can
mean population-wide and refer to (1) the epidemiologically measured health of a
population or group, (2) the distribution of health in a population, or (3) the underly-
ing social and environmental conditions impacting everyone’s health. Public also
can mean collectively accomplished and requiring (1) the concerted actions of many
people and institutions whether governmental or nongovernmental; (2) the coopera-
tion or involvement of the public, or (3) the public’s joint participation to realize the
health improvement.
In a practical field like public health, definition often takes the form of enumerat-
ing key activities, such as surveillance, sanitation, maintaining food and workplace
safety, disease prevention and control, and promoting healthy behavior. The identi-
fication of the ten essential services of public health illustrates this enumerative
approach (Fig. 1.1) (Public Health Functions Steering Committee 1994). These ser-
vices fall under three overarching functions of assessment, policy development, and
assurance that constitute an integrated cyclic process. The delivery of these services
in local, regional, or national public health agencies accordingly defines public
health practice. In this schema, research is a distinct practical service but also
integral to all public health activities, providing insights and innovative solutions at
every point. Public health ethics addresses the entire spectrum of ethical issues that
arise in any area of public health practice but especially in those areas where no
specific guidelines govern practice.
Such lists have the advantage of concretely specifying current activities but lack
criteria that definitions normally provide for including or excluding additional activ-
ities as a field develops. In 1920, Charles Edward A. Winslow, an influential public
health theorist and leader, pioneered a definition of public health that still informs
many European and international public health institutions, including WHO (Marks
et al. 2011).
Fig. 1.1 Essential Public Health Services. (1) Monitor health status to identify community health
problems. (2) Diagnose and investigate health problems and health hazards in the community. (3)
Inform, educate, and empower people about health issues. (4) Mobilize community partnerships
and action to identify and solve health problems. (5) Develop policies and plans that support indi-
vidual and community health efforts. (6) Enforce laws and regulations that protect health and
ensure safety. (7) Link people to needed personal health services and assure the provision of health
care when otherwise unavailable. (8) Assure competent public and personal health care workforce.
(9) Evaluate effectiveness, accessibility, and quality of personal and population-based health ser-
vices. (10) Research for new insights and innovative solutions to health problems (From Public
Health Functions Steering Committee 1994. Essential Public Health Services. Available at http://
www.cdc.gov/nphpsp/essentialServices.html)
Public health is the science and the art of preventing disease, prolonging life, and promoting
physical health and efficiency through organized community efforts … and the development
of the social machinery which will ensure to every individual in the community a standard
of living adequate for the maintenance of health (Winslow 1920).
Even more succinctly, the U.S. Institute of Medicine (IOM) defines public health
as “what we, as a society, do collectively to assure the conditions for people to be
healthy” (IOM 1988).
These two definitions highlight the importance of collective action to address the
health needs of populations. Public health’s population focus distinguishes it from
clinical medicine’s focus on individual patients, though examples like vaccination
indicate that the two fields can overlap. Epidemiologists statistically aggregate the
health data of individuals to provide a picture of population health, but populations
ultimately originate from communities of individuals who constitute social wholes.
Individuals in society stand in complex relations of interdependence, competition,

and solidarity that can impact health in ways that transcend the individual. Thus, in
addition to aggregating individual medical data, epidemiologists need to measure
the impact of various social factors on health. To tackle the complex, often compet-
ing health needs of social groups, public health practitioners need to dialogue and
partner with their communities. At a higher administrative level, public health offi-
cials need to manage intersectoral collaborations, navigate political processes, and
formulate public health law. Four distinguishing features of public health practice—
the pursuit of the collective good, a focus on prevention, the use of government or
collective action, and an emphasis on an outcome-based (utilitarian) approach—
generate most of the ethical challenges public health practitioners typically face
(Faden and Shebaya 2010).
1.2.1 Core Values
People value many things such as friends and family, material goods and resources,
knowledge, and art. Some things people value are ethical virtues like courage or
honesty, whereas others are ethical principles like justice and equality. People gen-
erally value what they consider important, what matters to them, and what gives
their lives meaning. Public health’s primary goals and commitments reflect its core
values, which are rooted in health, science, and the community (Public Health
Leadership Society 2002). Everyone recognizes the value of health, but public
health approaches health in relation to science and the community in its endeavor to
prevent disease and injury, protect the public from harm, and promote health and
well-being. But seeing how science and community represent values requires a
word of explanation.
The commitment to science as a value stance often becomes apparent only in
relation to people who distrust science or prioritize other value commitments such
as economic interests or religion. Public health values science by endeavoring to
base interventions and policies on the best available data and evidence-based prac-
tices. That endeavor entails a commitment to conduct surveillance and research,
because only by understanding the social burden of disease and its underlying or
structural causes can public health impact the health of the entire population. The
qualifier “best available” is a reminder of the need to continuously improve practice
and not rely on tradition or current practices. It also reminds us that during emergen-
cies, time and resource constraints limit the ability to gather evidence.
Public health values community in two obvious senses. First, it recognizes that
the success of most health interventions depends on a community’s acceptance,
cooperation, or participation. Second, it recognizes that to be successful, public
health must respect the community’s values and gain the trust of its members. Yet
there is a third, deeper sense in which community represents a value. A community
is, to emphasize again, neither a statistical abstraction nor a mere aggregate of indi-
viduals but rather a network of relationships and emotional bonds between people
sharing a life in common organized through a political and moral order (Jennings
2007). The value that best reflects this fundamental, relational character of social
life is solidarity. Solidarity can remain unspoken yet operative because it forms the
basis of social life and collective action. Just as communities are not mere aggre-
gates of individuals, neither are the agencies or organizations that make the collec-
tive decisions that affect the community. Personal interests, to be sure, can motivate
individuals, but the felt recognition of a common plight, that we are all in it together,
underlies the collective decisions society and public health must make to solve col-
lective problems. To say that public health values community means that it values
solidarity, even when solidarity remains unacknowledged as is often the case
(Dawson and Jennings 2012).
1.2.2 Health Equity, Social Justice, and Social Determinants

of Health
As the foregoing goals, definitions, core values, and commitments of public health
clearly suggest, the right to health and health equity are central, not peripheral, to
public health’s mission. Chapter 8 on international collaboration will examine some
practical challenges in addressing the right to health and social determinants of
health, so the emphasis here will be on the rationale for achieving health equity as a
matter of social justice.
Despite greater individual access to health care and advances in public health,
high burdens of disease remain across much of the globe. Some differences in dis-
ease burden result from genetics and some from variable risks of exposure to infec-
tious agents and other threats, but most of the differential burden arises from social,
economic, and political conditions. These conditions include poverty, lack of educa-
tion, and discrimination against particular social groups and often reflect historical
injustices or long-standing systemic, structural deficiencies. Collectively, these con-
ditions have come to be known as social determinants of health (Blane 1999).
Greater access to individual health care can mitigate their effect, but an adequate
response to them requires concerted public action to address their underlying causes.
Whether comparing countries or groups within countries, social stratification by
social determinants correlates with differences in health status (Marmot 2007).
These health differences have aroused widespread concern, but how one defines
them significantly affects public health practice (Braveman 2006). In particular, dis-
tinguishing health disparity from health inequity is critical. As a comparative indi-
cator of health status, health disparity is a neutral, epidemiologic term that need not
imply an ethical obligation to remedy. Health disparities, however, can and fre-
quently do reflect underlying inequities. WHO defines health inequities as health
differences that are “socially produced; systematic in their distribution across the
population; and unfair” (WHO 2007). Terms like “inequity” and “unfair” are ethical
terms that imply an obligation to redress an injustice. Justice has a range of mean-
ings that include giving people what they deserve or are owed and distributing
goods and services fairly. Justice in a medical context often involves the individual’s
access to health services. In public health, discussions of health equity usually
involve questions of how to distribute health benefits fairly or how to achieve better
health outcomes among communities or groups that suffer health inequities.
Attaining greater equity might involve the politically controversial strategy of dis-
proportionally distributing resources within a population, by, for example, distribut-
ing more to those most in need. A less-controversial strategy is to improve health
outcomes for all, even while devoting special efforts to those most in need. WHO
defines health equity as “the absence of unfair and avoidable or remediable differ-
ences in health among population groups defined socially, economically, demo-
graphically, or geographically” (WHO 2007).
Achieving health equity is most urgent for groups who have experienced histo-
ries of marginalization and discrimination and who continue to experience higher
rates of illness and premature deaths than members of the mainstream population.
Especially for these groups, “social injustice is killing people on a grand scale”
(WHO 2008). Realizing the goal of social justice with respect to health means
achieving health equity. Doing so requires not only a fair distribution of health out-
comes, it also means that “ideally everyone should have a fair opportunity to attain
their full health potential” and that “no one should be disadvantaged from achieving
this potential, if it can be avoided” (Whitehead 1992). For many, these goals imply
that social justice obligates public health to improve any social condition that pre-
vents people from maintaining a standard of life adequate to maintain health (Powers
and Faden 2006). Although some believe that improving social conditions that
affect health overextends public health’s mandate, such a broad mandate is arguably
consistent with both Winslow’s and IOM’s definitions of public health. Moreover,
such a broad mandate has both nineteenth century precursors in the social medicine
movement and more recent precedents in the “Health for All” strategy that empha-
sizes health promotion and the “Health in All Policies” strategy (Kickbusch 2003;
Freiler et al. 2013). But a major milestone was reached with the 2008 report of the
WHO Commission on Social Determinants of Health that sought to “marshal the
evidence on what can be done to promote health equity, and to foster a global move-
ment to achieve it” (WHO 2008). Although governments can guarantee human
rights and essential services, establish policies that provide an equitable basis for
health improvement, and gather and monitor data on health equity, achieving equity
ultimately will depend on the cooperation of government and civil society (Blas
et al. 2008).
1.3 Ethics
People strive to be “good,” to do the “right” thing and to lead a “good life,” but where
do such basic, familiar moral values as good and right originate? Throughout his-
tory, religious people have explained these ideas as revelations of divine command.
Anthropologists, however, view morals as customs that govern social interactions,

and because all cultures display such customs, interpret moral practices in terms of
a survival function rooted in human nature. By contrast, many social and political
thinkers emphasize that moral concepts result from social conventions or agree-
ments that are subject to deliberation and change. Governments today often consult
social scientists and health experts who empirically investigate what fosters or
improves human life, health, and happiness. Where science informs law and policy,
it helps define in a conventional sense what we mean by good and right. In particu-
lar, public health science helps establish what is considered good for the health of
populations and communities. Further below we will examine three ethical theories
prominent in public health ethics that offer contrasting perspectives on the nature
and basis of morality. In the meantime, we will address three general questions that
a public health practitioner first approaching the study of ethics might well ask: how
does science relate to ethics, what is the difference between ethics and morality, and
what sort of things count as principles or basic concepts in ethics?
1.3.1 Scientific Facts and Ethical Values
Public health practice increasingly requires appreciation of the complementary

roles facts and values play in making and justifying decisions. Observation reveals
facts, while scientific research controls and manipulates the experimental context to
discover causation or correlation. Data on disease burden, research on intervention
effectiveness, and estimates of the resultant health benefits for the population gener-
ally inform public health interventions. Health messaging can often inform the pub-
lic about the scientific rationale underlying public health interventions. Nevertheless,
in the mind of the public, scientific evidence does not always invalidate or outweigh
other sources of evidence or appeals to emotions, interests, and values. While public
health practitioners give more weight to community health and scientific evidence,
they also need to consider how the public will respond to an intervention.
Successfully implementing public health actions, then, will often entail weighing
the public’s attitudes, interests, and values in relation to public health’s core
values.
Two mundane features of public health practice often serve to conceal value
assumptions: shared core values and standard practice. First, sharing values can
render them invisible as assumptions, until they unexpectedly become contested.
Unwelcome surprises occur when interventions that presuppose core values affect
stakeholders who do not share those values, as when parents refuse to have children
vaccinated based on media hearsay or individuals reject a highly effective program
as governmental intrusion. Avoiding such surprises begins with becoming aware of
one’s own value presuppositions in relation to those of other stakeholders and com-
munity members. Second, routine use of evidence-based standards can conceal
underlying value assumptions. If developed and tested to address a known health
problem, as is common, an intervention’s purpose and effectiveness is taken for
granted. Standard interventions, then, generally require no more justification than

noting their standard status or seeing that “the facts dictated” their use. “Dictating”
facts are indicators that trigger use of a standard intervention (e.g., meeting the cri-
teria of a case definition or documenting exposure to a dangerous level of a contami-
nant). Such “dictating facts,” more properly speaking, only indicate the appropriate
intervention but cannot literally dictate that anything be done. What in the end dic-
tate actions are the values, goals, and obligations that the standard intervention pre-
supposes and that practitioners tacitly ratify each time they apply the standard. In
other words, values, goals, and obligations, even when tacit, form a necessary bridge
between knowledge and action.
Though standard practices tacitly incorporate ethical principles, they seldom
raise ethical challenges. Challenges more typically arise in unusual or extreme situ-
ations where standards are not yet in place, are changing, or are competing. These
situations include emergency operations, foreign cultural settings, emergent fields
with innovative interventions, or periods of severe budget constraints that force pri-
oritization of programs. In such challenging situations where no value consensus
exists or where evidence does not point to a single course of action, public health
ethics provides a process to determine and justify a course of action. That justifica-
tion can incorporate a number of factors: evidence base for the intervention,
cost effectiveness, analysis of relevant ethical rules and stakeholder values, a cre-
ative design of options or alternatives that embody these values, and a fair and trans-
parent decision-making process that incorporates stakeholder contributions.
Recognizing one’s own value assumptions in relation to those of the public will
be critical for implementing new interventions wherever success depends on public
acceptance. The public will not embrace interventions that embody or presuppose
values that clash with community values or whose relative importance is low com-
pared to other community values. Members of the public generally are more com-
mitted to their political views, ethical and religious values, and an intervention’s
impact on them personally than to scientific evidence or community impact. Public
health practitioners need to recognize that no matter how compelling to them, com-
munity impact and scientific rationale seldom resonate as deeply with the public.
Consequently, in communicating, public health practitioners need to supplement
scientific messaging with dialogue, an appeal to common values, or enlistment of
spokespersons who share the value orientation of the relevant stakeholders or com-
munity. Regarding some controversial matters, ultimate success in implementing an
intervention may require building a social consensus (Ortmann and Iskander 2013).
In certain situations, untangling factual claims based on science from value judg-
ments is critical for success. For example, suppose independent investigators have
scientifically verified the level of worker exposure to a toxic chemical used in indus-
try. Determining what level of exposure would be safe, however, remains a value
judgment that depends on the degree of concern that people have about safety.
Placing a higher value on safety might result in stricter controls that decrease risk
for workers, but the financial costs of decreasing risks could cut industry profits or
jobs, even as health costs fall. Stakeholders representing industry, workers, or public
health practitioners might have different positions regarding a safe level of exposure.
To make a good decision about a safe exposure level, the value of safety might have
to be discussed and weighed in relation to business, employment, and health consid-
erations. However, these varying positions regarding safety need not imply disre-
gard for safety or disagreement on the underlying facts. Rather, they illustrate that
conflicting value judgments can coexist despite a consensus on both the underlying
facts and the importance of a particular value such as safety.
Directly addressing the value conflicts in such situations through ethical delib-
eration makes more sense than calling into question the underlying facts and can
lead to better, fairer, and more transparent decisions. It is also important to recog-
nize that doubting the science often represents an underlying value dispute mas-
querading as a scientific dispute (Brunk et al. 1991). Sowing doubt on scientific
assessments merely as a tactic to oppose an evidence-based policy or recommenda-
tion undermines science. This doubt can exert pressure to test and retest results,
raising the bar for scientific validity ever higher (Michaels 2008). The solution is
not to litigate, as it were, the science, but to recognize that communicating risk is a
social process that goes beyond science messaging and must take cultural attitudes,
perceptions, and symbolic meanings into account (Krimsky and Plough 1988).
Where profound value disagreements prevail, public health legitimately prioritizes
its core values but cannot speak for everyone. Stakeholder views require a fair hear-
ing, whether through media research, stakeholder analysis, or direct solicitation of
input from individuals, focus groups, or public meetings. By design, a fair, transpar-
ent ethical decision-making procedure can help determine what value tradeoffs are
feasible and what values may be nonnegotiable. Such a deliberative procedure can
help to gain public acceptance and become part of the justification for a course of
action.
To those accustomed to rigorous research methods and evidence-based standards
of practice, navigating the world of ethical values and rules can be perplexing.
Values, as the term itself implies, manifest valences, that is, variable degrees of
commitment or estimations of importance along a continuum. Individuals rank val-
ues differently, change their rankings, and will alter their relative ranking of values
in different contexts. The range of options for ethical rules are far more limited,
namely, to obey or not obey. Nevertheless, the ethical rules governing particular
situations also vary from country to country or even from jurisdiction to jurisdiction
within a country. Despite this variability in values and ethical rules, reducing ethical
judgment to mere opinion or to a consensus of opinion relative only to personal or
cultural preferences would be a mistake. Ethical values and rules enjoy the approval
of history, custom, law, and religious tradition, but they also find anchor biologi-
cally, psychologically, and socially in human life. Value judgments and ethical
determinations, then, are not relative as much as correlative; that is, they correlate
and resonate with these deeper roots of human life that we share. If humans indeed
share a set of fundamental values, then ethical conflicts primarily reflect differences
in prioritizing values in a particular context, rather than a fundamental disagreement
about values. This point of view provides grounds for optimism about the possibil-
ity of finding a deeper basis for understanding and mutual respect, if not agreement,
when ethical tensions surface.
1.3.2 Ethics and Morality
Although many use the terms ethics and morality interchangeably, we will distin-
guish the formal discipline of ethics from the common morality that guides every-
day actions and behavior. Morality refers to a society’s shared, stable beliefs about
what is good and bad, right and wrong. Through upbringing and socialization, each
generation passes this common morality to the next. Common morality envelopes
the individual like an ecosphere of shared customs, rules, and values. For most cir-
cumstances, people habitually rely on this common morality to guide their conduct,
and it serves them well, just as standard practice generally serves professional prac-
titioners well. Still, common morality can fall short where its rules conflict, where
it inadequately illuminates novel moral problems, or where intense disagreement
prevails among rival stakeholders. In such instances, the formal discipline of ethics
offers a deliberate, systematic way of addressing troubling moral issues, conflicts,
and dilemmas. Ethics can assist in:
• Recognizing ethical issues and distinguishing them from factual issues;
• Providing a vocabulary to systematically discuss ethics;
• Identifying appropriate ethical principles to guide action in a particular context;
• Using these principles to analyze actions in regard to their ethical acceptability;
• Understanding the competing moral claims and values of stakeholders;
• Designing alternative courses of action that incorporate these claims and
values;
• Evaluating which alternative best fits a given context, all things considered
• Establishing a procedurally just, transparent process for decision making; and
• Justifying decisions regarding recommendations, policies, or interventions.
1.3.3 Ethical Principles
Principles are general categories, rules, or guidelines that form the basis of a disci-
pline. In ethics, there are various kinds of principles and many examples of each
kind. The kinds include basic ethical categories (e.g., virtues, values, or rights), ethi-
cal commands or rules of conduct (e.g., not stealing, not harming, or treating others
with respect), and guidelines for weighing outcomes (e.g., achieving the greatest
good for the greatest number, distributing burdens and benefits fairly, or properly
proportioning benefit to harm). Ethical principles like justice or respect for auton-
omy are simultaneously values, ideals, and the basis for deriving rules of conduct.
Such rules serve as ethical standards to evaluate past and pending actions, programs,
and policy recommendations. When addressing complex or controversial issues or
issues involving numerous stakeholders, many different principles can come into
play. But because ethical decision making depends on context (e.g., on local circum-
stances, community stakeholders, and decision makers), no formula can determine
the most relevant ethical principles. Nevertheless, most ethicists and practitioners
working in a field would agree that certain principles, theories, or frameworks pro-
vide more helpful guidance for that field. Given the need for flexibility, some prefer
to speak not of ethical principles but of “general moral considerations” that can
provide guidance in public health practice (Childress et al. 2002). At any rate, a
complex ethical challenge involving stakeholders with competing moral claims fre-
quently demands consideration of a variety of ethical principles and theories to
address the situation and justify a proposed intervention. For these reasons, it will
be useful both to examine below several ethical theories used in public health ethics
and to provide at the end of the chapter a framework that is generally applicable to
ethical issues that arise in public health.
1.3.4 Ethical Theories
As used here, an ethical framework refers to a tool or approach for practically

addressing ethical challenges that often includes a stepwise procedure. An ethical
framework may rely heavily on just one ethical theory, but frameworks generally
take a pragmatic approach that procedurally allows for using a variety of theories or
principles as the issue or context demands. Whereas an ethical framework has a
practical orientation, an ethical theory also addresses more fundamental questions,
so-called “metaethical” questions. Does morality originate in divine command,
human nature, or human convention? Is it essentially a habit, intuition, form of rea-
soning, or a quality or purpose of an action? An ethical theory will offer a distinct,
coherent understanding of the source and nature of morality that will shape how one
reasons about moral issues and determine which principles are most important. Two
persons employing the same theory, however, will not necessarily reach the same
conclusion about an ethical issue; much will depend on which aspects of the issue
they deem most important and on how they weigh different factors. Nevertheless,
because a particular ethical theory tends to favor certain principles or types of prin-
ciples, using the same theoretical approach will lead to similar lines of reasoning
and selection of principles.
The diversity of ethical theories does not imply their mutual opposition so much
as points to the extensive range of the moral landscape and the need to illuminate its
various contours. A helpful way of illuminating this landscape is to distinguish
theories depending on whether they focus on the actor, the action, or the results of
action. To illustrate this particular way of carving up the moral landscape, Table 1.1
describes some well-known ethical theories.
Aristotle’s virtue ethics is an ethical theory that focuses on the moral character of
the actor or agent (Bartlett and Collins 2011). Classic virtues are dispositions or
stable patterns of behavior that lie between extremes of vice; courage, for example,
lies between the extremes of cowardice and foolhardiness in taking risks. Habit and
practice are necessary to develop virtues whose possession we equate with good
character and that equip a person to be effective in society or an organization.
Because good character translates into virtuous action that others aspire to emulate,
Table 1.1 Ethical theories

Theory Agent-centered Deontology Utilitarianism
Focus Agent Action Result of action
Key figure Aristotle Immanuel Kant John Stuart Mill
Main Virtues: Acquired habits, Duties: Ethical rules or Results: Good or bad
concept skills, or dispositions that commands that constrain outcomes of actions and
make people effective in one’s action or define policies or their
social or professional obligations owed to beneficial or harmful
settings others effects on individuals
and society
Examples Honesty, courage, Ethical and religious Burdens, risks, harms,
modesty, trustworthiness, commandments, or costs versus the
transparency, reliability, obligations to seek justice benefits, advantages, or
and perseverance or respect persons and savings resulting from
their rights interventions or policies
Ethical Doing what a virtuous Fulfilling an obligation or Maximizing the net
action person would do in a duty owed to oneself or balance of benefits over
given situation society harms
Uses Assessing skills and Establishing compliance Conducting population-
capacities needed for rules and regulations, and level cost-benefit,
success in a community, setting standards for risk-benefit, or
organization, or evaluating actions and cost-effectiveness
profession behavior analyses
we tacitly invoke virtue ethics whenever we ask how an outstanding public figure or
health leader would handle a situation. In a modern professional context, virtues
also include the skills the profession has identified that lead to success in that pro-
fession and which professional education and training instill in practitioners. Once
established, virtues readily become the standards of obligation and accountability to
evaluate professional performance and function similarly to the rules and principles
of duty discussed below. Holding public health institutions accountable for the pro-
fessional competence of their employees illustrates virtue ethics (Public Health
leadership Society 2002). More recently, the capabilities approach has exploited the
potential of virtue ethics to guide decisions about policy or interventions in a way
that goes beyond matters of professional training and responsibilities. This approach
takes a broader developmental view of human agency and capacity building. It con-
ceives health as a fundamental capability necessary for individuals to succeed in
society, one on which many further capabilities depend (Sen 2009; Ruger 2010).
An ethical theory that focuses on action or, more properly, the rules governing
action, is deontology. The word deontology comes from the ancient Greek word,
deontos, which means duty. Because duties oblige us to obey rules that govern
actions or conduct, they bind or constrain the will ahead of action. In judging
whether an action is right or wrong, deontology ignores consideration of harmful or
beneficial consequences and relies on these rules of duty to serve as the standard of
judgment. People usually have rules of duty or obligation in mind when they speak
of ethical standards or worry that standards are breaking down. Examples of these
rules include religious commandments to honor parents, not lie, or not steal and
rules of social interaction such as treating people fairly, doing them no harm, or
respecting their rights. Rights often are said to stand in reciprocal relation to duties.
Thus, the right to free speech presupposes a duty to respect the right of others to
speak or the public health obligation to ensure conditions for maintaining health
presupposes a right to health.
Deontology as a theory owes most to Immanuel Kant’s view of the “good will”
and his closely linked account of autonomy. A person of morally good will does the
right thing for its own sake, which means acting purely for the sake of duty. Duties
are moral rules or laws that bind the will and limit the scope of action. For Kant,
basing decision for one’s action solely on duty without regard to the potential good
or bad consequences of the action is the only legitimate basis for moral action. Kant
even goes so far as to say that “a free will and a will under moral laws are one and
the same” (Gregor et al. 2012).
Kant conceives duty as the quintessential expression of autonomy, which may
come as a surprise to those who equate autonomy with rational free choice or even
just following one’s preferences without interference. However, the meaning of
autonomy for Kant derives from its literal meaning in Greek, autos (self) and nomos
(law); namely, self-legislating. Autonomy enacts from within the moral rules and
principles that bind the will and guide action. However, not every self-originating
impulse should be obeyed; only actions conceivable as universal laws morally bind
the will. Morally laying down the law for oneself entails legislating for everyone,
but universally legislating does not mean asserting one’s will over others. Nor does
it mean that the ethical content of a moral law or duty is valid eternally and every-
where. Rather, it refers to the “categorical imperative” an unconditional require-
ment for an action to be moral. To qualify as a duty, a rule that commands action
must apply to every rational person. Stealing, for example, could never qualify as a
duty, because a situation where everyone steals from everyone else would undercut
the one-sided advantage of stealing that the thief hopes to exploit. Although self-
directed, autonomous action is necessarily other-regarding.
Kant maintains that the categorical imperative can be expressed in two other
ways equivalent to universality, namely, “respect for humanity” and a “kingdom of
ends” (Gregor et al. 2012). In each, this other-regarding dimension of autonomy is
evident. Respecting humanity means never treating persons as mere means or
objects but always treating them as ends, that is, regarding them as fellow autono-
mous agents. Autonomously agreeing on actions, interventions, or policies requires
that decision makers mutually consider and understand their reasons for action and
be willing to abide by the rules derived from these reasons as laws they collectively
impose upon themselves (O’Neill 2002).
The idea of a fellowship of mutual consideration comes out most clearly in
Kant’s concept of a kingdom of ends. This concept is really the ideal of a systematic
union or commonwealth of autonomous individuals making laws that apply to
everyone. This ideal presupposes that ethical deliberation places respect for others
as ends, as autonomous agents, above self-interest. The core idea is that we only
consider actions that could gain acceptance by a community in which all see them-
selves as sovereigns who lay down universal laws binding on themselves and others.
The hope is that the body of law governing society progressively embodies this
ideal. Such mutual regard in laying down the moral laws that will bind one’s actions
differs significantly from insistence on noninterference with individual free choice,
let alone with personal preferences. Conversely, the aspiration behind Kant’s view
of autonomy harmonizes well with the public health obligation to address collective
problems through collective action.
For utilitarianism, judging the rightness of an action depends on an estimation of
its subsequent practical outcome or result rather than on its conformity to principles
of duty. Utilitarianism considers ethically best that course of action that will result
in the greatest net benefits over harms. A utilitarian approach underlies cost-benefit
analyses that weigh an intervention’s costs (risks, harms, burdens, or disadvantages)
against its benefits (advantages, utility, improvements, cost savings). In addition to
its focus on consequences, utilitarianism is egalitarian, communitarian, and scien-
tific in outlook. It is egalitarian in considering everyone’s benefit and equally
weighting each person’s good, as opposed to privileging certain people. It is com-
munitarian in attempting to increase benefits to society rather than individuals,
seeking the “greatest good for the greatest number.” It endeavors to be scientific by
quantifying harms and benefits, accounting for probability, and calculating net ben-
efit. Calculating net benefits over harms is less problematic when relevant factors
employ a common scale of measurement, for example, weighing the financial costs
of treating a disease with the cost savings from preventing that disease. Comparing
different outcomes (e.g., financial costs versus quality-adjusted life years) some-
times involves difficult judgments about the relative value of each outcome. Because
the utilitarian approach seeks to determine and promote the collective good based
on aggregate measures, it readily lends itself to justifying public health
interventions.
1.3.5 Law Versus Ethics
Laws share certain deontological features with ethical principles of action (and with
religious commandments). They all define one’s obligations or duties and typically
take the form of rules or commands regarding what one should or should not do.
They can lay down positive requirements to fulfill but more commonly establish
parameters that prohibit certain actions or constrain liberty in some way. Laws do
not differ from ethical rules primarily based on content, because an ethical rule can
become a law without changing the rule’s content. For Kant, at least, the crucial
difference between ethics and law concerns one’s reason for obeying; namely,
whether one acts purely voluntarily out of a sense of duty or merely in external
conformity with duty, either to appear to be moral or out of fear of penalty or pun-
ishment. Laws are rules enforced by penalty or punishment, which many people
might otherwise break. Society can tolerate the flouting of some rules, but disobedi-
ence of more important rules can disrupt society or create danger. For these reasons,
society establishes and enforces laws regarding socially important matters, not
leaving their compliance up to individual prerogative. An ethical rule’s enactment as

law, therefore, implies agreement by society or the law’s enactors on the importance
of strictly regulating the behavior the law governs. Law can be a blunt instrument
that effectively compels compliance, which suffices to satisfy the reasons for its
enactment, even if it cannot coax voluntary obedience from an inward sense of duty.
In theory, deontologically evaluating a past or proposed action is a straightfor-
ward binary determination of compliance or noncompliance with a legal or ethical
rule. In practice, however, defining a rule’s scope or determining exactly which
actions fall under it can prove difficult. Moreover, when different rules apply, deter-
mining which should take precedence often becomes problematic, especially when
they conflict. Lying to protect a relative, for example, can put the duty to speak
truthfully into conflict with familial obligations. Determining which rule takes pre-
cedence can involve reasoning clearly from ethical principles, weighing the under-
lying values embodied in the law, or considering the practical impact of the
intervention in context. Because laws demand compliance, they are more rigid.
Additional legal stipulations can prioritize or specify how to apply laws in certain
situations, but doing so increases their complexity. Ethical guidelines operate more
flexibly than rigid, compulsory laws and more readily accommodate compromise.
With ethical guidelines, decision makers can consider and rank the underlying val-
ues the ethical rules serve to promote. Doing so allows for trade-offs between com-
peting ethical considerations and for deciding which values it makes sense to
prioritize in the given context. Conversely, law’s comparative rigidity can be a virtue
where only stricter oversight and enforcement will ensure compliance and establish
order.
Across cultures, legal, ethical, and religious rules prohibiting basic offenses such
as lying, theft and murder show considerable overlap. However, cultures vary in
exactly which rules are matters of individual choice and which are matters of legal
enforcement and punishment. This variability also applies to the status of rules and
standards governing research on human subjects. Even within a country, significant
variability can prevail in whether human subjects’ research rules and standards are
legal regulations or ethical guidelines (U.S. Department of Health and Human
Services 2015). Some see the lack of legal regulation as a breach in protections, but
others prefer guidelines, arguing that regulations tie reviewer hands, making it more
difficult to make trade-offs or nuanced judgments based on moral discernment of
the particulars of each case (Verweij and Dawson 2009). Because each approach
offers advantages and disadvantages, political culture and local context must ulti-
mately decide whether human subjects’ research rules exist as enforceable regula-
tions or ethical guidelines.
Regardless of whether it takes the form of guidelines or law, research ethics will
govern only a fraction of the ethical issues that the field of public health must
address. In many areas of public health practice, there are no specific ethical guide-
lines or regulations. To address ethical challenges in these areas or to address emer-
gent challenges, the ethical practice of public health therefore requires the ability to
use general ethical frameworks. Such frameworks can employ checklists of ques-
tions and stepwise procedures. However, because novel challenges continually
emerge and changing contexts introduce nuances no set of rules can anticipate, pub-
lic health professionals ultimately need to practice ethical decision making over
time in order to cultivate moral judgment and discernment.
By laying down and enforcing what may, must, or cannot be done, legal rules
function as boundaries of acceptable behavior. Ethics, science, budgets or politics,
each in its own way, also can restrict the scope of action. Public health practitioners
and officials therefore first need to conduct a feasibility analysis to determine the
relevant limits on possible interventions or policies. Determining these limits sel-
dom will restrict the scope of action to a single possible course. Given multiple
possibilities, most people will aspire to the best course of action beyond the legal
floor of minimally acceptable behavior yet within the other relevant limits. As a
result, the ethical challenges public health practitioners face seldom involve stark
choices between right or wrong, good or evil. A good feasibility analysis will have
ruled out any unethical or illegal options or alternative courses of action in advance.
Rather, the tough choices more frequently involve selecting the best alternative
from among competing goods, each of which to a greater or lesser degree realizes
the public health goal and embodies relevant stakeholder values.
Whereas determining and complying with the various limits on action is largely an
analytic process, designing alternatives is a synthetic, creative process. Alternatives
should all realize the public health goal and incorporate the perspectives and values
of subject matter experts and relevant stakeholders. Deciding upon the best alterna-
tive must take into account how it will realize the public health goal in a particular
context and with respect to the stakeholders. For example, advocating contraceptives
to reduce unwanted teen pregnancy might seem to promise success based on effi-
cacy studies, but ethical controversy could render such a program less than optimal
in some contexts. Political culture or social norms can confer partisan advantage or
disadvantage to some alternatives, while other alternatives may enjoy an advantage
because of the experience and expertise of a health department. Whatever alterna-
tive practitioners finally choose, their choice will presuppose a prioritizing of val-
ues. The foregoing account highlights why public health practitioners need to see
ethics as something more than a compliance matter. It transcends compliance
because public health ethics also involves practical decision making, which should
include stakeholder analysis, the incorporation of stakeholder values in the design
of alternatives, and a fair, transparent deliberative process to evaluate alternatives.
1.4 Public Health Ethics
Compared with more established fields of practical ethics such as clinical ethics,
research ethics, and bioethics, the field of public health ethics is relatively new.
Consequently, many public health practitioners may be better acquainted with these
more established fields than with public health ethics. In particular, practitioners
may already be acquainted with the four principles these fields rely on for ethical
evaluation: beneficence, nonmaleficence, respect for persons (autonomy), and
justice (U.S. Department of Health, Education, and Welfare 1979; Beauchamp and
Childress 2012). Being applicable to health and research, these four principles also
are relevant to public health, but having arisen to address issues in other fields, they
need to be adapted to a public health context. Even then, they still fall short in
addressing the ethical challenges that arise in public health. Examining these related
ethics fields and showing how the four principles fit into a public health context can
serve by way of contrast to indicate what is distinctive about public health ethics.
1.4.1 Research Ethics, Clinical Ethics, and Bioethics:

Principlism and the Four Principles
Research ethics entails the wider notion of scientific integrity but is best known and
most developed in relation to medical research involving human subjects. The
development of human subjects’ research ethics guidelines can neither be divorced
from breaches of ethical conduct in human subjects’ research nor wholly reduced to
a reaction to these events. But beginning with the Nuremberg Code (1947), balanc-
ing risks and benefits to research subjects and getting their informed consent have
been cornerstones of international research ethics guidelines. Far more influential
than the Nuremberg Code, the Declaration of Helsinki from the World Medical
Association (WMA) is a fundamental document in international human subjects’
research ethics guidelines. Its initial 1964 version included provisions for proxy
consent for those with diminished autonomy. Its 1975 revision called for review of
research by an independent committee, now known as an ethics review committee
(WMA 1964, 1975, 2013). The use of such committees began spreading under the
aegis of WHO and then in response to the HIV/AIDS pandemic, as the number of
large-scale vaccine and drug trials grew in developing countries. In the United
States, research regulations set forth in the Common Rule govern ethics
review committees as well as all human subjects’ research that receives U.S.
government funding (U.S. Department of Health and Human Services 2009). In the
United States, a standing ethics review committee generally functions within a
specific governmental or university institution and therefore is referred to as an
institutional review board (IRB). Beginning in 1982, the Council for International
Organizations of Medical Sciences (CIOMS), in collaboration with WHO, proposed
international ethical guidelines for biomedical research involving human subjects
(CIOMS 2002).
Our discussion of these documents has only highlighted key provisions of what
is required to ensure the safety of human subjects. CIOMS’s most recent research
guidelines (2002), for example, contain more than 60 pages of text, explanation, and
commentary. But ensuring ethical conduct and scientific integrity in research
requires more than the oversight function of ethical review committees. It also
requires extensive training not only in research ethics but also in a number of related
areas. Training and guidelines should cover, among other things, mentoring of
junior researchers, authorship and publications policy, conflicts of interest that arise
in partnerships and collaborative science, and data acquisition, management, shar-
ing and ownership. Ethics training can help develop moral judgment. The hope is
that training and application will enable practitioners to reason about new, difficult,
or ambiguous cases in morally discerning ways.
Clinical ethics address the ethical issues that arise in clinical practice. Until the
advent of bioethics, medical professionalism emphasized the health care provider’s
obligation to prioritize the patient’s welfare, the health care provider’s professional
judgment about what would most benefit the patient, and the importance of estab-
lishing patient trust. The traditional model of clinical ethics was frankly paternalis-
tic. Under the influence of bioethics, many health care providers began embracing a
more patient-centered model of care that emphasized patient autonomy and
informed consent. This patient-centered model conceives care as a contract between
patient and provider. The emphasis on contracts strikes some as an inappropriate
consumerist model that undervalues professional judgment and undermines patient
trust in the medical profession. Tensions between these two models have led to a
compromise that reasserts the importance of medical professionalism and clinical
judgment, while acknowledging the importance of respecting patient autonomy
(ABIM Foundation et al. 2002).
Bioethics has a range of meanings, the first of which applies to ethical issues
brought about by advances in biomedicine and biotechnology. Ethical issues that
arise from using life-sustaining technologies in end-of-life and beginning-of-life
care epitomize this sense of bioethics. But bioethics also arose in response to medi-
cal paternalism and to the abuse of human subjects in medical research. Bioethics
has championed informed consent, patient autonomy in doctor-patient relationships
and the safety of human subjects in research. However, many bioethicists think the
focus on clinical ethics and on personal autonomy unduly restricts bioethics’ pur-
view. They advocate a more holistic, social justice approach in bioethics, which has
been referred to as “population-based bioethics” or “integrative bioethics” (Sodeke
2012). It can be argued that this expansion of bioethics beyond clinical ethics into
population issues moves bioethics into the arena of public health ethics (Callahan
and Jennings 2002).
Principlism came into being in a 1979 document called the Belmont Report
(U.S. Department of Health, Education, and Welfare 1979). The report was the work
of the U.S. National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research, which convened in 1974 partly in response to
the exposé of the U.S. Public Health Service Tuskegee Syphilis Study. The Belmont
Report became the basis for revising 45 CFR 46, the so-called Common Rule, part
of the legally binding U.S. Code of Federal Regulations, governing the protection of
human subjects (U.S. Department of Health and Human Services 2009). The
Belmont Report clearly explained the underlying ethical principles that informed
existing regulations and provided an ethical framework for thinking about subse-
quent regulations. Principlism has remained the predominant ethical framework in
biomedical ethics (Beauchamp and Childress 2012). Its explanatory groundwork
accounts for much of its success, but its relevance to medicine and research, the
prestige that attaches to these fields, and its compatibility with liberal individualism
also have played a role.
Beneficence (doing good) and nonmaleficence (doing no harm) date back to the
Hippocratic Oath as medical principles. Collapsing them both into beneficence, as
the Belmont Report does, underscores the practical consideration that biomedical
decisions generally aim to optimize net benefit over harm, rather than to maximize
only benefits or minimize only harms or risks. However, these principles are dis-
tinct, not mere opposites. Not doing harm has a certain priority (first, do no harm),
because not benefitting someone seems a less serious offense than doing that person
harm. That priority partly reflects the human tendency more readily to forgive over-
looked benefits (errors of omission) than deliberate actions resulting in harm (errors
of commission).
Justice has several meanings that include due process and fair deliberative proce-
dure, properly assessing what people are owed or due, and equitable distribution of
burdens and benefits. According to philosophic tradition, justice has always func-
tioned dually, applying to individuals but more importantly serving as an overarch-
ing principle for adjudicating competing claims in relation to the group or to other
members of society. The phrase, “social justice,” then, is redundant but in political
contexts marked by individualism serves as a reminder of justice’s social dimen-
sion. In fact, this phrase came into vogue in public health circles to counter the
ideology of “market justice,” which views the equal access of individuals to the free
market as a valid, reliable, and preferred means for sorting out issues of economic
and social justice (Beauchamp 1976). The notion of health equity, which compares
different groups, primarily refers to this social dimension of justice, although denial
of access to health care, a contributing factor to health inequity, violates what the
individual is owed.
Respect for persons emphasizes that individuals, as agents in charge of their own
lives and bodies, have the right to make decisions and choices free from undue
interference. Respect for persons forms the basis of informed consent, namely, the
right of patients and human research subjects to be informed of, and to assent to,
medical or research procedures they might undergo, especially procedures that pose
potential harm or risk. Conducting research on human subjects or performing medi-
cal procedures on patients without their prior knowledge or consent in most cases
violates their personal autonomy. However, health professionals have a special (i.e.,
paternal) obligation to look out for the welfare of people with diminished decisional
capacity—such as those in a coma or the very young—and to protect them from
harm.
These four principles were originally conceived as prima facie principles, that is,
each expressed a self-evident though not absolutely binding obligation and none
had an inherent priority over another. However, in many Western countries and in
the United States in particular, respect for persons has dominated discussion in bio-
ethics, clinical ethics, and research ethics where it often takes precedence as a moral
consideration over the other principles. This ascendancy most likely reflects the
high value that these countries place on liberty and freedom. At any rate, in public
discourse generally and in public debate about public health interventions, respect
for persons often amounts to an insistence on noninterference with individual free
choice or with personal preferences. Although Kant’s other-regarding idea of moral
autonomy, harmonizes well with collective decision making, the insistence on non-
interference with personal choice often creates impediments to the implementation
of public health interventions. In part for this reason, the social justice movement
has had to challenge the emphasis on respect for persons in order to promote the
public good and health equity.
1.4.2 Contrast between Clinical Ethics and Public Health

Ethics
Table 1.2 contrasts the individual focus of clinical ethics with the community/
population focus of public health ethics. Because public health and clinical practice
can overlap, the items in the respective columns represent tendencies along a con-
tinuum rather than stark opposites. Where separate agencies carry out public health
services and medical care, these contrasts may be more pronounced. The overlap
between public health and clinical practice makes it even more important to high-
light their differences to bring out distinctive features of public health ethics.
The table makes clear that the Belmont principles of beneficence (seeking ben-
efits), nonmaleficence (avoiding harm), respect for persons, and justice remain
important in public health, but must be extended to accommodate the broader scope
Table 1.2 Comparison of areas of focus/tendency in clinical ethics and public health ethics
Clinical ethics focus/tendency Public health ethics focus/tendency
Treatment of disease and injury Prevention of disease and injury
Medical interventions by clinical Range of interventions by various professionals
professionals
Individual benefit seeking and harm Social, community, or population benefit
avoidance based on health care provider’s seeking and harm avoidance based on collective
fiduciary relation to a patient action
Respect for individual patients Relational autonomy of interdependent citizens
Professional duty to place the interests of the Duty to the community to address health
patient over that of provider concerns that individuals cannot solve and that
require collective action
Authority based on the prestige and Authority based on law, which is a principal tool
trustworthiness of the physician and the of public health policy for creating health
medical profession as a whole regulations
Informed consent sought from an individual Community consent and building a social
patient for specific medical interventions consensus through ongoing dialogue and
collaboration with the public
Justice concerns largely limited to treating Central concern with social justice regarding
patients equally and ensuring universal health and achieving health equity
access to health care
of public health interventions. This broader scope entails many types of profession-
als, interventions and policies that display a political and social dimension, and a
wider range of activities such as community engagement, intersectoral collabora-
tion, collective decision making, and governmental administration. As a result, pre-
vailing political philosophies and culture will necessarily shape the way public
health functions. The crucial point is that differences of scale that produce a higher
order of complexity also produce qualitative differences that introduce different pat-
terns of causation. Among other things, this means that social factors do not merely
represent aggregated individual factors and so cannot always be addressed in the
same way as individual factors.
1.4.3 Individual Versus Relational Autonomy
For understanding what is qualitatively distinct about public health, the contrast
between respect for individual persons and the relational autonomy of community
members is key. Respect for persons upholds an individual’s right to make indepen-
dent decisions free from undue pressure, but relational autonomy emphasizes that
individual actions occur in the context of other people whom these actions will
affect. The potential harmful impact of individual action on the welfare of others
sets a limit to individual action. Relational autonomy draws attention, then, to the
interdependence of people living in communities and to the solidarity that arises
from the emotional bonds that shared lives create. Anthropology teaches that people
always find themselves in a network of social relations, while evolutionary biology
has shown how profoundly people are built from the physiological ground up as
sociopolitical beings. Because it presupposes the social context of language and
reasoning ability, individual autonomy also depends developmentally on relational
autonomy. That is, people only become autonomous through relations and interac-
tions with others. As African humanism (ubuntu philosophy) epitomizes it, umuntu
ngumuntu ngabantu, “a person is a person through other persons” (Louw 2008).
Familial and communal deliberate processes are foundational for the development
of individual autonomy and provide an even deeper basis for collective decisions
than the type of solidarity that comes to the fore in crises or in the face of common
predicaments. Kant would reject any suggestion that developmental context, emo-
tional bonds or feelings of solidarity underpin moral autonomy. Nevertheless, moral
autonomy and relational autonomy both display an inner-directed, but other-oriented
feature that readily aligns with collective decision making.
These points about the foundational character of social relatedness, solidarity,
interdependence, and communal decision making do not readily align with certain
features of social contract theory, on whose principles liberal democracy is based.
Whereas virtually every other political tradition conceives the sociopolitical realm
as a natural feature of human life, social contract theory posits humankind’s original
state, the state of nature, as one of solitary individualism. In this view, society or at
least civil society come into existence voluntarily through a contract that creates
government through the consent of the governed (Riley 1982). Although never seri-
ously advanced as a scientific account of society’s origins, social contract theory
nevertheless has exerted a powerful influence as a political founding myth. As such,
it has made personal liberty, free choice, and consent of the governed presumptive
values of societies whose governing political philosophy rests on social contract
theory. By “presumptive,” we mean that the value, norm, or claim is assumed to be
valid or have priority, so that the onus is on the person who objects to the presump-
tion to justify a different value, norm, or claim.
1.4.4 Personal Autonomy as a Presumptive Value of Liberal

Democracy
Personal autonomy in a clinical and research context generally means respect for
the patient’s right to receive an explanation of a medical procedure or research inter-
vention, to be informed of any potential benefits or harms, and to freely choose
whether to accept the procedure or participate in the research. More generally and
in other contexts, personal autonomy has come to mean an insistence on liberty, free
choice, and noninterference with personal preferences. Personal autonomy in this
more general sense owes more to John Stuart Mill’s nineteenth-century views on
liberty than to Kant’s eighteenth-century idea of autonomy (O’Neil 2002; Dawson
2011). An important aspect of Mill’s view of liberty is the “harm principle,” which
holds that “the only purpose for which power can be rightfully exercised over any
member of a civilized community, against his will, is to prevent harm to others”
(Mill 1989). What people choose to do regarding themselves is no business of gov-
ernment. Interfering with this private sphere of self-determination constitutes gov-
ernmental paternalism. This interference diminishes the sphere of liberty that
affords individuals the chance to direct their own lives and develop their talents and
character to the highest degree. A chief advantage of democratic society, one that
benefits the entire society, is the creative social dynamism that emerges from the
synergism between individuals who are developing their talents and abilities.
Arguably, the primary aim of the harm principle is to promote the kind of indi-
vidual self-development that benefits society rather than to champion every exercise
of free choice. At any rate, some have sought to distinguish this edifying version of
personal autonomy from an all-encompassing version that demands undue defer-
ence to any and all personal choices and preferences merely because they are per-
sonal (O’Neill 2002; Dawson 2011; Powers et al. 2012). Presuming, or insisting on,
the validity of personal autonomy makes more sense in the delimited context of
medicine and biomedical research on human subjects where an individual’s body is
the focus of activity. It makes less sense in the far wider sphere of public health
activity where social interactions and the interdependence of people come into play.
Absolutizing personal autonomy in the sphere of public health would give effective
veto power over every collective decision aimed at the public good to any individual
who felt constrained by that decision. A more moderate version might distinguish
levels of importance of personal choices and exercises of liberty. A collective deci-
sion concerning the public good could override some personal choices and limit
liberty, even when they did not involve direct harm to others. Such decisions, when
made in the context of a fair, transparent process of ethical deliberation involving
stakeholders, are more likely to get buy-in from a community and less likely to be
labeled paternalistic.
Because public health considers the relation between individuals and the collec-
tive good, it necessarily has a political dimension. How a country’s political culture
balances this relation will drive and constrain public health practice and so shape the
nature of the ethical frameworks that are appropriate to a country’s politics (Hyder
et al. 2008). In the brief history of public health ethics, the most important ethics
frameworks have emerged in the political context of liberal democracy. Many of
these frameworks reflect the tensions between public health’s obligation to act col-
lectively for the common good and the presumptive value of personal autonomy.
The principle of least infringement and Kass’s code of restraint illustrate the effort
to mediate such tensions (Kass 2001). The code of restraint strives to balance auton-
omy claims against the obligation to safeguard community health by determining
what intervention most effectively protects health while minimally infringing on
liberty. In a liberal political context that recognizes Mill’s harm principle, this strat-
egy justifies the trumping of personal autonomy as long as imminent harm threatens
the populace, for example, in a deadly outbreak of contagious disease. But where
the threat of harm to others is indirect or not immediate, as with the obesity epi-
demic, the harm principle less readily justifies a liberty-limiting intervention such as
banning or taxing certain foods. Utilitarian approaches that weigh the health advan-
tages of intervention and the disadvantages of obesity clearly support obesity inter-
vention, but limiting interventions to those that do not restrict personal choices also
have limited effectiveness. In Chap. 6, Jennings considers the relative merits of
these approaches in his overview of the ethical issues in environmental and occupa-
tional public health. His discussion raises the question of the extent to which an
ethical framework should adapt itself to the presumptive values of the political con-
text or should reflect the nature of the practical field under investigation. To some
extent, it must do both.
The three-step framework offered in the next section is designed to guide deci-
sion makers, through questions, to assess the ethical dimensions of a case, including
which moral considerations (e.g., population utility or liberty) may have more
weight than others, given the issue or context. This contextual approach provides
the flexibility and starting point for deliberation to accommodate the issues globally
and to uncover the varying perspectives of stakeholders with potentially different
presumptive moral norms (e.g., solidarity versus individual rights).
1.5 Ethical Frameworks
What at first glance demarcates public health ethics from related fields of health
ethics are the ethical problems that public health professionals typically encounter
in their practice and the ethical frameworks used in practice to address these prob-
lems. Regarding these ethical problems, this casebook offers a representative, but
not exhaustive, sample. Regarding ethical frameworks, this chapter has suggested
two competing criteria for choosing. On the one hand, ethical frameworks should be
grounded in their topics. Dawson (2011) expresses the point succinctly by arguing
that public health should be the foundation of public health ethics. Accordingly, we
have presented a view of public health ethics that builds on the definitions of public,
health, and public health, and on the goals of public health practice. But we have
also defined ethics and indicated how public health ethics draws on numerous ethical
theories and can provide a moral guide grounded in the norms of benefiting others,
preventing harms, and providing utility. We have pointed out its distinguishing
principles based on the facts of community and interdependence. Lastly, we have
situated public health ethics within the process of ethical decision making about
which options are the most justifiable means to achieve public health goals in a
particular context. In the end, grounding public health ethics in public health may
require public health leaders to have the courage to advocate public health values
and goals, even when that position is unpopular. Such a stance may be justified, for
example, where the feasibility of a much-needed public health intervention requires
a long-range strategy to change social norms or build social consensus.
On the other hand, precisely because public health itself is practical, pragmatic,
and community oriented, an ethical framework designed for it must accommodate
itself to a country’s presumptive values and political culture. This consideration
illustrates that the feasibility of public health interventions usually depends on their
alignment with the political culture, while their success usually implies public
acceptance. Many established frameworks, like that of Kass, seem designed with a
liberal political context in mind that gives presumptive weight to individual liberty,
which may limit the range of interventions that can be justified. Newer approaches
to ethical analysis in public health place more emphasis on social values like equity
and solidarity, although these newer approaches often are difficult to put into practice
(Lee 2012). In addition, while newer approaches may offer clear reasons to justify
a broader range of interventions, the reasons may be less persuasive if they do not
consider the presumptive values in context. For example, in Chap. 3, Daniels dis-
cusses the ethical conflicts that arise during pandemics between the standard goal of
improving population health and emergency contexts that demand allocating scarce
resources in a way that treats people fairly. He asks, if in the pandemic context we
believe that saving the most lives trumps giving priority to those who are sickest,
can we justify revising the usual priority given to the sickest in health care?
Arguably, what would be most useful is not a set of frameworks designed for
specific presumptive values, but, rather, a framework that can accommodate any
presumptive values and consider them in relation to values rooted in public health
or in context. The three-step framework that follows is a straightforward tool to help

practitioners analyze the ethical tensions in a particular context. It addresses
Daniels’ tough question directly by considering health care’s presumptive prioriti-
zation of the sickest in relation to the public health value of saving the most lives in
a pandemic.
1.6 A Three-Step Approach to Public Health Decision

Making
We offer the following framework, drawn from public health practice and described
by Bernheim et al. (2007), as an example of an analytic tool that can guide decision
makers through reasoning and deliberation. It is not meant to introduce a rigid
application of ethical principles, nor does it presume that any one moral norm has
greater weight that trumps other norms. Instead, the questions are designed to help
decision makers clarify whether a particular moral norm (e.g., solidarity or liberty
or equity) is weightier than others in context, and if so, then strong reasons must be
offered to override the presumptive moral norm. For example, during an epidemic,
equity may carry presumptive weight and trump other moral norms in some con-
texts. Ethicists at the Joint Centre for Bioethics offered the following insight from
the SARS experience:
In the case of an epidemic, it is important to control the spread of the disease, but as much
attention should be paid to the rights of the noninfected patients who need urgent medical
care. There may be as many people who died from other illnesses and could not get into
hospital as there were who died from SARS. Equity is required in the amount of attention
given to a wide array of people, including patients with and without SARS. Accountability
for making reasonable decisions, transparency and fairness are expected …. (Singer et al.
2003)
The questions clarify the relevant factors, such as stakeholder claims, alternative
actions, and possible justifications for deciding on one course of action.
1.6.1 An Approach to Ethical Analysis and Justification

in Context
Step I: Analyze the Ethical Dimensions of the Public Health Issue and Context
• What are the risks, harms, or concerns?
• What are the appropriate public health goals in this context?
• What is the scope and legitimacy of legal authority, and which laws and regu-
lations apply?
• What are the moral norms and claims of stakeholders, and how strong are
they?
• Are precedent legal or ethical cases relevant for identifying the presumptive
moral norms?
• Which features of the social-cultural-historical context apply?
• Do professional codes of ethics provide guidance?
Step II: Formulate Alternative Courses of Action and Evaluate their Ethical
Dimensions
• What are the short- and long-term options, given the assessment of the public
health issue and context in Step I?
• What are the ethical dimensions and tensions of each option?
– Utility: Does the public health action produce the best balance of benefits
over harms and other costs?
– Equity and Justice: Is health equity advanced? Are the benefits and bur-
dens distributed fairly (distributive justice)? Is there appropriate public
participation, including the participation of affected parties (procedural
justice)?
– Respect for Individual and Community Interests: Does the public health
action respect self-determination and human rights, as well as civic roles
and community values (e.g., trustworthiness, solidarity) (Dawson and
Jennings 2012)?
• Other Moral Considerations in Public Health: Are there other moral consider-
ations in public health that are important to consider? (For example, reciproc-
ity, solidarity, protecting privacy and confidentiality; keeping promises and
commitments; or disclosing information and speaking honestly, sometimes
grouped as transparency.)
Step III: Provide Justification for a Particular Public Health Decision
• Effectiveness: Is the public health action likely to be effective?
• Proportionality: Will the probable benefits of the action outweigh the infringed
moral considerations?
• Necessity: Is the action necessary (i.e., will overriding a conflicting ethical
norm achieve an important public health goal)?
• Least Infringement: Is the public health action the least restrictive means
available?
• Public Justification: Can decision makers offer public justification in the
political and cultural context that stakeholders, the public, and those most
affected find acceptable?
Consider the following scenario described by Melnick (2015a). A family adopted
several children from a developing country with a high tuberculosis (TB) preva-
lence, including multidrug-resistant TB (MDR-TB). Screening on arrival revealed
that the children were infected with TB but did not have active disease and were not
contagious. The family has strong religious beliefs about medical care and refused
treatment, immunizations, and other preventive care. The children were home-
schooled, but they did attend community activities. Soon after arrival one of the
teenage children developed TB symptoms, and after several months the family con-
sulted a pediatrician who diagnosed active pulmonary TB. Cultures revealed that
the child had MDR-TB. Directly observed treatment (DOT) is part of the standard
of care for active TB in the United States, and the local health department nurse
visited the family to provide DOT. The parents objected to the home visit, stating
that DOT was an invasion of their privacy and parental rights. The health depart-
ment has the statutory authority to require in-person DOT and even impose isolation
of the case and removal from the family to protect the public’s health. What should
health officials do? Drawing on questions in Step I, health officials might first clar-
ify the harms and risks and the goals of public health action. The public health goals
are to prevent TB transmission and ensure the child receives appropriate care.
Requiring DOT creates risks for the child such as side effects from treatment and
social and behavioral harms associated with isolation and loss of privacy during
visits, and potential community harm, by driving cases underground. Who are the
stakeholders, and what are their moral claims?
There are several stakeholders: the child, the child’s family (including parents but also sev-
eral siblings), and the public, which expects the health department to protect the community
from TB. Regarding moral claims, the child has some expectations of freedom of move-
ment, and privacy; the family has similar expectations regarding privacy, respect for paren-
tal rights, and the freedom to administer medications to their child at a convenient time and
place. However, these claims are not absolute, and competing moral claims can outweigh
them. The child has a moral claim that could compete with her parent’s claim, specifically,
that receiving DOT will reduce the risk of inappropriate treatment and relapse compared to
having her parents administer the medications. In addition, the public has a moral claim
based on two expectations: (1) that the health department will protect the community from
TB, and (2) that people contagious for TB and other infectious diseases will protect others
by behaving in an appropriate manner, including staying home when contagious and coop-
erating with treatment recommendations. This is especially concerning in this case because
the immigration health officials had discussed the risks with the parents, warning them to
seek treatment as soon as the child developed symptoms, yet the parents waited several
months before taking the child to a pediatrician (Melnick 2015a, 175).
Consider another short scenario that illustrates the value of exploring options
under Step II. A new policy is being considered that would require parental consent
for newborn screening. Parental consent currently is not required, although newborn
testing is not conducted if there are parental objections. The health department has
been asked to take a position on the pending policy. What position should the health
department take? What are the options?
Options include mandatory screening without consent, routine screening with
advance notification (Opt In), routine screening without advance notification (Opt Out)
(i.e., screening and testing done unless the parents object), voluntary screening (i.e.,
screening requires full consent and might also include a pre- and post-counseling
session with each new mother). Some arguments that might be offered against
requiring parental consent focus on the fact that (1) the benefits of screening are
obvious and substantial, relative to potential harms; (2) parents have few good rea-
sons to justify parental refusal and place their child at risk for harm; (3) obtaining
consent from each parent is difficult, costly, and an unwarranted expenditure of time
and money; and (4) the history of newborn screening has become acceptable and
routine. Some arguments that may be raised for requiring parental consent include
(1) parental consent is necessary because refusal of newborn screening is reasonable
given the increasing list of diseases included in the battery of newborn tests and the
low probability of many of these diseases; (2) newborn screening can have adverse
consequences such as psychological harms associated with false positive tests; (3)
long-term parental caretaking is enhanced when parents are included in all clinical
decisions about their children; and (4) the process of obtaining consent need not be
time-consuming or burdensome but rather can help enhance the health professional-
patient relationship (CDC 2012). Which arguments are stronger, and which of the
options are the most ethically justifiable? The answer may depend on the social and
political context in which the issue is considered, and which ethical values carry
weight in that context. Whether there were presumptive values in place would be
explored through the questions in Step I, which examines previous cases, the appli-
cable laws and policies, and stakeholder claims in context. So, for example, in a
society that has a strong moral norm or presumption for solidarity, there could be a
presumption for continuing population newborn screening without parental con-
sent. On the other hand, for a society that has a liberal political context that has a
presumption for individual liberty, there may be a presumption for an option that
seeks more explicit consent from parents. In either context, the presumptive moral
norms are not determinative but are rebuttable, so the arguments or reasons to over-
ride those norms must be stronger.
Consider a third case from public health practice in which a person (the index
case) infected with primary syphilis and HIV refuses to provide contact information
for his wife, insisting that he and his wife had not had sexual relations for several
years. Contact tracing and partner notification have been important tools historically
for public health officials, although these interventions can involve thorny ethical
tensions, requiring health officials to justify their decisions. In this type of situation,
health officers will consider several options, starting with those that infringe least on
the index case’s choices. For example, they might first provide to the index case
additional information and assurance about confidentiality while allowing him to
notify his wife voluntarily, either alone or with the help of public health workers. If
this proves unsuccessful, other interventions might be considered, such as incen-
tives, the threat of restrictions such as isolation, or attempts to notify the wife with-
out his knowledge or consent. Each of these options would be determined in context,
using the questions in Step III. Questions considered may include (1) Would the
options likely accomplish the goal of warning and testing the wife without risking
greater harm or possible adverse outcomes for the wife (e.g., domestic violence,
loss of income, or loss of housing)? (2) Is there significant concern about a risk of
harm to others, such as family members or children, so that the burdens and benefits
of the action would not be distributed fairly? (3) Is the action the least restrictive of
the important moral claims of the stakeholders? (4) Is it necessary now to override
conflicting claims to achieve the public health goal? Answering the questions in
Step III helps decision makers consider whether actions are justifiable. As one
health officer explains, “Public health officials should justify their decisions with
deliberations that build not only community support and trust, but also build support
and trust from the individuals and families directly affected” (Melnick 2015b).
As the scenarios illustrate, public health is a social and political undertaking.
Thus, making difficult choices in public health implicates important social, cultural,
and political norms embedded in a particular context and community of stakehold-
ers (Childress and Bernheim 2008). Regardless of whether decision makers work in
a government public health agency, community nonprofit, nongovernmental organi-
zation (NGO) from another country, or a global organization, decision makers must
rigorously assess the public health issue in context, to minimally be able to act “in
ways that preserve the moral foundations of social collaboration” at the core of col-
lective health activity (Calabresi and Bobbitt 1978).
The context specifically includes attention to stakeholders and relationships
among public health stakeholders and community members, including the common
understanding of their roles, obligations, and collaborations. Especially in global
public health, it is important to note that even the decision makers are stakeholders,
in some sense, and often, when they are health professionals, they have their own
social-cultural norms and their own professional codes that can provide guidance.
Appeals to the codes of particular professions, however, do not provide a sufficient
justification for a public health decision, since justifications should be grounded in
a society’s widely shared ethical values and norms.
Engaging stakeholders and addressing claims, especially those of the people
most affected by a public health issue, in ethical analysis, is especially important
and can sometimes support and strengthen the collaboration and cohesion needed
for public acceptance of a decision. The ways to engage and reason with stakehold-
ers in an ethical analysis will vary in different settings and communities, depending
on community values, cohesion, and expectations, and can range from establishing
an ethics board for deliberation, to gathering information from focus groups or
social media, to including stakeholder representatives on the decision-making team.
Stakeholder norms and claims are a critical feature for an ethical analysis in order
to achieve a primary goal in public health—the development and maintenance of
relationships of trust, defined in a report from IOM as “the belief that those with
whom one interacts will take one’s interests into account, even in situations in which
one is not in a position to recognize, evaluate, or thwart a potentially negative course
of action by those trusted” (IOM 1996).
Ethical analysis is a dynamic process and, particularly for the practice of public
health, is best accomplished through group deliberations that involve understanding
others’ perspectives and thinking independently and imaginatively. Public health
professionals often have to decide how best to realize numerous important societal
norms and values when pursuing public health goals. Ethical tensions do occur in
public health and at times require overriding an important principle, value, or moral
consideration to undertake a justifiable public health action. However, a structured
ethical analysis can often lead to imaginative alternatives that transcend or mini-
mize ethical tensions and to decisions that most or many stakeholders find
acceptable.
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Chapter 2
Essential Cases in the Development of Public
Health Ethics
Lisa M. Lee, Kayte Spector-Bagdady, and Maneesha Sakhuja
2.1 Introduction
While “public health” has been defined as what society does to “assure the condi-
tions for people to be healthy” (Institute of Medicine 2003, xi), public health ethics
is a “systematic process to clarify, prioritize, and justify possible courses of public
health action based on ethical principles, values and beliefs of stakeholders, and
scientific and other information” (Schools of Public Health Application Service
2013). Despite several important characteristics that distinguish public health from
clinical medicine, at its start public health ethics borrowed heavily from clinical
ethics and research ethics (see Chap. 1). In the 1980s, with the onset of the AIDS
epidemic and unprecedented advances in biomedicine, the inability of clinical eth-
ics to accommodate the ethical challenges in public health from existing frame-
works led pioneering ethicists to reframe and adapt clinical ethics from an individual
and autonomy focused approach to one that better reflected the tension between
individual rights and the health of a group or population (Bayer et al. 1986;
Beauchamp 1988; Kass 2001; Childress et al. 2002; Upshur 2002). Others called for
public health ethics to emphasize relational ethics and political philosophy (Jennings
2007). More recently, some authors have suggested outlining foundational values
from which operating principles for public health ethics can be articulated only after
careful consideration of the goals and purpose of public health. This approach
would require us to establish a clear definition of the moral endeavor of public
institutions.
L.M. Lee, PhD, MA, MS (*) • K. Spector-Bagdady, JD, M Bioethics
M. Sakhuja, MHS
Presidential Commission for the Study of Bioethical Issues, Washington, DC, USA
e-mail: lisa.lee@bioethics.gov

38 L.M. Lee et al.
health as a field (Lee 2012) and construct an ethical framework stemming from the
nature of it (Dawson 2011).
A versatile framework for public health ethics must accommodate public health
in practice and research. In public health practice, an ethics framework must guide
decisions about activities like infectious disease control, primary prevention, and
environmental health, as well as newer expectations of public health such as chronic
disease control and preparedness. In public health research, biomedical and behav-
ioral research ethics provide a great deal of guidance—but research that focuses on
population-based outcomes and community concerns reveals additional ethical
considerations.
A fundamental tension in public health is one between individual- and population-
based interests. Various political traditions place different value on each, and these
values can fluctuate within the same political structure over time. When authorities
intervene to affect population health, they must find an equilibrium between indi-
vidual and population interests in all political contexts, whether authoritarian,
socialist, or liberal individualist. To consider individual interests as well as popula-
tion interests, regardless of the philosophical tradition within which these interests
are valued, is a challenge for a public health ethics framework. The cases we present
in this chapter illustrate how this equilibrium between individual and population
interests has been established in the context of dynamic political and historical
influences.
One way of approaching public health ethics deliberation is through the method
of casuistry, defined as “the interpretation of moral issues, using procedures of
reasoning based on paradigms and analogies, leading to the formulation of expert
opinion about the existence and stringency of particular moral obligations, framed
in terms of rules or maxims that are general but not universal or invariable, since
they hold good with certainty only in the typical conditions of the agent and the
circumstances of action” (Jonsen and Toulmin 1988, 297). Consideration of case
studies and the use of casuistic methods of resolution of morally similar cases
through interpretation of ethical principles have played important roles in the devel-
opment of public health ethics—particularly before public health ethics was viewed
as distinct from clinical ethics. Individual case studies enable discussions about
which ethical norms we should adopt for the practice of public health and how pub-
lic health professionals should deliberate to resolve ethical problems in practice
(Centers for Disease Control and Prevention [CDC] 2012). In this chapter, we
review several seminal cases that shaped the ethics of public health research and
practice over the past century to provide the foundation of current public health eth-
ics and lay the groundwork for a casebook to enable casuist analysis.
Our first case example is Jacobson v Massachusetts, set in the beginning of the
twentieth century. Jacobson is a foundational U.S. public health legal case that sup-
ports states’ rights to create and enforce laws and regulations that limit individual
autonomy to protect the public’s health and stop the spread of communicable dis-
ease. Our second case study, from the mid-1900s, looks at two ethically troubling
U.S. Public Health Service (PHS) protocols for studying sexually transmitted dis-
eases (STDs) in the U.S. state of Alabama and Guatemala. These experiments, like
2 Essential Cases in the Development of Public Health Ethics 39
most research protocols, were not intended to benefit the subjects; rather their intent
was the broader benefit of the public’s health. They show however, that researchers,
despite the apparent motivation to advance public health, can breach public health
research ethics and harm research subjects. The final case, a contemporary example
of the New York City A1C Registry to monitor and address the diabetes epidemic in
the city, demonstrates how addressing the ethical dimensions of public health inter-
ventions can facilitate their implementation. This case moves our focus from public
health interventions targeting communicable diseases to those supporting second-
ary prevention of noncommunicable diseases. It focuses on the ethical dimensions
that can arise when technological advances in communication might affect indi-
vidual privacy. Unlike the consistent movement forward with which casuistry has
moved clinical ethics, (Jonsen 1991), the outcomes in the cases we describe here
shaped, and sometimes jolted, the nascent field of public health ethics.
These three case studies, occurring within the same political structure over the
span of a century, illustrate the tension between individual autonomy and protection
of public health in very different ways. The first case depicts a situation where the
balance tipped in favor of protection of the public’s health in the context of infec-
tious diseases. The second case demonstrates unconscionable exploitation of vul-
nerable research subjects for the benefit of other communities. Finally, the third case
presents a situation in which solutions to public health problems based on techno-
logical advances and access to data can strike a balance with individual health pri-
vacy concerns. Each case illustrates the quest for equilibrium between individual
and population interests.
2.2 Case Study: Jacobson v. Massachusetts
The earliest activities associated with modern public health are sanitation and infec-
tious disease control. From the first public health surveillance system in colonial
America that required tavern keepers in Rhode Island to report contagious disease,
to John Snow removing the Broad Street pump handle in London to end the 1854
cholera epidemic, control of communicable diseases has been firmly in the jurisdic-
tion of public health (Thacker 2010). Discovery of the physiological mechanisms of
vaccines in the eighteenth century gave us new tools to control infectious diseases
but also raised critical questions about how to carry out—effectively and ethically—
policies and plans that support individual and community health.
2.2.1 Background
By the turn of the twentieth century, public health campaigns—including improved

hygiene, sanitation, and access to safer food and water—had already extended the
average life expectancy in the United States (CDC 1999). But infectious diseases
40 L.M. Lee et al.
were still the leading cause of mortality, with tuberculosis, pneumonia, and diar-
rheal disease accounting for 30 % of U.S. citizen deaths (Cohen 2000). Evolving
support for the government’s involvement in protecting public health led to the
establishment of hygienic laboratories in 1887 (Kass 1986). These laboratories con-
tinue today to provide essential services such as diagnostics, public health surveil-
lance, research, and vaccine development.
Edward Jenner, who discovered that a vaccine for smallpox could be created
using cowpox lesions, sent his vaccine from England to Benjamin Waterhouse at
Harvard University in 1800 (Riedel 2005). After successfully vaccinating the mem-
bers of his household, Waterhouse began selling the vaccine in Boston, Massachusetts
(Kass 1986). Not all physicians vaccinated as meticulously as Waterhouse however,
and in one unfortunate incident, adulterated smallpox vaccine caused an epidemic
in the Boston area (Kass 1986).
As interest in and concern about the vaccine grew, the Board of Health of Boston
decided to perform one of the first controlled clinical trials in U.S. history, which
eventually demonstrated effectiveness of the vaccine (Kass 1986). A century later,
Massachusetts had established vaccination campaigns, but smallpox persisted: One
hundred cases were reported in Massachusetts in 1900 with 2314 cases by 1902
(Parmet et al. 2005). The Board of Health had originally promoted a voluntary vac-
cination scheme until January 1902 when two children, one in Boston, died of post-
vaccination complications within a month of each other (Willrich 2011). After
voluntary efforts stalled, the Board ordered mandatory vaccination in February, but
did not enforce the order. After an outbreak sent another 50 adults and children to
the hospital and caused seven deaths, the Board voted that the regulations needed to
be enforced (Willrich 2011).
Local public health officials employed creative ways to follow enforcement
orders, “many of which were scientifically sound but not all of which were apt to
inspire public trust” (Parmet et al. 2005, 653). The Boston Herald, for example,
reported in March 1902 that public health doctors and guards forcibly vaccinated
“Italians, negroes and other employees” (Parmet et al. 2005, 653). Despite the suc-
cess of the smallpox vaccine in curtailing disease, anti-vaccinationists described
compulsory vaccination as “the greatest crime of the age” and as “more important
than the slavery question, because it is debilitating the whole human race”
(Washington Post 1905; Gostin 2008, 122). Pro-vaccinationists were as polarizing,
describing the debate as “a conflict between intelligence and ignorance, civilization
and barbarism” (New York Times 1885; Gostin 2008, 122).
2.2.2 Case Description
It was in this context that the U.S. Supreme Court heard Jacobson v. Massachusetts,
which despite, and perhaps because of, the vastly different ways it has been inter-
preted and applied since then, is arguably the most important legal public health
case ever decided in the United States (Gostin 2005). Under the doctrine of “police
power,” it had already been established in the late 1800s that states had the authority
to enforce “sanitary laws, laws for the protection of life, liberty, health or property
within its limits [and] laws to prevent persons and animals suffering under conta-
gious or infectious diseases …” within their own boundaries (R. R. Co. v. Husen
1877, 465, 472). In 1885, the Supreme Court confirmed that this included ensuring
conditions essential to the “safety, health, peace, good order and morals of the com-
munity” as “even liberty itself… is only freedom from restraint under conditions
essential to the equal enjoyment of the same right by others” (Crowley v. Christensen
1890, 86, 89).
In 1902, in response to the increase in smallpox cases discussed above, the
Cambridge, Massachusetts Board of Health issued an order, which became law,
requiring citizens be vaccinated against smallpox or pay a $5 fine (the equivalent of
about $135 in 2015) (Massachusetts Revised Laws 1902; Commonwealth v.
Henning Jacobson 1903; Mariner et al. 2005). Henning Jacobson, a Cambridge
minister, refused both the vaccination and to pay the fine. He argued he had previ-
ously received the smallpox vaccination in Sweden as a child and had experienced
“great and extreme suffering, for a long period” as a result and that one of his sons
had experienced adverse events from vaccination as well (Commonwealth v.
Henning Jacobson 1903, 246). Jacobson argued that the law was thus “hostile to the
inherent right of every freeman to care for his own body and health in such way as
to him seems best ....” (Jacobson v. Massachusetts 1905, 26). The case went to trial.
At trial, Jacobson argued that his history of adverse reaction to the smallpox vac-
cine should grant him an exception from the law. However, the law did not actually
provide for such exceptions for adults (as it did for children). Jacobson was found
guilty of “the crime of refusing vaccination” (Willrich 2011, 285). He appealed to
the superior court, where the judge again ruled that Jacobson’s medical history was
“immaterial” to his legal violation. The judge also refused Jacobson’s plea to tell the
jury that the law was a violation of the constitutions of Massachusetts and the United
States because it offered no such exception. The court again found Jacobson guilty
(Willrich 2011).
Jacobson fared no better in the Massachusetts Supreme Court. It too rejected
Jacobson’s evidence of his prior adverse experience with the vaccination as well as
his son’s as “matters depending upon his personal opinion, which could not be taken
as correct, or given effect, merely because he made it a ground of refusal to comply
with the requirement” (Commonwealth v. Henning Jacobson 1903, 246). Moreover,
it pointed out that even if Jacobson could prove that he would suffer adverse effects
from the vaccine, the statute did not offer an exception for such a case. In response
to Jacobson’s argument that this deficiency rendered the statute unconstitutional, the
court responded that the “theoretical possibility of an injury in an individual case as
a result of its enforcement does not show that as a whole it is unreasonable. The
application of a good law to an exceptional case may work hardship” (Commonwealth
v. Henning Jacobson 1903, 247). However, the Massachusetts court held that if citi-
zens refused to be vaccinated it was not within the power of public health authorities
to vaccinate them by force (as the Boston Herald had reported occurring)
(Commonwealth v. Henning Jacobson 1903; Parmet et al. 2005).
42 L.M. Lee et al.
When the Jacobson case finally made its way to the U.S. Supreme Court, the
Court found that the vaccination statute was generally a reasonable protection of the
public health while maintaining individual liberty. The Supreme Court did conclude
that to subject someone to vaccination who was unfit because of a health condition
“would be cruel and inhuman in the last degree;” it stipulated that “we are not
inclined to hold that the statute establishes the absolute rule that an adult must be
vaccinated if it be apparent or can be shown with reasonable certainty that he is not
at the time a fit subject of vaccination or that vaccination, by reason of his then
condition, would seriously impair his health or probably cause his death” (Jacobson
v. Massachusetts 1905, 38–39). However, the Court found that Jacobson was “in
perfect health and a fit subject of vaccination” and that he simply “refused to obey
the statute and the regulation adopted in execution of its provisions for the protec-
tion of the public health and the public safety, confessedly endangered by the pres-
ence of a dangerous disease” (Jacobson v. Massachusetts 1905, 39). The Court
ordered Jacobson to submit to vaccination or pay the fine (Jacobson v. Massachusetts
1905). Three years after his legal fight began, Jacobson paid the $5 penalty (Willrich
2011).
2.2.3 Discussion
Legal cases since 1890 had allowed states to require citizens be vaccinated, but
around the turn of the century, limits to that right began appearing that included a
“present danger” standard requiring a real and immediate threat and adherence to
the harm avoidance principle protecting citizens from undue burden as much as pos-
sible (Willrich 2011). Jacobson has endured as a fundamental philosophical foun-
dation of the reconciliation of individual interests with those of the public’s health
in a political system emphasizing liberal individualism.
Despite the limitations of the facts in Jacobson, it has been interpreted in many
ways to support numerous public health activities over the past century. Notably, the
Supreme Court did not require that otherwise healthy citizens submit to vaccination,
only that it was constitutional to require citizens to be vaccinated or pay a fine. Also,
while the Court found that a lack of a health exception to the vaccination mandate
would be unconstitutional, it did not grant Jacobson this exception for himself.
However, as with so many examples in the lexicon of medical ethics, one of the
most important practical effects of historical cases is how they have been interpreted
and applied to future circumstances. Part of Jacobson’s legacy has been the Court’s
“community oriented philosophy” based in social-contract (or compact) theory
(Gostin 2005, 578): “a fundamental principle of the social compact [is] that the
whole people covenants with each citizen, and each citizen with the whole people,
that all shall be governed by certain laws for ‘the common good ….’” (Jacobson v.
Massachusetts 1905, 26). While the Court recognized individual liberty interests
protected by the Constitution, it found that these interests did not impart an absolute
right of freedom from restraint because “on any other basis organized society could
not exist with safety to its members” (Jacobson v. Massachusetts 1905, 26). It noted
that no citizen could enjoy full liberty in a society that recognized “the right of each
individual person to use his own [liberty] … regardless of the injury that may be
done to others” (Jacobson v. Massachusetts 1905, 26).
The Court also found that reasonable regulations to protect the public health and
safety were among these constitutional limits on liberty (Jacobson v. Massachusetts
1905). Despite the fact that Jacobson found mandatory vaccination distressing and
objectionable, it was the responsibility of the city board of health to “not permit the
interests of the many to be subordinated to the wishes or convenience of the few”
(Jacobson v. Massachusetts 1905, 29). As discussed above, the Court found that
exceptions were needed for citizens with established concerns for their health—but
did not apply this exception in Jacobson’s case.
The social contract implied in this case also needed to be reconciled with limits
on government and constitutional protections of individual liberty. While the Court
had already established a standard of fair application of public health interventions
(e.g., not targeting a specific race-based group) (Jew Ho v. Williamson 1900; Gostin
2008), Jacobson built on several cases to further explain standards of constitutional
protections (i.e., there must be a public health threat to the community, and the state
or board of health must design the public health intervention to combat that threat).
The Court found that the intervention must be proportionately tailored to that threat
creating a “reasonable balance … between the public good and the degree of per-
sonal invasion” and should not harm citizens in and of itself (Gostin 2008,
126–127).
While it is hard to reconcile some of the facts of Jacobson with its lofty consti-
tutional deliberation, it is the Court’s desire to reconcile individual interests with
those of the public health in a society that values liberal individualism that has
become its enduring legacy. Many court decisions following Jacobson reaffirmed
states’ use of police power for the public health (Gostin 2005), and in 1922 the
Supreme Court agreed that states could require vaccinations for children who attend
school (Zucht v. King 1922). Jacobson was an important step in the lengthy public
health battle against smallpox, culminating in its eradication in 1977 (Cohen 2000).
The legal and ethical boundaries between the individual and public health remain
mobile in public health law and policy despite the Jacobson decision.
Notwithstanding its rejection of forced vaccination, coercion—as opposed to the
modern emphasis on education—continued as a public health tactic, employed fre-
quently and often directed toward vulnerable citizens (e.g., quarantined sex work-
ers during World War I) (Colgrove and Bayer 2005). And despite the liberty
protections it carved out, the Court itself struggled with upholding both individual
rights and constitutional liberties. In 1927, citing Jacobson, the Court upheld a
forced-sterilization law in Virginia of “mental defectives.” The Buck v. Bell deci-
sion reasoned that “[i]t is better for all the world, if instead of waiting to execute
degenerate offspring for crime, or to let them starve for their imbecility, society can
prevent those who are manifestly unfit from continuing their kind. The principle
that sustains compulsory vaccination is broad enough to cover cutting the fallopian
tubes” (Buck v. Bell 1927, 207).
44 L.M. Lee et al.
In more communitarian-leaning societies, Jacobson’s value serves less as a map

for navigating public good in an individualist context, and more as an illustration of
how individual and community interests can be balanced within the political and
social structure. Even within the United States, however, Jacobson has been inter-
preted over the decades to be a foundation for diverse legal opinions supporting
remarkable expansions of federal power—including warrantless entry into homes in
time-sensitive circumstances of compelling need and a defense of the federal govern-
ment’s right to detain U.S. citizens without due process as “enemy combatants” (in a
dissenting opinion) (Willrich 2011). Many of these cases, and certainly Buck v. Bell
serve as a stark reminder that federal powers ostensibly in the public interest cannot
be used solely to maximize perceived public benefit—they must be tempered by jus-
tice and fairness to both communities and individuals (Lombardo 2008). But as the
legal community continued to struggle with what the implications and contours of
what Jacobson should be in the United States, officials continued to press on in what
was then an unregulated field—that of public health research.
2.3 Case Study: U.S. Public Health Service Research

on Sexually Transmitted Disease: Alabama
and Guatemala
Since the 1940s, contemporary research ethics has developed rapidly through a
desire to protect human participants in research. Internationally, the Nuremberg
Trials for Nazi war criminals, including the trial of Nazi physicians who conducted
torturous medical experiments on subjects, resulted in the Nuremberg Code (1947),
a compilation of guidelines for conducting research with human participants. In
1964, the World Medical Association’s (WMA) Declaration of Helsinki further
refined ethical guidance for research with humans, and in particular the participa-
tion of vulnerable populations (WMA 1964).
The next case study focuses on two separate mid-century U.S. PHS experiments
on sexually transmitted diseases in the U.S. state of Alabama and Guatemala. While
one of the ten essential public health services is to “conduct research to attain new
insights and innovative solutions to health problems” (CDC 2013b; Harrell et al.
1994, 29), these experiments demonstrate how an imbalance of population and indi-
vidual interests—coupled with disregard for respect for persons—can lead to tragic
results.
2.3.1 Background
In the early 1900s, STDs—and syphilis in particular—were major concerns for

public health. Conservative estimates suggested that syphilis affected 10–15 % of
the U.S. population (Jabbour 2000) with symptoms ranging from sores to paralysis,
blindness, and death (CDC 2013a). One leading expert at the time described syphi-
lis as a plague “which, in these times of public enlightenment, is still shrouded in
obscurity, entrenched behind a barrier of silence, and armed, by our own ignorance
and false shame, with a thousand times its actual power to destroy…” (Stokes
1920, 7). In 1905, German scientists isolated the microbe that caused syphilis, and
in 1910 other scientists proposed salvarsan (a preparation of arsenic) as the cure
(Jones 1993). Salvarsan treatment involved a painful set of injections over a long
period and ultimately turned out to be highly toxic (Jones 1993).
In 1912, the U.S. government established PHS to join other federal public health
efforts to improve administration and distribution of public health aid to the states,
to oversee interstate infectious diseases and sanitation, and to conduct public health
research (Jones 1993). In 1918, PHS established a Division of Venereal Disease to
organize and support state prophylactic and treatment work (Jones 1993). World
War I had highlighted the harmful effect of STDs on the U.S. armed forces, but after
interest in the disease from a wartime perspective abated, public health workers
focused on syphilis as a poverty-linked disease—and a disease that reportedly
affected African Americans in particular. Some physicians even argued that syphilis
was a “quintessential black disease” and African Americans a “notoriously syphilis-
soaked race” (Jones 1993, 24, 27).
Funding for and interest in preventing and treating STDs waned during peace-
time, though they remained a public health problem. With World War II on the
horizon, the director of the PHS Venereal Disease Research Laboratory argued that
“[t]he prevention of the primary invasion of the male by the syphilis spirochete, as
a means of minimizing the loss of effectiveness which is incident to established
disease, still constitutes one of the most pressing problems of military medicine”
(Mahoney 1936, 78–79). When the United States became involved in World War II,
public health officials once again became concerned about STD rates in American
troops and predicted “approximately 350,000 fresh infections with gonorrhea [in
the armed forces], [which] will account for 7,000,000 lost man days per year, the
equivalent of putting out of action for a full year the entire strength of two full
armored divisions or of ten aircraft carriers” (Presidential Commission for the
Study of Bioethical Issues [PCSBI] 2011, 12). The cost of treating the anticipated
infections was $34 million (about $465 million in 2015, adjusted for inflation)
(PCSBI 2011, 12).
In search of a more effective treatment for syphilis, U.S. PHS researchers in the
1930s had turned to African-American communities for public health research in
part because of the perception of high rates of infection, as discussed above. PHS
surveyed six southern counties and found the highest syphilis rates among black
men in Macon County, Alabama, where the city of Tuskegee serves as the county
seat. Created in part by a confluence of economic, social, and clinical
46 L.M. Lee et al.
factors—including the Great Depression, lack of public and private funds for con-
tinuation of development projects, pervasive racism in American medicine, and
failed attempts in the pre-penicillin era to treat syphilis with heavy metals—public
health researchers decided to conduct a study to observe the “natural progression”
of untreated syphilis (Brandt 1978; U.S. Department of Health, Education, and
Welfare [HEW] 1973).
The Tuskegee syphilis study or, more accurately, the U.S. Public Health Service
Study of Untreated Syphilis in the Male Negro, Macon County, Alabama, was an
observational study of 399 men with syphilis, and 201 men without, conducted from
1932 through 1972. After 40 years, it finally ended when a PHS STD investigator,
Peter Buxton, went to the press with allegations of gross ethical violations, includ-
ing a lack of informed consent for participation, deception, withholding treatment,
as well as racism and lack of scientific soundness (Jones 1993; Brandt 1978).
During this study, public health researchers posed as physicians and told the
men, who were already infected with syphilis, that they were going to treat them for
“bad blood” (which, in common vernacular referred to a range of chronic conditions
of unknown origin that could have included anything from syphilis to anemia). In
reality, the researchers were not treating the subjects for any of these diseases.
While during the salvarsan-era, nontreatment would not necessarily have made a
large difference clinically, once the Venereal Disease Research Laboratory estab-
lished that penicillin was a safe, effective, and inexpensive cure for syphilis in 1943,
the profound clinical detriment of being a study participant became clear. After
1943, the researchers actively kept subjects from receiving penicillin for other ail-
ments so as not to interfere with their ability to analyze the primary outcome of
interest, which was the natural progression of untreated syphilis (CDC 2013c).
Throughout the study, the public health researchers practiced active deceit result-
ing in 399 infected men being kept from penicillin treatment until their death or
1972 when the study was stopped. The Assistant Secretary for Health and Scientific
Affairs, under the then U.S. Department of Health, Education, and Welfare, char-
tered an advisory panel to investigate the circumstances surrounding the study. The
panel later issued the Final Report of the Tuskegee Study Ad Hoc Advisory Panel in
April 1973 (HEW 1973).
Meanwhile, the experience of soldiers during World War II had confirmed the
need for improved diagnosis and treatment of STDs. After the war, these efforts
were revitalized by animal studies that demonstrated the effectiveness of a new
post-exposure prophylaxis called “orvus-mapharsen.” PHS was interested in
whether this solution would be effective in humans, and it was believed that
establishing efficacy in humans required controlled intentional exposure in
humans—preferably via the “natural method” of sexual intercourse. Because, in
part, commercial sex work was legal in the prison in Guatemala City, Guatemala,
the researchers planned to conduct prophylaxis experiments there. The plan was to
intentionally expose prisoners to STDs through sexual intercourse with commercial
sex workers carrying infection (PCSBI 2011).
As a result, from 1946 through 1948, the U.S. government funded, via a federal
grant from the National Institutes of Health and approved by the highest echelons of
PHS (including Surgeon General Thomas Parran), STD, serological, and inocula-
tion experiments in Guatemala (Spector-Bagdady and Lombardo 2013). The
researchers, led on the ground by a senior surgeon in the PHS, John C. Cutler, soon
discovered that they could not reliably infect prison subjects with STDs through
sexual intercourse with commercial sex workers; the researchers were thus unable
to compare the effectiveness of the prophylaxis regimen they were testing. In an
effort to increase infection rates, researchers expanded to other vulnerable popula-
tions, such as soldiers and psychiatric patients, and engaged in more invasive meth-
ods of intentional exposure, such as abrasion of genitals and manually applying
syphilitic emulsion—despite objections of their PHS supervisors that the latter
methods of inoculation were scientifically unsound (PCSBI 2011).
By the end of these experiments, considered by some at the time to be “ethically
impossible” in design (Kaempffert 1947), public health researchers intentionally
exposed approximately 1300 Guatemalan prisoners, soldiers, commercial sex work-
ers, and psychiatric patients to syphilis, gonorrhea, and/or chancroid without
informed consent. The researchers documented some form of treatment for only
half of the subjects they exposed to infection (PCSBI 2011).
The Guatemala STD experiments ended in 1948 when the researchers decided
not to apply for a continuation of funding due to concerns about reporting project
activities to the approving study section and the new surgeon general in the United
States (PCSBI 2011). The Guatemala STD experiments remained undiscovered for
nearly 65 years until Cutler’s papers, uncovered in 2003, were brought to the atten-
tion of the U.S. government and presented at a professional meeting in 2010 (PCSBI
2011; Reverby 2011). Upon learning of the experiments, President Barack Obama
requested that his Presidential Commission for the Study of Bioethical Issues
(Bioethics Commission) conduct a historical review and ethical analysis of the stud-
ies in Guatemala. The Bioethics Commission concluded its analyses and reported
its results to President Obama in September 2011 (PCSBI 2011).
2.3.3 Discussion
The U.S. PHS Study of Untreated Syphilis in the Negro Male unmasked a range of
important ethical issues that fit into three fields of bioethics we now call profes-
sional ethics, public health ethics, and research ethics. Through the lens of profes-
sional ethics, the untreated syphilis study calls into question what it means to be an
ethical scientist, an ethical physician, and an ethical government steward of public
trust. Through the public health ethics lens, it raises issues of imposing the risk of
harm to individuals to benefit the community, appropriate engagement with the
affected community, and justice and fairness.
Far and away, however, the untreated syphilis study in Tuskegee had the most
substantial impact on research ethics. It was not the first study to egregiously
disrespect personal autonomy and grossly exploit vulnerable populations. Indeed,
by 1966, Henry Beecher had outlined 22 such studies in clinical research, some
48 L.M. Lee et al.
involving children, mentally and physically compromised patients, and incarcerated

individuals (Beecher 1966). Nor was it the first instance of African Americans being
mistreated by the medical establishment (Gamble 1997), but it was the first unethi-
cal study of this magnitude scandalously exposed by the mainstream media involv-
ing and funded by the U.S. federal government. While the original intent of the
untreated syphilis study in Tuskegee was to contribute to the greater and seemingly
more urgent social good, it has been remembered for withholding treatment from a
socially and politically vulnerable group by actively deceiving them.
Comprehensive scholarship has examined the legacy of the untreated syphilis
study. Its impact is as deep as it is broad in the bioethics community and the social
culture of the United States. This case study examines only the policy outcomes that
resulted from the ethical review and analysis of the untreated syphilis study, which
is but a small slice of its legacy, yet one that has profoundly shaped the way clinical
and public health research is conducted in the United States.
The Tuskegee Study Ad Hoc Advisory Panel (Advisory Panel) submitted its final
report to then Assistant Secretary for Health, Charles C. Edwards, in April 1973
(HEW 1973). The Advisory Panel found that the study was ethically unjustified in
1932 due to the lack of evidence that any consent was obtained from participants,
breaking “… one fundamental ethical rule…that a person should not be subjected to
avoidable risk of death or physical harm unless he freely and intelligently consents”
(HEW 1973, 7). Also, the lack of a study protocol or plan left the study’s scientific
soundness highly suspect, especially in light of the “disproportionately meager”
scientific data it produced (HEW 1973, 8).
Besides the lack of informed consent, other important ethical violations noted by
the Advisory Panel included researchers lying and withholding penicillin even after
it was established to be effective as a treatment for syphilis. The insults to basic
dignity and respect for persons forced on the men in the study convinced the
Advisory Panel to recommend a permanent body to regulate all federally supported
research involving human participants. This permanent body was to formulate poli-
cies for establishing institutional review boards (IRBs), compensating research par-
ticipants who suffer research-related injury, and reviewing protocols at local
institutions before beginning research studies. It also called for creating local sub-
ject advisory groups to monitor consent procedures (HEW 1973). While the
U.S. Department of Health, Education, and Welfare (now the U.S. Department of
Health and Human Services) had guidelines for research grants and contracts, the
Advisory Panel recommended “… that serious consideration should be given to
developing, through Congressional action, rules and procedures which apply to the
entire human research enterprise without reference to the source of funding” (HEW
1973, 37).
The Advisory Panel report paved the way for creation of the first congressionally
formed national bioethics committee: the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research (National Commission).
As a direct consequence of the ethical investigation into the untreated syphilis study,
and acknowledgment that this was not an isolated incident, the National Commission
began work in 1974 developing national guidelines for research involving human
participants.
The National Commission’s most cited work, the Belmont Report, outlined three
ethical principles for research still in use today: respect for persons, beneficence,
and justice (National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research 1979). It also provided guidance on informed
consent, special rules for vulnerable populations, and requirements for review of
protocols by IRBs. These recommendations, later codified into federal regulations
that govern federally funded research with human participants, continue to influ-
ence human research today—helping ensure the respectful and ethical treatment of
participants in biomedical and public health research (U.S. Department of Health
and Human Services 2009).
A more subtle, but enduring impact of the National Commission’s efforts spe-
cific to public health research was its focus on engaging the community in which
research is to be conducted. Although only anecdotally reported, a lack of trust in
government, health care, and research is widely believed to be a lasting consequence
of the untreated syphilis study (Gamble 1993; Swanson and Ward 1995). Empirical
data suggest, however, that the untreated syphilis study itself did not deter participa-
tion (Katz et al. 2008), but rather a lack of trust stemming from a larger social legacy
of racism and fears of exploitation originating in the era of slavery in the United
States (Gamble 1993). In recent times, these fears resurfaced at the onset of the
AIDS epidemic in the 1980s in the form of suspicion of intentional infection and
genocide (Jones 1993). This mistrust resulted in the distribution of misinformation
and difficulties in delivering education and care for those at high risk for HIV
(Thomas and Quinn 1991). Since then, methods and best practices for community
engagement have been developed and published both in the United States (Barnett
2012; U.S. Department of Health and Human Services 2011) and internationally
(World Health Organization [WHO] 2012; UNAIDS 2011).
When analyzing the effect of the Guatemala STD experiments on public health
ethics, it is important to note that while the experiments took place in the 1940s,
they were critically investigated only recently—65 years after their occurrence.
Despite the stark contrast of today’s regulated research context with research con-
ducted in the 1940s, scholars continue to examine the original research documents,
and our ability to learn from past errors continues. That the U.S. government, at
least, had learned lessons from the Tuskegee study is evident by the swiftness of its
response to the discovery of the Guatemala STD experiments. While it took 25 years
for a U.S. president to apologize to the Tuskegee syphilis study participants, fami-
lies, and community (The White House 1997), President Barack Obama called
President Alvaro Colom of Guatemala to apologize for the STD research immedi-
ately following the announcement of its discovery to the public in 2010.
The PHS research studies in Tuskegee and Guatemala demonstrate the serious
consequences that can result when the relative interests of the individual and the
population are inappropriately reconciled. Indeed, these abuses of individual
research subjects have created an enduring legacy of cautionary tales that, together
with an orientation toward liberal individualism, have provided a lasting and
powerful check on public health authority in the United States. Major policy
changes were put into practice after the discovery of the syphilis studies in Alabama.
50 L.M. Lee et al.
These policies were intended to protect research participants from being treated as
mere means to an end, to bring back into equilibrium the individual and population
interests that public health must reconcile. Still, public health interventions continue
to face resistance to actions perceived to limit individual choice—making substan-
tive engagement of the relevant community even more critical for turn-of-the-cen-
tury public health campaigns. The case that follows describing the New York City
A1C Registry highlights how, even after all of the regulatory and ethical work
accomplished over the past four decades, innovative approaches to public health
advances interpreted to curtail some individual liberty can still inspire debate about
the optimal role of government in promoting public health.
2.4 Case Study: The New York City A1C Registry
Public health increasingly has focused on secondary prevention, or the prevention

of disability from disease. As the burden of disease in the United States has shifted
from communicable diseases like smallpox and STDs to noncommunicable
diseases, public health professionals face new ethical challenges related to
monitoring chronic conditions and inspiring individuals to improve their health.
The following case illustrates how new technologies affect public health
interventions and can limit the precedent set by Jacobson when health risks are
neither communicable nor imminent. Such cases call for a recalibration of population
and individual interests when considering dramatically different health and social
settings.
2.4.1 Background
Although infectious diseases accounted for more than 80 % of deaths in the United
States in the 1900s (Steinbrook 2006), in 2011, WHO estimated that noncommuni-
cable diseases were responsible for 66 % of deaths worldwide (WHO 2013). These
changes in the causes of morbidity and mortality are typical of an “epidemiologic
transition,” a population health phenomenon that occurs when populations carry out
public health measures such as sanitation and immunization, which decrease death
rates from infectious diseases, increase life expectancy, and simultaneously begin to
increase risk for noncommunicable conditions (McKeown 2009).
Of noncommunicable disease deaths worldwide in 2008, deaths from diabetes
alone accounted for 1.3 million (WHO 2011). In the United States, 8.3 % of the
population (about 25.8 million people) had diabetes in 2011 (CDC 2011). Because
of the significant impact that noncommunicable diseases, such as diabetes, have on
health systems, WHO has promoted lifestyle modifications and other public health
interventions (WHO 2011).
Several interventions, such as providing advice about physical activity and a
healthy diet to people with impaired glucose tolerance, have lowered rates of diabe-
tes (Dornhorst and Merrin 1994; Ramachandran et al. 2006). Research also has
shown that controlling blood sugar levels (measured by A1C levels), blood pres-
sure, and LDL cholesterol can reduce the risk of long-term complications and death
among people with diabetes (Chamany et al. 2009). Some evidence suggests
improvements from educating patients in diabetes management, but more evidence
is needed (Chamany et al. 2009).
Although there are effective ways of controlling risk factors for complications
once diabetes is diagnosed, management of these risk factors across the United
States has been deemed inadequate (Chamany et al. 2009). In New York City the
percentage of adults who reported having diabetes more than doubled from 3.7 % in
1994 to 9.2 % in 2004 (Chamany et al. 2009). A 2005 report of the New York City
Department of Health and Mental Hygiene (NCY DOHMH) showed that diabetes
prevalence was higher among non-white residents (NCY DOHMH 2007; NCY
DOHMH 2006a). In 2004, NCY DOHMH found that diabetes was the fourth lead-
ing cause of death in the city’s population (NCY DOHMH 2004), and a survey of
New York City adults in 2004 showed that fewer than 10 % of those with diabetes
were able to manage blood sugar, blood pressure, and cholesterol satisfactorily
according to city public health standards (Chamany et al. 2009). In New York City,
37 % of diabetes patients on state and federally funded Medicaid had an A1C level
(reflecting average blood sugar) greater than 9 %—which suggests poor glycemic
control (Barnes et al. 2007). WHO has found that policies that promote manage-
ment of these risk factors have potential to reduce spending for individuals and the
public (WHO 2011).
In December 2005, the NCY DOHMH submitted a proposal to the New York City
Board of Health that would require laboratories with electronic reporting capabili-
ties to submit A1C test results for New York City residents to the NCY DOHMH
(NCY DOHMH 2005a). After a period for public comment, the New York City
Board of Health approved this proposal, creating the first U.S. program requiring
public health reporting of A1C results. Supported by evidence from the success of
other disease control programs (such as programs targeting lead poisoning and
tuberculosis), this program established a public health surveillance system to track
diabetes in the population and to support those who could benefit from diabetes
control (Chamany et al. 2009).
The mandate required applicable laboratories to submit A1C test results to the
NCY DOHMH within 24 h of completion. Data to be reported included date of
the test; name of the testing facility; name and address of the ordering facility or
provider; and name, address, and date of birth of the individual tested (Chamany
et al. 2009). The NCY DOHMH proposed to use the reported A1C results to gener-
ate a registry to monitor glycemic control in the New York City population and to
provide mechanisms to support patients and physicians in controlling diabetes
52 L.M. Lee et al.
(NCY DOHMH 2005a). The data in the registry were analyzed by various factors
including age, location, and type of health care facility to determine distinctions in
testing patterns, health care usage, and glycemic control. However, race and ethnic-
ity data were not reported and therefore not included in the longitudinal analysis
(Chamany et al. 2009).
After the A1C test results reached the NCY DOHMH, if the average blood sugar
level exceeded a predetermined threshold, the patient and provider were notified.
Providers were mailed a roster of their patients ordered from highest to lowest A1C
level, listing the patients’ two most recent test results calling special attention to
A1C levels greater than 9 % (NCY DOHMH 2006b). Patients at least 18 years of
age with an A1C level greater than 9 % or who were overdue for testing also received
a letter informing them of their test results, advising them on how to control their
A1C level, and specifically recommending a follow-up appointment with their pro-
vider. The letter was printed in English and Spanish (NCY DOHMH 2005a).
The goals of the provider and patient notification program were to increase pro-
viders’ knowledge about glycemic control in their patient population, facilitate pro-
viders in assisting and guiding patients at high risk for complications, and inform
and aid patients at high risk for devastating sequelae (NCY DOHMH 2012). While
patients had the option to opt-out of the provider and patient notification program,
laboratories were still required to report their data to the registry (NCY DOHMH
2005b). Reported data were held confidentially and were unavailable to insurers,
licensure organization, or employers (NCY DOHMH 2005c). In 2009, 3 years after
initiation of the program, 4.2 million A1C test results for almost 1.8 million indi-
viduals were registered with the NCY DOHMH (Chamany et al. 2009).
2.4.3 Discussion
The mandated reporting of A1C results in New York City and the interventions that
followed stimulated discussion about the role of government in preventing noncom-
municable diseases. Mandated communicable disease reporting is a longstanding
and widely accepted essential public health practice, but the modern technology
available to collect, analyze, and respond to health data today is unprecedented.
While there are clear population interests in controlling the sequelae of diabetes—
preventing limb amputations and reducing care disparities, for example—there are
also individual interests such as privacy and self-determination at stake. Current
public health ethics frameworks must consider the tension between individual and
population interests in conjunction with the social, epidemiologic, technologic, and
economic context of the case.
Proponents of the A1C Registry argued that outreach for noncommunicable dis-
ease is an integral part of public health practice and indeed is an obligation of public
health agencies, especially for a disease deemed epidemic (WHO 2011). They
argued that the A1C Registry allowed practitioners to identify patients in greatest
need of follow-up or referral—often patients with fewest resources—and develop
disease management strategies (Chamany et al. 2009). One of the program’s goals
in mailing test results to patients was to enable them to better manage their own
diabetes (e.g., only 10 % of people with diabetes know their own A1C level) (Berger
and Silver 2008).
Others criticized some of New York City Mayor Michael Bloomberg’s public
health policies and interventions as creating a “nanny state” (characterized by being
overly controlling of the lives of its citizens) (Magnusson 2014). Some patients
believed that the A1C Registry represented an unwarranted invasion of privacy
(Barnes et al. 2007), and some providers considered it an intrusion in the provider–
patient relationship (Goldman et al. 2008). Many who argued against public health
interventions such as the A1C Registry view choices about food and health—even
when damaging—as choices that should enjoy a high degree of autonomy uninflu-
enced by government (although they generally are silent about the influence of food
and beverage industry advertising). A public health entity with fiscal and moral
interests in the well-being of its citizenry should also work to ensure that individuals
have accurate and actionable information with which to make their health decisions
(Thaler and Sunstein 2008).
Unlike the early 1900s when Jacobson was decided, or the 1940s when the U.S.
PHS STD research was conducted in Alabama and Guatemala, we now have several
public health ethics frameworks that help us approach ethical issues more system-
atically (Kass 2001; Childress et al. 2002; Baum et al. 2007; Bernheim et al. 2007).
These frameworks reflect attempts to reconcile individual and population interests
outlined by the Jacobson Court. For example, the A1C Registry case raised issues
relating to principles of least infringement, social justice, health equity, and evi-
dence of benefit.
When applying these ethical precepts to the A1C Registry case, the principle of
least infringement requires that public health pursue the least intrusive course of
action that still achieves the public health goals. The A1C Registry attempted to
accommodate this principle by allowing people to opt out, which prevented NCY
DOHMH from contacting patients and their clinicians, but did not relieve the labora-
tory from submitting reports to the registry. While the opt-out mechanism gives indi-
viduals some control over how their data are used, it can still allow a public health
entity to seek to improve constituents’ well-being with minimal infringement.
Policy makers must also explain the aims of the program and whether benefits
and burdens are expected to be distributed equitably throughout the population. In
the A1C Registry case, these foundational values of social justice and health equity
in large part motivated the reporting system. In New York City, substantial differ-
ences in morbidity and mortality by race/ethnicity and neighborhood income level
were evident. NCY DOHMH use of the data to identify and then reduce these dif-
ferences promoted public health goals. One challenge in addressing such disparities
is to ensure efforts do not inadvertently increase disparities or cause other social
harms, including stigma or loss of social capital.
Finally, policy makers have a duty to ensure public health programs are effective,
including empirically evaluating programs to provide evidence of this effectiveness.
In developing the A1C Registry, policy makers compiled evidence from effective
54 L.M. Lee et al.
public health programs to help explain the need and potential effectiveness of this
program. As the NCY DOHMH evaluates the program and collects evidence of the
A1C Registry’s effect on diabetes in the city, it might alter policies and procedures.
Empirical data on the effectiveness of the registry are pending, and those results will
certainly play an important role in assessing the program’s scientific and ethical
rationale. As this brief analysis demonstrates, contemporary frameworks to guide
ethical public health decision making offer additional nuance to the foundational
tension between individual and population interests.
The case of the A1C Registry draws attention to important implications of the
Jacobson precedent and the continued influence of major historic breaches of public
health ethics. The current agreed-upon equilibrium in the United States emphasizes
individualism, even as similar noncommunicable disease public health campaigns
continue to be established (e.g., attempting to control the addition of trans fats to
foods and the size of sugar-sweetened beverages) (Gostin 2013). These contempo-
rary cases in the United States are being established and deliberated in a climate of
changing health care policy and in the absence of an agreed-upon framework for
public health ethics. The challenges they elucidate, however, are likely to have an
important impact on the future role of public health in health care.
2.5 Conclusions and Implications
The cases discussed here demonstrate how providing essential public health ser-
vices requires ethical principles and analysis as varied as the goals they hope to
achieve. Clinical and research ethics play a role, but are not sufficient for the con-
sideration of competing public health values. More substantial limits on liberty and
privacy can be justified as public health ethics aims to alleviate the “collective haz-
ard,” as opposed to individual risk, for both motivation and validation of interven-
tions (Bayer and Fairchild 2004). However, as the cases in Alabama and Guatemala
underscore, limitations on power are as important as justifications.
In different ways, the cases outlined here shaped public health practices and ethi-
cal expectations in the United States. However, as our world grows more connected
and our work increasingly crosses jurisdictional boundaries, it is clear that there are
common values that motivate public health ethics even in vastly different political,
social, and economic contexts. The global setting in which many public health pro-
fessionals work requires attention to such contextual factors.
Many of the cases outlined in the chapters that follow uncover additional ethical
considerations affecting daily public health practice wherever that practice occurs.
Whether it is social duty or political feasibility of the negative right to noninterfer-
ence, case studies can clarify ethical dimensions, help us examine alternatives for
approaching decisions, and remind us that ethical decision making in public health
is not an optional endeavor in any case. These case studies underscore the need to
identify decision-making frameworks that lead to careful consideration of individ-
ual and public interests, as a disregard for one or the other is perilous to both.
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Section II
Topics in Public Health Ethics
Chapter 3
Resource Allocation and Priority Setting
Norman Daniels
3.1 Resource Allocation in Public Health
There has been much discussion of resource allocation in medical systems, in the
United States and elsewhere. In large part, the discussion is driven by rising costs
and the resulting budget pressures felt by publicly funded systems and by both
public and private components of mixed health systems. In some publicly funded
systems, resource allocation is a pressing issue because resources expended on one
disease or person cannot be spent on another disease or person. Some of the same
concern arises in mixed medical systems with multiple funding sources.
Although much has been written on resource allocation issues in medicine, there
has been less discussion about how resource allocation affects public health. Federal,
state, and local public health budgets in the United States constrain investments in
health at those levels. In this regard, they are more like some foreign medical
systems than the more fragmented and mixed public-private medical system of the
United States. In the context of budget cuts domestically and in many countries
responding to an economic downturn, how to invest (and allocate) public health
resources is a pressing issue.
Most investments in public health aim to reduce population health risks, but
some risks are greater than others, and resource allocation decisions must respond
to risks. Sometimes resource allocation decisions focus on the immediate payoff of
reducing risks from a specific disease, whereas other resource allocation decisions
affect the infrastructure needed to respond to health risks over time. In addition,
resource allocation decisions may determine who faces risks—the distribution of
The opinions, findings, and conclusions of the author do not necessarily reflect the official position,
views, or policies of the editors, the editors’ host institutions, or the author’s host institution.
N. Daniels, PhD (*)
Department of Global Health and Population, Harvard T.H. Chan School of Public Health,
Boston, MA, USA
e-mail: ndaniels@hsph.harvard.edu

62 N. Daniels
risks matters, not just the aggregate impact. Resource allocation in public health
thus focuses on deciding what risks to reduce—which depends in part on their
seriousness as population factors and who faces them—and how to reduce risks.
The cases in this chapter that discuss resource allocation force us to contemplate
decisions about priorities in public health as opposed to the more frequently
discussed medical issues about health care priorities. Later we suggest that making
decisions about these issues should be part of a deliberative process that emphasizes
transparency, stakeholder participation, and clear, relevant reasoning.
3.2 Collective Lessons from the Cases
Collectively, these resource allocation cases bring out several important points.
Separately, they raise other central issues. It is worth noting these general issues
before commenting on the more specific problems raised by each case.
The first point the cases collectively make is that efficiency has ethical and not
just economic importance (Daniels et al. 1996). If one health system is more efficient
than another, it can meet more health needs per dollar spent than the less efficient
one. If we want systems to meet more health needs, and we should, then we prefer
more efficient health systems. Specifically, if we think we have obligations to meet
more health needs, or if we think meeting more “does more good,” and we ought to
do as much good as we can with the resources we have, then we have an ethical
basis for seeking more efficient health systems. The economic pursuit of efficiency
should not, then, be dismissed as something that has no ethical rationale.
A second point the cases collectively make is that efficiency is not the only goal of
health policy, for we have concerns about how health benefits are distributed as well as
how they add up. Health policy is not only concerned with improving population health
as a whole, but also with aiming to distribute that health fairly (Daniels 2008). That
means many resource allocation decisions involve competing health policy goals.
The point about competing goals is illustrated by a problem often encountered in
policy decisions: should we always favor getting the best outcome from the use of a
resource, or should we give people “fair” chances to get a benefit if it is at least
significant (Brock 1988)? For example, during an influenza pandemic, should we
allocate ventilators to those with the best chance of survival, or should we give
significant but lesser chances to a broader group?
Reasonable people often disagree about when the difference in expected benefits
means we should favor best outcomes over fair chances, or even about what counts
as a fair chance. Hence, a third point emerges from the cases taken collectively:
reasonable people often disagree about the choice, and it is not possible to simply
dismiss one side as irrational or insensitive to evidence and argument (Daniels and
Sabin 2008). Indeed, reasonable people will disagree about how much priority to
give to the sickest (or worst off) patients. They may think we have to weigh the
seriousness of an illness against the potential benefit that we know how to deliver,
they may disagree about how to trade off those considerations, or they may disagree
3 Resource Allocation and Priority Setting 63
about when modest benefits to larger numbers of people outweigh greater benefits
delivered to fewer people. Together these “unsolved rationing” problems—the best
outcome versus fair chances problem (when to prefer best outcomes to fair chances),
the priorities problem (how much priority to give to those who are worst off), and
the aggregation problem (when do modest benefits to more people outweigh signifi-
cant benefits to fewer people)—mean that there is pervasive ethical disagreement
underlying many resource allocation problems (Daniels 1993).
There are other common sources of disagreement. One of the most common
sources of controversy in resource allocation decisions arises when a particular inter-
vention is seen as the last chance to extend life by some—a necessity if we are to act
compassionately—and when it is seen primarily as an unproven intervention by others
that we have no obligation to provide it. Denials of such interventions in last-chance
cases have been considered the “third rail” of resource allocation decisions (Daniels
and Sabin 2008). Here we have two competing public values—compassion and stew-
ardship—and most public officials would prefer to be seen by the public as commit-
ted to saving lives rather than as hard-nosed stewards of collective resources.
The cases taken collectively bring out one final point: our main analytic tools for
aiding resource allocation decision making are limited in several ways, particularly
by insensitivity to various ethical issues, especially issues of distribution. In short,
these tools may take the first point, about the importance of efficiency, seriously, yet
fail to help us with the second and third lessons the cases collectively bring out, that
we are also interested in distributing efficiently produced health fairly, and that rea-
sonable people disagree about how to do that. To see this, consider two widely used
tools: comparative effectiveness research (CER), which has been given prominence
as a research focus in the Patient Protection and Affordable Care Act of 2010, and
cost-effectiveness analysis (CEA). Both help to answer policy-making questions. For
example, a typical use of CER compares the effectiveness of two interventions
(drugs, procedures, or even two methods of delivery), and policy makers may want
to know if a new technology is more effective than older technologies.
Of course, they may also want to know if the new technology provides additional
effectiveness at a reasonable cost, which points to a shortcoming of much CER in
the United States, where considerations of cost are generally avoided. Similarly, if
there is only one effective treatment for a condition, CER tells us nothing useful. It
also tells us nothing about whether a more effective intervention is worth its extra
cost. And, CER cannot help us compare intervention outcomes across different
disease conditions, since it uses no measure of health that permits a comparison of
effectiveness. Indeed, decision makers face many resource allocation questions that
cannot be answered by CER, even if CER can help avoid wasteful investments in
interventions that do not work or that offer no improvement over others.
In Germany, however, CER is combined with an economic analysis that takes cost
into account and that allows the calculation of “efficiency frontiers” for different classes
of drugs (Caro et al. 2010). Presumably, this method could be extended to different
classes of public health interventions if they are grouped appropriately. To calculate an
efficiency frontier, the effect of each drug in a class in producing some health outcome
is plotted against its cost, and the curve is the efficiency frontier for that class of drugs.
64 N. Daniels
It is then possible to calculate if a new intervention in that drug class improves effec-
tiveness at a price more or less efficient than what is projected from the existing effi-
ciency frontier. This use of CER allows German decision makers to negotiate the price
of treatments with manufacturers, rejecting payments that yield inefficient improve-
ments. German policy makers can then cover every effective intervention sold at a price
that makes it reasonably efficient. Still, because German use of CER cannot make
comparisons across diseases, it allows vast differences in efficiency across conditions.
CEA aims for greater scope than CER. It deploys a common unit for measuring
health outcomes, either a disability-adjusted life year (DALY) or a quality-adjusted
life year (QALY). This unit purports to combine duration with quality, permitting us
to compare health states across a range of disease conditions. With this measure of
health effects, we can construct a ratio (the incremental cost-effectiveness ratio, or
ICER) of the change in costs that results from the new intervention with the change
in health effects (as measured by QALYs or DALYs). We can then calculate the cost
per QALY (or DALY) and arrive at an efficiency measure for a range of interven-
tions that apply to different conditions.
Critics have noted problematic ethical assumptions in the construction of the
health-adjusted life-year measures and in the use of CEA (Nord 1999; Brock 2004).
To see some of these problems, consider the following table:
Rationing problem CEA Fairness

Priorities No priority to worst off Some priority to worst off
Aggregation Any aggregation is OK Some aggregations OK
Best outcomes/Fair chances Best outcomes Fair chances
CEA systematically departs from judgments many people will make about what
is fair. The priorities problem asks how much priority we should give to people who
are worse off. By constructing a unit of health effectiveness, such as the QALY,
CEA assumes this unit has the same value, regardless of who gets it or wherever it
goes in a life (“A QALY is a QALY” is the slogan). But intuitively, many people
think that a unit of health is worth more if someone who is relatively worse off
(sicker) gets it rather than someone who is better off (less sick) (Brock 2002). At the
same time, people generally do not think we should give complete priority to those
who are worse off. We may be able to do little for them, so giving them priority
means we would have to forego doing more good for others. Few would defend
creating a bottomless pit out of those unfortunate enough to be the worst off.
Similarly, CEA assumes that we should aggregate even small benefits. Then, if
enough people get small benefits, it outweighs giving large benefits to a few. But
intuitively, most people think some benefits are trivial goods that should not be
aggregated to outweigh larger benefits to a few (Kamm 1993). Curing many people’s
colds, for example, does not outweigh saving a single life.
Finally, CEA favors putting resources where we get a best outcome, whereas
people intuitively favor giving people a fair (if not equal) chance at a benefit.
Locating an HIV/AIDS treatment clinic in an urban area may save more lives than
placing a clinic in a rural area, but in doing so, we may deny many people a fair
chance at a significant benefit (Daniels 2004).
In all three of these examples of rationing problems, CEA favors a maximizing

strategy, whereas people making judgments about fairness are generally willing to sac-
rifice some aggregate population health to treat people fairly. In each example, whether
it is giving some priority to those who are worse off, viewing some benefits as not
worth aggregating, or giving people fair chances at some benefit, fairness deviates from
the health maximization that CEA favors. Yet we lack agreement on principles that tell
us how to trade off goals of maximization and fairness in these cases. People disagree
about what trades they are willing to make, and this ethical disagreement is pervasive.
Determining priorities primarily by seeing whether an intervention achieves some
cost/QALY standard is adopting a health maximization approach. This approach departs
from widely held judgments about fairness, even where people differ in these judg-
ments. Thus, the National Institute of Clinical and Health Excellence (NICE) in the
United Kingdom has had to modify its more rigid practice of approving new inter-
ventions only if they met a cost/QALY standard in the face of recommendations from
its Citizens Council. This council, intended to reflect representative social and ethical
judgments among British citizens, has proposed relaxing NICE’s threshold in vari-
ous cases where judgments about fairness differed from concerns about health maxi-
mization. The judgments of the Citizens Council in this regard agree with what the
social science literature suggests are widely held views in a range of cultures and
contexts (Dolan et al. 2005; Menzel et al. 1999; Nord 1999; Ubel et al. 1999, 2001).
There are, of course, those who criticize departures from the NICE threshold of
the sort that the Citizens Council recommended. Compromising the maximization
of health that CEA promotes may be seen as a moral error, perhaps the result of
elevating the rescue of an “identified” victim (say, a cancer patient whose life might
be extended modestly by a new drug) over benefits to “statistical” lives (using the
resources to provide greater benefits to others). The reasonable disagreement about
how to proceed suggests that we should view CEA as an input into a discussion
about resource allocation, not as an algorithm for making decisions. This “aid to
decision making” role was proposed by the Public Health Service in its recommen-
dations about the use of CEA (Gold et al. 1996). In short, controversial ethical
positions are embedded in CEA, and using CEA uncritically commits one to these
views, even though many disagree with them.
3.3 Specific Ethical Issues in Resource Allocation
We have already noted that the efficiency of a health system has ethical consequences.
But what should we count as efficiency? Should we use our resources to generate
more revenues for a unit of the health system—say, a hospital? Doing so would
define efficiency the way most businesses do: other things being equal, an allocation
that produces a greater return on investment is a more efficient use of stockholder or
owner resources. Alternatively, we might narrow the range of effects to health effects
on the covered population. Then we have greater efficiency when an allocation pro-
duces more positive health effects in that population than an alternative allocation.
66 N. Daniels
The case Guzmán brings from Colombia raises this issue forcefully. Should
hospitals, or a specific health plan, allocate resources favoring services (certain
treatments) that raise more revenues than an alternative allocation (certain preven-
tive measures)? Perhaps the gains from the treatments will involve fewer population
health gains over time than those obtained by the preventive or health promotional
measures, even if they show their improvement more quickly and so look better
sooner. Which plan should the policy maker adopt?
This issue examines our purpose in designing a health system. Is it to meet the
health needs of a population or is it to provide a good return on investment for those
who invest in health services? We might think that this question is easier to answer in
a system where health care delivery is seen largely as a public undertaking aimed at
improving population health. In such a system, it might seem that there is only one
purpose behind the health care system. Return on investment for the taxpayer funding
such a system should be measured by how efficiently the system improves popula-
tion health. In systems where resources are owned privately (and there are many of
these), however, it seems we must consider at least two goals. Even if the private
sector must in part seek to improve population health, which may be a requirement
of state-imposed health care regulation or, in some people’s opinions, a social respon-
sibility of corporations, private health-care organizations still must deliver a reason-
able return on investment for owners. Thus, policy makers within private health-care
organizations have a dual task. Balancing return on investment with improvement in
population health thus becomes the central issue in the Colombian case study.
The Chilean case written by Gómez and Luco raises a similar issue, but this case
focuses on measurable differences in the cost effectiveness of certain services and
in the severity of two conditions. If we consider only cost effectiveness, we view
efficiency in one way—the best health outcomes in the aggregate for the population
for an investment in health. If we take severity of condition into account, we might
view this as an equity demand—in which case, we have an efficiency-equity conflict
and must make a trade-off. Or, we might think of efficiency as a ranking of needs by
severity of condition. In the latter, the resource allocation case turns on how we
define efficiency. Specifically, the Chilean category of Guaranteed Health Interventions
could include cataract surgery (the leading cause of blindness in the Chilean population),
but not multiple sclerosis (MS) treatments, which might be viewed as maximizing
efficiency in a standard sense. Or, the Guaranteed Health Interventions scheme
could include the less cost-effective treatment of MS but not cataract surgery, since
MS is viewed as a more severe condition (because it can be life threatening and lead
to premature death), even if it is far less prevalent than cataracts. If this were the
case, the more efficient system, in this nonstandard view, would rank treating more
severe conditions as more efficient than treating less severe conditions. If budget
limitations mean only one should be included in the Guaranteed Health Interventions
program, either MS or cataract surgery, which should it be?
The cataract surgery intervention delivers a significant benefit in terms of QALYs
to a larger part of the population than does the intervention package for MS, but the
greater severity of premature death seems to be an important reason for favoring
MS. If this reason is given priority over cost effectiveness and over the standard
view of efficiency, then are less effective treatments for more severe conditions
supposed to have priority over more effective and cost-effective treatments for less
severe conditions? If so, what kind of a health system does that produce if all needs
can not be met given resource limits? Alternatively, do we want a system that always
weighs cost effectiveness more highly than the severity of a condition that some
people have? That too seems problematic.
Suppose we think improving population health is a worthwhile and defensible
goal of a health system, we favor improving population health over increasing
revenues for the private sector (in the Guzmán case), and we also favor giving prior-
ity to cost effectiveness over severity of a condition (in the Gómez and Luco case).
A conflict still remains between health maximization in the aggregate and concerns
about equity, as illustrated in the Blacksher and Goold case (and arguably in the
case about triage in pandemics by Smith and Viens).
In the case that Blacksher and Goold describe, the task is to decide whether to
reallocate resources from a program focused on maternal-child health and reduction
of black-white infant mortality disparities to a program that may get more health per
dollar spent through other interventions. Infant mortality among blacks and whites
has declined rapidly in the United States; and in absolute terms, the decline has been
more rapid for blacks. Still, the ratio of black infant mortality to white infant mortal-
ity has increased. Because the public health department is in a highly segregated
city, this shift in program focus might seem to require viewing the remaining black-
white health disparities as morally acceptable (especially given the high rate of
improvement that past programs gave to black infant mortality rates). When should
we view health disparities as morally acceptable? When should we weigh reducing
health disparities as more important than some aggregate gains in health that we
know how to produce in a population? If public health has two goals—improving
population health and distributing that health fairly—how should we weigh the
goals when they conflict?
One important feature of the Blacksher and Goold case, namely the opinions
within the community whose inequalities are at issue, is really a feature to which
nearly all cases warrant attending. People affected by a policy ought to have some
influence in determining that policy. Some people might believe this is what democ-
racy requires. A difficulty this view of democracy faces, however, is that those who
speak for the community may not appropriately represent the community affected
by the decision. Nevertheless, the opinions of a broader range of stakeholders may
improve deliberation (depending on how those opinions are managed). It may also
improve the acceptance of the decisions, which arguably enhances the legitimacy of
the decision-making process.
Resistance to including a broader range of stakeholders in decision making about
health priorities may come from a concern that they bring with them “partiality.”
This resistance may come from the view that greater impartiality leads to better
deliberation. Arguably, this concern about partiality ignores the positive gains that
partiality often brings to deliberation, especially if we know how to manage such
deliberation so that we minimize the risks that partiality sometimes brings. We need
such management skills in any case since partiality is unavoidable in most contexts.
Rather than banning what cannot be eliminated, managing partiality in deliberations
is the best way to improve decision making in contexts of reasonable disagreement.
68 N. Daniels
The conflict between improving population health and treating people fairly can
arise in other contexts. Arguably, the problem raised by Smith and Viens about the
principle that should govern triage in pandemics can be viewed as a conflict between
health maximization, in this case, saving the most lives, versus recognizing the
claims that the sickest people have on us for assistance. Ordinarily, health systems
give some priority to those who are sickest, but should that priority disappear in favor
of saving lives when scarce resources, such as ventilators, are allocated in pandemic
conditions? If we allocate our ventilators to the sickest patients, we may save fewer
lives than if we allocate them to those whose lives we can better expect to save. Even
if we think we should give priority to those worst off, do we ordinarily think that
concern for them should govern triage policy in pandemics? If we believe saving the
most lives trumps concerns about helping those who are sickest in pandemics, can we
justify why the priority we give to the sickest should be revised in pandemics?
Suppose we have an acceptable way of measuring the burden of disease in a popu-
lation, and according to this measure, mental illness is not given the priority it ought
to have. That is, it contributes more to the burden of disease than is normally recog-
nized in standard health systems, which provide too few services to meet mental
health needs. This is the problem upon which Rentmeester et al.’s case focuses.
Specifically, some mental health conditions require significant resources for what
Medicaid terms as “behavioral management,” which is seen as a social support
service not a medical treatment. As a result, these services, to the extent they are
provided, fall to state-funded social service budgets. The services place a burden on
state finances that would be diminished if they were instead included in Medicaid
budgets (50 % of which are financed by each state). Arguably, the stigma that attaches
to mental health issues is one important reason for this underprovision of social sup-
ports for people with mental health issues. In Nebraska, the political opposition to
expanded Medicaid coverage through the Affordable Care Act adds to the burden on
state budgets and the potential under-servicing of these mental-health induced needs.
It takes resources to meet public health needs. Suppose we can increase the resources
to meet some of those needs by accepting a public-private partnership that improves a
compromised private partner’s image? Should we meet health needs at this price?
That is the issue posed by the Hernández-Aguado case from Spain. Specifically,
should public health authorities put their stamp of approval, in the form of their
logo, on flu epidemic notices printed on soft drink labels? The inclusion of the logo
is a requirement of the private entities that are willing to donate space on the labels
of their products. Obviously, this provides a form of public support for soft drinks
that arguably contribute to obesity in a population and thus to the prevalence of
noncommunicable diseases associated with obesity. But in view of the low budgets
available for flu warnings, is this a price worth paying? What would the decision
maker have to know about the effects of such labels to decide this case, or is the
decision something that can be made independently of the specific payoffs of imple-
menting the warning system? Is there a way to consider the cost and assess whether
the outcome of the warning is worth this price? Is this simply an efficiency calcula-
tion about the cost effectiveness of reducing a disease burden in this way?
3.4 Decision-Making Process
One final crosscutting issue lurks behind all the cases in the resource allocation
chapter (perhaps all the cases in the volume)—namely, the nature of the decision-
making process that addresses the issues they raise. Public health decisions about
resource allocation—judging from the cases on that topic in this volume—face
reasonable ethical disagreement. That is because the tradeoffs involved in the two
main goals of public health policy—improving population health and distributing
health fairly—are trade-offs about which people often reasonably disagree. How
can public health decisions be made in real time, given these ethical disagreements,
in ways that enhance their legitimacy and are arguably fair to all parties?
One approach to the problem is to construct a fair process for making those decisions
and to rely on the outcomes of such a process. People will judge the outcomes of a fair
process to be fair (Daniels and Sabin 2008). What conditions should such a decision-
making process meet if it is to be considered fair? Four conditions are arguably neces-
sary (even if some may think they are not sufficient and want to add others): (1) The
decisions and the rationales for them should be made public. (2) They should be based
on reasons all think are relevant. (3) They should be revisable in light of new evidence
and arguments. And (4), these conditions should be enforced so that the public can see
that they obtain. Some explanation is needed for these conditions.
The publicity condition is widely embraced, even if it is fairly strong. It calls for
the grounds for decisions—not just the content of the decisions—to be transparent.
People have a right to know why decisions that affect their health are made the
way they are. Moreover, making the reasoning for such decisions public is a way of
exposing them to scrutiny so errors in reasoning or evidence can be detected and
decisions improved. Even though we may not be able to be explicit in advance about
all criteria we use to decide such cases, that is, we may work out our reasons through
deliberation, we can explain on what we base our decisions. And that gives people
affected by our decisions the knowledge they have a right to possess.
The search for reasons that all consider relevant to making a reasonable public
health decision about resource allocation can narrow disagreement considerably.
Even if people can agree on what reasons they think are relevant—in the spirit of
finding mutually justifiable grounds for their decisions—they may not agree about
the weight they give these reasons. One way to test the relevance of such reasons is
to subject them to scrutiny by an appropriate range of stakeholders. What counts as
appropriate may vary with the case. Who should be heard in deliberations is itself
worthy of deliberation. Stakeholders raise different arguments that should be heard,
and including their voices improves buy-in to decisions. Since stakeholders may not
in many instances be elected representatives, we may be skeptical about whether the
democratic process is improved by including them, but, if the deliberation is well
managed, the quality of the discussion may improve greatly.
The revisability condition, requiring that decisions be modifiable in light of new
evidence and argument, is also widely embraced and not considered controversial.
Decisions are made on the basis of evidence and arguments, and better evidence and
70 N. Daniels
arguments may emerge that require revisiting some decisions. Some decisions can
then be modified, though it may be too late for others, and our consolation is that we
made the best choices we could, given the evidence and arguments.
The intent of the enforcement condition is to ensure that the other, more substan-
tive, conditions are met. Sometimes enforcement is a matter of state regulation.
Sometimes it can be the result of voluntary conformance with a process.
Since ethical disagreements abound in resource allocation decisions, we need a
process that enhances legitimacy. But can we claim that a decision-making process that
is fair yields fair outcomes? One view is that we may ultimately become persuaded by
a good argument that fairness requires a different decision than one that emerged from
a fair process. We can in this way defeat the fairness we might ordinarily attribute to the
outcome of a fair process. Does the prospect of defeating the fairness of a decision
emerging from a fair process mean that we should not attribute fairness to the out-
comes? Alternatively, we can admit that the fairness that comes from a deliberation is
only “defeasible” fairness, but it is the fairest conclusion we can reach at the time.
References
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tion technology: Ethical, legal, and public policy issues, ed. D. Matheiu, 86–99. Boulder:
Westview Press.
Brock, D. 2002. Priority to the worst off in health care resource prioritization. In Medicine and social
justice, ed. M. Battin, R. Rhodes, and A. Silvers, 362–372. New York: Oxford University Press.
Brock, D. 2004. Ethical issues in the use of cost effectiveness analysis for the prioritization of
health care resources. In Handbook of bioethics: Taking stock of the field from a philosophical
perspective, ed. G. Khushf, 353–380. Dordrecht: Kluwer Academic Publishers.
Caro, J.J., E. Nord, U. Siebert, et al. 2010. The efficiency frontier approach to economic evaluation
of health-care interventions. Health Economics 19(10): 1117–1127.
Daniels, N. 1993. Rationing fairly: Programmatic considerations. Bioethics 7(2/3): 224–233.
Daniels, N. 2004. How to achieve fair distribution of ARTs in “3 by 5”: Fair process and legitimacy
in patient selection. Geneva: World Health Organization/UNAIDS.
Daniels, N. 2008. Just health: Meeting health needs fairly. New York: Cambridge University Press.
Daniels, N., and J. Sabin. 2008. Setting limits fairly: Learning to share resources for health, 2nd
ed. New York: Oxford University Press.
Daniels, N., D. Light, and R. Caplan. 1996. Benchmarks of fairness for health care reform.
Dolan, P., R. Shaw, A. Tsuciya, and A. Williams. 2005. QALY maximization and people’s
preferences: A methodological review of the literature. Health Economics 14: 197–208.
Gold, M.R., J.E. Siegal, L.B. Russell, and M.C. Weinstein. 1996. Cost-effectiveness in health and
medicine. New York: Oxford University Press.
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University Press.
Menzel, P., M. Gold, E. Nord, L. Pinto-Prades, J. Richardson, and P. Ubel. 1999. Toward a broader
view of values in cost-effectiveness analysis in health care. Hastings Center Report 29(3): 7–15.
Nord, E. 1999. Cost value analysis in health care: Making sense out of QLAYs. Cambridge:
Cambridge University Press.
Patient Protection and Affordable care Act (PPACA). 2010. http://www.gpo.gov/fdsys/pkg/PLAW-
111publ148/html/PLAW-111publ148.htm. Accessed 8 June 2015.
Ubel, P.A., J. Richardson, and J.L. Pinto-Prades. 1999. Life saving treatments and disabilities: Are
all QALYs created equal? International Journal of Technology Assessment in Health Care 15:
738–748.
Ubel, P.A., J. Baron, and D.A. Asch. 2001. Preference for equity as a framing effect. Medical
Decision Making 21: 180–189.
3.5 Case 1: Priority Setting and Crisis of Public Hospitals

in Colombia
María del Pilar Guzmán Urrea
Department of Community Medicine
El Bosque University
Bogotá, Colombia
e-mail: mapiguzmanu@gmail.com
This case is presented for instructional purposes only. The ideas and opinions
expressed are the author’s own. The case is not meant to reflect the official position,
views, or policies of the editors, the editors’ host institutions, or the author’s host
institution.
3.5.1 Background
During the 1990s, many Latin American countries began reforming their health sys-
tems according to a neoliberal development model that emphasizes free markets
(Homedes and Ugalde 2005; Stocker et al. 1999). Approved in 1993, health reform in
Colombia was supposed to overcome problems such as low coverage, inequality in
access and use of health care services, and inefficiency in the allocation and distribu-
tion of resources. But the reform also hoped to encourage more focus on illness pre-
vention and health promotion and more community participation in health
decision-making processes. The reformers advocated predominantly for neoliberal
values like efficiency, free choice, universality, and quality. Although they were also
committed to the communitarian values of solidarity, equity, and social participation.
The Colombian health reform was one of the first examples of implementing
managed competition in the developing world (Plaza et al. 2001). To stimulate com-
petition among insurers and health service providers, both public and private, health
reformers applied the theory of managed competition (Enthoven 1993). According
to this theory, competition achieves efficiency and reduces cost, making health care
services responsive to consumer needs (Londoño and Frenk 1997). Hospitals
become responsive when they are able to sell services and become financially sus-
tainable. To achieve sustainability, supply subsidies (direct transfers from the state
to hospitals) had to replace demand subsidies (transfers directed to the poor through
a subsided security plan).
72 N. Daniels
The Colombian reform established a General Social Security System in Health

that featured two insurance plans: (1) The Contributory Plan, financed by manda-
tory contributions (formal employees and employers from the public and private
sectors). (2) The Subsidized Plan, funded by resources from the Contributory Plan
and from taxes and other sources, which covered people unable to pay (Vargas et al.
2010). The actors of the system are the insurance companies, the health service
providers, and the state regulatory organizations. Insurance companies contract
with health service providers, and the regulatory organizations control compliance
with the defined basic health packages.
To optimize resources, the reform placed controls on medical practitioners and
established explicit priority criteria based on clinical guidelines that defined benefit
packages. From 1993, some adjustments to the reform have been introduced, such
as the creation, in 2012, of the Institute for Health Technology Assessment to
provide an evidence base for health decisions. The Institute recommends which
medical technologies should be paid with public resources on the basis of which
technologies optimally improve the quality and cost effectiveness of medical care.
To determine these technologies, it conducts health outcomes research that guides
technology development, evaluation, and use (Giedion et al. 2012).
Nevertheless, 20 years later, the promise of reform lies unfulfilled and many
patients still experience high out-of-pocket costs, long wait times, or denial of services.
To access health services, frustrated citizens are turning to the legal system as a last
resort and, by so doing, congesting the courts (Defensoría del Pueblo 2012). Physicians
are responding to economic incentives and penalties by restricting hospitalization
time and decreasing the use of expensive diagnostic tests and specialist referrals
(Abadía and Oviedo 2009). To further reduce labor costs, service providers have
increased the workload of health professionals and the number of patients seen per
day, while reducing the time spent with each patient (Defensoría del Pueblo 2007).
Insurance companies often take a long time to pay health service providers, and
they also contract their own service network (a process known as vertical integration),
so many public hospitals are in serious financial difficulties. Meanwhile, hospital
workers frequently disrupt the normal operation of hospitals as they strike to improve
work conditions and have their paychecks issued more promptly. Should hospitals
fail—40 % of the 968 public hospitals in Colombia are classified as being at medium
or high financial risk—nearly ten million people could be left without health service
(Ministerio de Salud y Protección Social 2012; Quintana 2002). Add to that, the
reforms have increased inequity, as more affluent patients can more easily access
quality health care services than can low-income patients (Vargas et al. 2010).
The described problems reflect a complex situation that requires profound
structural reform. As one way to address the immediate problems of efficiency and
quality, Colombia in 2012 instituted public hospital accreditation. Accreditation
requires hospital directors to reach goals in service delivery related to financial
viability, quality, and efficiency. Hospital boards can now fire directors who fail to
meet these goals within a specified period (Rodríguez 2012). Given the imbalances
between budgets, service demands, and ongoing costs, hospital directors face enor-
mous challenges and ethical dilemmas in formulating and executing their
mana gement plans.
You are a director of a public hospital that focuses on health promotion and prevention
activities, such as general practice, dentistry, clinical laboratory, hospitalization,
and emergency care. In developing your management plan, you must make deci-
sions about which services to prioritize. If you prioritize services that represent
higher revenues and lower costs as a way of conserving resources, you may have to
reduce priority for some services. To guide your decision making, you conducted a
retrospective study of service billing in the past 2 years and learned that the clinical
laboratory and external medical consultation yielded higher incomes. The lowest
yielding programs in the short term—vaccination, educational programs to improve
lifestyles, and provision of micronutrient supplements to children and pregnant
women—were associated with the best long-term health results.
Taking seriously your fiduciary responsibilities, you try to guarantee financial
sustainability by containing labor costs, restricting consultation times, and shorten-
ing hospital stays. Your challenge is to do these things without diminishing the
quality of patient care. But because you compete with other institutions, you must
also assure sufficient reserves to maintain and update medical equipment that will
improve the “sale of services.” Knowing that every management decision you make
will affect the population you serve, you begin to reflect on the factors affecting
your hospital management plan.
3.5.3 Discussion Questions
1. Who are the major stakeholders in this case and what are their interests, values,
and moral claims? Between which of them are there ethical conflicts or
tensions?
2. Which of these interests, values, and moral claims should be prioritized? How
would you justify your priorities?
3. Would you prioritize programs that in the short term brought in needed revenues
or those programs that had highest impact long term?
4. How can tensions between the goals of efficiency, financial viability, and quality
be resolved? What weight should be assigned to each goal by the hospital board
when evaluating your performance?
5. At least in the short run, the new reforms seem to be prioritizing efficiency, via-
bility, and quality over equity. Should a health system attain the former goals
before tackling the problem of equity, or should it insist on equity from the start?
6. Can equity in health care be achieved without doing something about wealth
inequity and other social determinants of health?
7. Should you justify your decisions by emphasizing solidarity with other hospital
directors and seeking community support?
8. How could collaborations between public health, communities and the health care
system begin to address neoliberal concerns with efficiency, viability, and quality?
74 N. Daniels
References
Abadía, C.E., and D.G. Oviedo. 2009. Bureaucratic itineraries in Colombia: A theoretical and
methodological tool to assess managed-care health care systems. Social Science & Medicine
68(6): 1153–1160.
Defensoría del Pueblo, Colombia. 2007. Autonomía Médica y su Relación con la Prestación de los
Servicios. http://www.defensoria.gov.co/red/anexos/publicaciones/aut_med.pdf. Accessed 30
Apr 2013.
Defensoría del Pueblo, Colombia. 2012. La Tutela y el Derecho a la Salud 2011: 20 Años del Uso
Efectivo de Tutela 1992–2011. http://www.federacionmedicacolombiana.com/index.
php?option=com_content&view=article&id=1335:la-tutela-y-el-derecho-a-la-salud-2011&cat
id=58:libros&Itemid=104. Accessed 30 Apr 2013.
Enthoven, A. 1993. The history and principles of managed competition. Health Affairs 12(suppl
1): 24–48.
Giedion, U. A., Muñoz, and A. Ávila. 2012. Serie de Notas Técnicas Sobre Procesos de Priorización
de Salud: Introducción a la Serie de Priorización Explicita en Salud. http://www.iadb.org/en/
publications/publication-detail,7101.html?id=42686%20&dcLanguage=es&dcType=All.
Accessed 30 Apr 2013.
Homedes, N., and A. Ugalde. 2005. Why neoliberal health reforms have failed in Latin America.
Health Policy 71: 83–96.
Londoño, J.L., and J. Frenk. 1997. Structured pluralism: Towards an innovative model for health
system reform in Latin America. Health Policy 41: 1–36.
Ministerio de Salud y Protección Social, Colombia. 2012. Informe de Rendición de Cuentas.
https://www.minsalud.gov.co/Documentos%20y%20Publicaciones/Audiencia%20
P%C3%BAblica%20Minsalud%202012.pdf. Accessed 4 May 2013.
Plaza, B., A.B. Barona, and N. Hearst. 2001. Managed competition for the poor or poorly managed
competition? Lessons from the Colombian health reform experience. Health Policy and
Planning 16(suppl 2): 44–51. http://heapol.oxfordjournals.org/content/16/suppl_2/44.long.
Quintana, S. 2002. Los Actores e Intermediarios del Sistema de Salud en Colombia. Médicos sin
fronteras. http://www.disaster-info.net/desplazados/informes/msf/accesointermediarios.htm.
Rodríguez, C. 2012. Gerentes de Hospitales Públicos y Acreditación en Salud. http://www.elhos-
pital.com/eh/secciones/EH/ES/MAIN/IN/ESTUDIOS_CASO/doc_89824_HTML.
html?idDocumento=89824. Accessed 30 Apr 2013.
Stocker, K., H. Watzkin, and C. Iriart. 1999. The exportation of managed care to Latin America.
New England Journal of Medicine 340(14): 1131–1136.
Vargas, I., M.L. Vásquez, A.S. Mogollón-Pérez, and J.-P. Unger. 2010. Barriers of access to care in
a managed competition model: Lessons from Colombia. BMC Health Services Research 10:
297. http://www.biomedcentral.com/1472-6963/10/297. Accessed 30 Apr 2013.
3.6 Case 2: Intersection of Public Health and Mental Health:

Meeting Family Needs
Christy A. Rentmeester
AMA Journal of Ethics
American Medical Association
Chicago, IL, USA
e-mail: christy.rentmeester@ama-assn.org
Sarah Ann Kotchian

Education and Early Childhood Policy
Holland Children’s Movement and the Holland Children’s Institute
Omaha, NE, USA
Sherry Fontaine
Department of Management
University of Wisconsin-La Crosse
La Crosse, WI, USA
This case is presented for instructional purposes only. The ideas and opinions expressed
are the authors’ own. The case is not meant to reflect the official position, views, or
policies of the editors, the editors’ host institutions, or the authors’ host institutions.
3.6.1 Background
The Global Burden of Disease (GBD) compares disease burdens based on epidemio-
logical measures of prevalence, mortality, disability, and associated costs. The GBD
for mental illness amounts to 14 % of the world’s total disease burden (World Health
Organization 2005). In the United States alone, every fifth child suffers from a mental
disorder (Perou et al. 2013). Although mental illness clearly causes disabilities (Prince
et al. 2007), underservice to those with mental illness is commonplace. Lack of access
to mental health services counts as the first of many hurdles facing families who have
a child with a mental illness. Stigma and the lack of parity in health coverage for
physical and mental illness are other hurdles for these families. Not surprisingly, these
hurdles can critically affect the development of children with mental illness.
Lack of access to mental and behavioral health services for children 5 years and
younger especially threatens their development. Rapid brain growth occurs in the
first 5 years of life, which lays the foundation for cognitive, emotional, and moral
development. Exposure to chronic stress can prompt the release of hormones in the
brain that can have enduring consequences for how the adult brain is organized and
how it functions (Shonkoff and Phillips 2000). Because poor health can show up in
children as developmental delay, access to mental and behavioral health services is
critical. Longitudinal studies demonstrate positive and long-acting effects of early
childhood interventions, such as environmental enrichment programs, on a range of
cognitive and noncognitive skills, social behaviors, academic achievement, and
adult job performance (Heckman 2008). The estimated annual rate of return on
investment from targeted early childhood development programs is 7 %, and early
intervention reduces the predictable need for higher, more costly levels of care in
later life (Heckman et al. 2010).
In the United States, Medicaid is a government-funded program that provides
health coverage to people with certain disabilities and to low-income adults and
their children. The Federal Medicaid Act (FMA) requires states participating in
Medicaid programs to provide medically necessary treatment to eligible children.
76 N. Daniels
Under federal Medicaid law, states must provide “early and periodic screening,
diagnostics, and treatment,” also known as EPSDT services, to eligible Medicaid
recipients under age 21 (U.S.C. § 1396d(a)(4)(B)). The definition of EPSDT
includes necessary health care, diagnostic services, treatment, and other measures
described in the Medical Assistance subchapter for the United States Code (42
U.S.C. § 1396d (a)) (2012) that correct or ameliorate defects and physical and men-
tal illnesses and conditions discovered by the screening services, regardless of
whether such services are covered under the state plan (42 U.S.C. § 1396d (r)(5))
(2013). The medical necessity standard, which is based on clinical standards of care,
refers to interventions that may be justified as reasonable, necessary, or appropriate.
States must comply with the FMA standard to cover all treatments for a Medicaid-
eligible child’s physical or mental condition, even if service coverage is optional for
adults covered by Medicaid. FMA also bars states from arbitrarily denying or reducing
the amount, duration, or scope of a required service to an otherwise eligible recipient
solely because of the diagnosis, illness, or condition (Nebraska Legislature 2012).
Despite the provisions of FMA, the U.S. Department of Health and Human
Services, which oversees the Medicaid program, excludes certain behavioral health
treatments for children with developmental disabilities and autism (National Health
Law Program 2012; Autism Society of Nebraska 2012). In addition, some states’
Medicaid contracts allow insurers more freedom than other states to deny payment
for services. States also vary in who—the claimant or the insurer—must prove
whether coverage provisions are adequate or fall short of federal Medicaid legal
standards (Rosenbaum and Teitelbaum 1998). Differences among states in approval
of payment for specific treatments, including mental and behavioral health treat-
ment, illustrate the need for more consistency in Medicaid coverage provisions and
the lack of parity between mental and physical health coverage. Mental health ben-
efits must be offered at parity with medical services to newly eligible recipients as
part of the 2010 Patient Protection and Affordable Care Act (ACA), and Medicaid
expansion controversy is clear evidence that parity is a work in progress (Mental
Health America 2013; U.S. Department of Labor 2008).
Because of inadequate coverage for mental and behavioral health services for
Medicaid-eligible children, some parents have no option other than to surrender their
child to the child welfare system so that the child will receive full coverage for neces-
sary mental and behavioral health care services. This results in significant cost-shift-
ing from Medicaid to the state’s child welfare system. That is, when a state provides
federally mandated services to Medicaid-eligible children, it receives a financial
match from the federal government to pay the costs. When a state denies federally
mandated Medicaid services and a family surrenders a child to state custody so the
child can receive care, the state pays the expense of the previously denied Medicaid
costs plus the expense of entitlements the child acquires as a ward of the state.
The ACA Medicaid expansion offers a window of opportunity to increase cover-
age for behavioral health treatment for children with mental illnesses. Although the
federal government will bear the primary financial burden of Medicaid expansion,
some states have elected, for political reasons, not to participate in this expansion.
For participating states, ACA Medicaid expansion will replace state and local men-
tal health services funds with federal Medicaid money that will cover a wider range
of home and community-based services for mental illness treatment (Bazelon

Center for Mental Health Law 2012).
Public health agencies and leaders often provide input for the Medicaid system,
helping to develop protocols, criteria, and rules about which treatments are defined
as medically necessary. Such decisions about medical necessity affect clinicians,
patients, and families because they determine which treatments get recommended at
the clinical level and influence which treatments insurers cover.
You are the Medicaid director of a state with the country’s highest percentage of
children in the child welfare system. Twenty-five percent of children in the state’s
foster care system are there not because of abuse or neglect, but because of behav-
ioral problems and mental illnesses. As a state official, you are aware that this results
in significant cost-shifting from Medicaid to the state’s child welfare system.
Recently, the case of 4-year-old Sam has come to your attention. Sam’s family
cannot afford mental and behavioral health care for Sam, although he is Medicaid-
eligible and insured through Magiscare (a private company with a state contract to
administer Medicaid for mental and behavioral health services). Sam’s parents are
considering surrendering their boy to become a state ward to get him the mental
health services he needs.
Sam, you learn, eats random objects and dirt, throws tantrums, bangs his head on
the ground, hits and bites himself and others, and often runs away. Recently diag-
nosed by his physician as having autism, Sam was referred to a psychologist who
recommended outpatient behavioral therapy. Both the physician and the psycholo-
gist expect this therapy to be covered through the family’s Magiscare plan.
Magiscare denied the psychologist’s requests for payment on the grounds that,
for children of Sam’s age, behavioral management is not covered under state law
because it is not “medically necessary.” Magiscare substantiated their denial of
payment because Sam’s behaviors primarily reflect developmental disabilities
related to autism, which are not covered under their contract with the state. When
you ask the Magiscare executive director about this case, she suggests that Sam’s
parents could attend therapy sessions to help them cope with their son’s behaviors,
but she reasserts that behavioral management is not covered for children as young
as Sam under state law because it is not medically necessary.
Members of the state legislature and child mental health advocacy groups are try-
ing to expand access to home-based and community-based mental health services.
They have asked you to support their efforts. You also consider that your governor,
who is your boss, has publically stated his firm opposition to ACA Medicaid expan-
sion, thus denying the state the opportunity to expand coverage for children’s mental
and behavioral health treatment through the ACA. At present, you know that your
state is offering limited mental and behavioral health services and that narrow defini-
tions of medical necessity are used to limit access to those services.
As the state Medicaid director, which steps should you take?
78 N. Daniels
1. Who are the main stakeholders in this case, and what are their primary interests?
2. “Passing” the expense of coverage denied by Medicaid to other components of pub-
lic service, such as the child welfare system, has fiscal and social implications.
(a) What are some of these implications?
(b) How should prevalence, mortality, disability, and cost be factored into think-
ing about ways to balance short- and long-term risks and benefits to indi-
viduals and to the public in this case?
3. Suppose a policy advisor warns that expanding behavioral health care for chil-
dren will strain the Medicaid budget and require cuts in services for adults or
reduce their eligibility.
(a) How should you respond?
(b) Which considerations or priorities would guide your funding allocations?
4. What role should ethical principles such as stewardship, public health leader-
ship, and moral courage play in this case?
5. Medical necessity implies an acute care model of health service delivery and
reflects a clinical perspective. How well does this idea apply to a public health
prevention model of health service delivery? Are there better alternatives?
6. Parity in insurance coverage for mental health is federally mandated for private
insurers, which covers most citizens, but has proven to be an elusive goal for
people who do not have private insurance or do not have enough coverage.
Medicaid is a public (government funded) insurance program, not a private one.
Although Medicaid beneficiaries receive coverage for medically necessary men-
tal health services, each state defines medical necessity uniquely.
(a) Should a federal mandate define medical necessity for mental and behavioral
services?
(b) What financial implications would such a mandate have from a state per-
spective and from an overall perspective?
7. The term principle-policy gap can be used to characterize situations in which
most people support health coverage in principle; but in practice, they are unable
to pay for coverage or unwilling to take the political, social, cultural, or fiscal
risks necessary to enable such coverage. What do such gaps tell us about which
values the majority favors, and how might the term principle-policy gap help us
understand the dynamics in this case? What roles should public health leaders
play in responding to principle-policy gaps?
Acknowledgements The authors thank student Chelsea Williams for her assistance in assem-
bling the facts of the case. We also thank Creighton University’s Center for Health Policy & Ethics.
References
Autism Society of Nebraska. 2012. Nebraska Appleseed—Cases of denial of behavioral health

coverage for children are needed. http://www.autismnebraska.org/2012/06/13/nebraskaapple-
seed-cases-of-denial-of-behavioral-health-coverage-for-children-are-needed/. Accessed 6 Nov
2012.
Bazelon Center for Mental Health Law. 2012. Take advantage of new opportunities to expand
medicaid under the Affordable Care Act: A guide to improving health coverage and mental
health services for low-income people, following the Supreme Court ruling on the Affordable
Care Act. http://www.bazelon.org/LinkClick.aspx?fileticket=cwAuDZLEmQI%3D&ta
bid=619. Accessed 3 June 2013.
Heckman, J.J. 2008. Schools, skills, and synapses. Economic Inquiry 46(3): 289–324.
Heckman, J.J., S.H. Moon, R. Pinto, P.A. Savelyev, and A. Yavitz. 2010. The rate of return to the
High/Scope Perry Preschool Program. Journal of Public Economics 94(1–2): 114–128.
Mental Health America. 2013. Medicaid expansion fact sheet. http://www.mentalhealthamerica.
net/go/action/policy-issues-a-z/healthcare-reform/fact-sheet-medicaid-expansion/fact-sheet-
medicaid-expansion. Accessed 23 May 2013.
National Health Law Program. 2012. Lawsuit fi led to protect the rights of Nebraska children with
autism and development disability. http://www.conntact.com/component/content/article/121-
press-release/13284-lawsuit-fi led-to-protect-the-rights-of-nebraska-children-with-autism-an-
ddevelopmental-disabilities.html. Accessed 6 Nov 2012.
Nebraska Legislature. 2012. Floor debate on LB 1063. http://www.legislature.ne.gov/
FloorDocs/102/PDF/Transcripts/FloorDebate/r2day47.pdf. Accessed 1 Apr 2013.
Perou, R., R.H. Bitsko, S.J. Blumberg, et al. 2013. Mental health surveillance among children –
United States, 2005–2011. Morbidity and Mortality Weekly Report 62(2): 1–35.
Prince, M., V. Patel, S. Saxena, et al. 2007. No health without mental health. Lancet 370:
859–877.
Rosenbaum, A., and J.B. Teitelbaum. 1998. Coverage decision-making in Medicaid managed
care: Key issues in developing managed care contracts. Washington, DC: The Center for
Health Services Research and Policy, George Washington University Medical Center, School
of Public Health and Health Services. http://sphhs.gwu.edu/departments/healthpolicy/CHPR/
downloads/behavioral_health/bhib-1.pdf. Accessed 1 Apr 2013.
Shonkoff, J.P., D.A. Phillips, and Committee on Integrating the Science of Early Childhood
Development; Board on Children, Youth, and Families; Institute of Medicine; Division of
Behavioral and Social Sciences and Education (eds.). 2000. From neurons to neighborhoods:
The science of early childhood development. Washington, DC: National Academy Press.
United States Code. 2012, 2013. Title 42: Public health and welfare. 42 U.S.C.A § 1396d(a)(4)(B)
(West 2012) and 42 U.S.C. § 1396d (r)(5) (suppl 2013). http://www.gpo.gov/fdsys/pkg/
USCODE-2010-title42/pdf/USCODE-2010-title42-chap7-subchapXIX-sec1396d.pdf .
Accessed 29 May 2013.
U.S. Department of Labor. 2008. The Mental Health Parity and Addiction Equity Act of 2008: Fact
sheet. Pub L 110–343. http://www.dol.gov/ebsa/newsroom/fsmhpaea.html. Accessed 23 May
2013.
World Health Organization (WHO). 2005. Mental health: Facing the challenges, building solu-
tions. Report from the WHO European Ministerial Conference. Copenhagen: WHO Regional
Office for Europe.
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3.7 Case 3: Public-Private Partnerships: Role of Corporate

Sponsorship in Public Health
Ildefonso Hernández-Aguado and Blanca Lumbreras
Department of Public Health, History of Science and Gynecology
Universidad Miguel Hernández and CIBER de Epidemiología y Salud Pública
San Juan, Alicante, Spain
e-mail: ihernandez@umh.es
expressed are the authors’ own. The case is not meant to reflect the official position,
views, or policies of the editors, the editors’ host institutions, or the authors’ host
institutions.
3.7.1 Background
Public health systems are usually underfunded in comparison with health care sys-
tems. In fact, the Organisation for Economic Co-operation and Development
(OECD) countries allocate on average only 3 % of their health spending to public
health and prevention activities (OECD 2011). This low funding of public health
programs hinders the capacity to implement effective public health policies (Robert
Wood Johnson Foundation 2011).
Population health challenges, such as influenza pandemics, are increasingly
complex, and tackling them involves urgently executing a wide array of public
health measures to prevent disease transmission. In the case of influenza pandemics,
measures can vary from border quarantine, social distancing, provision of antivirals
and vaccines, and personal hygiene strategies. Recommendations often need to be
made quickly even when knowledge about the seriousness and potential health and
social effects are incomplete. The target for preventive interventions is the entire
population. However, resources for intense and sustained health campaigns through
mass communications are expensive. In addition, the social determinants of the dis-
ease must be understood and considered (Crowcroft and Rosella 2012). This typi-
cally involves the need for policies that engage the health and non-health sectors,
such as educational policies and social or economic factors (Savoia et al. 2012).
This complexity, together with decreasing funds and other factors, has contributed
to increasing private sector involvement in health care.
According to the World Health Organization (WHO), a public-private partner-
ship gathers a set of actors for the common goal of improving population health
through agreed roles and principles. This may also be described as public sector
programs with private sector participation (WHO 2013). WHO has described sev-
eral types of partnerships, including philanthropic, transactional, and transforma-
tional. Sponsorship is a form of a public-private partnership defined as “any form of
monetary or in-kind payment or contribution to an event, activity, or individual that
directly or indirectly promotes a company’s name, brand, products, or services”

(Kraak et al. 2012). In this sense, sponsorship is a commercial transaction, not type
of philanthropy.
Public-private partnerships have become increasingly common for public health
campaigns. Some transnational companies and their corporate foundations collabo-
rate with public institutions, such as United Nations agencies and governments, to
tackle complex public health problems, such as treatment of diarrhea in developing
countries (Torjesen 2011), tuberculosis, and malaria (Ridley et al. 2001). These col-
laborations have been encouraged by international institutions and experts as a way
to mobilize resources and expertise, which could complement the public sector.
WHO has also encouraged using public-private partnerships to deliver health ser-
vices for a range of health problems, including HIV infection, malaria, tuberculosis,
trachoma, and vaccine-preventable diseases (Buse and Walt 2000a, b). However,
corporations’ increasing role in public health has been criticized as jeopardizing the
mission of public health and its commitment to population health (Hastings 2012;
Ludwig and Nestle 2008). Some corporations have used tactics that discredit public
health actions, such as distorting scientific information and using financial tactics
and political influence to avoid unfavorable regulations (Wiist 2011).
Public health professionals, public health agencies, and governments often must
decide whether to collaborate with the private sector to improve population health.
These decisions are increasingly frequent as health department budgets shrink and
public-private partnerships are seen as a way to secure funds for core public health
programs. Ethical considerations can help us decide whether and when to form such
partnerships. However, the available public health ethics frameworks (e.g., Public
Health Leadership Society 2002; Nuffield Council on Bioethics 2007; Kass 2001)
do not specifically discuss public-private partnerships. Only the Public Health
Leadership Society provides guidance for such collaborations. Principle 10 pro-
poses that, “Public health institutions and their employees should engage in collabo-
rations and affiliations in ways that build the public’s trust and the institution’s
effectiveness.” Continued discussion about the ethical implications of private-public
partnerships is needed.
Top health officials in an industrialized country have declared a public health emer-
gency due to an influenza pandemic. The head of the country’s health department
receives a call from the president of a multinational company that produces sugary,
high-calorie drinks. The company president expresses his concern about the pan-
demic and wants to collaborate with the government to prevent the spread of flu.
The company offers the health department a considerable amount of space, one-
third of each can, on its star product (a soft drink) free of charge, to include mes-
sages on flu prevention. The company insists that the health department logo be
included on the can along with the preventive messages. For them, the association
82 N. Daniels
between the health department (through the logo) and their product is essential for
the collaboration as it would be an acknowledgement by the health department of
the company’s social responsibility.
The head of the health department arranges a meeting with several health authori-
ties and officials to consider the offer. On one side, some members of the group sup-
port the proposal because of the need to carry out far-reaching public health
campaigns to limit the impact of pandemic flu. At that stage, the incidence of pan-
demic flu is increasing quickly and the number of new outbreaks in schools is wor-
rying the health authorities and the population. There have been recent budget cuts to
the health department, and some officials argue the company’s contribution may be
the best option to ensure a far-reaching campaign on prevention measures to benefit
the population. They see sponsorship as a form of social responsibility because the
company does not have any apparent economic interest in flu-related activities. They
also note that there are no other companies offering a similar collaboration.
But other officials say the company’s soft drink products contribute to the obe-
sity and diabetes epidemic and that the company’s use of the health department logo
would label it a pro-health industry with the backing of the highest health authority
in the country. They also raise concerns about risking the independence of the health
department in future regulatory action on sugar-rich beverages.
As the head of the health department, you must decide if you should collaborate
with the company.
1. What considerations should the health department director weigh when deciding
whether to collaborate with the beverage company?
2. Who are the major stakeholders the health department should consider, and what
values might each of these stakeholders bring to this decision?
3. In making your decision, what values should be prioritized?
4. What positive or negative impacts would displaying the health department logo
on the soft drink cans have on health department operations?
5. How might sponsorship by a company that produces sugary beverages affect
public trust in the health department and the institution’s effectiveness?
6. Would the decision be different if the company produced healthy foods and the
department’s logo was placed on a healthy product?
7. Would community involvement facilitate decision making and the consideration
of the ethical questions? What ethical criteria or guidance should be established
to accept or reject a future donations or sponsorship of a public health program
by a company?
Acknowledgements We thank Mr. Jonathan Whitehead for language editing.
References
Buse, K., and G. Walt. 2000a. Global public-private partnerships: Part I—A new development in
health? Bulletin of the World Health Organization 78: 549–561.
Buse, K., and G. Walt. 2000b. Global public-private partnerships: Part II—What are the health
issues for global governance? Bulletin of the World Health Organization 78: 699–709.
Crowcroft, N.S., and L.C. Rosella. 2012. The potential effect of temporary immunity as a result of
bias associated with healthy users and social determinants on observations of influenza vaccine
effectiveness; Could unmeasured confounding explain observed links between seasonal influ-
enza vaccine and pandemic H1N1 infection? BMC Public Health 12: 458.
Hastings, G. 2012. Why corporate power is a public health priority. British Medical Journal 345:
e5124.
Kass, N.E. 2001. An ethics framework for public health. American Journal of Public Health
91(11): 1776–1782.
Kraak, V.I., P.B. Harrigan, M. Lawrence, P.J. Harrison, M.A. Jackson, and B. Swinburn. 2012.
Balancing the benefits and risks of public-private partnerships to address the global double
burden of malnutrition. Public Health Nutrition 15(3): 503–517.
Ludwig, D.S., and M. Nestle. 2008. Can the food industry play a constructive role in the obesity
epidemic? JAMA 300(15): 1808–1811.
Nuffield Council on Bioethics. 2007. Public health: Ethical issues. London: Nuffield Council on
Bioethics. http://nuffieldbioethics.org/wp-content/uploads/2014/07/Public-health-
ethicalissues.pdf. Accessed 22 May 2015.
Organisation for Economic Co-operation and Development (OECD). 2011. Health at a glance
2011. In OECD indicators. OECD Publishing. http://www.oecd.org/els/healthsys-
tems/49105858.pdf. Accessed 22 May 2015.
Ridley, R.G., J. Lob-Levyt, and J. Sachs. 2001. A role for public-private partnerships in controlling
neglected diseases? Bulletin of the World Health Organization 79(8): 771–777.
Robert Wood Johnson Foundation. 2011. Investing in America’s health: A state-by-state look at
public health funding and key health facts. http://healthyamericans.org/report/83/. Accessed 22
May 2015.
Savoia, E., M.A. Testa, and K. Viswanath. 2012. Predictors of knowledge of H1N1 infection and
transmission in the U.S. population. BMC Public Health 12: 328.
Torjesen, I. 2011. Coca-Cola supply chain helps bring diarrhoea treatments to developing world.
British Medical Journal 343: d5825.
Wiist, W.W. 2011. The corporate play book, health and democracy: The snack food and the bever-
age industry’s tactics in context. In Sick societies: Responding to the global challenge of
chronic diseases, ed. D. Stuckler and K. Siegel, 206–216. New York: Oxford University Press.
World Health Organization (WHO). 2013. Public-private partnerships for health. http://www.
who.int/trade/glossary/story077/en/. Accessed 22 May 2015.
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3.8 Case 4: Black-White Infant Mortality: Disparities,

Priorities, and Social Justice
Erika Blacksher
Department of Bioethics and Humanities
University of Washington
Seattle, WA, USA
e-mail: eb2010@u.washington.edu
Susan D. Goold
Department of Internal Medicine and Department of Health Management
and Policy Center for Bioethics and Social Sciences in Medicine
University of Michigan
Ann Arbor, Michigan, USA
3.8.1 Background
Preterm births, the leading cause of infant mortality, are increasing annually worldwide
(World Health Organization 2012). The United States shares company with Nigeria,
India, and Brazil among the top ten countries with the highest numbers of preterm births
and ranks 31st among Organisation for Economic Co-operation and Development (OECD)
nations in infant mortality (OECD 2010). Within the United States, racial and ethnic
disparities in infant mortality remain entrenched and have increased (MacDorman and
Mathews 2009). U.S. health policy leaders have made the elimination of health dispari-
ties a top public health priority (Centers for Disease Control and Prevention 2011;
U.S. Department of Health and Human Services 2011). Infant mortality is an important
area of focus for eliminating disparities, both in its own right and because the rate of
infant mortality serves as an indicator of the nation’s health due to its association with
maternal health, social and economic conditions, racial discrimination, access to health
care, and public health practices (MacDorman and Mathews 2009).
During the twentieth century, U.S. infant mortality declined 93 % (MacDorman
2011). In 1900, about 100 infants died per 1000 live births. By 2000, that number
fell to 6.89. During the last half of the twentieth century, the rate of black infant
mortality dropped dramatically. In 1950, black infant mortality was 43.9 deaths per
1000 live births compared with 26.8 deaths per 1000 live births among whites
(Mechanic 2002). But by 1998 black infant mortality fell to 13.8 deaths per 1000
live births compared with 6.0 deaths per 1000 live births among whites. As these
numbers show, both groups made significant absolute gains, with blacks gaining
more in absolute terms—a reduction of 30.1 for blacks and 20.8 for whites. Yet,
black infant mortality still remained about twice that of whites.
These disparities have persisted in the twenty-first century. In 2006, non-Hispanic

black women experienced the highest rate of infant mortality, with 13.4 infant
deaths per 1000 live births, while non-Hispanic white women had a considerably
lower rate, with 5.6 infant deaths per 1000 live births. Citing a 2006 report from the
National Healthy Start Association, MacDorman and Mathews (2009) report that
programmatic efforts to reduce disparities in black-white infant mortality have had
some successes at local levels, but eliminating the disparities is difficult.
The U.S. Centers for Disease Control and Prevention and the U.S. Department of
Health and Human Services have prioritized both the elimination of health dispari-
ties and improvement in overall population health. These twin goals—one distribu-
tive, the other aggregative—are separate and sometimes conflict (Anand 2004).
Increases in health disparities often accompany advances in aggregate gains in popu-
lation health (Mechanic 2007). Although this case is specific to the United States, the
dilemma is not. Data show that significant progress on child mortality has been made
in many countries but that this overall success is often coupled with increased
inequalities between advantaged and disadvantaged groups (Chopra et al. 2012). In
China and India, for example, disparities in mortality persist between boys and girls
younger than 5 years, a function of entrenched gender discrimination (You et al.
2010). These examples raise challenging questions about how ethically to assess
such cases and set priorities for the allocation of scarce public health resources.
You serve as the director for the local health department in a racially segregated
urban city in the Midwest with one of the greatest concentrations of African
Americans in the United States. The city has a long history of civil rights activism
that led to protests and marches that ultimately empowered and mobilized black
communities and organizations. Your health department has a history of prioritizing
maternal-child health and the elimination of black-white disparities in infant mor-
tality in its programs, an investment of resources affirmed by the city residents
through the department’s community outreach program and planning processes.
Chronic underfunding of public health, made worse by the economic downturn,
has resulted in drastic and unprecedented reductions in the public health budget. In
consultation with your staff and community board of health, you have raised the
possibility of redirecting resources from maternal-child health into other programs
based on a number of practical and ethical considerations. As with national statis-
tics, the city has seen significant declines in black infant mortality, even as black-
white disparities remain. You note that although the maternal-child health programs
are cost-effective, their impact on reducing black-white disparities seems to have
stalled. Other programs appear to meet targets more consistently. To help support
these other programs, you note that allocating resources to more effective programs
provides more “health” per dollar, thus meeting the utilitarian demand to maximize
overall health, which many view as the primary goal of public health and health
policy (Powers and Faden 2006). In addition, although black-white disparities in
86 N. Daniels
infant mortality persist, blacks have made significant gains, declining more than
whites in some decades. You note that remaining inequalities could be deemed ethi-
cally acceptable by some standards of equity, such as the “maximin” principle.
Although this distributive principle is subject to interpretation (Van Parijs 2003), it
is generally understood to require that social and economic inequalities work to
benefit society’s least advantaged groups. Thus, inequalities (even significant ones)
are morally acceptable as long as the least advantaged have significantly benefited
(Powers and Faden 2006).
The director of community outreach proposes that the health department not
make this decision unilaterally, but instead listen to community opinions on these
questions of priorities and fairness. He suggests that the health department collabo-
rate with community partners to host a series of public forums. He insists that a
topic of such historic and contemporary concern to the community must be subject
to public deliberation. Despite having a history of supporting community discus-
sions, you are concerned about the cost of community forums, noting that they will
drain resources from an already slim budget.
1. Have local health departments met their ethical obligations when community
health improves overall, but health disparities persist? If not, why not? If so, on
what grounds?
2. Is there something about infant mortality that makes it special in considerations
of fairness? If so, what is it?
3. Should the role of race and racism in infant mortality shape priority setting and
the allocation of resources in public health? If so, why?
4. On what grounds and how should you as the local health department director
make resource allocation decisions? What standards—evidence, principles of
justice, public opinion—should influence priority setting?
5. Should the community have a role in identifying community health priorities or,
more specifically, in providing input into allocation decisions that directly affect
them? If so, how should the community be involved and who represents the
community?
References
Anand, S. 2004. The concern for equity in health. In Public health, ethics, and equity, ed. S.
Anand, F. Peter, and A. Sen, 15–20. New York: Oxford University Press.
Centers for Disease Control and Prevention. 2011. About CDC’s Office of Minority Health &
Health Equity (OMHHE). http://www.cdc.gov/minorityhealth/OMHHE.html. Accessed 29 Apr
2013.
Chopra, M., H. Campbell, and I. Rudan. 2012. Understanding the determinants of the complex
interplay between cost-effectiveness and equitable impact in maternal and child mortality
reduction. Journal of Global Health 2(1): 1–10.
MacDorman, M.F. 2011. Infant deaths—United States, 2000–2007. MMWR Supplement 60:
49–51.
MacDorman, M.F., and T.J. Mathews. 2009. The challenge of infant mortality: Have we reached a
plateau? Public Health Reports 124(5): 670–681.
Mechanic, D. 2002. Disadvantage, inequality, and social policy. Health Affairs 21(2): 48–59.
Mechanic, D. 2007. Population health: Challenges for science and society. The Milbank Quarterly
85(3): 533–559.
Organisation for Economic Co-operation and Development (OECD). 2010. OECD health data:
Infant mortality. https://data.oecd.org/healthstat/infant-mortality-rates.htm. Accessed 25 May
2015.
U.S. Department of Health and Human Services. 2011. HHS action plan to reduce racial and
ethnic health disparities. http://www.minorityhealth.hhs.gov/npa/templates/content.
aspx?lvl=1&lvlid=33&ID=285. Accessed 25 May 2015.
Van Parijs, P. 2003. Difference principles. In The Cambridge companion to Rawls, ed. S. Freeman,
World Health Organization (WHO). 2012. Born too soon: The global action report on preterm birth.
http://whqlibdoc.who.int/publications/2012/9789241503433_eng.pdf. Accessed 29 Apr 2013.
You, D., G. Jones, T. Wardlaw, and M. Chopra. 2010. Levels and trends in child mortality, 1990–
2009. Lancet 376(9745): 931–933.
3.9 Case 5: Priority Setting in Health Care: Ethical Issues
M. Inés Gómez and Lorna Luco

Centro de Bioética, Facultad de Medicina
Clínica Alemana–Universidad del Desarrollo
Santiago, Chile
e-mail: migomezb@gmail.com
institutions.
3.9.1 Background
The Chilean System of Guarantees in Health—created by law in 2004—aims to

establish guaranteed health care interventions in health promotion, disease and
injury prevention, diagnosis and treatment, rehabilitation and palliative care
(Ministerio de Salud 2004). The law mandates that public and private insurers pro-
vide the resources needed to protect the public against excessive health-related
88 N. Daniels
spending and guarantee timely and universal access to authorized interventions

based on standards of care.1
National health objectives, established by the Ministry of Health, determine the
list of guaranteed interventions. This list, however, is reviewed every 3 years and
amended as new scientific and health information emerges. As of 2013, the System
of Guarantees in Health included interventions for 80 health-related conditions
(Ministerio de Salud 2013), accounting for almost 60 % of the Chilean burden of
disease. The System of Guarantees in Health is a priority system based on acknowl-
edged criteria, namely scientific evidence and socially shared values. For the system
to be effective, the criteria must be transparent, publicly accepted, and open to
review and modification.
The law that created the System of Guarantees in Health also mandated a proce-
dure for selecting the guaranteed interventions (Ministerio de Salud 2004). The
procedure factors in public opinion research to identify social consensus on health
priorities, studies to identify effective interventions that prolong and improve qual-
ity of life, and assessments of interventions’ cost effectiveness (Burrows 2008). The
procedure determines priorities with an algorithm that includes these factors and
information on disease burden and health system capacity (Missoni and Solimano
2010). After choosing the health interventions, the health ministry elaborates on a
package of interventions related to specific health conditions and develops clinical
guidelines for such interventions.
You direct a team within the Ministry of Health that is responsible for recommend-
ing priorities for guaranteed health interventions. The priority ranking system
emphasizes the selection of cost-effective interventions for conditions with the
greatest burden. However, the health ministry also has authorized including expen-
sive interventions that are less effective or treating health conditions with low prev-
alence, if that condition or those interventions significantly impact health. Because
of budget reductions, a number of interventions are under review. Your team has
been asked to recommend funding interventions for two health
conditions—cataract (a common condition with highly effective treatment) and
multiple sclerosis (a less prevalent condition but one with significant health and
social impact).
1
Law 19.966 for the System of Guarantees in Health includes the following definitions for guaran-
tees: Guaranteed Access—Public and private health insurers must grant the resources to provide
guaranteed interventions; Guaranteed Opportunity—Guaranteed interventions must be delivered
within a deadline established in the protocols elaborated by the Ministry of Health; Guaranteed
Quality: Interventions must be delivered by registered and accredited health care providers;
Financial Protection—A maximum copayment is established to avoid the insured falling into
financial insolvency.
Cataract, the main cause of blindness, primarily affects people over 40. This
health problem has a high impact as measured by quality-adjusted life years
(QALYs) (Ministerio de Salud 2007). Its surgical treatment is effective for 80–95 %
of patients. The package of guaranteed interventions includes diagnostic confirma-
tion within 180 days after suspected diagnosis and surgical treatment 90 days after
confirmation. In 2013, it was expected that 48,424 cataract surgeries would be
performed in Chilean public hospitals and 416 in private institutions.
Multiple sclerosis, an autoimmune inflammatory disease leading to demyelin-
ation in the central nervous system, produces a progressive deterioration of health
and quality of life. It represents a minimal disease burden at the population level,
mainly due to premature death. In Chile, it is estimated that 385 patients are treated
for multiple sclerosis each year. The package of guaranteed interventions includes
diagnostic confirmation within 60 days; confirmed cases must receive treatment
within 30 days. Treatment includes pharmacological therapy and physiotherapy.
1. What are some of the ethical, scientific, and social considerations that should be
weighed in deciding if interventions for both cataract and multiple sclerosis
should be covered by the System of Guarantees in Health?
2. Is there an obligation for health systems to cover all health problems affecting a
population? Are there limits?
3. How should health problems be prioritized and who should have the authority to
make these decisions? Which criteria should receive the most weight in ranking
priorities?
4. How should resources be distributed among health conditions affecting many
people versus health conditions affecting few people?
5. How should resources be distributed among procedures that are preventive ver-
sus treatments for existing conditions?
6. How does taking a public health perspective versus a clinical medicine perspec-
tive affect your thinking about including these two conditions in the System of
Guarantees in Health?
7. What role should transparency play in the selection procedure?
References
Burrows, J. 2008. Inequalities and healthcare reform in Chile: Equity of what? Journal of Medical
Ethics 34: e13.
Ministerio de Salud. 2004. Establece un Régimen General de Garantías en Salud. Ley No. 19.966.
http://www.leychile.cl/Navegar?idNorma=229834. Accessed 8 June 2015.
Ministerio de Salud. 2007. Estudio Carga Enfermedad y Carga Atribuible. http://epi.minsal.cl/epi/
html/invest/cargaenf2008/Informe%20final%20carga_Enf_2007.pdf. Accessed 27 June 2013.
90 N. Daniels
Ministerio de Salud. 2013. Decreto Supremo No. 4. Aprueba Garantías Explícitas en Salud del
Régimen General de Garantías en Salud. http://web.minsal.cl/portal/url/item/d6924d33612dd
5e6e040010164015e8f.pdf. Accessed 8 June 2015.
Missoni, E., and G. Solimano. 2010. Towards universal health coverage: The Chilean experience,
Background paper, no. 4. Geneva: World Health Organization. http://www.who.int/healthsys-
tems/topics/financing/healthreport/4Chile.pdf. Accessed 27 June 2013.
3.10 Case 6: Critical Care Triage in Pandemics
Maxwell J. Smith
Dalla Lana School of Public Health and the Joint Centre for Bioethics
University of Toronto
Toronto, ON, Canada
e-mail: max.smith@utoronto.ca
A.M. Viens
Centre for Health, Ethics and Law, Southampton Law School
University of Southampton
Southampton, UK
institutions.
3.10.1 Background
Infectious diseases such as pandemic influenza and severe acute respiratory syn-
drome (SARS) have attuned the attention of policy makers and health practitioners
to the importance of protecting and promoting the public’s health in the face of
increased care needs and extreme resource scarcity. In particular, acute care needs
for the critically ill and discussions of treatment priorities have been the subject of
much debate in pandemic planning (Hick et al. 2007; Melnychuk and Kenny 2006;
Uscher-Pines et al. 2006). This is not surprising, as it has been estimated that more
than 700,000 Americans may require mechanical ventilation during a pandemic, far
outnumbering available ventilators (Rubinson et al. 2010; U.S. Department of
Health and Human Services 2005). Additionally, shortages of hospital beds, person-
nel, and other equipment can be expected during a pandemic, which may limit the
ability to meet an expected increase in patient volume (World Health Organization
2008).
Prudentially planning for the public’s increased care needs during a pandemic
requires assessing surge capacity, especially in critical care units (CCU). However,
as pandemics increase in severity, they can overwhelm critical care capacity and
contingency arrangements. To make the best use of resources and personnel (even
in the absence of a pandemic), patients are triaged—evaluated to determine the type
and priority of care to be received. While medical information informs the develop-
ment of triage criteria, ethical considerations about triage goals—whether explicit
or implicit—also play a role. For public health emergencies that overwhelm capac-
ity, some propose adjusting critical care triage criteria to emphasize certain public
health goals, like saving the most lives possible (Christian et al. 2006; Silva et al.
2010).
Some contend that utilitarian reasoning should predominate in critical care tri-
age, based on the intuition that, when resources are scarce, allocation decisions
should produce the greatest good for the greatest number (Charlesworth 1993;
Childress 2004). Critics of utilitarianism reply that it requires coercion or covert-
ness to succeed, because the public will not voluntarily sacrifice their lives or their
loved ones for the greater good (Baker and Strosberg 1992). Utilitarian triage may
be unpalatable to the public on the further ground that it quantifies and judges the
value of one life over another, which could disproportionally impact particular pop-
ulation groups (Hoffman 2009). Others therefore would base triage decisions on
egalitarian considerations, for instance, by giving everyone an equal chance at
obtaining a scarce good, an approach for which historical precedent exists (Baker
and Strosberg 1992).
Whatever approach is adopted, prior arrangements between policy makers, prac-
titioners, and the public based on thoughtful, transparent deliberation about the
most ethical approach to CCU triage usually will improve the legitimacy of deci-
sions. Those who promote an approach based on fairness and equity need to con-
sider that, during public health emergencies, the goal of saving lives may force a
retreat to utilitarian ethics (Kirkwood 2010; Veatch 2005). While not necessarily
unethical in itself, a retreat that overturns prior arrangements lays itself open to
charges of illegitimacy.
Variability in the frameworks used to allocate public health resources illustrates
the importance of reflecting upon the values that undergird policy decisions and
individual practices, like critical care triage. Appealing spontaneously in the heat of
the moment to values that have not been adequately reflected upon or discussed in a
transparent and deliberative manner may lead to undesirable outcomes and accusa-
tions of unethical practices. While discussions of CCU triage criteria ultimately
concern institutional clinical policy and practice, they reflect a larger discussion
about the overarching public health goals in the face of large-scale, widespread
public health emergencies, like pandemics.
An outbreak of a novel influenza virus has progressed to the point that the World
Health Organization has declared a pandemic. In the pandemic’s first wave, hospital
capacities were sufficient to handle the influx of pandemic influenza patients, whose
92 N. Daniels
morbidity and mortality rates mirrored rates for seasonal influenza. However,
despite a vaccination campaign and other measures, such as ensuring surge capac-
ity, rates of morbidity and mortality associated with the virus have increased drasti-
cally during the pandemic’s second wave.
The resulting increased number of patients needing hospital beds has over-
whelmed even the surge capacity of the CCUs of a metropolitan city’s tertiary care
hospitals. To meet this challenge, a teleconference has been scheduled between sev-
eral members of the hospitals’ administration, the CCU directors from each hospi-
tal, and public health officials involved in leading the jurisdiction’s pandemic
response. As a public health official who played a central role in developing the
pandemic plan for your jurisdiction, you have been included on the call to provide
guidance for the pandemic response.
During the meeting, a number of CCU directors report that their physicians and
nurses are concerned about the type of patients being admitted into the CCU. Some
of the directors see a trend that they suggest is ultimately undermining the efficiency
of the pandemic response. They argue that, as the severity of the pandemic contin-
ues to increase, their triage criteria should be modified so as to use CCU resources
to save the most lives possible. They worry that admitting those who present with
the most need is preventing treatment of those who will benefit most from CCU
admission. “So long as our triage scheme saves the most lives, it is ethically justifi-
able” a number of them declare.
The group takes up the proposal of a CCU director to triage according to
Sequential Organ Failure Assessment (SOFA) scores—which are derived using a
tool that determines a patient’s organ function and failure rate to predict outcomes
(Vincent et al. 2000). Were the pandemic’s severity to increase, the group suggests
that, in addition to the CCU director’s proposal to use SOFA criteria, even more
inclusion, exclusion, and priority criteria could be added with the goal of saving as
many lives as possible. They’ve proposed exclusion criteria for CCU admittance
that include patients with a poor prognosis, patients with other known health issues,
and some mention of age cut-offs, to name a few.
Others involved in the teleconference question whether this is the right approach
to take. They argue that, by aiming to save the most lives possible, those who may
benefit less from CCU admission, like older adults or individuals with disabilities,
will be unfairly affected. They say, “we should not just aim to save lives, but rather
save lives fairly.” As you and your public health colleagues are leading the pan-
demic response, the hospital administrators and CCU directors look to you for a
recommendation or decision about how to proceed.
1. Ensuring that the CCU has surge capacity is a common strategy to accommodate
an influx of patients who have been infected with pandemic influenza.
(a) Does surge capability require alternative critical care triage criteria?
(b) If the population’s health needs exceed contingency arrangements, should
alternative critical care triage criteria be used?
(c) How should these decisions be made?
(d) What principles, values, or processes should influence these decisions?
2. What considerations might exist during a pandemic that do not exist in everyday
critical care and critical care triage that do or do not support the modification of
triage criteria? If pandemic critical care triage requires a unique conceptual
framework, what principles ought to be valued in such a framework (e.g. need,
equality, utility, efficiency)?
3. Would the severity of a pandemic ever warrant the use of a utilitarian scheme for
critical care triage, given that the public generally finds it unpalatable and carry-
ing out such a plan could require coercion? How could an adverse public reac-
tion to coercive or covert measures be mitigated?
4. In a pandemic, the most seriously ill patients with the lowest probability of being
saved might be left untreated because their care would require too many resources
with little prospect of recovery. This illustrates a conflict between the common
good and the best interests of individual patients. What other conflicts might
arise when triaging in a pandemic?
5. Triage can be used to maximize the number of lives saved with available
resources. Should we aim to maximize the number of lives or, alternatively, the
number of life years saved? This can also give rise to questions about the quality
of those lives and years lived. Is it ever appropriate to make allocation decisions
based on quality of life or life years?
Acknowledgements MJS is supported by a Canadian Institutes of Health Research Frederick

Banting and Charles Best Canada Graduate Scholarship and the Canadian Institutes of Health
Research Douglas Kinsella Doctoral Award for Research in Bioethics. AMV is supported by the
Faculty of Medicine, Ruhr-University Bochum.
References
Baker, R., and M. Strosberg. 1992. Triage and equality: An historical reassessment of utilitarian
analyses of triage. Kennedy Institute of Ethics Journal 2(2): 103–123.
Charlesworth, M. 1993. Bioethics in a liberal society. New York: Cambridge University Press.
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Childress, J. F. 2004. Disaster triage. Virtual Mentor 6(5). http://journalofethics.ama-assn.

org/2004/05/ccas2-0405.html (accessed on 20 Nov 2015).
Christian, M.D., L. Hawryluck, R.S. Wax, et al. 2006. Development of a triage protocol for critical
care during an influenza pandemic. Canadian Medical Association Journal 175(11):
1377–1381.
Hick, J., L. Rubinson, D. O’Laughlin, and J. Farmer. 2007. Allocating ventilators during largescale
disasters—Problem, planning, and process. Critical Care 11(3): 217–226.
Hoffman, S. 2009. Preparing for disaster: Protecting the most vulnerable in emergencies. UC
Davis Law Review 42: 1491–1547.
Kirkwood, K. 2010. In the name of the greater good? Emerging Health Threats Journal 2(E12):
1–3.
Melnychuk, R.M., and N.P. Kenny. 2006. Pandemic triage: The ethical challenge. Canadian
Medical Association Journal 175(11): 1393–1394.
Rubinson, L., F. Vaughn, S. Nelson, et al. 2010. Mechanical ventilators in US acute care hospitals.
Disaster Medicine and Public Health Preparedness 4(3): 199–206.
Silva, D.S., J.X. Nie, K. Rossiter, S. Sahni, and R.E. Upshur. 2010. Contextualizing ethics:
Ventilators, H1N1 and marginalized populations. Healthcare Quarterly 13(1): 32–36.
U.S. Department of Health and Human Services. 2005. HHS pandemic influenza plan. http://www.
flu.gov/planning-preparedness/federal/hhspandemicinfluenzaplan.pdf. Accessed 7 Jan 2013.
Uscher-Pines, L., S.B. Omer, D.J. Barnett, T.A. Burke, and R.D. Balicer. 2006. Priority setting for
pandemic influenza: An analysis of national preparedness plans. PLoS Medicine 3(10):
1721–1727.
Veatch, R.M. 2005. Disaster preparedness and triage: Justice and the common good. The Mount
Sinai Journal of Medicine 72(4): 236–241.
Vincent, J.L., F. Ferreira, and R. Moreno. 2000. Scoring systems for assessing organ dysfunction
and survival. Critical Care Clinics 16(2): 353–366.
World Health Organization (WHO). 2008. Addressing ethical issues in pandemic influenza plan-
ning: Discussion papers. http://www.who.int/csr/resources/publications/cds_flu_ethics_5web.
pdf. Accessed 2 July 2013.
Chapter 4
Disease Prevention and Control
Michael J. Selgelid
4.1 Introduction
Ethical issues surrounding public health policy and practice regarding disease pre-
vention and control often involve conflicting rights and values. Such conflicts partly
arise from tension between individual and community interests or tension involving
cultural beliefs and practices. This chapter outlines how such conflicts and tensions
arise in the context of disease prevention and control by exploring ethical issues
associated with mandatory treatment and vaccination, disease screening and sur-
veillance, diseases prone to stigma, access to care, health promotion incentives, and
emergency response.
4.2 Mandatory Treatment and Vaccination
In standard biomedical ethics (as opposed to public health ethics) discourse, the
patient’s right to informed consent to medical intervention is often considered sac-
rosanct. A primary aim of informed consent is to avoid medical paternalism, such as
coercing a patient to do something for his or her own benefit. The transition in clini-
cal practice from medical paternalism to informed consent was largely based on the
ideas that (1) a well-informed patient is better placed than the doctor to determine
which actions are in the patient’s best interests (Goldman 1980) and (2) that a
patient’s autonomy should, in any case, be respected.
The opinions, findings, and conclusions of the author do not necessarily reflect the official posi-
tion, views, or policies of the editors, the editors’ host institutions, or the author’s host
institution.
M.J. Selgelid, MA, PhD (*)
Centre for Human Bioethics, Monash University, Melbourne, Australia
e-mail: michael.selgelid@monash.edu

96 M.J. Selgelid
In public health, however, treatment and vaccination may, in addition to the health
of the individual, be important to population health. As such, individual patients are
not the only stakeholders whose interests must be considered. In the context of tuber-
culosis (TB), coercive treatment is common—in so far as, in many jurisdictions,
patients with active TB are required to undergo (often directly observed) treatment
under threat of confinement if they refuse. While TB treatment usually benefits those
subjected to this kind of coercion, the primary motive for such policies is the protec-
tion of public health rather than paternalism. Because patients with untreated active
TB remain contagious, their treatment is essential to prevent infection of others.
Though objections to paternalism are not as relevant to mandatory treatment in this
context, ethical issues remain. Because mandatory treatment (aimed at protection of
others) conflicts with individual liberty, there is a conflict between legitimate values—
i.e., individual liberty versus public health. There are also conflicting rights—i.e., the
right of coerced individuals to autonomy versus the rights of others to health (or their
rights not to be harmed by being infected). Each of these values and rights is legiti-
mate; and, arguably, none should be given absolute priority over the others. A key
ethical question about mandatory treatment is, thus, how great the threat to others (and
public health in general) would need to be in order for mandatory treatment to be
justified.1 It is noteworthy that TB is relatively exceptional—i.e., there are not many
other cases of infectious diseases for which treatment is routinely required.
Similar issues arise in the context of vaccination. While vaccination usually benefits
the vaccinated, it also benefits others via contribution to herd immunity (Verweij and
Dawson 2004). Mandatory vaccination is also more common than mandatory treat-
ment. In some jurisdictions, for example, vaccination of children is required for school
attendance. The case presented by Simón-Lorda et al. considers the scenario of a mea-
sles outbreak, resulting from a low rate of vaccination uptake, at a school in Spain. In
the scenario, the conflicting rights associated with mandatory medical intervention
again come into play. The suggestion that unvaccinated children should not be permit-
ted to attend school, for example, is initially rejected by health authorities on the
grounds that this would conflict with their right to education. Unvaccinated children’s
right to education, thus, conflicts with the rights of other children not to be infected.
How should such a conflict of rights be resolved? In the case presented by Simón-
Lorda et al., the outbreak finally becomes so widespread that mandatory vaccination is
called for as an emergency measure. Assuming such a decision would be legitimate in
the scenario under consideration, it might be grounded on the belief that public health
outweighs individual liberty when the stakes are sufficiently high (rather than the belief
that the value of public health outweighs the value of liberty in general).
A complicating factor regarding mandatory vaccination is that when one unvac-
cinated child ends up becoming infected with a disease (such as measles) and then
goes on to infect others, it could be argued that those others who become infected
do not in fact have their rights violated because they could have avoided infection
1
With respect to the public health ethics framework discussed in Chap. 1, the question here is what,
exactly, the proportionality requirement should be thought to consist in. For further discussion of
this issue, see Selgelid (2009).
4 Disease Prevention and Control 97
by getting vaccinated themselves. It would usually be parents, rather than children,

however, who make decisions about childhood vaccination. This raises the question
of who (e.g., parents or the government) should have authority to make decisions
about children’s health and well-being—and vaccination in particular. Assuming
that parents should usually retain decision-making authority about childhood vac-
cination, the relevance of cultural differences to public health ethics is highlighted
by the fact that some parents may refuse vaccination of their children for what are
ultimately cultural reasons (e.g., religious beliefs). This leads to questions (also
raised by other cases presented in this chapter) about whether, and to what extent,
cultural beliefs and practices should influence public health policy and practice.
4.3 Disease Screening and Surveillance
As in the cases of treatment and vaccination, informed consent to diagnostic testing is

usually considered essential in standard biomedical ethics discourse regarding doctor-
patient relationships. In public health, however, diagnostic testing is sometimes
required, for example as a condition of employment (such as tuberculin skin testing of
restaurant and hospital employees) or immigration (for which both TB and HIV test-
ing are common). Testing of tissues or other biological samples also sometimes takes
place, for research or surveillance purposes, without patients’ or donors’ awareness or
consent (e.g., testing of stored sputum samples to determine TB drug resistance preva-
lence). Cases such as these may pose conflict between the goal to promote public
health, on the one hand, and the goals to respect individual autonomy and privacy, on
the other. As with mandatory treatment and vaccination, however, such practices are
arguably justifiable in cases where public health benefits are sufficiently high (which
is not to say that public health generally trumps autonomy and privacy).
As with vaccination, questions about parental authority in decision making
regarding childhood health arise in the context of disease screening. The case pre-
sented by Nicholls et al., raises such issues. Bloodspot screening is commonly used
to test newborns for numerous serious health conditions, and stored bloodspots are
sometimes later used for research and surveillance that lead to important public
health benefits. Given the potential importance of such practices for a child’s health,
and to public health more generally, to what extent is parental informed consent to
bloodspot screening or secondary use of stored bloodspots essential? The case pre-
sented by Nicholls et al. raises the worry that more parents, out of privacy concerns,
might refuse newborn bloodspot screening if a thoroughgoing informed consent
process (as opposed to the current opt-out model) were required, and that this could
have adverse effects for both newborns and, given the benefits of research and
surveillance with stored bloodspots, public health more generally. Among other
important questions, Nicholls et al. ask, “How should clinically actionable results
[of secondary investigations involving bloodspots] be dealt with?” When surveil-
lance testing of stored bloodspots or other stored tissues leads to identification of
not-previously-recognized disease (or predispositions thereto), for example, to what
extent do investigators have duties to track down and inform individuals from whom
98 M.J. Selgelid
bloodspots or other stored tissues were originally obtained? Like research, surveil-
lance raises ethical issues about standards of care (Selgelid 2012).
Ethical issues concerning testing and surveillance are also highlighted in the case
presented by Bhattacharya. In this case, the criminalization of HIV transmission
and mandatory name-based reporting requirements (in the case of HIV diagnosis)
are portrayed as deterrents to sex workers’ seeking of HIV testing. In the case of
criminalized transmission, the disincentive to testing is that criminal penalties asso-
ciated with prostitution are greater (in some jurisdictions) for those who have tested
HIV positive. Among other things, criminalizing HIV makes it difficult for public
health workers to promote HIV testing of sex workers (who are an especially vul-
nerable group, and for whom testing is especially important—for their own sake and
for public health more generally) while adhering to mandatory reporting require-
ments. This challenge is further exacerbated by socio-economic and cultural factors
that promote prostitution to begin with.
This case also raises more general issues about the criminalization of infectious
disease transmission. Many argue that there is a moral obligation to avoid infecting
others, based on a duty not to harm others (Harris and Holm 1995). Criminalizing
infectious disease transmission involves the legal enforcement of such a moral duty.
Given that HIV transmission usually involves consenting adults knowingly taking
risks, one might question whether criminalization of HIV transmission, in particu-
lar, is necessary. It should be noted, however, that it is usually intentional transmis-
sion of HIV that is criminalized. In any case, criminalization of HIV transmission
raises questions about the extent to which intentional transmission of other diseases
should also be criminalized and whether, or why, negligent transmission (of HIV or
other diseases) should also be subject to legal penalties.
The case by Bhattacharya also raises ethical questions about name-based report-
ing, which is legally required upon positive diagnosis of numerous diseases of pub-
lic health importance (Fairchild et al. 2007). As a surveillance measure, the purpose
of name-based reporting pertains to contact tracing and, among other issues, estima-
tions of disease incidence or prevalence, which are used to inform public health
policy and practice (Lee et al. 2010). While mandatory name-based reporting may
have important public health benefits, it conflicts with privacy and informed
consent. It may also have adverse effects upon public health if it ends up driving
epidemics underground, when those especially in need of testing and treatment are
reluctant to seek care due to concerns about privacy or lack of trust in health care
providers. What the overall public health consequences of name-based reporting
actually are, with any reportable disease, is ultimately an empirical question.
4.4 Stigma
Related to the privacy issues considered above is the problem of disease stigmatiza-
tion, which can lead to discrimination and other abuses of those known (or, perhaps
wrongly, believed) to be affected. The extent and nature of disease stigmatization, and
the effects thereof, are often largely related to cultural factors or misunderstanding of
the diseases in question. The unjust discrimination and abuse commonly associated
with disease stigmatization are especially problematic because they make matters
worse for those who are already badly off (by virtue of health status). As in the case
considered above, stigma can also deter those in need from seeking testing or health
care to begin with. The problem of stigma could be reduced via better public educa-
tion about the nature of stigmatized diseases and better legal protections against unjust
discrimination and other abuses associated with stigma.
Ways in which stigmatization can interfere with individual and public health is
illustrated in the case presented by Henning and Nair. While risks of vertical HIV
transmission from infected mother to newborn can be reduced by replacing breast-
feeding with formula and providing antiretrovirals to the mother, in some southern
African countries HIV is so heavily stigmatized that women may be reluctant to
pursue such measures in fear they will suffer violence or be abandoned by their
husbands (if such measures reveal, or raise suspicions about, their HIV status). In
the case presented by Henning and Nair, such fears on the part of a mother create a
dilemma for her doctor, who, based on best medical practice and concern for the
baby (and public health), would presumably want to encourage such measures, but,
based on concern for the mother’s privacy and well-being, might not want to insist
on them. While there is no obvious answer to the question of what the doctor should
immediately do in this poignant case presented by Henning and Nair, the long-term
solution to this kind of problem would presumably require cultural change involv-
ing reduction of HIV stigma via public engagement and awareness-raising, and
greater empowerment and protection of women in general.
4.5 Access to Care
It is commonly believed that there is a universal human right to health and/or health
care, and such rights are enshrined by the Universal Declaration of Human Rights
and other human rights instruments (Selgelid and Pogge 2010). In addition to being
a matter of human rights and justice, access to care is also important for public
health. In the context of infectious diseases, for example, lack of access to care
results in perpetuation of epidemics when those left untreated remain contagious.
This is one reason the burden of infectious disease is more heavily shouldered by
impoverished developing nations, where access to care is limited, largely due to
resource constraints. When such diseases run rampant in developing countries, this
poses threats to global health more generally—because infectious diseases show no
respect for international borders. This points to self-interested reasons, in addition
to egalitarian and human rights reasons, for wealthy countries to do more to pro-
mote health care improvement in developing countries.
Although the right to health care is widely recognized (if not always well respected
and protected) it is questionable whether such a right should be considered absolute.
Some means of health care may be too expensive, even in wealthy countries, to be
routinely provided. In other cases, providing health care to individual patients might
itself have adverse effects on public health. When patients fail to complete a full
100 M.J. Selgelid
course of antimicrobial treatment, for example, this promotes emergence of drug

resistance (which increases danger to others who might be infected). Luco et al. pres-
ent a case involving a TB patient who repeatedly fails to complete his prescribed
course of medication and ends up with drug-resistant TB as a result. In light of this
patient’s history of noncompliance, his adherence to further courses of treatment
might be considered unlikely. The patient nonetheless pleads for a new course of
treatment and promises to adhere to the prescribed regimen. Whether providing addi-
tional treatment in a case like this would be warranted depends at least partly on
whether there is a decent chance the treatment will succeed (assuming the patient
does in fact adhere) in light of the current level of drug resistance. If the patient’s TB
is already resistant to all available treatments, then further treatment (even if the
patient adheres) might at best be futile or at worst lead to greater drug resistance.
If, on the other hand, the patient’s TB remains susceptible to treatment then
deciding whether to provide additional medication might partly depend on the like-
lihood that the patient will comply with treatment in the future. One might argue
that a doctor’s decision to withhold treatment based on predictions about continued
noncompliance would involve unjust discrimination based on the doctors’ judgment
of the patient’s character, and that doctors, in general, have no special expertise for
making such judgments or predicting patients’ behavior in the first place (World
Health Organization [WHO] 2010). If the patient is left untreated, then this would
arguably infringe on his right to health care and threaten public health (i.e., if the
patient remains infectious and at large in the community). On the other hand, based
on past experience, there appears to be a legitimate concern that providing care (or
respecting the patient’s right to care) may conflict with others’ right to health and
public health more generally (i.e., as continued noncompliance may lead to increased
drug resistance). Consideration of this case motivates further reflection on manda-
tory treatment (discussed above) because if treatment compliance was better
enforced to begin with, then dilemmas posed by cases like this might be avoided.
4.6 Health Promotion Incentives
Public health policies often involve incentivizing health promoting behaviors (e.g.,
provision of financial benefits to parents when children are vaccinated) and/or dis-
incentivizing unhealthy behavior (e.g., heavy taxation of things like cigarettes and
alcohol). While such policies might be considered manipulative or paternalistic in
spirit, they do not rely on outright coercion if people are still ultimately free to
behave as they wish, and so autonomy is largely respected. Their legitimate aim is
health improvement. Such policies, however, may sometimes involve tension with
cultural beliefs and practices. In the case presented by Bhati, for example, cash
incentives are used to encourage childbirth in health care institutions in India, where
homebirth remains traditional. This situation leads to a tragic conclusion in the case
of a mother who resists her in-laws’ pressure (apparently based on monetary motive)
toward institutional delivery. She ends up losing her child due to delivery
complications while traveling to her home village where she planned to give birth
and is then faced with “the wrath of her husband and in-laws.” While the cash incen-
tive aims to promote the health of mothers and children, and public health more
generally, the point of this case is to show how this kind of health promotion incen-
tive might exacerbate pressures on women who, in the cultural milieu of India,
already suffer diminished autonomy. The warning is that, despite good intentions,
health promotion incentives can backfire if they lack adequate cultural sensitivity.
4.7 Emergency Response
Emergencies are extreme situations (Viens and Selgelid 2012) where threats to pub-
lic health can be exceptionally severe. Examples include epidemics, other natural
disasters (e.g., floods, hurricanes, earthquakes), and manmade disasters (e.g., war,
terrorism, severe environmental damage). As noted in cases previously discussed,
public health policies and practices often give rise to conflicts between the rights and
liberties of individuals, on the one hand, and the goal to promote public health, on the
other. It has also been repeatedly suggested (above) that the importance of public
health protection is more likely (than would otherwise be the case) to outweigh the
importance of protecting/respecting individual rights and liberties in cases where the
magnitude of threat to public health is especially great. During emergencies, there-
fore, it may be more necessary than in other contexts to resort to liberty infringing
measures. In the case of a severe epidemic, for example, social distancing measures
such as isolation and quarantine might be justified despite the fact that they interfere
with one of the most basic human rights, freedom of movement.
Emergencies also often put unprecedented pressure on limited resources and
thus require difficult ethical decisions regarding resource allocation. Given the
spectre of a future severe influenza pandemic, for example, there has been much
debate about who should be given priority for resources like antivirals, vaccines,
and ventilators if (as may be expected) need outstrips supply (Verweij 2009).
Emergencies, finally, also often call for urgent action. So, decisions must be
made quickly, and other time-saving measures may be needed to mitigate harm.
While urgent research might be needed to understand and control an epidemic
caused by a novel pathogen, for example, it has been argued that the usual proce-
dures for ethical clearance of research (which can be very slow) might need to be
altered in the case of emergency research in particular (WHO 2009).
The issue of urgency is well illustrated by the case presented by Peacock and col-
leagues. In the event of a major bioterrorist attack involving anthrax, it might be nec-
essary to vaccinate large numbers of people quickly. Administration of vaccine shortly
after exposure is important because anthrax vaccine provides prophylactic protection.
Because anthrax vaccine has not been tested in children, however, its use in children
would require informed consent of parents according to U.S. law. In a scenario where
huge numbers of children would need to be vaccinated quickly, however, going
through usual informed consent processes might take too much time (and perhaps
102 M.J. Selgelid
lead to unrest among those waiting to be vaccinated). This motivates examination of

possible ways to hasten the consent process, for example, via group information ses-
sions rather than the usual one-on-one consent process. While group consent proce-
dures may facilitate more timely vaccination of children, the question is whether, or
the extent to which, group sessions would ultimately compromise informed consent
and whether such compromise would be justified by public health benefits. As with
other cases presented in this chapter, the case presented by Peacock et al. illustrates
how cultural factors may pose special difficulties. For example, quick consent would
be especially challenging in cases where children’s parents do not speak English.
Quick consent (to a vaccine that has not been studied in children) may likewise be
difficult in cases where parents are generally skeptical about vaccine safety.
The case presented by Viens and Smith explores a range of ethical challenges
associated with mass evacuation that might be called for in an emergency scenario
involving a major hurricane. Among other issues, this case raises questions about
when evacuation should be voluntary or mandatory (while the latter, like isolation
and quarantine, would involve interference with freedom of movement); whether, or
how, mandatory evacuation should be enforced; whether there are duties to rescue
those who refuse to comply with calls for evacuation; whether such people should
be financially sanctioned if they are in fact rescued; who should be given special
assistance with evacuation efforts, and how those in need of assistance should be
prioritized; whether it might be acceptable to abandon unstable patients who cannot
be moved (or for whom movement would be excessively expensive); whether com-
pensation might be due to those who suffer financial (or other) loss as a result of
compliance with calls for voluntary or mandatory evacuation; and whether there
should be legal protections against price gouging of commodities like gasoline.
4.8 Conclusion
This chapter has illustrated ways in which ethical issues associated with disease
prevention and control involve conflicting rights and values, tensions between indi-
vidual and community interests, and tensions involving cultural beliefs and prac-
tices. While the cases discussed in this chapter provide a good overview of many of
the most important and difficult ethical issues associated with disease prevention
and control, the discussion above reveals that their resolution would require resolu-
tion of both empirical questions (about the extent to which alternative values would
likely be promoted or compromised by one practice or policy or another) and philo-
sophical questions (about how to balance legitimate values in cases of conflict). It is
also important to recognize that resolution of any of the specific issues in the cases
discussed above would not necessarily imply resolution of the more general issues
raised by these cases. Resolving the question of whether or not there should be
mandatory measles vaccination in Spain, for example, would not resolve the ques-
tion of whether there should be mandatory vaccination of measles in other coun-
tries, or whether there should be mandatory vaccination against other diseases (in
Spain or elsewhere). A virtue of case studies is that context is crucial to the empiri-
cal questions that ethical issues (partly) turn on.
References
Fairchild, A.L., R. Bayer, and J. Colgrove. 2007. Searching eyes: Privacy, the state, and disease
surveillance in America. Berkeley: University of California Press.
Goldman, A. 1980. The moral foundations of professional ethics. Totowa: Rowman and Littlefield.
Harris, J., and S. Holm. 1995. Is there a moral obligation not to infect others? British Medical
Journal 311: 1215–1217.
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public health surveillance. New York: Oxford University Press.
Selgelid, M.J. 2009. A moderate pluralist approach to public health policy and ethics. Public
Health Ethics 2(2): 195–205.
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Vaccine 22(23–24): 3122–3126.
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Geneva: World Health Organization. http://www.who.int/ethics/gip_research_ethics_.pdf.
Accessed 5 Nov 2013.
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control. Geneva: World Health Organization. http://whqlibdoc.who.int/publications/
2010/9789241500531_eng.pdf. Accessed 5 Nov 2013.
4.9 Case 1: Mandatory Vaccination in Measles Outbreaks
Pablo Simón-Lorda
Primary Health Care Centre Chauchina
UGC Santa Fe, Granada, Spain
Department of Health and Social Welfare–Regional Government of Andalusia
Granada, Spain
e-mail: psimoneasp@gmail.com
Isabel Marin-Rodríguez
Provincial Office of Health and Social Welfare of Granada
Granada, Spain
Juan Laguna-Sorinas
Department of Epidemiological Surveillance, Provincial Office of Health
and Social Welfare of Granada
Granada, Spain
Maite Cruz-Piqueras and Maribel Tamayo-Velázquez
Andalusian School of Public Health
Granada, Spain
104 M.J. Selgelid
Miguel Angel Royo-Bordonada

National School of Public Health
Madrid, Spain
4.9.1 Background
In 2005, the European Regional Office of the World Health Organization (WHO-
EUR), which includes 53 countries, set the goal of eliminating measles in Europe in
2010 (WHO 2005). The Pan American Health Organization (PAHO) declared the
WHO Region of the Americas free from endemic measles in 2002 (Castillo-
Solorzano et al. 2011). Nevertheless, that region has continued to experience peri-
odic outbreaks, probably due to importation of measles from other parts of the
world. In 2008, WHO’s Executive Board (EB) began to determine whether to extend
the goal of eradicating measles to the rest of the world (WHO 2010a).
The decrease in measles cases after a vaccine was introduced in the 1980s made
the WHO-EUR goal of eliminating measles in Europe realistic. However, in 2006–
2007, the vaccine coverage rates remained below 90 % in many European countries,
and although the number of cases continued to fall, epidemic outbreaks still occurred
periodically (Muscat et al. 2009). At the end of 2009, an explosion of outbreaks was
recorded and the number of cases began to increase sharply. This upward trend con-
tinued throughout 2010, when 30,639 measles cases were reported (WHO 2011).
This forced WHO-EUR to postpone its eradication goal until 2015 (WHO 2010b).
The increase in measles cases can be attributed to the inability to achieve appro-
priate levels of vaccine coverage (>90 %) either because people cannot access health
services, or because they hold personal beliefs against vaccination (Muscat 2011).
The latter group includes members of the anti-vaccination movement, which makes
extensive use of the Internet and social networks to share ideas (Kata 2010). After
rumors spread about an association between measles vaccination and autism, vaccine
coverage rates decreased in countries such as the United Kingdom, where “anti-
vaccination” sentiment has gradually grown during the past 10 years (Flaherty 2011).
Measles is a notifiable disease in the 53 WHO-EUR countries, all of which
employ a two-dose regimen for immunization. However, measles vaccination is
not mandatory in all WHO-EUR countries. A study of 29 of the 53 WHO EUR
member countries showed that, in 2010, vaccination against measles was only
obligatory for children in 8 of the 29 (Haverkate et al. 2012). Within the 21 remain-
ing countries, vaccination was recommended but voluntary. The debate about
which of the two positions, voluntary or compulsory vaccination, is better from an
ethical point of view, remains open (Moran et al. 2008; Schröder-Bäck et al. 2009).
Spain is one of the European countries where measles has reappeared. The first
childhood immunization schedule (CIS) was introduced in Spain in 1975. In 1978,
Spain began to vaccinate against measles (one dose at 15 months) which beginning in
1981 was administered as a measles-mumps-rubella (MMR) vaccine. Starting in 1990,
a second dose at 11 years of age was introduced. In 2004, the age at which the second
dose was administered was revised to 8 years of age. As a result, the illness almost
disappeared over the course of a 20-year period: 220,096 cases in 1986, but only 17
cases in 2005. However, since that time, cases have increased, with periodic local out-
breaks: 2006 (349 cases), 2007 (260 cases), 2008 (305 cases), 2009 (43 cases), 2010
(285 cases) and 2011 (3507 cases) (WHO 2012). In 2011, an infected person died.
In contrast with countries such as the United States, Spain has made childhood vac-
cination voluntary and not a requirement for attending school (Colgrove 2006; Stadlin
et al. 2012). However, the average vaccine coverage rates are high (>90 %) (Masa et al.
2010). This can be attributed largely to the public health system’s primary care teams,
distributed throughout the country and composed of family doctors, pediatricians and
nurses. Even so, there are still places where coverage is less extensive, particularly in
poor parts of large cities with low levels of socioeconomic development.
In Spain, health professionals document administration of childhood vaccines in
handwriting in a paper booklet maintained by the parents. They also register this
information in the child’s medical record, which is commonly computer based.
However, discrepancies can occur between the two vaccine registration systems.
You are the chief public health officer in a province of Spain. One day, a pediatrician
tells you about a 13-year-old who is suspected to have measles. The child and his
family attended a wedding the week before. Within 10 days, six more people who
also attended the wedding were diagnosed with measles and nine secondary cases
are confirmed. Of the secondary cases, seven were thought to have been exposed at
school and two were in the hospital emergency ward.
All cases occurred in a historic quarter of the city with a large degree of cultural,
economic, religious, ethnic, and social diversity. This multicultural identity diverges
from the relative homogeneity of the rest of the city.
The public primary school of the historic quarter is now the focal point of the
outbreak. There are 216 students enrolled in the school. You order two initial
public health measures outlined in the regional health ministry’s Alert Protocol
for Measles: (1) that a letter be sent to parents asking them to bring their child’s
vaccination booklet to the school, and (2) that a meeting be held with the parents
to have health professionals inform them about the disease and the immunization
process.
106 M.J. Selgelid
As a result of the letter, the parents of 137 children take the vaccine booklet to
the school, which shows a low degree of measles vaccine coverage (60 %). Those
children not immunized are then vaccinated with their parents’ consent. However,
the parents of 79 children fail to bring the vaccine booklet to the school.
In the parent meeting, some of the parents express their support for the anti-
vaccination movement. They express sentiments such as “the disease is a natu-
ral process, so we prefer to organize measles parties;” “risk of measles is very
low, but vaccines are toxic poisons;” “a lot of hidden complications of vaccines
exist, for example, autism;” and “Big Pharma and politicians are looking out for
profits, not for the welfare of our kids.” They also allege, “vaccination is not
obligatory in Spain, and we have a right to educate our children in accordance
with our values.” These remarks generated a heated dispute between parents for
and against vaccination. The majority of parents seem misinformed about the
risks and benefits of vaccination and do not even know the immunization status
of their own children.
The next day, the measles outbreak at the school comes to the attention of the
local and national media. Alarmist messages and negative stories about
anti-vaccination groups grab headlines. There are stories that seem to blame the
outbreak on the cultural diversity of the historic quarter. You worry that the negative
media reports may stigmatize the people living in this quarter or, even more worri-
some, blame specific religious or ethnic groups.
Therefore, you consider adopting additional public health measures such as
maximizing surveillance in the city, controlling emergency rooms to decrease (or
eliminate) transmission, and vaccinating health professionals and children under
6 months. You also consider having unvaccinated children stay home, but health
authorities reject the idea, alleging it would violate the right to education. Little by
little, a number of parents consent to having their children vaccinated, or the chil-
dren are stricken and become immune.
Nevertheless, new cases linked to the school continue to occur. In the regional
health ministry, attention is turned to the possibility of requiring vaccination via a
court order, citing a fundamental law that enables such exceptional actions in public
health emergencies.
Finally, a request is put to the judge to authorize the enforced vaccination of 35
children. He does and you inform the parents. Two nurses, accompanied by a police
officer, visit the houses one by one. The majority of the parents give consent to the
vaccination. Ten days later, only nine children remain unvaccinated as a result of the
refusal of their parents. You inform the judge that the number is so low that the situ-
ation of special risk generated has now been overcome. You suspend compulsory
vaccinations.
Since the first case was diagnosed, 10 months have elapsed. A total of 308 cases
have been confirmed, 96 in minors younger than 1 year old. And 71 patients required
hospitalisation (23 %), including five adults.
1. What are the values, ethical principles, and rights that come into conflict in this
case? If it is not possible to respect all of them, how should they be
prioritized?
2. Is the decision to allow unvaccinated children to attend the school justified?
3. Think of a solution that adequately balances the freedom of choice of parents
who are against vaccination with the protection of the health of a community
where vaccination is not compulsory.
4. Was there sufficient epidemiological risk to justify the court order? Were there
other possible solutions? Once the judicial measure had been adopted, why was
it not pursued to its conclusion? Does the argument to suspend administering
vaccines provide sufficient grounds for this decision?
5. Once the outbreak has subsided, what measures should be introduced to avoid
further outbreaks? If the vaccination rate in the country later falls and new out-
breaks occur, should the government consider mandatory vaccination?
Acknowledgements The authors would like to acknowledge the EuroPubHealth Consortium
(www.europubhealth.org) for funding the academic stay of Pablo Simón as visiting scholar at
the Mailman School of Public Health, Columbia University, New York (USA), during October
through November 2012. This support made his preparation of the case possible.
References
Castillo-Solorzano, C.C., C. Ruiz-Matus, B. Flannery, C. Marsigli, G. Tambini, and J.K. Andrus.

2011. The Americas: Paving the road toward global measles eradication. Journal of Infectious
Diseases 204(suppl 1): S270–S278.
Colgrove, J. 2006. State of immunity: The politics of vaccination in twentieth-century America.
Berkeley: University of California.
Flaherty, D.K. 2011. The vaccine-autism connection: A public health crisis caused by unethical
medical practices and fraudulent science. The Annals of Pharmacotherapy 45(10):
1302–1304.
Haverkate, M., F. D’Ancona, C. Giambi, K. Johansen, P.L. Lopalco, and V. Cozza, et al. 2012.
Mandatory and recommended vaccination in the EU, Iceland and Norway: Results of the
VENICE 2010 survey on the ways of implementing national vaccination programmes. Euro
Surveillance 17(22): pii: 20183. http://www.eurosurveillance.org/ViewArticle.
aspx?ArticleId=20183. Accessed 10 June 2015.
Kata, A. 2010. A postmodern Pandora’s box: Anti-vaccination misinformation on the internet.
Vaccine 28(7): 1709–1716.
Masa, J., T. Castellanos, and M. Terrés. 2010. Annual report of the Spanish plan for the eradication
of measles and rubella–2010. Working Party of the Spanish Plan for the Eradication of Measles
and Rubella of the National Center of Epidemiology – Carlos III Institute of Health. http://
www.isciii.es/ISCIII/es/contenidos/fd-servicios-cientifico-tecnicos/fd-vigilancias-alertas/fd-
enfermedades/fd-enfermedades-prevenibles-vacunacion/Informe-Anual-Plan-Eliminacion-
del- Sarampion-Rubeola-y-Sindrome-de-Rubeola-Congenita-Espana-2010.pdf. Accessed 10
June 2015.
108 M.J. Selgelid
Moran, N.E., S. Gainotti, and C. Petrini. 2008. From compulsory to voluntary immunisation:
Italy’s national vaccination plan (2005–2007) and the ethical and organisational challenges
facing public health policy-makers across Europe. Journal of Medical Ethics 34(9): 669–674.
Muscat, M. 2011. Who gets measles in Europe? The Journal of Infectious Diseases 204(suppl 1):
S353–S365.
Muscat, M., H. Bang, J. Wohlfahrt, S. Glismann, K. Mølbak, and EUVAC.NET Group. 2009.
Measles in Europe: An epidemiological assessment. Lancet 373(9661): 383–389.
Schröder-Bäck, P., H. Brand, I. Escamilla, J.K. Davies, C. Hall, K. Hickey, et al. 2009. Ethical
evaluation of compulsory measles immunisation as a benchmark for good health management
in the European Union. Central European Journal of Public Health 17(4): 183–186.
Stadlin, S., R.A. Bednarczyk, and S.B. Omer. 2012. Medical exemptions to school immunization
requirements in the United States—Association of state policies with medical exemption rates
(2004–2011). The Journal of Infectious Diseases 206(7): 989–992.
World Health Organization (WHO). 2005. Eliminating measles and rubella and preventing con-
genital rubella infection: WHO European Region Strategic Plan 2005–2010. http://www.euro.
who.int/__data/assets/pdf_file/0008/79028/E87772.pdf. Accessed 10 June 2015.
World Health Organization (WHO). 2010a. Proceedings of the global technical consultation to
assess the feasibility of measles eradication, 28–30 July 2010. The Journal of Infectious
Diseases 204(suppl 1): S4–S13. doi:10.1093/infdis/jir100.
World Health Organization (WHO). 2010b. Resolution: Renewed commitment to elimination of
measles and rubella and prevention of congenital rubella syndrome by 2015 and sustained
support for poliofree status in the WHO European Region. Regional Committee for Europe
(EUR/RC60/R12). http://www.euro.who.int/__data/assets/pdf_file/0016/122236/RC60_
eRes12.pdf. Accessed 10 June 2015.
World Health Organization (WHO). 2011. Increased transmission and outbreaks of measles,
European region, 2011. Weekly Epidemiological Record 86(49): 557–564.
World Health Organization (WHO). 2012. Centralized information system for infectious diseases
(CISID): Measles. Geneva: World Health Organization. http://data.euro.who.int/cisid. Accessed
10 June 2015.
4.10 Case 2: Public Health Approaches to Preventing

Mother-to-Child HIV Transmission
Margaret Henning
International Health Systems Program
Harvard T. H. Chan School of Public Health
Boston, MA, USA
Health Science
Keene State College
Keene, NH, USA
e-mail: mhenning@keene.edu
Indira Nair
Department of Engineering and Public Policy
Carnegie Mellon University
Pittsburgh, PA, USA
4.10.1 Background
The pursuit of global public health takes place in an unjust world, demanding that its prac-
titioners judge when and to what extent to compromise their ideals and standards in order
to remain effective. (Wikler and Cash 2009)
Mother-to-child transmission (MTCT)—also known as vertical transmission—is

the primary cause of HIV infection in children under 10 years of age (Interagency
Coalition on AIDS and Development 2011). Each year, more than 600,000 infants
become infected with HIV from prenatal transmission during pregnancy, labor and
delivery, or breastfeeding, primarily in under-resourced countries (Centers for
Disease Control and Prevention 2012; Interagency Coalition on AIDS and
Development 2011; Mnyani and McIntyre 2009).
For women who are HIV-negative, breastfeeding is the preferred child survival
strategy. It is linked to a lower risk of various health problems for babies, including a
reduction in the risk of death from diarrhea and malnutrition (World Health
Organization 2007; O’Reilly et al. 2012). However, the risk of an HIV-positive woman
transmitting the virus to her baby in the absence of any intervention ranges from 15 to
45 % (De Cock et al. 2000; World Health Organization 2015). Avoidance of breast-
feeding (use of replacement feeding) reduces the risk of neonatal transmission to
20 % (Interagency Coalition on AIDS and Development 2011). Modified feeding,
also known as mixed feeding (liquids or solids), results in a risk of transmission of
about 30–35 % (Coutsoudis et al. 1999). The safety of replacing breastfeeding depends
on access to clean water, a reliable supply of formula, and availability of instruction.
Thus, use of mixed feeding techniques can be a challenge in many middle- or low-
income countries (World Health Organization 2007; O’Reilly et al. 2012).
To help reduce the risk of babies becoming infected with HIV and to ensure quality
services across the different levels of the health system, the World Health Organization
(WHO) released revised guidelines in 2010 for use by managers of national HIV and
AIDS programmers, as well as local managers and health care providers. The guide-
lines emphasize treatment for pregnant, HIV-infected women. Those with stage 3 or
stage 4 disease (CD4 count ≤350 cells/μL) require lifelong three-drug antiretroviral
therapy (ART) to treat their own HIV infections and for prevention of mother-to-child
transmission of HIV (PMTCT). For women with less-advanced disease, WHO rec-
ommends a country- or program-level choice between Option A (maternal zidovudine
during pregnancy and infant nevirapine [NVP] throughout breastfeeding), and Option
B (maternal three-drug ART regimens throughout pregnancy and breastfeeding)
(WHO 2010). Mutations of the virus can occur when the required course of treatment
is not followed (Interagency Coalition on AIDS and Development 2011).
In many countries, social stigma, fear of the risk of discrimination, rejection, and
violence can thwart a woman’s intention to have an HIV test, take antiretroviral
drugs, or substitute breast milk (Interagency Coalition on AIDS and Development
2011). Such obstacles arise in part from traditional beliefs and values and from
unfamiliarity with the practice of biomedicine. In some cultures, a woman is viewed
as responsible for her own HIV infection and that of her child, and she may suffer
emotional or physical abuse at the hands of her family if her HIV status is discovered.
110 M.J. Selgelid
However, it can be important for her family to be aware of her HIV status, as they
are often the ones who advise her on child feeding practices. Dealing with a wom-
an’s fear of being exposed as an HIV-positive mother is a challenge inherent in
programs that focus on PMTCT.
In a sub-Saharan African country, Dr. Charles directs a rural health clinic that an
international organization funds. Funding requires the clinic to follow new WHO
guidelines for the PMTCT. The guidelines specifically recommend using antiretro-
viral drugs throughout the breastfeeding period by HIV-positive women (WHO
2010). The district health office is also requiring Dr. Charles to develop guidance
for his clinical staff on how to carry out the guidelines in a way that takes the values
and beliefs of the community into account. Implementing the guidelines poses a
major challenge for Dr. Charles because of the country’s weak health infrastructure,
the small number of paid staff in his clinic, and an inadequate facility with limited
general supplies. However, his facility boasts a lab, and he has received some fund-
ing to support the PMTCT program.
Recently, a woman in labor came to the clinic and told Dr. Charles she was HIV
positive. She wanted to know how she could breastfeed without awakening suspi-
cions of her HIV status. She was worried that if neighbors or family found out, her
husband would abandon her, and she would have to support herself and the child in
a hostile environment.
1. How should this patient’s plight influence Dr. Charles as he helps his clinic carry
out the WHO guidelines? From a public health perspective, what conflicts does
Dr. Charles have in meeting his patient’s needs?
2. Who are the stakeholders Dr. Charles should consider as he develops his guid-
ance and what information does he need to ensure success in reducing mother-
to-child transmission of HIV in this community?
3. What procedures can he put in place to decrease the risk of HIV-positive women
being stigmatized by their partners, family, or community?
4. How should the infant’s well-being be balanced with maintaining the mother’s
health, social welfare, and survival?
5. To what extent should Dr. Charles consider the culture of his community in which
family decision making and traditions about infant feeding often hamper mothers’
efforts to decrease the risk for HIV transmission? How can public health programs
build flexibility that anticipates cultural diversity in beliefs, values, and practice?
6. Instead of just focusing on his patients, should Dr. Charles consider holding struc-
tured conversations with people in the community to influence social norms or with
village elders as a way to influence social norms counterproductive to program aims?
References
Centers for Disease Control and Prevention. 2012. HIV for women. http://www.cdc.gov/HIV/risk/
gender/women/facts/index.html. Accessed 23 May 2013.
Coutsoudis, A., K. Pillay, E. Spooner, L. Kuhn, and H.M. Coovadia. 1999. Influence of infant-
feeding patterns on early mother-to-child transmission of HIV-1 in Durban, South-Africa: A
prospective cohort study. Lancet 354(9177): 471–476.
De Cock, K.M., M. Fowler, E. Mercier, et al. 2000. Prevention of mother-to-child HIV transmis-
sion in resource-poor countries: Translating research into policy and practice. JAMA 283(9):
1175–1182. doi:10.1001/jama.283.9.1175.
Interagency Coalition on AIDS and Development. 2011. HIV/AIDS: Mother-to-child transmission.
http://www.icad-cisd.com/. Accessed 23 May 2013.
Mnyani, C., and J. McIntyre. 2009. Preventing mother-to-child transmission of HIV. BJOG: An
International Journal of Obstetrics & Gynaecology 116(suppl 1): 71–76.
O’Reilly, C.E., P. Jaron, B. Ochieng, et al. 2012. Risk factors for death among children less than 5
years old hospitalized with diarrhea in rural western Kenya, 2005–2007: A cohort study. PLoS
Medicine 9(7): e1001256. doi:10.1371/journal.pmed.1001256.
Wikler, D., and R. Cash. 2009. Ethical issues. In Global public health: A new era, ed. R. Beaglehole
and R. Bonita, 249–266. Oxford: Oxford University Press.
World Health Organization (WHO). 2007. HIV transmission through breastfeeding: A review of
available evidence. http://whqlibdoc.who.int/publications/2008/9789241596596_eng.pdf.
World Health Organization (WHO). 2010. Antiretroviral drugs for treating pregnant women and
preventing HIV infection in infants. http://www.who.int/hiv/pub/mtct/guidelines/en/. Accessed
1 May 2013.
World Health Organization (WHO). 2015. Mother-to-child transmission of HIV. http://www.who.
int/hiv/topics/mtct/en/. Accessed 1 June 2015.
4.11 Case 3: Newborn Bloodspot Screening: Personal Choice

or Public Health Necessity? Storage and Ownership
of Newborn Bloodspots
Stuart G. Nicholls
School of Epidemiology, Public Health and Preventive Medicine
University of Ottawa
Ottawa, ON, Canada
e-mail: snicholl@uottawa.ca
Jennifer Milburn
Newborn Screening Ontario
Children’s Hospital of Eastern Ontario
Ottawa, ON, Canada
Daryl Pullman
Division of Community Health and Humanities, Faculty of Medicine
Memorial University
112 M.J. Selgelid
institutions.
4.11.1 Background
Newborn bloodspot screening (NBS) is the process in which a small blood sample is
collected from the heel of a newborn, sent to a laboratory, and tested for serious and
life-limiting conditions. If diseases are detected in the newborn period, treatment can
begin immediately. NBS is conducted on almost 100 % of the newborn population in
North America, roughly four million infants per year in the United States (Botkin
et al. 2012). Screening panels have steadily increased the number of conditions tested,
with upward of 40 conditions included in some NBS programs. This momentum to
include more conditions in screening panels reflects a transition away from an ‘emer-
gency’ model to a ‘public health service’ model. In the emergency model, testing
identifies conditions amenable to treatment or associated with catastrophic morbidity
or mortality. In contrast, a key goal of the public health service model is to inform
decision making or avoid a “diagnostic odyssey” (Bailey et al. 2006; Buchbinder and
Timmermans 2011; Metcalfe et al. 2012). Advances in newborn screening have
increased our ability to detect previously unidentifiable conditions. However, they
have also raised a number of ethical challenges about how to best use the information.
For example, testing can now reveal someone’s carrier status (i.e., the person carries a
recessive copy of a genetic disorder without being affected by the condition). Knowing
a child’s carrier status can inform future reproductive decision making but may induce
anxiety, lead to potential stigma, or reveal non-paternity (Hayeems et al. 2008).
Newborn screening is a routine practice in many states. In the U.S. state of
Nebraska, for example, screening is mandatory without exception (Schweers 2012;
Foral 2006). In other U.S. states, screening proceeds on an opt-out basis, although
studies indicate that often parents are not afforded the opportunity to consent or are
poorly informed about the opt-out option (Botkin et al. 2012). This may even be the
case where screening proceeds in an ostensibly informed choice manner, such as in
the United Kingdom (Nicholls 2012; Nicholls and Southern 2012).
Dried bloodspot samples are often stored for a number of years after collection,
but the length of storage varies by jurisdiction (Botkin et al. 2012). Samples are
retained for various reasons including repeat testing, quality control of testing proce-
dures, or as part of diagnosis. In addition, samples also may be used (anonymously)
for external quality assurance and research. While there is no consensus, a recent
expert panel recommended a minimum storage period of about 3 months to allow for
quality assurance, and indefinite storage when initial positive (i.e., disease suspected)
results are confirmed by diagnostic testing (Botkin et al. 2012). In five U.S. states, a
parent has the legal right to request destruction or release of dried bloodspot samples,
and in three states children may do so when they reach the age of majority (Lewis
et al. 2011). A number of other jurisdictions have followed suit with similar proce-
dures (Newborn Screening Ontario 2011). In most cases, release or destruction of the
bloodspot requires a signed formal request by a parent or legal guardian.
Research to date has provided important findings for both clinical decision making
and public health. For example, studies exploring childhood leukemia have used
bloodspots to identify whether genetic changes are present at birth, or have accumu-
lated over time, helping to clarify how the disease is caused. Others have considered
the effects of public health policies, such as the removal of perfluorinated compounds,
and examined the levels of these in bloodspot samples, noting significant declines in
analyte levels following the phasing out of these compounds (Spliethoff et al. 2008).
As such, bloodspots may provide a useful resource for evaluating public health policy.
Bloodspot samples may also be requested by the coroner’s office or be used in foren-
sic investigations as was proposed, for example, in the Netherlands following an
explosion at a fireworks factory (Couzin-Frankel 2009; Douglas et al. 2012).
However, there has been a great deal of media discussion regarding the retention,
storage, and use of dried bloodspots due to public concerns about privacy (Couzin-
Frankel 2009; Muchamore et al. 2006; Bombard et al. 2012). In particular, there has
been debate regarding the secondary use of stored bloodspots for research, which
are seen as having tremendous research value (Tarini 2011). This has culminated in
several lawsuits in the United States and Canada (Lewis et al. 2012; Armstrong
2010) that have led to changes in storage policy and the destruction of millions of
dried bloodspot samples (Lewis et al. 2012).
As manager of a newborn screening program, you are responsible for the daily
operations of the program, as well as risk and resource management, program eval-
uation, and quality improvement initiatives. Your program screens approximately
150,000 newborns annually for 28 conditions. Each year, on average, 140 babies are
identified as affected by at least one of the screened conditions.
Your program publishes a leaflet and hosts a website that provides information
for parents regarding the screening process, the conditions for which screening is
conducted, and about storage. Your jurisdiction’s regulations recommend that
bloodspot samples be stored for a minimum of 5 years. Parents have the legal right
to request destruction or release of a bloodspot sample at any time. To do so, the
parents or legal guardian must complete a request form.
While parents are informed of the screening process and retention of bloodspots,
consent is not required, and screening proceeds on an ‘opt-out’ basis (i.e., screening
proceeds unless parents explicitly object). There is no distinction between decisions
for screening and decisions regarding retention of bloodspots.
The recent debate regarding the secondary use of stored bloodspots for research
has increased researcher awareness of bloodspots as a resource and has put increased
pressure on your office to facilitate research requests. At the same time, you have
114 M.J. Selgelid
also received political pressure from the health ministry to review storage and con-
sent policy due to public concerns about privacy.
In light of increasing media and researcher interest and political pressure, the
health ministry has asked the standing advisory committee on newborn screening to
convene a working group to review your jurisdictions’ policy on the retention of
newborn bloodspots and the information provided to parents. You have been charged
with advising the committee regarding potential policy changes and the potential
impacts of these on the screening program.
You are aware of the potential conflict between public health benefits and parental
consent to the secondary use of bloodspots for research. However, you are concerned
that providing too much information or raising concerns with parents may decrease
uptake of what is an important population screening program.
1. Newborn bloodspot screening is both a public health program and a tool for
individual clinical care. How should the public health gains from newborn
screening weigh against individual privacy concerns?
2. Given expressed concerns, how should participation in newborn screening be
managed? Should the current opt-out policy be retained or would an informed
consent model be ethically more justifiable? Should screening be distinguished
from secondary use? If so, how should these two elements be handled?
3. To what extent, if any, should the screening program attempt to persuade parents
to withdraw their requests for return or destruction of bloodspots?
4. Studies indicate that anonymized research data might be de-anonymised via sur-
name inference using genealogy databases (Gymrek et al. 2013) or based on date
of birth, gender, and 5-digit ZIP code (Sweeney et al. 2013). Should parents have
the right to consent or opt out of studies even in cases where only anonymised
data is used, and which may provide improvements to population health?
5. Should residual dried bloodspots ever be made available to researchers? How
should clinically actionable results be dealt with?
6. One option is the indefinite storage of residual bloodspots. Is this permissible,
and if so, should the consent of the child be sought when they reach the age of
majority?
References
Armstrong, J. 2010. Storage of newborns’ blood samples raises privacy concerns. The Globe and
Mail, May 11. http://www.theglobeandmail.com/news/british-columbia/storage-of-newborns-
blood-samples-raises-privacy-concerns/article4318768/. Accessed 30 May 2013.
Bailey Jr., D.B., L.M. Beskow, A.M. Davis, and D. Skinner. 2006. Changing perspectives on the
benefits of newborn screening. Mental Retardation and Developmental Disabilities Research
Reviews 12(4): 270–279. doi:10.1002/mrdd.20119.
Bombard, Y., F.A. Miller, R.S. Hayeems, et al. 2012. Citizens’ values regarding research with
stored samples from newborn screening in Canada. Pediatrics 129: 239–247. doi:10.1542/
peds.2011-2572.
Botkin, J.R., A.J. Goldenberg, E. Rothwell, et al. 2012. Retention and research use of residual
newborn screening bloodspots. Pediatrics 131(1): 1–8. doi:10.1542/peds.2012-0852.
Buchbinder, M., and S. Timmermans. 2011. Newborn screening and maternal diagnosis:
Rethinking family benefi t. Social Science & Medicine 73(7): 1014–1018. doi:10.1016/j.
socscimed.2011.06.062.
Couzin-Frankel, J. 2009. Newborn blood collections. Science gold mine, ethical minefield. Science
324(5924): 166–168.
Douglas, C., C. van El, M. Radstake, S. van Teeffelen, and M.C. Cornel. 2012. The politics of
representation in the governance of emergent ‘secondary use’ biobanks: The case of dried
blood spot cards in the Netherlands. Studies in Ethics, Law, and Technology 6(1): Article 4.
doi:10.1515/1941-6008.1178.
Foral, F.E. 2006. Necessity’s sharp pinch: Parental and states’ rights in conflict in an era of new-
born genetic screening. Journal of Health & Biomedical Law 11(1): 109–128.
Gymrek, M., A.L. McGuire, D. Golan, and Y. Erlich. 2013. Identifying personal genomes by sur-
name inference. Science 339(6117): 321–324. doi:10.1126/science.1229566.
Hayeems, R.Z., J.P. Bytautas, and F.A. Miller. 2008. A systematic review of the effects of disclos-
ing carrier results generated through newborn screening. Journal of Genetic Counseling 17(6):
538–549. doi:10.1007/s10897-008-9180-1.
Lewis, M.H., A. Goldenberg, R. Anderson, E. Rothwell, and J. Botkin. 2011. State laws regarding
the retention and use of residual newborn screening blood samples. Pediatrics 127(4): 703–
712. doi:10.1542/peds.2010-1468.
Lewis, M.H., M.E. Scheurer, R.C. Green, and A.L. McGuire. 2012. Research results: Preserving
newborn blood samples. Science Translational Medicine 4(159): 1–3.
Metcalfe, S.A., A.D. Archibald, and A.L. Atkinson, et al. 2012. Conflicting views on newborn and
infant genetic screening: Perspectives of relatives of children with genetic conditions causing
developmental delay and parents of healthy children. Paper presented at the 62nd annual meet-
ing of the American Society of Human Genetics, San Francisco, CA, 6–10 November.
Muchamore, I., L. Morphett, and K. Barlow-Stewart. 2006. Exploring existing and deliberated
community perspectives of newborn screening: Informing the development of state and
national policy standards in newborn screening and the use of dried blood spots. Australia and
New Zealand Health Policy 3: 14. doi:10.1186/1743-8462-3-14.
Newborn Screening Ontario. 2011. Storage and secondary use of the newborn screening samples.
Ottawa. http://www.newbornscreening.on.ca/data/1/rec_docs/434_Storage_and_Secondary_
Use_of_the_Newborn_Screening_Samples.pdf. Accessed 28 Jan 2014.
Nicholls, S.G. 2012. Proceduralisation, choice and parental reflections on decisions to accept new-
born bloodspot screening. Journal of Medical Ethics 38: 299–303. doi:10.1136/
medethics-2011–100040.
Nicholls, S.G., and K.W. Southern. 2012. Informed choice for newborn blood spot screening in the
United Kingdom: A survey of parental perceptions. Pediatrics 130(6): e1527–e1533.
doi:10.1542/peds.2012-1479.
Schweers, R.L. 2012. Newborn screening programs: How do we best protect privacy rights while
ensuring optimal newborn health? DePaul L Rev 61: 869.
Spliethoff, H.M., L. Tao, S.M. Shaver, et al. 2008. Use of newborn screening program blood spots
for exposure assessment: Declining levels of perfluorinated compounds in New York State
infants. Environmental Science & Technology 42(14): 5361–5367.
Sweeney, L., A. Abu, and J. Winn. 2013. Identifying participants in the personal genome project
by name. Cambridge, MA: Harvard University Data Privacy Lab. White Paper 1021–1. http://
privacytools.seas.harvard.edu/files/privacytools/fi les/1021-1.pdf. Accessed 30 May 2013.
Tarini, B.A. 2011. Storage and use of residual newborn screening blood spots: A public policy
emergency. Genetics in Medicine 13(7): 619–620. doi:10.1097/GIM.0b013e31822176df.
116 M.J. Selgelid
4.12 Case 4: Decoding Public Health Ethics and Inequity

in India: A Conditional Cash Incentive Scheme—Janani
Suraksha Yojana
Divya Kanwar Bhati
World Health Organization Collaborating Centre for District Health System
Based on Primary Health Care
Indian Institute of Health Management Research University
Jaipur, Rajasthan, India
e-mail: bhatidivyak@gmail.com
are the author’s own. The case is not meant to reflect the official position, views, or
policies of the editors, the editors’ host institutions, or the author’s host institution.
4.12.1 Background
The domestic sphere of home and family defines the lives of most women in India,
where they assume the role of caregiver, either as wife or mother. Overall, age and
sex govern the household’s hierarchy of authority, older over younger, men over
women. Women, especially those living in northern India, experience decreased
autonomy and increased inequalities in all areas of life (Iyengar et al. 2009; Bloom
et al. 2001). Limited autonomy harms women’s maternal health outcomes, restrict-
ing their ability to choose safe childbirth options. In India, most births still occur in
the home; less than 41 % occur in an institutional setting (International Institute for
Population Sciences 2007).
Worldwide, more than half a million women die each year from complications
during pregnancy and childbirth (UNICEF 2009). About 99 % of these deaths occur
in developing countries. Based on maternal mortality trends from 1990 to 2008,
developing countries, especially India, contribute about 18 % of the global burden
of maternal deaths (Dikid et al. 2013). Data during 2007 through 2009 indicated that
India’s maternal mortality ratio (MMR) was 212 per 100,000 live births (Registrar
General of India 2011). Regional differences in MMR are found in India; during
2007 through 2009 the MMR in northern states was 308/100,000 compared with
207/100,000 in the southern states.
India has had a long history of redistributive poverty-reduction programs, but few
programs provide direct cash assistance to the needy (Mehrotra 2010). Cash incentive
programs started in the 1990s predominantly in Latin America where their success led
to adoption in other parts of the world (Powell-Jackson et al. 2009b). These programs
vary in size and scope; examples include programs that address vaccinations, educa-
tion, health care, safe childbirth, sterilization, and poverty. An example from an Asian
country is the Safe Delivery Incentives Programme (SDIP), which was started in
2005 in Nepal with funds from the U.K. Department of International Development
and the Nepalese government (Powell-Jackson et al. 2009a; Karki 2012). The pro-
gram provided cash incentives to women who gave birth in health facilities and to
health providers for each attended delivery (either in the woman’s home or in a facil-
ity). The program implementers or administrators expected that the cash incentive
would reduce transportation barriers and delays in maternal care seeking (Bhandari
and Dangal 2012). The program was most effective in changing health care-seeking
behavior wherever women’s groups highlighted the importance of effective commu-
nication of the policy to the public (Powell-Jackson et al. 2008). Women exposed to
the program were 24 % more likely to deliver in government health institutions, 5 %
less likely to deliver at home, and 13 % more likely to have their delivery attended by
a skilled health worker. Deliveries in government health institutions went from 34 %
in the first year (2005/2006) to 59 % in the third year (2007/2008). Overall, the pro-
gram was well received, however certain aspects of the policy were not accepted,
including a condition that limited receipt of the cash incentive to women who had no
more than two living children (Powell-Jackson et al. 2008).
India’s conditional cash transfer program, Janani Suraksha Yojana (JSY), is one
of the largest programs of its kind in the world (Lim et al. 2010). JSY is funded
through the central government, provides welfare to women living in indigent fami-
lies, and includes efforts to empower women to choose institutional childbirth rather
than home delivery.
JSY represents a novel and useful way to ensure the social welfare of women by
integrating cash assistance with childbirth delivery and post delivery care. The pro-
gram focuses on poor pregnant woman, especially those living in states with high
MMRs and low institutional delivery rates. These low-performing states include Uttar
Pradesh, Uttaranchal, Bihar, Jharkhand, Madhya Pradesh, Chhattisgarh, Assam,
Rajasthan, Orissa, and Jammu and Kashmir (Tiwari 2013). An important component
of this program is its focus on monitoring, evaluating, and providing, health care for
the mother and her baby (Lim et al. 2010). District-level household surveys have
documented a decline in the proportion of home deliveries, which dropped from 59 %
in the 2002–2004 survey (International Institute for Population Sciences 2006) to
52 % in the 2007–2008 survey (International Institute for Population Sciences 2010).
Despite indicators of success, the JSY program has raised a number of concerns.
One of the aims of JSY is equity in addition to coverage; the JSY program does not
include private health care providers. The increased deliveries (from 35 % to 65 %)
in public health care facilities may raise issues in the quality and standards of health
care (MacDonald 2011). Another concern is that the lack of comprehensive emer-
gency obstetric care at many institutions compromises the safety of institutional
deliveries (International Institute for Population Sciences 2010). A final concern is
that socioeconomic status, caste, and education create large inequities in access to
the program’s cash incentives, while women who do gain access lack financial con-
trol over the cash incentives (Gopichandran and Chetlapalli 2012).
118 M.J. Selgelid
A 19-year-old woman from a poor area in India is pregnant for the first time and
only weeks from her delivery date. Wearing a long pardah to cover the lower half of
her face and traditional maang tikka jewelry on her forehead to indicate married
status, her attire reflects the traditional values embedded in her culture. She wants to
deliver her baby in her home village, which is an overnight’s journey away. But her
husband and in-laws have other ideas. They have just learned of a government pro-
gram that provides a cash payment of 1000 rupees to women who opt for institu-
tional delivery over home delivery. Her mother-in-law insists that the delivery take
place in their district institution. The woman’s parents, believing the in-laws to be
driven purely by greed, support their daughter. With encouragement from her par-
ents, the woman disobeys her husband and in-laws to travel to her parent’s home,
but goes into labor on the road and loses her child due to complications in the deliv-
ery. The young woman not only is disconsolate over the loss of her child, she must
now face the wrath of her husband and in-laws.
This is a poignant case, but only one in a dossier full of similar cases that you, as
the state director for the maternal cash incentive program, have read that involve
clashes between traditional ways and the incentive program. As a result, you have
decided to convene an expert panel to consider recommendations to smooth not
only the cultural friction the program is causing, but also the program’s impact on
the quality and safety of care, as well as access to it.
1. Who are the main stakeholders in the case of the 19-year-old woman and what
values and cultural perspectives does each stakeholder bring to this situation?
2. How should you consider the issues about this and similar cases when deciding
whether to revise the cash incentive program?
3. What are the pros and cons of cash incentive programs from a public health
perspective?
4. What role should government play in improving the public’s health?
5. In the context of inequities based on socioeconomic status, caste, and education,
to what extent should you attempt to ensure that a woman’s autonomy is not
violated? Should the same notion of autonomy be applied in India or other
unique contexts as prevails in European and North American countries?
6. Due to a financial downturn, the state government is thinking about eliminating
the maternal cash benefit program. How can an ethical analysis assist in making
this decision? What factors should be considered as part of this ethical analysis?
References
Bhandari, T.R., and G. Dangal. 2012. Maternal mortality: Paradigm shift in Nepal. Nepal Journal
of Obstetrics and Gynecology 7(2): 3–8.
Bloom, S.S., D. Wypij, and M. Das Gupta. 2001. Dimensions of women’s autonomy and the influ-
ence on maternal health care utilization in a north Indian city. Demography 38: 67–78.
Dikid, T., M. Gupta, M. Kaur, S. Goel, A.K. Aggarwal, and J. Caravotta. 2013. Maternal and peri-
natal death inquiry and response project implementation review in India. Journal of Obstetrics
and Gynaecology of India 63(2): 101–107.
Gopichandran, V., and S.K. Chetlapalli. 2012. Conditional cash transfer to promote institutional
deliveries in India: Toward a sustainable ethical model to achieve MDG 5A. Public Health
Ethics 5(2): 173–180.
International Institute for Population Sciences (IIPS). 2006. District Level Household Survey
(DLHS-2), 2002–04: India. Mumbai: IIPS. http://www.rchiips.org/PRCH-2.html. Accessed 29
May 2013.
International Institute for Population Sciences. 2010. District Level Household Survey (DLHS-3),
2007–08: India. Mumbai: IIPS. http://www.rchiips.org/pdf/INDIA_REPORT_DLHS-3.pdf.
International Institute for Population Sciences and Macro International. 2007. National Level
Household Survey (NFHS-3), 2005–06: India: Volume I. Mumbai: IIPS. http://www.rchiips.
org/nfhs/nfhs3_national_report.shtml. Accessed 29 May 2013.
Iyengar, S.D., K. Iyengar, and V. Gupta. 2009. Maternal health: A case study of Rajasthan. Journal
of Health, Population, and Nutrition 27(2): 271–292.
Karki, A. 2012. Safe delivery incentive program under maternal health financing policy of Nepal:
A case of Kailali district in Nepal. Dhaka: North South University. Accessed 29 May 2013.
Lim, S.S., L. Dandona, J.A. Hoisington, S.L. James, M.C. Hogan, and E. Gakidou. 2010. India’s
Janani Suraksha Yojana, a conditional cash transfer programme to increase births in health
facilities: An impact evaluation. Lancet 375(9730): 2009–2023.
MacDonald, R. 2011. Janani Suraksha Yojana—The Indian way of improving maternal and child
health. PLOS Medicine Community Blog. http://blogs.plos.org/speakingofmedicine/2011/12/19/
janani-suraksha-yojana-%E2%80%94-the-indian-way-of-improving-maternal-and-child-
health/. Accessed 29 May 2013.
Mehrotra, S. 2010. Introducing conditional cash transfers in India: A proposal for five CCTs.
Institute of Applied Manpower Research, Planning Commission. http://www.google.com/url?s
a=t&rct=j&q=&esrc=s&frm=1&source=web&cd=1&ved=0CCYQFjAA&url=http%3A%2F
%2Fwww.ids.ac.uk%2Ffiles%2Fdmfile%2FConditionalCashTransfersforDevChange2.
doc&ei=MBrpUpbqN5C_sQTo74G4Bg&usg=AFQjCNHUgH8o22hjaLX1SNVgsjwK8Ww_
YQ&bvm=bv.60157871,d.cWc. Accessed 29 May 2013.
Powell-Jackson, T., B.D. Neupane, S. Tiwari, J. Morrison, and A. Costello. 2008. Evaluation of the
safe delivery incentive programme: Final report of the evaluation. Nepal: Support to Safe
Motherhood Programme. http://s3.amazonaws.com/zanran_storage/www.safemotherhood.
org.np/ContentPages/2469459188.pdf. Access 29 May 2013.
Powell-Jackson, T., J. Morrison, S. Tiwari, B.D. Neupane, and A.M. Costello. 2009a. The experi-
ences of districts in implementing a national incentive programme to promote safe delivery in
Nepal. BMC Health Services Research 9: 97. http://www.biomedcentral.com/content/pdf/1472-
6963-9–97.pdf. Accessed 29 May 2013.
Powell-Jackson, T., B.D. Neupane, S. Tiwari, K. Tumbahangphe, D. Manandhar, and A.M.
Costello. 2009b. The impact of Nepal’s national incentive programme to promote safe delivery
in the district of Makwanpur. Advances in Health Economics and Health Services Research 21:
221–249.
Registrar General of India. 2011. Maternal and child mortality and total fertility rates: Sample
registration system. New Delhi: Registrar General of India. http://censusindia.gov.in/vital_sta-
tistics/SRS_Bulletins/MMR_release_070711.pdf. Accessed 29 May 2013.
120 M.J. Selgelid
Tiwari, D. 2013. Role of national rural health mission in promoting institutional delivery services
in rural Uttar Pradesh, India: An assessment of Janani Suraksha Yojana. Paper presented at the
2013 annual meeting of the Population Association of America, New Orleans, 10–13 April.
UNICEF. 2009. The state of the world’s children 2009: Maternal and newborn death. http://www.
unicef.org/sowc09/docs/SOWC09-FullReport-EN.pdf.
4.13 Case 5: HIV Criminalization and STD Prevention

and Control
Dhrubajyoti Bhattacharya
Department of Population Health Sciences, School of Nursing and Health
Professions
University of San Francisco
San Francisco, CA, USA
e-mail: dbhattacharya@usfca.edu
4.13.1 Background
About 34.0 million people live with HIV worldwide, with 1.1 million residing in the
United States (Centers for Disease Control and Prevention 2010). The lack of a
cure, coupled with the ailment’s debilitating and potentially fatal consequences, has
prompted governments to enact structural interventions that, although well-
intentioned, may be ineffective in preventing and controlling the spread of HIV.
HIV-specific criminal statutes are one example of a structural intervention used in
at least 63 countries, including the United States. In the United States, the initial fed-
eral response to HIV included potential criminal prosecution for people aware of their
HIV-positive status who knowingly engaged in sexual activity with the intent to
expose others to HIV. Under the original text of the Ryan White Care Act of 1990, no
federal grant would be issued to a state unless it had criminal laws under which to
prosecute an HIV-infected person who knowingly engaged in sexual relations, donated
blood (or semen or breast milk), or injected himself with a needle and provided the
needle to another, with the intent to expose the other person to HIV (Public Law
101–381 1990). The Ryan White Care Act of 1990 became a template for many states,
leading to the passage of laws that included a determination of guilt for HIV-infected
individuals who engaged in sexual activity or shared drug paraphernalia. Consent was
a defense so long as the uninfected person knew of the partner’s HIV-positive status
and provided informed consent before engaging in the activity (i.e., sexual or drug-
related) (Public Law 101–381, 1990). Although the provision to award grants on the
condition of having an HIV-criminal law in place was repealed in 2000, more than 33
states currently have one or more HIV-specific criminal laws in effect.
While the merits of using criminal law to prevent HIV transmission remains
questionable, there has not been enough thought given to the related effect of laws
criminalizing commercial sex work that, coupled with HIV-criminalization laws,
poses unique challenges for women and public health professionals. Together, these
laws disproportionately affect women by virtue of their voluntary participation in—
or coercion into—prostitution, and the harsher sentencing that may ensue upon con-
viction. In the state of Florida, for example, prostitutes who test positive for HIV
before committing a crime have their sentence increased from a misdemeanor (serv-
ing a term of imprisonment not exceeding 1 year) to a felony (serving a term of
imprisonment not exceeding 5 years) (Fl. Stat. Ann. § 796.08(4)(2010)). Notably, a
person convicted of prostitution in Florida must undergo mandatory HIV testing.
Consequently, the specter of criminal prosecution and up to 5 years imprisonment
may deter many women from getting tested in the first place, increasing the risk of
acquiring and transmitting the virus.
Globally, women are at heightened risk of contracting HIV because of social,
economic, and cultural factors stemming from human rights violations, gender
inequality, and inadequate forums to pursue legal redress (Murthy and Bhattacharya
2010). An estimated 60 % of people infected with HIV in sub-Saharan Africa are
women; and females ages 15–24 years make up 75 % of those afflicted with the
virus. Moreover, “male-to-female transmission during sex is about twice as likely to
occur as female-to-male transmission, if no other sexually transmitted infections are
present” (Joint United Nations Programme on HIV/AIDS [UNAIDS] 2004). For
commercial sex workers, this disproportionate risk of exposure is exacerbated.
Researchers have found that among female sex workers 15–49 years old, the preva-
lence of HIV infection is 13.5 times higher than the prevalence among the general
population of women (Kerrigan et al. 2013).
Public health practitioners are faced with a dilemma of promoting HIV testing
and simultaneously adhering to mandatory reporting requirements. All states in the
United States have enacted laws or regulations requiring laboratory reporting of
HIV infection, with 32 states (and the District of Columbia) also enacting laws
requiring reporting of CD4 levels (white blood cells that protect against infection)
and viral loads of people who test positive (Centers for Disease Control and
Prevention 2013). Nonexistent or inadequate surveillance of commercial sex work-
ers, however, may prevent researchers from understanding the evolving nature of
HIV and the burden it poses on this particular population. For example, a recent
study found that a common CD4 gene variant (i.e. alteration of the gene sequence)
is associated with an increased risk of HIV-1 infection in Kenyan female commer-
cial sex workers (Oyugi et al. 2009). The researchers suggest that the effect of this
variant on the epidemic in Africa could be dramatic.
For many human rights activists, laws criminalizing sex work discriminate
against women and deny them their right to work. For others, prostitution is inher-
ently exploitative, with all commercial sex workers being victims who are denied
legitimate (i.e., alternative) forms of employment. In most countries, however, the
122 M.J. Selgelid
law does not discriminate between these types of women or their reasons for engag-
ing in commercial sex work, compelling many women to avoid HIV testing alto-
gether (UNAIDS 2012a). By contrast, where voluntary counseling and testing have
been extended to commercial sex workers, the results have been far more promis-
ing. A recent study found that voluntary counseling and treatment among a cohort
of 421 commercial sex workers in Guinea resulted in 92 % of participants returning
for their results (Aho et al. 2012).
The 35th anniversary of the international Convention on the Elimination of All
Forms of Discrimination against Women (CEDAW) affords an opportunity for gov-
ernments to affirm that extending HIV services to commercial sex workers and pro-
moting public health are not mutually exclusive endeavors. As the only treaty that
rejects sex-discrimination in employment and in health care access, CEDAW helps
women show the link between health and human rights, and particularly the right to
health and employment. The CEDAW Committee, which oversees the treaty’s exe-
cution, has advocated for the decriminalization of prostitution, in countries like
China, where women are disproportionately prosecuted in lieu of the traffickers and
pimps; and encourages governments to focus on rehabilitating and reintegrating
women into society, enhancing opportunities, and providing support to ensure that
their civil liberties are not violated (CEDAW 1981, Committee on the Elimination of
Discrimination Against Women 2006). As of 2013, 187 countries are parties to
CEDAW, but the United States has not ratified it (United Nations 2013).
You are the sexually transmitted infections (STI) program manager of the
Communicable Disease Control Unit in a public health department in a large city. A
recent news story of an HIV-positive commercial sex worker has prompted public
concern. While reviewing the county’s HIV surveillance report for the last period of
data collection, you note that the department does not conduct official surveillance of
commercial sex workers. Studies have found that the HIV infection rate among
female prostitutes has been as low as 12 % in Atlanta and as high as 57 % in northern
New Jersey (Elifson et al. 1999). You are also aware of a UNAIDS report that found
“where health and social services are provided and sex workers are actively engaged
in efforts to provide universal access to HIV prevention, treatment, care and support,
HIV incidence declines” (UNAIDS 2012b). Therefore, you are eager to start an inter-
vention program that encourages commercial sex workers to undergo HIV testing.
You recall that an intervention in a neighboring state used caseworkers to offer pros-
titutes testing for STIs, including HIV. However, a number of challenges abound.
Prostitution is illegal in your state, with penalties ranging from a Class A misde-
meanor (punishable by up to a year in prison) for first-time offenders, to a Class 4
felony (punishable by 1–3 years in prison) for repeat offenders. Moreover, state law
requires that health care providers report to the Department of Health the names of
patients who test HIV-positive.
As an STI program manager, you are aware of the role of social determinants of
health and the need to think broadly about possible interventions and collaborations
with other agencies. You have been influenced by a study on 222 commercial sex
workers from the Center for Impact Research (2002) that found the following:
• 72 % of young commercial sex workers had run away from home and were likely
to have used drugs or alcohol growing up;
• 60 % reported domestic violence in the household;
• 25 % had completed a high school education or passed a general educational
development (GED) test;
• More than 50 % grew up in a household in which prostitution took place;
• 87 % had someone suggest they engage in prostitution while they were growing up;
• 22 % reported they were HIV-positive;
• 21 % indicated being raped more than 10 times;
• 50 % of women worked on behalf of another person (i.e., pimp), with 75 %
reporting they believed the other person would harm them if they discontinued
their services;
• More than 90 % increased their drug or alcohol use after becoming commercial
sex workers;
• Almost 75 % of them had been arrested at least once, with close to 50 % of them
reporting that the arrest took place before age 18; and
• More than 50 % were homeless.
Your health department provides services related to homeless prevention and
substance abuse treatment, yet eligibility is dependent on an ability to meet mone-
tary obligations (rent, utilities, etc.) after the assistance has been granted based on
current or anticipated income. It is unlikely that commercial sex work would satisfy
this criterion.
You consider all of these issues as you think about how to begin an intervention
program for commercial sex workers to encourage them to undergo HIV testing.
1. Who are the main public and private stakeholders in this case?
2. How should the criminal nature of commercial sex work influence the interven-
tion you develop to encourage commercial sex workers to undergo HIV testing?
Should your intervention also target other risk factors for illness, such as home-
lessness, unemployment, and substance abuse?
3. Are you obligated to seek help from law enforcement to carry out your
intervention?
4. What standard should you use to evaluate your intervention’s success? How would
you treat empirical findings alongside issues of equity and discrimination?
124 M.J. Selgelid
5. Given the many social determinants implicated by prostitution and its attendant
health effects, what other agencies should you collaborate with and what other
services should you consider providing along with, or instead of, HIV testing?
6. Does the threat of prison ever get in the way of promoting healthy behaviors? If
so, what criteria should be used to determine which activities and behaviors
merit criminalization? Does reducing the number of women engaged in com-
mercial sex work or their incidence of HIV—or both—satisfy these criteria?
7. Should the public health department conduct surveillance of the incidence of
HIV among commercial sex workers? What challenges exist for the department
in undertaking this task?
8. Do you think ratification of international laws like CEDAW can improve the
health of commercial sex workers?
References
Aho, J., V.K. Nguyen, S.L. Diakité, A. Sow, A. Koushik, and S. Rashed. 2012. High acceptability
of HIV voluntary counselling and testing among female sex workers: Impact of individual and
social factors. HIV Medicine 13(3): 156–165.
Center for Impact Research. 2002. Sisters speak out: The lives and needs of prostituted women in
Chicago. A research study. http://www.healthtrust.net/sites/default/files/publications/sisters-
speakout.pdf. Accessed 1 June 2015.
Centers for Disease Control and Prevention. 2010. HIV in the United States: At a glance. http://
www.cdc.gov/hiv/statistics/basics/ataglance.html. Accessed 29 May 2013.
Centers for Disease Control and Prevention. 2013. State laboratory reporting laws: Viral load and
CD4 requirements. http://www.cdc.gov/hiv/law/states/laboratory.htm. Accessed 1 June 2015.
Committee on the Elimination of Discrimination Against Women. 2006. Concluding comments of
the committee on the elimination of discrimination against Women: China. http://www.un.org/
womenwatch/daw/cedaw/cedaw36/cc/CHINA_advance%20unedited.pdf. Accessed 1 June
2015
Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW). 1981.
Sex role stereotyping and prejudice. Article 5(a)-(b), Sept. 3, 1981, 1249 U.N.T.S. 13. http://
www.un.org/womenwatch/daw/cedaw/cedaw.htm. Accessed 1 June 2015.
Elifson, K.W., J. Boles, W.W. Darrow, and C.E. Sterk. 1999. HIV seroprevalence and risk factors
among clients of female and male prostitutes. Journal of Acquired Immune Deficiency
Syndromes and Human Retrovirology 20(2): 195–200.
Joint United Nations Programme on HIV/AIDS (UNAIDS). 2004. Report on the Global AIDS
epidemic. http://www.unaids.org/sites/default/files/en/media/unaids/contentassets/documents/
unaidspublication/2004/GAR2004_en.pdf. Accessed 25 June 2015.
Joint United Nations Programme on HIV/AIDS. 2012a. Criminalisation of HIV non-disclosure, expo-
sure and transmission: Background and current landscape. http://www.unaids.org/en/media/unaids/
contentassets/documents/document/2012/BackgroundCurrentLandscapeCriminalisation
HIV_Final.pdf. Accessed 1 June 2015.
Joint United Nations Programme on HIV/AIDS. 2012b. UNAIDS guidance note on HIV and sex
work. http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublica-
tion/2009/JC2306_UNAIDS-guidance-note-HIV-sex-work_en.pdf. Accessed 1 June 2015.
Kerrigan, D., A. Wirtz, S. Baral, et al. 2013. The global HIV epidemics among sex workers.
Washington, DC: World Bank. http://www.worldbank.org/content/dam/Worldbank/document/
GlobalHIVEpidemicsAmongSexWorkers.pdf. Accessed 1 June 2015.
Murthy, P., and D. Bhattacharya. 2010. Human rights and women’s health. In Rights-based
approaches to public health, ed. E. Beracochea, C. Weinstein, and D. Evans, 169–182. New
York: Springer Pub. Co.
Oyugi, J.O., F.C. Vouriot, J. Alimonti, et al. 2009. A common CD4 gene variant is associated with
an increased risk of HIV-1 infection in Kenyan female commercial sex workers. Journal of
Infectious Diseases 199(9): 1327–1334.
Public Law 101–381. 1990. Ryan White Comprehensive AIDS Resources Emergency Act of 1990.
Section 2647(a)(1)-(a)(2). http://history.nih.gov/research/downloads/PL101-381.pdf. Accessed
1 June 2015.
United Nations. 2013. United Nations treaty collection: Chapter IV human rights (8) convention on
the elimination of all forms of discrimination against women. http://treaties.un.org/Pages/
ViewDetails.aspx?src=TREATY&mtdsg_no=IV-8&chapter=4&lang=en. Accessed 1 June 2015.
4.14 Case 6: Ethics of Administering Anthrax Vaccine

to Children
Georgina Peacock
Division of Human Development and Disability, National Center
on Birth Defects and Developmental Disabilities
Centers for Disease Control and Prevention
Atlanta, GA, USA
e-mail: ghn3@cdc.gov
Michael T. Bartenfeld
Children’s Preparedness Unit, Disability and Health Branch, Division of Human
Development and Disability, National Center on Birth Defects and Developmental
Disabilities, Centers for Disease Control and Prevention
Atlanta, GA, USA
e-mail: vdv4@cdc.gov
Cynthia H. Cassell
Birth Defects Branch, Division of Birth Defects and Developmental Disabilities,
National Center on Birth Defects and Developmental Disabilities
Atlanta, GA, USA
Daniel M. Sosin
Office of Public Health Preparedness and Response
Atlanta, GA, USA
institutions.
126 M.J. Selgelid
4.14.1 Background
Bacillus anthracis is a hardy, spore-forming bacterium that leads to anthrax disease

upon infection. The organism has long been considered a likely agent for biological
warfare. A weaponized form of the agent would likely result in widespread inhala-
tion anthrax, a severe form of the disease that carries a high (>50 %) case fatality
rate. B. anthracis spores can last inside the body for weeks before germinating to
induce infection and can persist for years in the environment. Anthrax disease is
preventable if antibiotics and vaccine are administered prophylactically before
someone has symptoms.
The U.S. Centers for Disease Control and Prevention (CDC) and U.S. Department
of Homeland Security are concerned about B. anthracis as an agent of biological
terrorism due to its ease of dispersal, severe health impact, persistence in the envi-
ronment, and the special public health response it requires (CDC 2013). The U.S.
anthrax attacks in 2001 infected 22 people, 5 of whom died, all from inhalation
anthrax. The U.S. Department of Health and Human Services prepares for a number
of disaster scenarios, one of which is an aerosolized anthrax attack. In this scenario,
B. anthracis spores are released into the air in a densely populated area, potentially
infecting thousands of people.
Children (<18 years) are given special considerations in an anthrax attack sce-
nario, one of which involves receiving the anthrax vaccine, Anthrax Vaccine
Adsorbed (AVA). The U.S. Advisory Committee on Immunization Practices rec-
ommends giving AVA in conjunction with 60 days of antibiotics for post-exposure
prophylaxis of the exposed population against anthrax (Wright et al. 2010). This
60-day antibiotic regimen covers the disease’s incubation period and allows for
protection before the vaccine takes effect. The vaccine is likely to protect people
longer than antibiotics alone and potentially protects against multiple strains of
anthrax disease, including bioengineered strains that are resistant to antibiotics
(Joellenbeck et al. 2002).
While most of the U.S. population can receive the anthrax vaccine under an
Emergency Use Authorization (EUA), children must receive the vaccine under
an investigational new drug (IND) protocol as approved by the U.S. Food and
Drug Administration. The IND protocol requires informed consent from parents,
which is not required under an EUA. The informed consent requirement stems
from the lack of safety or efficacy data for AVA in children. Also, due to a
requirement under the IND, a subset of the children with IND consent will be
asked to enroll in a research IND so that safety and immunogenicity data in chil-
dren may be obtained during the emergency. The Presidential Commission for
the Study of Bioethical Issues debated the study of AVA in children before the
event, and has laid out a strict framework for approaching how best to ethically
collect these data from a research perspective (Presidential Commission for the
Study of Bioethical Issues 2013).
A terrorist group has released an anthrax aerosol over a major city in the United
States and in a country with a weak public health infrastructure. Of the more than
9 million people in the U.S. metropolitan area at the time, 1.39 million people are
exposed, 329,430 of whom are children (Kyriacou et al. 2012). All 1.39 million
people exposed will need the vaccine and a 60-day supply of antibiotics to pro-
tect them from developing disease. It is unclear what plans have been made to
provide prophylaxis to the population living in the other country. In the United
States, people thought to be exposed will receive antibiotics and vaccine at points
of dispensing (PODs) run by local health departments. The dispensing of antibi-
otics, which must begin within the first 48 h and finish within 10 days, would
require 20 sites providing medicine to 500 people per hour to achieve the goal for
the exposed population. Vaccination routinely takes more time and involves
additional staff and separate sites to care for the entire population. Additional
steps will require more resources and time. Timeliness is essential to ensure
those exposed are protected.
In the United States, children needing vaccine come to the vaccination clinic
with their parents, slowing the lines to meet the informed consent requirements.
Unaccompanied children also show up, slowing the lines to a crawl, as staff
attempt to contact parents. The complexity of different vaccine needs for different
people, especially those who do not speak English, is overwhelming vaccination
staff. To keep lines moving, the staff has created a separate line for families with
children, but the slow pace of this line is challenging the clinic’s effort to achieve
high vaccine coverage rates among children. Tempers flare as families watch
adults without children move through the clinic quickly while the family lines
grow ever longer. But the parents, who have lots of questions, cannot be rushed to
provide their consent. They have been hearing disconcerting media stories high-
lighting issues related to anthrax vaccine side effects and the lack of testing and
safety data. Many parents worry about immunizing their child with an untested
vaccine never given to children and posing unknown risks. The vaccination clinic
manager, who has had little time to plan, quickly devises the following scenarios
to speed decision making:
• Provide parents with the informed consent document and have a public health
nurse meet with them to answer questions and discuss concerns about risks and
benefits.
• Discuss the informed consent document with a group of families, answering
questions and working through concerns about risks and benefits in the larger
group, but having a nurse on call to answer confidential questions and speak to
families privately.
• Show a large group of families assembled in an auditorium a video produced
by the local health department explaining the safety and efficacy profile of the
vaccine in adults, and afterward have a nurse discuss with parents the informa-
tion from the informed consent document and allow parents to ask questions.
128 M.J. Selgelid
1. Of the options listed above, which should you choose? Justify your answer in
terms of the benefits gained, harms avoided, respect for parental autonomy, pri-
vacy and confidentiality, fairness, or other ethical values, such as trust and pro-
tecting vulnerable populations.
2. Consider how placing families with children in separate lines affects the distribu-
tion of vaccine. Is this the fairest or optimal way to distribute the vaccine? Are
there innovative or better options for administering the IND that adhere to FDA
rules and achieve maximum vaccination coverage for children? Are these options
ethically justifiable?
3. If following the IND protocol for unaccompanied children makes vaccine cover-
age impossible, what should the vaccine clinic manager and staff do? How would
you ethically justify your decision? Would this justification hold if the group in
question were all children, not just unaccompanied children?
4. What roles will government trustworthiness and the public’s trust in the govern-
ment play in the vaccination campaign?
5. What ethical concerns are presented by collecting data for research purposes
during such an event?
6. The other country under anthrax attack, which is resource poor and lacks public
health infrastructure, has received vaccine from the United States, but is under
no obligation to follow the mandated U.S. procedures through which antibiotics
are administered. To ensure that vulnerable populations are protected against
anthrax, what ethical principles, values, and concerns should this country con-
sider? Do these ethical principles, values, and concerns differ from those in the
United States? If yes, how? If no, why not?
7. A high percentage of the parents with young children do not speak English.
Because the informed consent forms are only in English, translating them will
take a lot longer, or an interpreter will need to be available. How would you bal-
ance the obligation to protect vulnerable populations with the obligation to maxi-
mize coverage?
References
Centers for Disease Control and Prevention (CDC). 2013. Bioterrorism agents/diseases. http://
www.bt.cdc.gov/agent/agentlist-category.asp. Accessed 3 Jan 2013.
Joellenbeck, L., L.L. Zwanziger, J.S. Durch, and B.L. Strom (eds.). 2002. The anthrax vaccine: Is
it safe? Does it work? Washington, DC: National Academy Press.
Kyriacou, D.N., D. Dobrez, J.P. Parada, et al. 2012. Cost-effectiveness comparison of response
strategies to a large-scale anthrax attack on the Chicago metropolitan area: Impact of timing
and surge capacity. Biosecurity and Bioterrorism 10(3): 264–279.
Presidential Commission for the Study of Bioethical Issues. 2013. Safeguarding children: Pediatric
medical countermeasure research. http://bioethics.gov/sites/default/files/PCSBI_Pediatric-
MCM_2.pdf. Accessed 2 June 2015.
Wright, J.G., C.P. Quinn, S. Shadomy, and N. Messonnier. 2010. Use of anthrax vaccine in the
United States: Recommendations of the Advisory Committee on Immunization Practices
(ACIP), 2009. MMWR Recommendations and Reports 59(6): 1–30.
4.15 Case 7: Non-adherence to Treatment in Patients

with Tuberculosis: A Challenge for Minimalist Ethics
Lorna Luco and M. Inés Gómez
Centro de Bioética, Facultad de Medicina
Santiago, Chile
e-mail: lornamuriel@gmail.com
M. Gabriela Doberti
Hospital Padre Hurtado, Facultad de Medicina
Santiago, Chile
institutions.
4.15.1 Background
In Chile, tuberculosis (TB) belongs to the list of “mandatory notification” dis-

eases, a status that allows for the confidential registration and monitoring of cases.
Mandatory notification, part of Chile’s Communicable Disease Surveillances
System, is legally authorized by the 1968 Sanitary Code of the Ministry of Health,
specifically the Regulation on Notification of Communicable Diseases (Código
Sanitario 1968). By the early 1970s, health authorities created the Program for
Control and Eradication of Tuberculosis (PROCET), a model program in its tech-
nical conception and application of control measures. The program illustrates how
to confront a public health care problem properly through systematically applied,
adequate coverage and continuous quality evaluation (PROCET 2005).
Currently, TB prevalence is low in Chile, with the country significantly reduc-
ing the disease’s mortality and morbidity rates in the closing decades of the twen-
tieth century (Pan American Health Organization 2006). By 2000, this reduction
had allowed Chile to cross the eradication threshold (i.e., to reduce the incidence
rate below 20 cases per 100,000 people). Over the first decade of this century,
however, the pace of reduction in the annual TB incidence rate slowed, decreasing
from 7.5 % (1996–2000) to 4.2 % (2000–2005) to just 1.3 % (2005–2010).
130 M.J. Selgelid
This slowing resulted in a 2010 incidence rate of 13.2 cases per 100,000 people—
still below the eradication threshold—but falling short of the official target of 10
cases per 100,000 people. To explain the slowing pace, researchers have studied
a number of variables, most notably, the role of treatment procedures (Herrero
et al. 2011).
To meet the target of 10 TB cases per 100,000 people, PROCET established the
following goals: (1) 90 % recovery rate for treated cases, (2) <5 % withdrawals from
treatment, and (3) <3 % mortality rate for those undergoing treatment. Achieving
these goals requires a stringent treatment regimen that consists of health care work-
ers delivering TB medication on an outpatient basis and directly observing patients
while they take their medication. The medications are free for patients within the
health care system, including those who have multidrug-resistant TB (MDR-TB).
Analysis of the treatment outcomes for the 2008–2010 cohort of TB patients
indicates a recovery rate of 80 %, a withdrawal rate of 7 %, and a mortality rate of
10 % (Ministerio de Salud 2012). Although the latter two numbers are high, analy-
sis reveals that TB treatment continues to be effective, given that the treatment fail-
ure percentage, less than 1 %, is quite small. However, the unsatisfactory withdrawal
and mortality rates suggest PROCET needs to improve its performance in getting
patients to adhere to treatment and in following up more quickly with patients to
prevent mortality.
Pedro is a 42-year-old divorced father of two. He is a mechanic, but is unemployed

and living with his parents.
Diagnosed in 2009 with sputum-smear positive pulmonary TB, Pedro received
first-line treatment at an outpatient primary care clinic in Santiago. In October 2009,
he moved to the northern part of the country to work as a driver and withdrew from
treatment for the first time. While up north, his sputum-smear again tested positive.
However, after five attempts in 3 years, Pedro was unable to complete the daily
phase of the treatment. As indicated by medical staff, he either refused to attend the
local medical center for treatment or rejected the treatment and even verbally
attacked staff when they tried to administer medicines.
In January 2012, he returned to Santiago seeking care at the same primary care
clinic he had previously visited, continuing to test positive but now presenting respi-
ratory symptoms. A final attempt at treatment, this time with second-line treatment,
failed after 2 months due to his irregular attendance at the health care facility and
failure to take the medication regularly.
Pedro acknowledged he understood the consequences of his behavior and the
possibility of microbial mutations leading to antibiotic resistance, which would
change his condition to incurable. Yet, when questioned about the reasons for his
behavior, he refused to take responsibility, claiming, among other things, that TB
drugs made him feel sick.
In October 2012, he again visited the primary care medical clinic, this time
accompanied by his mother and claiming he wanted to “start over.” He was feel-
ing ill, having night sweats, losing weight, and had diminished functional capac-
ity that prevented him from working. Because of his previous history, he was
now referred to a specialized center, where the physician in charge of the TB
program evaluated his case and wrote in his medical records, “The patient does
not seem to understand his situation and the risk he is posing to his family…it
seems to me that health care personnel are more concerned about patient’s dis-
ease than the patient himself.” The specialist concluded that the chance of the
patient completing treatment after six failures was unlikely. The specialist
therefore decided not to renew treatment “since this would cause even more
microbial resistance. Disciplinary discharge would be more fitting for this
patient,” the physician added, “especially in view of the great demand for hos-
pital care.”
Pedro subsequently revisits the medical center demanding treatment, this time
claiming he will not withdraw from therapy because he has joined a church and has
had “an awakening of consciousness to the will of God, which is to serve and love
your neighbor as yourself, and therefore, not to infect others.”
Despite the earlier decision of the physician in charge of the TB program, doctors
reevaluate the case and decide that he should receive further TB treatment. Doctors
refer him to a social worker for a mental health assessment and the initiation of men-
tal health treatment if needed as a condition of restarting TB treatment.
1. Do you agree with the doctors’ decision to allow further TB treatment for the
patient? Why or why not?
2. Can denial of treatment to a patient with a potentially curable disease be ethi-
cally justified, considering that this denial could lead to the patient’s death? On
what ethical basis should the decision to deny or not deny treatment be made?
3. Given that health resources are limited, what role does the principle of distribu-
tive justice play in determining whether patients should be allowed to start treat-
ment after multiple episodes of noncompliance with previous treatment?
4. In view of the risk that the patient could infect his family with TB, should he be
denied further treatment or should he be given another chance to complete it?
How would you ethically justify your decision?
5. What role should social factors such as educational level, economic status, or
family situation play in making such decisions?
6. When a patient could transmit a serious infectious disease, should there be legal
enforcement of the requirement to get treated?
132 M.J. Selgelid
References
Código Sanitario. 1968. D.F.L. N° 725/67. Publicado en el Diario Oficial de 31.01.68. Gobierno
de Chile. Ministerio de Salud. www.bcn.cl/leyes/pdf/actualizado/5595.pdf. Accessed 11 Feb
2014.
Herrero, M., A. Greco, S. Ramos, and S. Arrossi. 2011. From individual risk to social vulnerabil-
ity: Factors associated with non-compliance with anti-tuberculosis treatment. Rev Argent Salud
Pública 2(8): 36–42.
Ministerio de Salud. 2012. Programa Nacional de Control y Eliminación de la Tuberculosis.
Informe de Situación 2008 – 2011. http://web.minsal.cl/sites/default/files/fi les/TB2008-2011.
pdf. Accessed 11 Feb 2014.
Pan American Health Organization. 2006. Tuberculosis: Regional plan for tuberculosis control,
2006–2015. Washington, DC: PAHO. http://www.stoptb.org/assets/documents/global/plan/tb-
reg-plan-2006-15%20AMRO.pdf. Accessed 11 Feb 2014.
Programa Nacional de Control y Erradicación de la Tuberculosis (PROCET). 2005. Manual de
Organización y Normas Técnicas. Subsecretaría de Salud Pública, Departamento de Prevención
y Control de Enfermedades, Ministerio de Salud de Chile. http://web.minsal.cl/portal/url/item/
803048171acc60f8e04001011f0148e2.pdf. Accessed 11 Feb 2014.
4.16 Case 8: Mass Evacuation
A.M. Viens
Centre for Health, Ethics and Law, Southampton Law School
University of Southampton
Southampton, UK
e-mail: a.m.viens@soton.ac.uk
Maxwell J. Smith
Toronto, ON, Canada
4.16.1 Background
Mass evacuation involves moving people (and sometimes their property and ani-
mals) to alternative locations to protect them from threats to their health and safety
(Kemetzhofer and Weinstein 2012). Threats to public health can be direct or indirect.
Direct threats include natural hazards (e.g., hurricanes, floods, earthquakes, wild-
fires) and human-caused hazards (e.g., release of hazardous materials, nuclear inci-
dent, bioterrorist attack). These threats can also negatively affect essential public
services (e.g., water, sewage, electricity) or create conditions for the proliferation of
waterborne and vectorborne diseases. Mass evacuation is an important public health
response, but it raises practical and moral issues (Settles 2012; Kodama 2015).
The sudden and unpredictable nature of some threats limits opportunities to pro-
vide notice for safe, orderly, and rapid evacuation. Such threats often force large
numbers of people with different capabilities to travel great distances. Given limited
time, resources, and personnel, those requiring assistance in evacuating will need to
be categorized according to method of evacuation (e.g., medevac, ambulance, bus)
and in what order they should be evacuated.
Although evacuation aims to promote or protect the well-being of the population,
its use also raises considerations of fairness. Because evacuation orders may nega-
tively affect vulnerable and marginalized populations disproportionately (Morrow
1999), special attention needs to be paid to these populations (Van Willigen et al.
2002). Public health officials need to consider socioeconomic disparities that can
disadvantage community members in ways that impede compliance with evacuation
orders. For example, during the 2005 Hurricane Katrina in New Orleans, lack of
access to transportation or to financial resources prevented many people from evac-
uating. To mitigate such disadvantages and deficiencies, evacuation policies and
procedures must be established for vulnerable or marginalized populations.
Mass evacuation can be voluntary or mandatory. Most evacuations will be
voluntary because most people will comply with the recommendation to evacu-
ate. Nevertheless, implementation seldom occurs without complication, and pre-
dicting evacuation behavior of a population is inherently difficult (Baker 1991;
Perry and Lindell 1991; Riad et al. 1999; Dash and Gladwin 2007). Evacuations
are often ordered by different levels of government and carried out by local
responders, requiring a high level of coordination among agencies. Mandatory
evacuation adds further complications. Requiring people to leave their homes or
work whether or not they consent raises moral questions, such as justifying lib-
erty restrictions.
Whether evacuation is voluntary or mandatory, a small segment of the commu-
nity will choose not to evacuate, even if they have the ability to do so. In all cases,
efforts should be made to educate the public about the personal risks and societal
costs of noncompliance with evacuation orders. Those who do not comply with
evacuation orders raise the issue of whether they should be forced to evacuate and
whether first responders have a moral obligation to go back and rescue them.
Enforcement of evacuation orders illustrates how law might be used as a public
health tool (e.g., a jurisdiction may criminalize failure to comply with an evacuation
order) (Viens et al. 2013).
Attention also has to be paid to the process of returning evacuated populations to
their communities. Here, too, both practical and ethical issues arise: the extent to
which damaged property and infrastructure should be rebuilt, the level of compen-
sation or restitution that could be paid to evacuees or first responders, and possible
sanctions to be levied on nonevacuators later rescued.
134 M.J. Selgelid
Your community is a large, metropolitan city under a category 5 hurricane warning.

The hurricane, which has been forecasted to make landfall in 48–72 h, threatens
massive flooding and property damage. A large number of people widely dispersed
in the city will need to be evacuated. They speak many languages, have varying
levels of access to transportation, and require various levels of care. Special needs
and vulnerable populations (e.g., the disabled, ill and injured, homeless, and the
incarcerated) will also need help to evacuate.
As a result of emergency preparedness incident-training simulations, some agen-
cies have developed evacuation plans. These plans are not always easily accessible
to all first responders and the lack of coordination between agencies has led to con-
fusion. Responders are unclear about who should be given priority in evacuation
assistance, which resources and personnel should be devoted to evacuation efforts,
and when to halt evacuation and rescue efforts and shift to recovering bodies. Of
particular concern are the number of high-rise commercial buildings and medical
facilities in the city. Although these buildings and facilities have individual evacua-
tion plans, most only make evacuation provisions for short-term events, such as
power outages or fires. Worse, no central registry or database lists which community
members will require help to evacuate.
In less affluent neighborhoods, some residents lack access to a car or sufficient
money to transport their family outside the hurricane’s path. Some of those unable
to evacuate will be able to stay with friends or family. However, evacuees who can-
not stay with people they know are quickly overwhelming the capacity of evacua-
tion facilities in nearby towns. Decisions will need to be made about how to
coordinate and efficiently use resources and personnel to maximize the number of
people protected from the hurricane.
Officials managing the evacuation have realized that mass evacuation raises some
logistical and ethical issues shared by public health measures involved in the move-
ment or restriction of people (e.g., quarantine, isolation, social distancing). They
have therefore asked you, an experienced public health official, to provide input on
which groups of people should be evacuated, how, and in what order of priority. Your
special concern in planning and coordinating with other agencies will be the health
of the population, mitigating inequalities and the safety of the first responders.
1. What are the relevant ethical considerations for deciding who should be evacu-
ated first and whether the evacuation order should be mandatory or voluntary?
Of those to be evacuated, who should we evacuate first? How should decisions
be made regarding who to evacuate when not all can be evacuated?
2. What role should community engagement play in determining the order of prior-
ity of groups to be evacuated?
3. How should authorities deal with those who do not comply with an evacuation
order? What are the ethical implications of allowing people not to evacuate? Do
authorities have obligations toward people who refuse to evacuate and later
need to be rescued? Should people who had the ability to evacuate but failed to
do so be blamed or punished in some way when they later need to be rescued?
4. What kind of legal protections are needed to protect people who are made more
vulnerable by virtue of having to evacuate? For example, should there be provi-
sions to prevent price gouging on gasoline or to keep extra police officers around
to prevent looting?
5. Are those who comply with voluntary evacuation orders owed anything? To
what extent must resources be provided for the evacuated population? How
much effort should be put into keeping families together? Should compensation
be paid when people are asked to evacuate with little time for protecting valuable
items that end up getting lost, damaged, or destroyed? How would your answers
to these questions change if the evacuation orders were mandatory?
6. In a clinical setting, some patients will be too unstable to be moved or, if mov-
able, will require disproportionate medical care and resources. Would it ever be
acceptable to abandon some patients? If so, under what conditions? Would it be
morally required that a clinician or first responder stay within the evacuation area
with such patients—at greater risk to themselves—to provide constant care until
rescue can be provided at a later time?
Acknowledgements Maxwell J. Smith is supported by a Canadian Institutes of Health Research

Frederick Banting and Charles Best Canada Graduate Scholarship and the Canadian Institutes of
Health Research Douglas Kinsella Doctoral Award for Research in Bioethics.
References
Baker, E.J. 1991. Hurricane evacuation behavior. International Journal of Mass Emergencies and
Disasters 9(2): 287–310.
Dash, N., and H. Gladwin. 2007. Evacuation decision making and behavioral responses: Individual
and household. Natural Hazards Review 8: 69–77.
136 M.J. Selgelid
Kemetzhofer, P., and E.S. Weinstein. 2012. Evacuation. In Oxford American handbook of disaster
medicine, ed. R.A. Partridge, L. Proano, and D. Marcozzi, 227–237. Oxford: Oxford University
Press.
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361–363.
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Perry, R.W., and M.K. Lindell. 1991. The effects of ethnicity on evacuation decision-making.
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perception, social influence, and access to resources. Journal of Applied Social Psychology
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Cambridge: Cambridge University Press.
Chapter 5
Chronic Disease Prevention and Health
Promotion
Harald Schmidt
5.1 Introduction
Chronic diseases include conditions such as heart disease, stroke, cancer, diabetes,
respiratory conditions, and arthritis. In high-income countries, chronic diseases
have long been the leading causes of death and disability. Globally, more than 70 %
of deaths are due to chronic diseases, in the United States, more than 87 % (World
Health Organization [WHO] 2011). Almost one in two Americans has at least one
chronic condition (Wu and Green 2000). Aside from the cost in terms of human
welfare, treatment of chronic disease accounts for an estimated three quarters of
U.S. health care spending (Centers for Disease Control and Prevention [CDC]
2012). Chronic diseases directly affect overall health care budgets, employee pro-
ductivity, and economies. Globally, noncommunicable diseases account for two-
thirds of the overall disease burden in middle-income countries and are expected to
rise to three-quarters by 2030, typically in parallel to economic development (World
Bank 2011). Of particular concern to many low- and middle-income countries is
that threats to population health occur on two fronts simultaneously: “In the slums
of today’s megacities, we are seeing noncommunicable diseases caused by unhealthy
diets and habits, side by side with undernutrition” (WHO 2002).
Four modifiable risk factors are principal contributors to chronic disease, associ-
ated disability, and premature death: lack of physical activity, poor nutrition, tobacco
use, and excessive alcohol consumption (CDC 2012). One in three adult Americans
is overweight, another third is obese, and almost one-fifth of young people between
H. Schmidt, MA, PhD (*)

Department of Medical Ethics & Health Policy, Center for Health Incentives and Behavioral
Economics, University of Pennsylvania, Philadelphia, PA, USA
e-mail: schmidth@mail.med.upenn.edu

138 H. Schmidt
6 and 19 years of age is obese, even though rates are not increasing at previous lev-
els (Katz 2013). Although smoking has declined considerably over recent decades,
about 20 % of Americans still smoke. Rates of smoking are markedly different
across socioeconomic groups, and much higher among economically disadvantaged
people (Garrett et al. 2011). Globally, deaths from smoking are expected to increase
dramatically in low-income countries. In the twentieth century, tobacco-use killed
around 100 million people worldwide. In the twenty-first century, an estimated one
billion will die prematurely—a tenfold increase. By 2030, more than 80 % of deaths
attributable to tobacco will be in low-income countries (WHO 2012).
In principle, if a risk factor can be modified, then much illness and suffering
(morbidity) and early death (mortality) can be avoided or prevented. Therefore,
prevention and health promotion policies seek ways in which the impact of modifi-
able risk factors can be reduced. How one analyzes the causal pathways that lead to
the development of risk factors may encourage one to explore a range of different
interventions. An obvious starting point is to focus on individual behavior or life-
style, because what an individual does (or fails to do) typically plays a central role
in chronic disease. Consider the following line of thought by John H. Knowles, an
outspoken critic of the American health care system in the 1970s:
Prevention of disease means forsaking the bad habits which many people enjoy—[but the]
cost of sloth, gluttony, alcoholic intemperance, reckless driving, sexual frenzy, and smoking
is now a national, and not an individual, responsibility. This is justified as individual free-
dom—but one man’s freedom is another man’s shackle in taxes and insurance premiums. I
believe the idea of a ‘right’ to health should be replaced by the idea of an individual moral
obligation to preserve one’s own health—a public duty if you will. The individual then has
the ‘right’ to expect help with information, accessible services of good quality, and minimal
financial barriers (Knowles 1977).
Knowles comment is interesting on several counts. First, it underscores that even

though population health usually features centrally in health promotion, cost con-
siderations are never far removed and are equally prominent in current debates,
especially in political fora.1
Second, in invoking three of the deadly sins (gluttony, sloth, and lust), Knowles
illustrates in a frank way that discussions about health promotion are not confined
to medical or public health concepts. Implicitly or explicitly, these discussions
almost always entail moral concepts (such as personal responsibility or deserving-
ness) that are embedded in deeply held normative frameworks.
1
For an example of such a political debate, see the 2012 platform of the U.S.’s Republican Party:
“… approximately 80 % of health care costs are related to lifestyle—smoking, obesity, substance
abuse—far greater emphasis has to be put upon personal responsibility for health maintenance …”
(GOP 2012). Reforming Government to Serve the People is available at https://www.gop.com/
platform/. This quote also illustrates the inaccurate use of statistics. Although the burden of chronic
diseases is indeed roughly 80 %, it is an exaggeration to claim that personal responsibility alone
accounts for the total burden. Exact estimates may not be straightforward due to complex interac-
tions of different factors. Consequently, a more realistic estimate attributes 40 % to personal
behavior, 30 % to genetic predispositions, 15 % to social circumstance, 10 % to inadequate health
care, and 5 % to environmental causes (Schroeder 2007).
5 Chronic Disease Prevention and Health Promotion 139
Fig. 5.1 Factors determining health and chronic diseases (Originally published in Dahlgren and
Whitehead (1991). Reproduced from Acheson (1998). Reproduced with permission)
And finally—although Knowles acknowledges elsewhere in his essay the role of

taxes and other measures to improve health and eradicate poverty—he concludes by
stating “the costs of individual irresponsibility in health have now become prohibi-
tive. The choice is individual responsibility or social failure” (Knowles 1977). The
policy interventions he mentions aim for broader recognition of personal responsi-
bility and therefore focus on education and information campaigns to empower
people to behave responsibly. But this analysis is shortsighted. It fails to consider
the responsibility of those who produce, market, and sell products (e.g., unhealthy
foods, drinks, or tobacco) and of those who regulate markets or set business stan-
dards (e.g., trade groups or national or regional policy makers). His point could best
be made if all people lived in similar environments and conditions, had sufficient
disposable income, had ready access to healthy and affordable food, had equal
opportunity to exercise, and experienced other health-conducive conditions. But
this is not the case. People live in vastly different contexts, and many different fac-
tors determine health (Fig. 5.1).
Although Fig. 5.1 provides a useful overview of many factors that affect health,
the concept of “lifestyle,” commonly encountered in the broader debate around
chronic diseases is problematic. It can suggest that people choose, for example,
smoking or heavy drinking as others might decide between taking up golf or tennis
as a hobby. The point is that “lifestyle” implies degrees of freedom and the possibil-
ity of genuine opportunity and choice. But assume that you grew up in an inner-city
140 H. Schmidt
borough as a child of low-income obese and smoking parents. Many in your family
and social environment smoke and are obese. Compared to the national average,
you are among the most overweight, and you fail to lose weight as an adolescent.
You remain obese. Calling your obesity a matter of lifestyle makes little sense. Now
assume you started smoking as a minor (<18 years of age) just as 88 % of U.S.
adults who smoke daily (U.S. Department of Health and Human Services 2012). It
can be cynical to treat this “lifestyle” as voluntary and freely chosen if, for example,
many of your role models smoke and if smoking in your social setting and challeng-
ing environment functions as a coping mechanism to relieve stress. The different
spheres in the diagram therefore need to be understood as highly interdependent.
Regarding terminology, the concept of lifestyle factors should be replaced with that
of personal behavior. Doing so acknowledges that powerful constraints can severely
infringe on the development of healthy habits and behavior. In the worst case, these
constraints may thwart development of healthy habits and behaviors altogether,
even when individuals have the best of intentions.
Focusing on just the individual is therefore overly narrow when identifying poli-
cies to prevent chronic diseases. Yet, removing the individual from the equation is
also unhelpful (Schmidt 2009). The central ethical issues surrounding health pro-
motion and prevention of chronic diseases concern the relative responsibilities of all
agents whose actions influence the health of others. These agents include, in addi-
tion to individuals, health workers, governments (at different levels), and corporate
entities.
5.2 Individuals
Except for some genetic conditions and extremely toxic environments (i.e., chemi-
cal exposure), individual behavior typically plays a causal role in bringing about
bad—as well as good—health. People may or may not eat healthily; they may or
may not use tobacco or illegal drugs; they may consume alcohol excessively or in
moderation; they may exercise too little or too much; and they may regularly brush
their teeth, go for medically recommended checkups, and take their medications—
or fail to do so. However, it is important to recognize that implementation of mea-
sures such as praise or blame, or financial rewards, or penalties—although they
presuppose a certain degree of causal responsibility—do not mean that individuals
also automatically need to be held fully responsible in a moral (or legal) sense.
Causal responsibility in the present context simply means that a person has behaved
in ways that contributed to, say, poor health. Therefore, a smoker with lung disease
arguably has some causal responsibility for the condition. But if it turns out that the
smoker started becoming addicted as a child, it is clear that the outcome cannot
simply be treated as the result of an entirely voluntary choice. Where there is no, or
limited, opportunity of choice, there is the risk of “victim blaming” (Crawford
1977) and holding people responsible for factors that are, in fact, beyond their
control. Conversely, ignoring the scope of possible behavior change can lead to
fatalism and resignation (Schmidt 2009).
For individuals to take causal and other responsibility for their health, they
require, among other things, information that they can understand, affordable access
to health care, and, oftentimes far more important, environments conducive to health
in which capabilities may be developed so that one can flourish in life (e.g., residen-
tial, work, and play settings) (Venkatapuram 2011; Ruger 2006). According to the
adage “ought implies can,” we can only hold people responsible for their actions if
they could have acted otherwise. Of course, it is true in some sense that people who
smoke, or overconsume unhealthy food, or fail to exercise, could oftentimes have
acted otherwise, in principle: it was not literally impossible for them to act other-
wise. However, the relevant question is not whether it is literally possible to engage
in healthy behavior, but whether it reasonably feasible for people to engage in
healthy behavior. Talk of personal responsibility therefore requires a clear focus on
the settings in which people live and on their behaviors when presented with differ-
ent choices. Consideration should also be given to the possibility that policies
implementing personal responsibility through, for example, rewards and penalties,
may impact core values underlying a health system, such as a sound doctor-patient
relationship, equity, or risk sharing, which may affect their overall acceptability in
positive or negative ways (Schmidt 2008).
5.3 Formal and Informal Health Workers
Health professionals play a central role in chronic disease prevention and health
promotion (Dawson and Verweij 2007). In primary prevention, they focus on avert-
ing poor health in the first place and on promoting good health. In secondary pre-
vention, they offer information, tests, and screenings aimed at early detection and
treatment of diseases. Diabetes, blood pressure, and some cancer screenings can
have utility, especially when targeting at-risk populations in a nonstigmatizing way.
Primary care physicians are often in a good position to decide on the appropriate-
ness of screenings. Their knowledge of patient background and overall situation can
help them tailor tests on the supply side to the actual needs on the demand side,
bearing in mind patient preferences and individual risks.
Cost effectiveness aside, a physician would be wrong to offer every available test
to every patient because the clinical benefit is not always clear. A recent systematic
review and meta-analysis of randomized controlled trials concerning general health
checkups (i.e., comprising health risk assessments and biometric screening for high
blood pressure, body mass index, cholesterol, and blood sugar) found no association
with lower overall mortality or morbidity (Krogsbøll et al. 2012). On the basis of
these findings, the researchers caution that checkups may needlessly increase diag-
noses and use of drugs. They recommend clinically motivated testing of individuals
to initiate preventive efforts but discourage screening at the population-level for
142 H. Schmidt
lack of evidence. The authors acknowledge limitations in their research, including

that most of the trials were relatively old and that changes in interventions and care
pathways reduce applicability to current practice. All studies entailed voluntary
invitations to get checkups, so selection bias may have overrepresented privileged
people (in typically better health to start with) and not reached those needing atten-
tion the most (Krogsbøll et al. 2012). The focus on all-cause mortality has also been
criticized as setting too high a threshold (Sox 2013). Yet despite the somewhat intui-
tive appeal of using general health checkups in secondary prevention, there is little
robust evidence from randomized controlled trials to show any major impact on
overall mortality.
An ethical problem arises when offering preventive screenings that do not fol-
low evidence-based guidelines (U.K. National Screening Committee 2013). Such
screenings may increase the number of “worried well” who oftentimes are con-
fused by complex probabilities of detecting and preventing diseases. Clinicians
must therefore do their utmost to understand risks and benefits of screening tests
and communicate these to patients in ways that are easily comprehensible and not
misleading (Wegwarth and Gigerenzer 2011). For example, a physician might tell
his 50-year-old patient that she should undergo breast cancer screening because it
reduces risk by 14 %. But this information is incomplete, as relative risk rates
alone obscure the basic reference point against which the comparison is made.
Another way of providing the same information would be to use absolute risk
rates and to say that if one screens 1000 women for 20 years, four breast cancer
deaths can be averted, even though eight among all screened women still die from
breast cancer. In addition, over the 20 years, the 1000 women taking part in
screening experience 412 false positives, and of 73 women who are diagnosed
with breast cancer, 19 experience overdetection and are treated for a cancer that
would not have developed into a lethal tumor, with treatment typically consisting
of hormone- radio- or chemo-therapy, and partial or full surgical breast-removal
(Hersch et al. 2015). This way of presenting data (Fig. 5.2), especially when com-
bined with other relevant information about screening accuracy and rates of over-
diagnoses, provides more adequate context for considering benefits and risks—yet,
this presentation method is far from being universally adopted (Gigerenzer et al.
2010).
Adequate risk information in secondary prevention matters not only from a
patient-empowerment perspective but also because it can mitigate real or perceived
conflicts of interests of physicians. Physicians, anyone who markets or manufac-
tures screening equipment, and those who analyze data typically experience finan-
cial gain when more patients undergo screening. Therefore, a central ethical issue of
secondary prevention is not only how to avoid premature mortality in the most effi-
cient and cost effective way but also how to eliminate potential conflicts of inter-
ests. Patients can become entangled in competing interests, as illustrated by the
controversy surrounding prostate-specific antigen, or PSA, testing to detect prostate
cancer. Although physicians and others experienced financial gain, patients experi-
enced no reduced mortality and instead higher morbidity and loss of quality of life
Relative risk data can be misleading or confusing. Absolute risk data can provide more
appropriate information and minimize possible conflicts of interest. Visual illustrations
similar to the ones shown below are helpful as part of evidence-based mammography
screening decision-aids.
Fig. 5.2 Communicating benefits and harms of breast screening (Originally published in Hersch
et al. (2015). Used with permission)
due to the entailed procedures (Ablin 2010). The question of “what is the magnitude
of benefits and risks, and to whom?” is therefore an important one to ask in all sec-
ondary prevention, especially because the net gain for patients is not always
obvious.
For these and other reasons, many in the public health community are skeptical
about the relative utility of secondary prevention in a clinical context. Often this is
paired with a call for shifting political and financial support to primary prevention
and the broader sphere of public health (Sackett 2002; Mühlhauser 2007). Here, the
objective is to avoid poor health in the first place by empowering people with differ-
ent ways to lead healthy lives. Too often, only the privileged few in certain popula-
tions have this capability (WHO 2008).
Of course, this way of thinking immediately broadens the concept of health pro-
fessional. Clearly, it is outside the scope of, say, a hospital-based general internist to
reduce junk-food outlets or to increase exercise opportunities in a low-income part
of town, even if the internist has good reasons to believe these structural features are
key contributors toward rising levels of obesity among patients. But once we recog-
nize how differences among settings in which people live can affect the incidence
and prevention of chronic diseases, it becomes apparent that public health profes-
sionals outside the clinical context have as much, if not more, of a role to play
compared to physicians when it comes to chronic disease prevention and health
promotion.
A range of corresponding interventions are relevant to this discussion, including
literacy, safe sex, hygiene and health awareness campaigns, financial subsidies for
healthy food or gyms, exercise stations in parks, breastfeeding rooms in workplaces,
144 H. Schmidt
and fluoridation of water. The public health field is heterogeneous and comprises
numerous different actors both in and outside a clinical context. Public health,
despite its many contexts and support from government and private sectors, is typi-
cally underfunded. This is especially true for informal grassroots campaigns, which
often have a considerable competitive advantage over formal program structures.
Grassroots campaigns evolve from the communities they seek to help. Because
nearly every intervention that addresses chronic diseases has to do with how one
lives one’s life, top-down interventions are often experienced as intrusive forms of
external meddling (Morain and Mello 2013). Conversely, initiatives led by a com-
munity member can be perceived more sympathetically than instructions from men
in white coats who speak in formal and technical terms (unless, of course, that hap-
pens to be the target population, which, typically, it is not).
Health professionals working on chronic disease prevention and health promo-
tion therefore span a wide field. In a looser sense, many professionals not generally
seen as concerned with health could be included too, such as teachers, architects,
town planners, or spiritual leaders. Each has perspectives that can be highly influen-
tial, but each is inherently limited in scope because chronic conditions result from
complex interplay of different factors. This raises another key ethical issue involv-
ing how to determine the optimal mix of strategic approaches, bearing in mind the
relative strengths and weaknesses.
Further, just as users and payers of health care should have a keen interest in hav-
ing systematic studies and evaluations done to determine which of several drugs
aimed at reducing, for example, severe headache, is most efficacious (and cost
effective), we should be interested in the evidence base for possible benefits and
harms of different interventions being implemented by health professionals con-
cerned with chronic conditions. Yet, in an almost tautologic approach, health profes-
sionals often assume any preventive method will be good because its aim is
prevention. But several strategies could be aimed at the same problem. Given that
budgets are generally limited, it can be useful to determine which intervention is
most effective and, for example, how its relative effectiveness and cost compare
with its intrusion into peoples’ lives. Such comparisons can help achieve value for
money, even if the complex interplay of agents complicate this process.
5.4 Governments (At Different Levels)
Chronic disease prevention and health promotion policies often face criticism for
promoting a “nanny state.” This means that although government may legitimately
use taxes and other measures to create health-conducive infrastructure that pre-
vents chronic disease such as clean water supplies, sanitation services, or clean air
acts, it should otherwise stay out of people’s lives, and, in particular, refrain from
telling citizens how to live their life (Childress et al. 2002; Gostin 2010; Dawson
Fig. 5.3 Male life expectancy, between- and within-country inequities, selected countries (Figure
is adapted from World Health Organization (2008))
and Verweij 2007). Many good reasons support this viewpoint. Still, many vari-
ables related to chronic diseases are linked to legitimizing governments in the first
place.
For example, consider the U.S. Declaration of Independence. It declares that
“all men are created equal; that they are endowed by their Creator with certain
unalienable Rights; and that among these are Life, Liberty, and the pursuit of
Happiness.” Numerous countries express similar sentiments in legal frameworks
and charge states with providing environments that enable conditions for a good
life, and prevent harm. Moreover, building on the United Nations’ (U.N.)
International Covenant on Economic, Social and Cultural Rights of 1966 and
clarifying General Comment 14 by the U.N.’s Committee on Economic, Social
and Cultural Rights, several countries have incorporated the right to health in their
constitutions (WHO 2013). Yet, not all people live equally long, nor are they
equally happy (in a nontrivial sense). For example, life expectancy differs widely,
not just between countries at different levels of development, but also within
countries, and sometimes with differences of almost 30 years across just 10 miles
(see the data on two areas in Glasgow, Scotland, located near one another,
Fig. 5.3). Chronic diseases are a major contributor to this variation.
Going back to the focus on personal responsibility, one might argue this variation
in life expectancy is due to some people simply not wanting to be healthy or living
long. But this is clearly myopic. Government planning at different levels has
immense impact on both the prevalence and prevention of chronic diseases. It is
sometimes argued that the best prevention is to instill in people the desire to live
long and healthily (Rosenbrock 2013). For some, this might entail a state-guaranteed
minimum income (irrespective of whether one works), since economic livelihood is
146 H. Schmidt
of course a major factor in how one views one’s own future. While a positive impact
of such policies on the incidence of chronic disease and mortality would certainly
be plausible, there is a wide range of less radical and politically more feasible
options in the menu of different levels of government action. These include town
planning, zoning laws, school and university meal plans, and, of paramount impor-
tance, regulation of industry where markets fail. These and other interventions can
only be implemented by governments. An important part of chronic disease preven-
tion and health promotion is to monitor where differences in morbidity and mortal-
ity are such that government action is warranted, and to impress on elected officials
their responsibility in creating appropriate environments.
The monolithic notion of “the” government is, of course, an overly simplistic
one. Key personnel in health departments may well wish to limit the size of, for
example, soft drinks. Or they may wish to standardize ways in which nutritional
content is shown on food packaging. Such measures would enable more informed
consumer choice, and, more indirectly, incentivize producers to reconsider
whether food composition can be optimized for health impact, given the second-
ary “showcasing” effect of labeling.2 But their colleagues in trade or industry, as
well as in the treasury, may point out the risk of tax shortfalls that could result
from lower consumption. Or they may worry about pushback from lobbyists in
the corporate sector who fear losing profits for their clients. Politicians may often
be more concerned with their short-term re-election prospects than with making
substantial (or even just incremental) longer-term progress on chronic disease
prevention. These conflicting perspectives within government are inevitable. But
only government can determine the playing field and ground rules for industries
producing, selling and marketing food, drink, tobacco, and other products contrib-
uting to unhealthy behavior. In liberal economies that, typically, pursue a hands-
off approach toward regulating markets, the central ethical challenge then is to
decide at which points markets are considered to have failed, other options of
market regulations are unfeasible, and government action is warranted, despite
possible drawbacks.
A second closely related question is what intervention to pursue once the need
for action has been identified. Figure 5.4 shows the Intervention Ladder published
in a report by the Nuffield Council on Bioethics (2007) on public health ethics. The
model suggests that governments have a range of different options at their disposal
that become increasingly intrusive or paternalistic the higher one moves up the lad-
der. At the same time, each rung up the ladder requires more robust justification and
evidence, although the report points out the bottom rung, “doing nothing or simply
monitoring,” also requires justification.
2
For example, it has been shown that large U.S. chain restaurants changed menus in anticipation
of a legal mandate requiring public calorie posting, resulting in a 12 % reduction in calories (or
about 56 fewer calories per item, see Bleich et al. 2015).
In preventing chronic diseases and promoting health, governments have a range of

policy options differing in justification, evidence requirements, and extent of
intrusion.
• Eliminate choice: Prohibit substances such as transfats. Remove obese children

from their home.
• Restrict choice: Ban unhealthy foods from shops or restaurants. Add fluoride to water.
• Guide choice through disincentives: Tax cigarettes. Discourage the use of cars
in inner cities through charging schemes or by limiting parking spaces.
• Guide choice through incentives: Give tax breaks to commuters.
• Guide choice by changing the default policy: In restaurants, instead of

providing fewer health options and including fries as a standard side dish (with
healthier options available) make healthy options standard menu fare (with fries
optional). Regulate salt levels of fast food meals because consumers can add salt
afterwards.
• Enable choice: Create tax-funded smoking cessation programs, build cycle lanes,
or provide free fruit in schools.
• Provide information: Implement campaigns to encourage people to walk more

or to eat certain amounts of fruit and vegetables daily.
• Do nothing or simply monitor the current situation.
Fig. 5.4 The intervention ladder (Adapted from Nuffield Council on Bioethics (2007))
5.5 Corporate Entities
In the United States, the Institute of Medicine (1988) defines public health as “what
we, as a society, do collectively to assure the conditions in which people can be
healthy.” In the United Kingdom, the Faculty of Public Health (2010) of the Royal
Colleges of Physicians suggests that public health is the “science and art of prevent-
ing disease, prolonging life, and promoting health through organized efforts of soci-
ety.” These, and other conceptualizations, emphasize the collective nature of public
health work (Verweij and Dawson 2007). Companies that facilitate consumer access
to tobacco or to healthy and unhealthy food and drink are part of society and con-
tribute via goods, services, and employment opportunities. In return, they often
receive generous tax breaks. Company operations benefit further from diverse finan-
cial arrangements and infrastructures put in place by governments to ensure stability
148 H. Schmidt
of civic and economic life, since both are essential to how markets function. It is
therefore reasonable to ascribe some responsibilities for public health to companies.
In many instances, this is achieved through voluntary corporate social commit-
ments, such as charters or formal partnerships with charitable or community orga-
nizations. Increasingly, companies view their own ethical actions as an attractive
side of their branding, especially in countries where consumers’ awareness is high.
Although many companies generate profits through healthful products, many
others benefit from bringing products to market that will likely cause harm. Product
demand is rarely a function of basic human needs but, rather, is defined by social
and cultural norms. These norms are often fueled—if not generated—by aggressive
marketing to adults and children. The basic tension regarding the role of companies
in relation to public health is their prima facie obligation to contribute to population
health, while also maximizing owners or shareholders’ profits. Public health would
be promoted by measures such as providing honest nutritional information and
other content of products; avoiding claims that are misleading (as is sometimes the
case with vitamins, supplements, or some diagnostic tests); not denying or under-
playing potential harm (as with so-called alcopops, which are high-alcohol drinks
made to look like soft drinks); or not exploiting the “pester power” of children,
particularly by marketing products to them and confusing the boundary between
giving information and advertising. But realizing these aspirations typically curbs
consumption and therefore reduces market shares and profits.
Companies therefore prefer as little regulation as possible and favor information-
based over price-based interventions or more intrusive options (Fig. 5.4). In all
high-income countries, company and government officials liaise to negotiate con-
sumer protection policies, insofar as political and consumer pressure creates
demand. These negotiations often reveal the limitations of corporate social respon-
sibility, as perhaps illustrated most clearly by the tobacco industry. For decades, the
industry pursued the strategy that there was no hard evidence that tobacco was
harmful to health. When this strategy became too absurd to sustain, and, in particu-
lar, when the evidence of the harmful effects of secondary smoke became over-
whelming, the industry caved in and agreed to implement a series of consumer
protection measures in most developed countries (Brandt 2007). However, in many
instances, this tug-of-war was repeated in other countries, despite a range of robust
provisions in WHO’s Framework Convention on Tobacco Control (2003), the only
supranational hard law instrument on a major risk factor for chronic conditions that
is legally binding in more than 170 countries. From a narrow business perspective,
this behavior is entirely rational. But from an ethical viewpoint, it is extremely ques-
tionable. For example, it has been accepted in the United States and Europe that it
is not appropriate to glorify tobacco on billboards, to give cigarettes away for free
in promotions at rock concerts geared towards young people, or to sell them indi-
vidually, then why should these and other practices be commonplace in many low-
income countries, especially in Africa (Action on Smoking and Health 2007)? The
obscene tenfold global increase in deaths attributable to tobacco in the twenty-first
century has already been noted. What makes this prospect all the more appalling is
the industry’s refusal to take seriously the standards it agreed to uphold in high-
income countries. For if these standards were upheld, history would not repeat itself
with such horrific consequences.
5.6 Case Studies
In the following five cases, the reader is put in the position of a public health prac-
titioner to illustrate how key ethical issues can arise in the prevention of chronic
diseases and health promotion. The cases highlight several real-world, practical
constraints: limited budgets; insufficient evidence for how interventions will work
in structurally different settings; organizational constraints, particularly from spe-
cific formats for decision making; and clashes of perspectives and worldviews.
Three cases concern children, an especially vulnerable population (Verweij and
Dawson 2011). The cases ask whether the parents alone can make sound health
decisions for their children, and if not, what interventions would be acceptable to
reach the parents. The interventions range from chemical and behavioral to social
ones, and central to each are ethical questions around their justification (because of
competing interests) and oftentimes unclear evidence. Several cases touch on
whether or not to engage the public in decision making—and if so, how? Public
engagement is an increasingly popular approach being applied broadly to health
policy. Yet, it is not always clear who should be involved in which decision-making
processes and on what grounds (Kreis and Schmidt 2013).
Mah et al. provide an intriguing scenario in which a municipal public health
department needs to decide whether to accept increased contributions to a youth
after-school program from a local fast food-chain in exchange for mentioning the
chain’s name as part of the (renamed) program. The background section describes
how food and beverages are marketed to children and notes that globally, self-
regulation models are the most common approach. This case combines real and
perceived conflicts of interests for the company and for notoriously cash-strapped
public health workers. Woven into the case is the media’s role. The discussion ques-
tions invite analyses from the vantage points of different stakeholders and address
ways to modify the base scenario, adding layers of complexity.
Blacksher’s case focuses on obesity prevention, media campaigns, and stigma.
She describes the human and financial toll of obesity worldwide, focusing on chil-
dren as an especially vulnerable group. She also presents a range of different policy
options to address childhood obesity before charging the reader, acting as a state
commissioner for health, to recommend a statewide obesity policy for a dispropor-
tionately poor and vulnerable population. The process for reaching consensus on
this policy recommendation is common. A task force of a dozen members is
appointed, half the seats are reserved for state legislator appointees, and half
reserved for public health professionals and community representatives. Due partly
to their different background and priorities, the task force disagrees about how
intrusive the policy should be. Members settle, however, on a statewide media cam-
paign aimed at changing social norms. Still, how hard-hitting should the campaign
150 H. Schmidt
be? In the discussion questions, readers may consider, among other things, the evi-
dence needed to justify different campaign types and if other stakeholders should
(or need not) be included in the decision-making process to confer legitimacy.
The case by Goldberg and Novick focuses on an intervention program in which
task force members grapple with whether the use of stigma might be acceptable
under certain circumstances. The authors describe empirical research findings and
conceptual arguments that suggest stigma is always correlated with negative health
outcomes—especially in otherwise disadvantaged populations, and certainly in the
case of obesity. They describe how stigmatizing approaches are based on certain
conceptions of personal responsibility that fail to consider the broad underlying
structural determinants of obesity. Then the case shifts focus to another situation
often encountered in public health practice: applicability of evidence base in mul-
tiple settings. Here, a program intended to empower residents to take control of their
weight through meal planning, physical activity, and behavioral modification proves
effective in controlled studies. The director of the county health department,
attracted to the program on grounds of potential cost effectiveness, readily embraces
the program. Later, however, during a program meeting, one of the department’s
public health nurses expresses concern about an overly strong focus on personal
responsibility, which she feels makes the program unfair. Based on her knowledge
of the target population, she also feels the program will be rejected. Could the
program nonetheless be effective? And how might risks of stigma be minimized?
These and related issues form part of the questions section.
Whereas the first three cases are set in the United States, the case by Aspradaki
et al. takes us to Greece and concerns issues raised by water fluoridation. The dis-
ease burden attributable to preventable tooth decay is laid out along with the risks of
using fluoride. Oral disease is on the rise in low- and middle-income countries, with
poorer populations disproportionately affected. The authors describe water fluorida-
tion in different countries before suggesting that the primary ethical tension sur-
rounding water fluoridation arises between the concepts of autonomy and
paternalism. The case description puts the reader in the position of Greece’s central
oral health director providing a consult to the head of public health programs in the
health ministry. Negotiations on a national strategy have been held up by political
and organizational digressions and by public skepticism. Still, the health ministry
wants to go ahead and put in place a countrywide fluoridation program. Your task is
to identify which stakeholders should be involved, how the different elements of
empirical data and ethical values should be considered, and what role economic
pressures might play in the decision making.
The case by Aleksandrova-Yankulovsak is about banning smoking in public
places in Bulgaria. Almost half of the men and a third of the women in Bulgaria are
smokers. The case provides context to smoking in Europe and nearby regions before
summarizing the regulatory framework that prompted Bulgaria to consider the ban.
The political process, threatened by business interests and strife within government
departments, is also addressed. The case then poses the question if you, as director of
the regional health inspectorate, can guarantee implementation of the new law. Other
questions invite discussion on whether the law is the right tool to achieve lower
smoking rates, in principle, and how the public might view temporary legal provi-
sions that could be repealed if political support dwindles. A further central point is
how or whether economic costs can ever be set against cost in human welfare.
The cases illustrate but a fraction of the ethical issues that arise in chronic disease
prevention and health promotion. Many cases will present differently depending on
the country and its culture, infrastructure, health care system, and legal and political
system. Similarly, this introduction is far from exhaustive. Yet, when combined, the
cases and introduction introduce many central ethical issues that arise in global
public health. Analyzing the ethical issues that featured centrally in justifying poli-
cies (or in the refusal of policy makers or other actors to change existing policies)
will deepen the reader’s engagement and reflection and, ideally, contribute to better
policy and practice in the future.
Acknowledgements I am grateful to Anne Barnhill for helpful comments on an earlier version

of this introduction.
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5.7 Case 1: Municipal Action on Food and Beverage

Marketing to Youth
Catherine L. Mah
Faculty of Medicine
Memorial University
e-mail: catherine.mah@mun.ca
Brian Cook
Toronto Food Strategy, Toronto Public Health
Toronto, ON, Canada
Sylvia Hoang
Social and Epidemiological Research Department
Centre for Addiction and Mental Health
Toronto, ON, Canada
Emily Taylor
Dalla Lana School of Public Health
Toronto, ON, Canada
154 H. Schmidt
institutions.
5.7.1 Background
Children are exposed to a greater intensity and frequency of marketing than ever
before. Evidence has demonstrated that marketing of food and beverages to children
contributes adversely to health, affecting food knowledge, attitudes, dietary habits,
consumption practices, and health status. Marketing to children has always raised
concerns. But recently, numerous nongovernmental and international organizations
and all levels of government have expressed their concern about food and beverage
marketing and advertising to children as a public health issue.
Often used interchangeably with “advertising,” the term “marketing,” actually
encompasses a broader range of issues. The World Health Organization (WHO)
(2010) defines marketing as “any form of commercial communication or message
that is designed to, or has the effect of, increasing the recognition, appeal and/or
consumption of particular products and services. It comprises anything that acts to
advertise or otherwise promote a product or service.”
Two large-scale global systematic reviews of evidence in the last decade have
concluded that food and beverage marketing substantially affects young people and
is associated with adverse health outcomes. In 2003, the U.K. Food Standards
Agency commissioned a systematic review of the influence of food promotion on
children’s food-related knowledge, preferences, and behaviors (Hastings et al.
2003). WHO updated the report in 2007 and 2009 (Hastings et al. 2007; Cairns et al.
2009). In 2006, the U.S. Institute of Medicine conducted a systematic review of the
influences of food and beverage marketing on the diet and diet-related health of
children and youth (McGinnis et al. 2006). Key findings from these reports follow:
• Food and beverages developed for and advertised to young people are predomi-
nantly calorie dense and nutrient poor;
• Marketing influences children’s food and beverage preferences, purchase
requests, and short-term consumption, even among young children (ages
2–5 years); and
• There is strong evidence that child and youth exposure to television advertising
is significantly correlated with poor health status, although sufficient evidence of
a causal link with obesity is not yet available.
The authors of the 2009 WHO report suggest that existing research “almost cer-
tainly underestimates the influence of food promotion” and that more research is
needed, especially for newer forms of media (Cairns et al. 2009).
As part of its global strategy for the prevention and control of noncommunicable
diseases (WHO 2004), WHO subsequently endorsed policy recommendations for
governments to take action on food and beverage marketing to children (2010,
2012). The recommendations emphasize governments’ key role in developing poli-

cies to protect the public interest, including leadership roles in managing intersec-
toral processes and negotiating stakeholder rights and responsibilities.
The scope of existing policy interventions that address food advertising to chil-
dren includes statutory regulation (i.e., general restrictions or outright prohibitions)
and industry self-regulatory codes. Globally, industry self-regulatory approaches
tend to be the most common approach.
Many organizations promote the adoption of comprehensive public policy inter-
ventions, with the scope of these interventions ranging from total ad bans (all com-
mercial advertising) to food ad bans or junk food ad bans (WHO 2012).
Other organizations suggest stepwise approaches that target particular expo-
sures, products, ages, or specific forms of marketing or media. For example, such
approaches could include limiting marketing in venues such as schools, restricting
junk food, protecting children younger than a certain age, defining certain television
broadcasts as children’s programs, or restricting promotions in television broadcasts
before 10 pm, respectively (WHO 2012).
In recent years, many food and beverage companies, working with industry asso-
ciations, have issued voluntary pledges to alter marketing practices toward children.
For example, such pledges typically include criteria for the nutritional quality of
foods advertised to children, limitations on the use of licensed characters, and mar-
keting in schools. However, critics argue that these types of voluntary changes are
not sufficient to reduce the risks of food marketing to children in a substantive way.
Despite this array of interventions, the absence of widespread agreement on the
most appropriate form of collective action has led many policy makers to default to
inaction.
You direct the Healthy Public Policy program for a large municipal public health
department that recently has come under fire in a newspaper exposé about contribu-
tions from fast food companies to after-school programs for youth that the city
government runs. The exposé highlighted the contributions of Big Boss Burger, a
local fast food hamburger chain with 12 locations across the city. Big Boss Burger
donates cooking equipment to the city’s high-priority, after-school cooking program
for 9- to 11-year-olds. Although the program is well-liked by youth, it is regularly
threatened by funding cuts. The chain has recently offered to scale-up its annual
cash donation to cover all food and equipment costs in exchange for renaming the
program “The Big Boss Burger Community Kitchen” and for placing the chain’s
logo on all signage and promotional materials.
The highly successful Big Boss Burger chain is owned by a beloved, self-made
restaurateur who has spent his entire career in the local food industry. Considered a
colorful local personality, he frequently sends Twitter updates that reflect his over-
156 H. Schmidt
the-top advertising style. One tweet, for example, offered a free sample of the
chain’s “quadruple bypass” burger to anyone who visited one of the chain’s loca-
tions within the hour.
Media spokespersons for the mayor, meanwhile, have reiterated the community
benefits of cultivating positive partnerships with local businesses. They note that only
registered public health nutrition staff run the city’s cooking programs, while insisting
that Big Boss Burger has no influence whatsoever on city policies or youth curricula.
The media furor nevertheless has prompted city officials to explore developing a
sponsorship policy for municipal child and youth programs. The Medical Health
Officer has asked you to prepare a briefing note outlining the key public health con-
siderations that such a sponsorship policy needs to address.
You face a dilemma. On the one hand, several years ago your Healthy Public
Policy team launched a study of the impact of food and beverage advertising on
children. Last year’s update on the study to the Board of Health included a recom-
mendation that city-operated venues and programs avoid commercial advertising of
food and beverages targeting children younger than 13 years of age. Thus far, the
recommendation has not led to any formal policy changes. Municipal employees
partly attribute this inaction to the reluctance of local authorities to act when there
are no state or national policies that govern sponsorship or marketing restrictions.
On the other hand, the financially strapped city relies on engagement with the
local business community to fund many city-run programs, including health educa-
tion activities. It is also well-known that the owner of Big Boss Burger grew up in a
local low-income community and frequently volunteers his time at events in his
former neighborhood.
1. What key points will you emphasize in your briefing note? How will scientific
information from past public health reports and decisions influence your
response? How should ethical considerations influence your briefing note?
2. What population groups are you most concerned about with regard to the spon-
sorship policy? What if the cooking program sponsored by Big Boss Burger was
for 14- to 16-year-olds instead of 9- to 11-year-olds? For adults? For children in
a high-income neighborhood?
3. Does corporate sponsorship constitute food promotion? What benefits to the
municipality might be derived from Big Boss Burger’s contributions (for exam-
ple, local economic benefits or having increased public attention and private-
sector support of priority neighborhoods)? How should the public health
department weigh these benefits against population health benefits and harms?
Consider your response if Big Boss Burger
(a) Had offered its support without the naming rights request;
(b) Had instead offered a cash donation to a parents’ association supporting the
program;
(c) Was an organic, vegan comfort food restaurant; or

(d) Was a large, multinational fast food corporation.
4. How will public opinion inform your briefing note? How will you handle the
situation given that Big Boss Burger is a highly popular fast food chain and that
the owner is a local public personality?
5. What are (and should be) the roles and responsibilities for various city depart-
ments in defining the sponsorship policy? Consider, for example, city depart-
ments responsible for public health, parks and recreation, municipal licensing,
social services, and economic development.
6. Let’s imagine that you are a parent of two girls, ages 6 and 9 years. In an ideal
world, how much food and beverage marketing do you think they should be
exposed to? How does your perspective as a parent enter into your professional
decisions as director of the Healthy Public Policy program? How about your
perspective as a voting citizen or city resident?
References
Cairns, G., K. Angus, and G. Hastings. 2009. The extent, nature and effects of food promotion to
children: A review of the evidence to December 2008. Geneva: World Health Organization.
http://whqlibdoc.who.int/publications/2009/9789241598835_eng.pdf. Accessed 29 May 2013.
Hastings, G., M. Stead, L. McDermott, et al. 2003. Review of research on the effects of food promo-
tion to children: Final report prepared for the food standards agency. Glasgow: Centre for
Social Marketing. http://tna.europarchive.org/20110116113217/http:/www.food.gov.uk/multi-
media/pdfs/foodpromotiontochildren1.pdf.Accessed 29 May 2013.
Hastings, G., L. McDermott, K. Angus, M. Stead, and S. Thomson. 2007. The extent, nature and
effects of food promotion to children: A review of the evidence. Technical paper prepared for
the World Health Organization. Geneva: World Health Organization. http://whqlibdoc.who.int/
publications/2007/9789241595247_eng.pdf. Accessed 29 May 2013.
McGinnis, J.M., J.A. Gootman, and V.I. Kraak (eds.). 2006. Food marketing to children and youth:
Threat or opportunity? Committee on Food Marketing and the Diets of Children and Youth,
Institute of Medicine of the National Academies. Washington, DC: National Academies Press.
World Health Organization (WHO). 2004. Global strategy on diet, physical activity and health.
Geneva: World Health Organization. http://www.who.int/dietphysicalactivity/strategy/
eb11344/strategy_english_web.pdf. Accessed 29 May 2013.
World Health Organization (WHO). 2010. Set of recommendations on the marketing of foods and
nonalcoholic beverages to children. Geneva: World Health Organization. http://whqlibdoc.
who.int/publications/2010/9789241500210_eng.pdf. Accessed 29 May 2013.
World Health Organization (WHO). 2012. A framework for implementing the set of recommenda-
tions on the marketing of foods and non-alcoholic beverages to children. Geneva: World Health
Organization. http://www.who.int/entity/dietphysicalactivity/MarketingFramework2012.pdf.
158 H. Schmidt
5.8 Case 2: Obesity Prevention in Children: Media

Campaigns, Stigma, and Ethics
Erika Blacksher
Department of Bioethics and Humanities
University of Washington
Seattle, WA, USA
e-mail: eb2010@u.washington.edu
institution.
5.8.1 Background
Worldwide obesity has doubled since 1980 and kills some 2.8 million adults each
year (World Health Organization [WHO] 2012). Childhood obesity also has
increased at alarming rates with some 42 million children estimated to be over-
weight (WHO 2013). Among Organisation for Economic Cooperation and
Development (OECD) countries, the United States has the highest rate of obesity
(OECD 2012). More than 35 % of adults and almost 17 % of children are obese
(Ogden et al. 2012), with especially high rates among poor and minority children
(Centers for Disease Control and Prevention [CDC] 2012).
Childhood obesity has serious short- and long-term health consequences. Obese
children are more likely to have risk factors for cardiovascular disease, including
high cholesterol and blood pressure; type 2 diabetes; skeletal problems; sleep apnea;
and mental health issues, such as low self-esteem and depression (CDC 2012; Reilly
et al. 2003). Children now account for half of all new cases of type 2 diabetes.
Obese children are also subject to systematic discrimination (Strauss 2002). More
than 50 % of overweight children become obese adults who experience elevated
health risks for heart disease, stroke, diabetes, osteoporosis, lower-body disability,
some types of cancer, and premature mortality (Freedman 2011; CDC 2012).
The burdens of obesity are also economic. Rising health care costs are mostly
driven by obesity-related costs. Estimates indicate that in 2008 some 10 % of medi-
cal spending in the United States was related to obesity, amounting to as much as
$147 billion (Finkelstein et al. 2009). Experts estimate obesity-related costs will
account for 21 % of medical spending by 2018 if obesity rates continue to rise
(United Health Foundation 2009).
As the human and financial costs of obesity have become better recognized, gov-
ernment officials and public health leaders increasingly have called for strong
action. Comprehensive approaches that act on environmental and social determi-
nants of food choice and activity level are widely recommended (OECD 2012). The
complexity of such an approach is reflected in the following recommended policies
and strategies: taxing unhealthy foods and beverages, such as soda and snack food,
to make them cost prohibitive; providing agricultural subsidies to lower the cost of
healthy foods, such as fresh produce and whole grains; setting standards to lower
sodium levels and prohibit the use of trans fatty acids in food products; banning
unhealthy foods from public schools and child care facilities; restricting or banning
the advertising of unhealthy foods to children; posting calorie counts on restaurant
and take-out menus; using “counter-advertising” to show the harmful effects of
unhealthy foods; redesigning communities and streets to incorporate parks,
sidewalks, and bike paths; and reducing sedentary behavior by limiting time view-
ing television and playing computer games (Frieden et al. 2010; Butland et al.
2007).
Children’s status as developing agents further complicates childhood obesity
prevention. Parents have primary responsibility for rearing children and consider-
able discretion over cultural and lifestyle matters, including many daily decisions
that directly affect a child’s food and activity-related environments and behaviors
(Blacksher 2008). Some measures would likely confer benefit regardless of parental
behavior (e.g., banning food advertising to children or removing trans fats from
packaged foods). But others will have their intended effect only if parents make
certain choices, some of which will require that they change their health-related
habits.
Many preventive measures will be controversial because they involve govern-
ment action and seek to shape personal choice. Perhaps the least controversial of the
measures enable healthier choices by providing people with information and mak-
ing healthy options more available and affordable; however, many are more coer-
cive, ranging from those that eliminate and restrict choice to those that guide choice
through disincentives and default policies (Nuffield Council on Bioethics 2007).
Intervening in voluntary choices where effects impose no harm to others constitutes
strong paternalism and is difficult though not impossible to justify (Childress et al.
2002). However, society may justifiably intervene to prohibit behaviors that expose
others to serious harms, and this “harm principle” has been appealed to as the basis
for removing children from homes where parental practices are judged to contribute
to severe childhood obesity and attendant comorbidities (Murtagh and Ludwig
2011). Removing a child from the home poses other potential harms, further com-
plicating the ethical dilemma (Black and Elliott 2011). These ethical considerations
in combination with the difficulty of changing health habits makes obesity preven-
tion one of the more challenging public health priorities of the twenty-first
century.
160 H. Schmidt
Your state is the poorest in the nation with high rates of childhood poverty, obesity,
and diabetes. Located in the southeastern part of the United States in what is known
as the “stroke belt,” adults disproportionately suffer from stroke and its risk fac-
tors—hypertension, high cholesterol, diabetes, and obesity. As the state’s new com-
missioner of health, the governor has tasked you with making obesity prevention a
public health priority. The governor is concerned about public health and rising
health care costs. More than 50 % of the state’s children and some 20 % of adults
are enrolled in Medicaid (a federal-state program that provides health care services
for low-income Americans), making it the largest item in the state budget.
The governor has requested that you convene and chair a 12-member task force
to make recommendations for a statewide obesity prevention strategy. Six seats are
reserved for state legislator appointees because the recommendations will need
political support to be implemented. The other seats are reserved for public health,
health care, and community representatives. For several months, task force mem-
bers debated measures that eliminate or restrict adult choice through government
action, such as taxes and bans on unhealthy foods and drinks. Those who favored
such measures argued they would be the most effective, citing the success of tobacco
taxes and smoking bans in reducing smoking, and could be justified on grounds that
obesity-related costs constitute an economic harm to others (Pearson and Lieber
2009). Yet, many task force members, particularly elected representatives, found
such measures objectionable forms of government intrusion into adult choices.
Task force members did, however, agree to tackle obesity prevention in children
on grounds that the state has a role in protecting them. To that end, they endorsed
measures to improve school lunches and to remove vending machines that sell soda
and other sugary beverages from public school grounds. Task force members also
wanted to invest in a statewide media campaign about the causes and harms of
childhood obesity because they believed it would raise awareness and promote
informed choices. They also thought a media campaign would help to change social
norms, which they deemed essential to long-term change in their state, where fried
and fatty foods are part of the cultural heritage.
Task force members cannot, however, agree on the orientation of such a cam-
paign. Some favor an approach used by a nearby state that has attracted attention for
its graphic depiction of obese and unhappy children accompanied by hard-hitting
messages, such as “It’s hard to be a little girl if you’re not.” Opponents believe the
campaign blames the victims and further stigmatizes obese children. They propose
instead an approach that highlights environmental barriers to healthy choices and
depicts unhealthy food as the culprit, not those who consume it. But proponents of
the more hard-hitting approach say it is honest about the facts and highlights the
essential role of parents in regulating children’s behavior. To support their case, they
cite the use of similarly graphic media campaigns in tobacco cessation efforts and
note that public health efforts have often relied on stigma as a tool of disease pre-
vention, despite the controversy (Bayer 2008; Burris 2008). The task force has for-
mulated a series of questions to take up at the next meeting.
1. What harms are associated with childhood obesity?

2. Are the harms of obesity and tobacco use analogous? Is the economic cost of obe-
sity a harm to others in the same way that secondhand smoke is a harm to others?
3. Do public media campaigns that depict images of obese children stigmatize
them? What is stigma?
4. Is it ever ethically permissible to use stigmatization as a tool of disease preven-
tion and health promotion? If so, in what sort of cases? Should children ever be
the targets of stigmatization?
5. Do public media campaigns that highlight the role of parents in regulating chil-
dren’s food and activity-related environments and choices blame the victims?
6. Should the task force consider gathering community input, particularly from
people who are overweight or obese, about the sorts of messages they would find
effective in changing their health habits and also find ethically acceptable? If so,
should children be included in these focus groups? If so, at what age?
References
Bayer, R. 2008. Stigma and the ethics of public health: Not can we but should we. Social Science
& Medicine 67(3): 463–472. doi:10.1016/j.socscimed.2008.03.017.
Blacksher, E. 2008. Children’s health inequalities: Ethical and political challenges to seeking
social justice. Hastings Center Report 38(4): 28–35.
Black, W., and R.L. Elliott. 2011. Childhood obesity and child neglect. Journal of the Medical
Association of Georgia 100(4): 24–25.
Burris, S. 2008. Stigma, ethics, and policy: A commentary on Bayer’s “Stigma and the ethics of
public health: Not can we but should we”. Social Science & Medicine 67(3): 473–475.
Butland, B., S. Jebb, P. Kopelman, et al. 2007. Foresight. Tackling obesities: Future choices.
London: Government Office for Science.
Centers for Disease Control and Prevention (CDC). 2012. Adolescent and school health: Childhood
obesity facts. http://www.cdc.gov/healthyyouth/obesity/facts.htm. Accessed 11 June 2013.
Childress, J.F., R.R. Faden, R.D. Gaare, et al. 2002. Public health ethics: Mapping the terrain.
Journal of Law Medicine & Ethics 30(2): 170–178.
Freedman, D.S. 2011. Obesity—United States, 1988–2008. Morbidity and Mortality Weekly
Report. Surveillance Summaries 60(01): 73–77.
Finkelstein, E.A., J.G. Trogdon, J.W. Cohen, and W. Dietz. 2009. Annual medical spending attrib-
utable to obesity: Payer- and service-specific estimates. Health Affairs 28(5): w822–w831.
Frieden, T.R., W. Dietz, and J. Collins. 2010. Reducing childhood obesity through policy change:
Acting now to prevent obesity. Health Affairs 29(3): 357–363.
Murtagh, L., and D.S. Ludwig. 2011. State intervention in life-threatening childhood obesity.
Journal of the Medical Association 306(2): 206–207.
Nuffield Council on Bioethics. 2007. Public health: Ethical issues. http://www.nuffieldbioethics.
org/public-health. Accessed 11 June 2013.
Organisation for Economic Cooperation and Development (OECD). 2012. Obesity update 2012.
http://www.oecd.org/health/49716427.pdf. Accessed 11 June 2013.
162 H. Schmidt
Ogden, C.L., M.D. Carroll, B.K. Kit, and K.M. Flegal. 2012. Prevalence of obesity in the United
States, 2009–2010. National Center for Health Statistics Data Brief, no. 82. http://www.cdc.
gov/nchs/data/databriefs/db82.pdf. Accessed 11 June 2013.
Pearson, S.D., and S.R. Lieber. 2009. Financial penalties for the unhealthy? Ethical guidelines for
holding employees responsible for their health. Health Affairs 28(3): 845–852.
Reilly, J.J., E. Methven, Z.C. McDowell, et al. 2003. Health consequences of obesity. Archives of
Disease in Childhood 88(9): 748–752.
Strauss, R.S. 2002. Childhood obesity and self-esteem. Pediatrics 105(1): 152–155.
United Health Foundation. 2009. The future costs of obesity: National and state estimates of the
impact of obesity on direct health care expenses. United Health Foundation in collaboration
with the American Public Health Association and Partnership for Prevention. http://www.
nccor.org/downloads/CostofObesityReport-FINAL.pdf. Accessed 11 June 2013.
World Health Organization (WHO). 2012. Obesity and overweight (Fact Sheet no. 311), updated
March 2013. http://who.int/mediacentre/factsheets/fs311/en/. Accessed 11 June 2013.
World Health Organization (WHO). 2013. Global strategy on diet, physical activity and health.
Childhood overweight and obesity. http://who.int/dietphysicalactivity/childhood/en/. Accessed
11 June 2013.
5.9 Case 3: Obesity Stigma in Vulnerable and Marginalized

Groups
Daniel S. Goldberg
Department of Bioethics and Interdisciplinary Studies, Brody School of Medicine
East Carolina University
Greenville, NC, USA
e-mail: goldbergd@ecu.edu
Lloyd Novick
Brody School of Medicine
East Carolina University
Greenville, NC, USA
institutions.
5.9.1 Background
For empirical and normative reasons, stigma is an enormous public health problem
that can have devastating psychosocial impact (Vanable et al. 2006; Chapple et al.
2004). Moreover, there is evidence that even after controlling for confounders,
stigma is robustly correlated with adverse health outcomes (Vardy et al. 2002; Puhl
and Brownell 2003). Stigma increases human suffering and diminishes health, both
of which anchor ethical concerns. However, its ethical deficiencies are not solely a
function of its health effects; as Burris notes, “even if [stigma] had no adverse
effects on health … it may readily be seen as repugnant in a humane society” (Burris
2002; Courtwright 2013).
According to Hatzenbuehler et al. (2013), stigma in a public health context con-
sists of two central components: (1) an in-group marks an out-group as different on
the basis of some common demographic characteristic, and (2) the in-group assigns
a negative evaluation to the characteristic. Stigma is therefore intimately connected
to entrenched social power structures (Link and Phelan 2006; Scambler 2006).
Unsurprisingly, while precise estimates are lacking, evidence suggests that the
burden of such stigma is unequally distributed along the social gradient, and that
already disadvantaged groups are more likely to experience more intense levels of
stigma (Scambler 2006; Shayne and Kaplan 1991). The prospect of compound dis-
advantage and inequalities renders stigma a critical issue for public health ethics,
one that strongly implicates concerns of distributive and social justice (Powers and
Faden 2006; Courtwright 2009).
Recent data shows that the prevalence of obesity is 35.7 % in the United States
(Ogden et al. 2012) and 12.0 % globally (Stevens et al. 2012). Tracking these high
estimates, obesity stigma is one of the common and ethically alarming health stig-
mas (Puhl and Heuer 2009; Puhl and Brownell 2003). Puhl and Heuer (2010)
expressly link the commonality of obesity stigma to the emphasis on personal
responsibility in the United States, which is the subject of an active debate (Wikler
2002). This debate has nineteenth century roots but is ongoing (Leichter 2003) and
influences public perceptions on whether collective action in the name of public
health is warranted. Moreover, such perceptions vary with particular public health
problems. For example, although many advocate for greater individual responsibil-
ity in wearing seat belts, few contend that such responsibility eliminates the need for
guardrails and speed limits. The perceived linkages between obesity and personal
responsibility suggest that approaches to health promotion emphasizing the latter
run a significant risk of intensifying obesity stigma (Puhl and Heuer 2010). Goldberg
(2012) argues that such risk renders these approaches ethically suboptimal.
In addition, it is well recognized that background socioeconomic conditions are
primary components of obesity-creating environments (McLaren 2007; Pickett
et al. 2005). The fact that socioeconomic conditions have an immense impact in
determining patterns of obesity among and within populations suggests reasons for
doubting that public health interventions targeted at individual lifestyle change will
be particularly effective in countering obesity (MacLean et al. 2009). Indeed, the
evidence obtained from analysis of other major risk factors, such as smoking,
strongly suggests a lack of longitudinal efficacy for such interventions (Jarvis and
Wardle 2006; Ebrahim and Smith 2001; Rose 1985).
There exists significant debate over the effectiveness of stigmatization in chang-
ing risky health behaviors. Some commentators argue that the denormalization and
stigmatization of smoking has produced positive public health consequences given
164 H. Schmidt
the overall decline in incidence in the United States (Bayer 2008; Bell et al. 2010)
and in parts of Europe (Ritchie et al. 2010). One leading bioethicist even recently
endorsed a kind of “stigmatization lite” as a tool to reduce obesity (Callahan 2013).
Although the evidence for efficacy of stigma as a means to enhancing public health
in general remains in dispute, the evidence as to obesity overwhelmingly suggests
that stigma is more likely to exacerbate obesity than to reduce it (Puhl et al. 2013;
Puhl and Heuer 2010).
Finally, there is excellent evidence that interventions that target individual behav-
ior change have the unfortunate tendency to expand health inequalities. Capewell
and Graham (2010) term such interventions “agentic” because the extent of their
benefits depends on the resources the individual agent can bring to bear. Thus, for
example, even when the least well-off are targeted, smoking cessation programs
disproportionately benefit the affluent. The result is that effective programs target-
ing lifestyle change can unintentionally expand health inequalities, a fact that raises
significant concerns of justice.
Ultimately, though efforts to counter obesity are critically needed, it is all too
easy to implement public health interventions that intensify obesity stigma, expand
health inequalities, and take little account of the role background social conditions
play in structuring patterns of obesity and limiting health choices. Efforts to address
obesity must therefore grapple with significant ethical issues centering primarily on
justice and on health equity.
The Brennan County Health Department (BCHD) is considering a new health pro-
motion program to ameliorate the high and growing rates of adult obesity in the
county (prevalence and incidence of 38 and 3.5 %). The program emphasizes the
need to “Take Control” by (1) assessing weight; (2) losing weight; and (3) prevent-
ing weight gain (Centers for Disease Control and Prevention 2012). It highlights the
significance of personal responsibility in countering obesity and aims to empower
individuals to implement lifestyle change. The program consists of twice-weekly
meetings facilitated by a nutritionist held over 8 weeks, with screening performed
by a family nurse practitioner. The regimen consists of modules on meal planning,
physical activity, behavioral modification, and cooking instruction. The meetings
would occur at 6:30 pm at Brennan County Memorial Hospital.
The hospital is located in the town of Bernsville, which sits in the northwestern
corner of the county. Brennan County is rural and geographically large, with a small
population spread across large distances. Multiple bodies of water traverse the
county. Road quality is uneven. Educational attainment is low, with only 43 % of
residents having completed some college. Thirty-eight percent of children in
Brennan County live in poverty, and the violent crime rate per 100,000 people is 605
(the national benchmark is 73). Unemployment is 14.2 %. Farming is a chief eco-
nomic activity, with several migrant labor camps existing in the southeastern part of
the county. In terms of demographics, 40 % of Brennan County residents are

Caucasian, 35 % are African-American, 14 % are Hispanic/Latino, 10 % are Native
American, and 1 % is Asian/Asian-American.
The BCHD obesity program is based on reasonably good evidence. Several con-
trolled studies of model programs have demonstrated both reduction in body weight
and prevention of weight gain. Such effects decreased over time, but statistically
significant improvements were maintained at 8-month follow-up. Ongoing studies
are intended to assess effect endurance at 18 and 24 months postintervention.
At a recent BCHD meeting, Pauline, a public health nurse employed by the
health department, expressed concern about the implementation of the program.
Surprised, several attendees ask Pauline why she is hesitant, and she replies that she
is concerned that the obesity program’s emphasis on personal responsibility and
lifestyle change might not be received well in a resource-poor county that serves
multiple vulnerable populations, many of whom have documented levels of medical
and institutional mistrust. The BCHD director, James, admits that Pauline’s con-
cerns are legitimate, but he also notes the evidence suggesting the intervention’s
efficacy. He argues that such results are so important that they justify immediate
implementation. James also notes that several county commissioners have publicly
declared an obesity crisis in Brennan County and have privately indicated to him
that BCHD is expected to lead a transparent and vigorous response. In addition,
James points out that the county does not have the funds to devote to more upstream
interventions and they have several staff already trained in lifestyle change methods,
so that the costs could be low.
Pauline shakes her head and says that while it is critical to address obesity in
Brennan County, the program ignores the environmental and background conditions
in which the most at-risk communities in Brennan County live, work, and play. She
reiterates her concern that the program as it currently stands is unfair.
1. To what extent does the program risk creating or intensifying obesity stigma
against marginalized and vulnerable groups in Brennan County? Why does this
matter ethically?
2. Why are the social and economic conditions residents of Brennan County expe-
rience relevant to an ethical assessment of the obesity program?
3. How does the rural nature of Brennan County influence the ethical analysis of
the program?
4. What concerns related to justice and/or health equity does the program raise?
5. How should obesity interventions be structured to minimize risks of stigma?
6. To what extent should public health interventions intended to counter obesity
target upstream social determinants of obesity and obesity-related diseases?
166 H. Schmidt
References
Bayer, R. 2008. Stigma and the ethics of public health: Not can we but should we. Social Science
& Medicine 67(3): 463–472. doi:10.1016/j.socscimed.2008.03.017.
Bell, K., A. Salmon, M. Bowers, J. Bell, and L. McCullough. 2010. Smoking, stigma and tobacco
‘denormalization’: Further reflections on the use of stigma as a public health tool. Social
Science & Medicine 70(6): 795–799.
Burris, S. 2002. Disease stigma in U.S. public health law. Journal of Law, Medicine & Ethics
30(2): 179–190.
Callahan, D. 2013. Obesity: Chasing an elusive epidemic. Hastings Center Report 43(1): 34–40.
Capewell, S., and H. Graham. 2010. Will cardiovascular disease prevention widen health inequali-
ties? PLoS Medicine 7(8): e1000320.
Centers for Disease Control and Prevention. 2012. Healthy weight. http://www.cdc.gov/healthy-
weight. Accessed 20 Dec 2012.
Chapple, A., S. Ziebland, and A. McPherson. 2004. Stigma, shame, and blame experienced by
patients with lung cancer: Qualitative study. British Medical Journal 328(7454): 1470.
Courtwright, A.M. 2009. Justice, stigma, and the new epidemiology of health disparities. Bioethics
23(2): 90–96.
Courtwright, A. 2013. Stigmatization and public health ethics. Bioethics 27(2): 74–80.
Ebrahim, S., and G.D. Smith. 2001. Exporting failure? Coronary heart disease and stroke in devel-
oping countries. International Journal of Epidemiology 30(2): 201–205.
Goldberg, D.S. 2012. Social justice, health inequalities and methodological individualism in U.S.
health promotion. Public Health Ethics 5(2): 104–115.
Hatzenbuehler, M.L., J.C. Phelan, and B.G. Link. 2013. Stigma as a fundamental cause of popula-
tion health inequalities. American Journal of Public Health 103(5): 813–821.
Jarvis, M.J., and J. Wardle. 2006. Social patterning of individual behaviors: The case of cigarette
smoking. In Social determinants of health, 2nd ed, ed. M.G. Marmot and R.G. Wilkinson,
224–237. Oxford/New York: Oxford University Press.
Leichter, H.M. 2003. “Evil habits” and “personal choices”: Assigning responsibility for health in
the 20th century. Milbank Quarterly 81(4): 603–626.
Link, B.G., and J.C. Phelan. 2006. Stigma and its public health implications. Lancet 367(9509):
528–529.
MacLean, L., N. Edwards, M. Garrard, N. Sims-Jones, K. Clinton, and L. Ashley. 2009. Obesity,
stigma and public health planning. Health Promotion International 24(1): 88–93.
McLaren, L. 2007. Socioeconomic status and obesity. Epidemiologic Reviews 29: 29–48.
Ogden, C.L., M.D. Carroll, B.K. Kit, and K.M. Flegal. 2012. NCHS Data Brief No. 82: Prevalence
of obesity in the United States, 2009–2010. http://www.cdc.gov/nchs/data/databriefs/db82.pdf.
Pickett, K.E., S. Kelly, E. Brunner, T. Lobstein, and R.G. Wilkinson. 2005. Wider income gaps,
wider waistbands? An ecological study of obesity and income inequality. Journal of
Epidemiology and Community Health 59(8): 670–674.
Puhl, R.M., and K.D. Brownell. 2003. Psychosocial origins of obesity stigma: Toward changing a
powerful and pervasive bias. Obesity Reviews 4(4): 213–227.
Puhl, R.M., and C.A. Heuer. 2009. The stigma of obesity: A review and update. Obesity 17(5):
941–964.
Puhl, R.M., and C.A. Heuer. 2010. Obesity stigma: Important considerations for public health.
Puhl, R., J.L. Peterson, and J. Luedicke. 2013. Motivating or stigmatizing? Public perceptions of
weight-related language used by health providers. International Journal of Obesity 37(4):
612–629.
Ritchie, D., A. Amos, and C. Martin. 2010. “But it just has that sort of feel about it, a leper”—
Stigma, smoke-free legislation and public health. Nicotine & Tobacco Research 12(6):
622–629.
Rose, G. 1985. Sick individuals and sick populations. International Journal of Epidemiology
14(1): 32–38.
Scambler, G. 2006. Sociology, social structure and health-related stigma. Psychology, Health &
Medicine 11(3): 288–295.
Shayne, V.T., and B.J. Kaplan. 1991. Double victims: Poor women and AIDS. Women & Health
17(1): 21–37.
Stevens, G.A., G.M. Singh, Y. Lu, et al. 2012. National, regional, and global trends in adult over-
weight and obesity prevalences. Population Health Metrics 10(1): 22.
Vanable, P.A., M.P. Carey, D.C. Blair, and R.A. Littlewood. 2006. Impact of HIV-related stigma on
health behaviors and psychological adjustment among HIV-positive men and women. AIDS
and Behavior 10(5): 473–482.
Vardy, D., A. Besser, M. Amir, B. Gesthalter, A. Biton, and D. Buskila. 2002. Experiences of stig-
matization play a role in mediating the impact of disease severity on quality of life in psoriasis
patients. British Journal of Dermatology 147(4): 736–742.
Wikler, D. 2002. Personal and social responsibility for health. Ethics & International Affairs 16(2):
47–55.
5.10 Case 4: Water Fluoridation: The Example of Greece
Aikaterini A. Aspradaki
Joint Graduate Programme in Bioethics
University of Crete
Crete, Greece
e-mail: kasprad@yahoo.gr
Ioannis Tzoutzas
School of Dentistry
National and Kapodistrian University of Athens
Athens, Greece
Maria Kousis
Center for Research and Studies in Humanities, Social Sciences and Pedagogics
University of Crete
Crete, Greece
Anastas Philalithis
Department of Social Medicine, Faculty of Medicine
University of Crete
Crete, Greece
institutions.
168 H. Schmidt
5.10.1 Background
Dental caries is a condition with major public health impact worldwide. In most
industrialized countries, it affects 60–90 % of school children and most adults,
whereas in several Asian and Latin American countries, it is the most prevalent oral
disease (Petersen and Lennon 2004). Dental caries significantly affects individuals
and communities, leading to pain and discomfort, impairment of oral and general
health, and reduced quality of life. It also highly correlates with health systems,
living conditions, behavioral and environmental factors, and implementation of
preventive measures (World Health Organization [WHO] 2005, 2007; Shariati et al.
2013). In low- and middle-income countries, the prevalence of oral diseases is on the
rise; and in all countries, the greatest burden of oral diseases falls on disadvantaged
and poor populations (Petersen 2008). Although oral disease ranks as the fourth most
expensive disease to treat (WHO 2007), effective prevention and health promotion
measures can greatly reduce the cost of dental treatment. As a result, the WHO has
emphasized the importance of developing global oral health policies, especially the
implementation of fluoride programs to prevent dental caries (WHO 2012).
For the past 60 years, fluoride use has consistently proven to be one of public
health’s most successful interventions (Clarkson et al. 2000). Used in tablets,
mouthwash, toothpaste, gels or varnishes, fluoride also may be added to salt or
drinking water to protect against dental caries (WHO 2011). High fluoride levels in
drinking water (>10 mg l−1), are associated with dental fluorosis, a discoloring or
mottling of tooth enamel, while levels below 0.1 mg l−1 are associated with higher
levels of dental decay (Edmunds and Smedley 1996). A level of about 1 mg l−1 is
associated with lower incidence of dental caries, particularly in children (Fawell
et al. 2006). Water fluoridation adjusts the fluoride concentration of a public water
supply to an optimal level to prevent dental caries (WHO 2002). Countries such as
Australia, Malaysia, Ireland, Spain, the United Kingdom, and the United States use
water fluoridation, delivering fluoride to about 300 million persons worldwide
(Clarkson et al. 2000).
Despite the demonstrated effectiveness of fluorides in preventing dental carries,
public discussions about the effectiveness of water fluoridation continue (Awofeso
2012; Rugg-Gunn and Do 2012). Several publications discuss the benefits and
harms of water fluoridation (McDonagh et al. 2000; European Commission,
Directorate General for Health and Consumers, Scientific Committee on Health and
Environmental Risks 2011; Phillips et al. 2011; Community Preventive Services
Task Force 2013). However, a lack of good-quality evidence on the potential bene-
fits and harms has been reported (Nuffield Council on Bioethics 2007). Moreover,
with the advent of genomic techniques in studying oral diseases, susceptibility to
dental caries has been shown in part to be due to genetic variations (Eng et al. 2012),
increasing in this way the complexity and the multicausality of dental caries.
Implementing water fluoridation programs can be controversial and generate
tension between competing ethical principles and values—primarily conflicts
between the principles of paternalism and autonomy. While water fluoridation is
considered to be a “test case” in the discussion about the paternalism of “collective

decisions” (Dworkin 1988), appeals to paternalism point to water fluoridation’s
benefits for entire communities (e.g., health needs of children, reduction in health
risks and health inequalities). However, those who prioritize autonomy point out
that water fluoridation intervenes in an important area of personal life without the
consent of those affected, essentially coercing adults to lead healthy lives (Nuffield
Council on Bioethics 2007). Despite the controversy, water fluoridation is “the most
celebrated example” of “collective action/efficiency” to justify public health pro-
grams and policies (Faden and Shebaya 2010). In deliberative democracies, govern-
ments tend to address the conflict between paternalism and autonomy by focusing
on elements of procedural justice—rational explanations, transparency of the deci-
sion-making process, and involvement of individuals and stakeholder groups in
decision making (Nuffield Council on Bioethics 2007).
Greece, a coastal Mediterranean country in southeastern Europe, has nearly 11
million people. Among 12-year-olds, the average number of dental caries—mea-
sured as the number of decayed, missing, or filled teeth—is 2.07 per child (Kravitz
and Treasure 2009). Public institutions such as universities, hospitals, and health
centers of the National Health System provide limited oral health care. Most oral
health care takes place in private clinics, where dental patients pay the entire cost of
care. Oral health care constitutes an estimated one-third of the total expenditure on
private health care in Greece (Kravitz and Treasure 2009). Since 2009, Greece has
faced a severe fiscal crisis. In providing health care, public health authorities have
to deal with severe budget limitations. The financial crisis is also straining the abil-
ity of individuals to pay for private sector dental treatment.
The Greek central government regulates many public health programs, including
oral disease prevention and oral health promotion policies, but implementation is
local. Although the government mandated water fluoridation in 1974, as of 2013 the
program had not been implemented because of diffuse public resistance to such
interventions. In 2008, a special commission proposed to the Ministry of Health and
Social Solidarity to include water fluoridation in the national strategy for public
health (Ministry of Health and Social Solidarity 2008). Given the long hiatus in
implementing the program, reasonable questions could be raised about its justifica-
tion, political legitimization, and social acceptance. A two-part study on these ques-
tions was carried out (Aspradaki 2012). It included interviews with key figures in
the dental community from academia, the professions, and trade unions. It also
included a systematic content analysis of all mentions of water fluoridation by the
involved actors (e.g., dental professionals, policy makers) reported in the Journal of
the Hellenic Dental Association for 1983 through 2011. The results showed strong
skepticism among professionals about the program’s feasibility—reflecting the
public’s concerns over this issue. Significant concerns were about a lack of techni-
cal infrastructure and organizational problems in the institutions that would
implement water fluoridation. The vigorousness of the opposing arguments in the
autonomy/paternalism debate in terms of justice, procedural justice, and public
interest added to the skepticism. Concerns were also raised about the overall
170 H. Schmidt
importance of oral health for human life, the significance of prevention in dental
care, and the concept of dental caries as an epidemic.
You serve as the central oral health policy director. One morning you receive a call
from Dr. Papadakis, head of the Public Health Programs and Policies Division at the
Ministry of Health and Social Solidarity. Dr. Papadakis is considering implement-
ing mandatory water fluoridation but is concerned about the many difficulties he
may confront (i.e., ethical, legal, political and social challenges). Dr. Papadakis asks
you to provide input about what to consider before mandatory water fluoridation is
implemented in Greece.
1. Who are the stakeholders to consider in deciding if this program should be

implemented? What are their values, perspectives, and primary interests?
2. How should the relevant values be considered, in particular, scientific evidence,
ethical concerns, and economic factors?
3. Do public health institutions have special obligations to protect oral health?
4. When public health interventions are environmental, should public participation
and democratic deliberation be considered in the decision-making processes?
5. How important is transparency about the benefits and risks of these interven-
tions, in the light of the rapid progress and the tremendous achievements in life
sciences and biotechnologies?
6. How would the rationale for such public health interventions change if the gov-
ernment and individuals were not facing a severe financial crisis?
Acknowledgements We thank the peer reviewers and editors for their comments. We also thank
Professor Stavroula Tsinorema, Director of Studies of the Joint Graduate Programme in Bioethics,
University of Crete, Crete, Greece, for her valuable support.
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mental_risks/docs/scher_o_139.pdf. Accessed 10 Nov 2012.
Faden, R., and S. Shebaya. 2010. Public health ethics. In Stanford encyclopedia of philosophy, ed.
E. N. Zalta. http://plato.stanford.edu/archives/sum2010/entries/publichealth-ethics/. Accessed
10 Mar 2011.
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water. London: World Health Organization, IWA Publishing.
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178 part 11: “Individual Country Sections -Greece” Council of European Dentists: Cardiff.
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McDonagh, M.S., P.F. Whiting, P.M. Wilson, et al. 2000. Systematic review of water fluoridation.
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plan of action on oral health 2008–2012. http://www.moh.gov.gr/articles/health/domes-kaidra-
seis-gia-thn-ygeia-ethnika-sxedia-drashs/95-ethika-sxedia-drashs?fdl=222. Accessed 3 June
2015.
Nuffield Council on Bioethics. 2007. Public health: Ethical issues. http://nuffieldbioethics.org/
project/public-health/. Accessed 20 Dec 2011.
Petersen, P.E. 2008. World Health Organization global policy for improvement of oral health—
World Health Assembly 2007. International Dental Journal 58(3): 115–121.
Petersen, P.E., and M.A. Lennon. 2004. Effective use of fluorides for the prevention of dental car-
ies in the 21st century: The WHO approach. Community Dentistry and Oral Epidemiology
32(5): 319–321.
Phillips, C., B. Amphlett, and I.J. Robbé. 2011. The long-term effects of water fluoridation on the
human skeleton. Journal of Dental Research 90(5): 683.
Rugg-Gunn, A.J., and L. Do. 2012. Effectiveness of water fluoridation in caries prevention.
Community Dentistry and Oral Epidemiology 40(suppl 2): 55–64.
Shariati, B., M.I. MacEntee, and M. Yazdizadeh. 2013. The economics of dentistry: A neglected
concern. Community Dentistry and Oral Epidemiology 41(5): 385–394.
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http://who.int/water_sanitation_health/oralhealth/en/. Accessed 10 Dec 2012.
World Health Organization (WHO). 2005. The Liverpool declaration: Promoting oral health in the
21st century. A call for action. http://www.who.int/oral_health/events/liverpool_declaration/
en/. Accessed 10 Dec 2012.
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integrated disease prevention. In Sixtieth world health assembly: Resolutions and decisions,
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cover-intro-60-en.pdf. Accessed 10 Dec 2012.
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Organization. http://www.who.int/mediacentre/factsheets/fs318/en/. Accessed 30 Mar 2013.
5.11 Case 5: The Prohibition of Smoking in Public Places

in Bulgaria
Silviya Aleksandrova-Yankulovska
Faculty of Public Health, Department of Public Health Sciences
Medical University of Pleven
Pleven, Bulgaria
e-mail: silviya_aleksandrova@hotmail.com
institution.
5.11.1 Background
Chronic noncommunicable diseases, including cardiovascular diseases, malignant

neoplasms, and noninfectious pulmonary diseases, are a major cause of the global
burden of disease in the European Region3 (86 % of the 9.6 million deaths and 77 %
of the 150.3 million disability-adjusted life years (DALYs) (Vassilevsky et al. 2009).
Commonly associated risk factors include smoking, alcohol consumption, unhealthy
diet, and low physical activity.
Tobacco smoking alone produces 12 % of the global disease burden in the
European Region (ranges from 3 to 27 % for the individual countries) and it causes
2–21 % of all deaths. For Bulgaria, these rates are 13.5 % and 12.4 %, respectively
(Vassilevsky et al. 2009). Annually, more than four billion people die worldwide
from diseases related to tobacco products. By 2030, this number is expected to
reach ten million, which will turn tobacco smoking into the biggest single cause of
death (World Bank 1999).
Bulgaria is among the countries with the highest level of morbidity and mortality
from cardiovascular diseases, especially cerebrovascular disease. Standardized
death rates of all smoking-related causes of death for 2011 were estimated to be 318
3
As of 2015, the European Region includes 51 countries (see http://www.who.int/choice/demogra-
phy/euro_region/en/).
per 100,000 people, whereas the average for the European Union (EU)4 was 195 per
100,000 people. Standardized death rates of stroke in Bulgaria were about three
times higher than the average level for the EU. Only Ukraine, Moldova, Kyrgyzstan,
and Russia had higher rates (World Health Organization [WHO] 2012).
At the same time, Bulgaria is a leading country in cigarette use among Central
and Eastern European countries (Ministry of Health, Bulgaria 2008). About 40 % of
the population are smokers: 47 % of men and 33 % of women (Vassilevsky et al.
2010). Cigarettes smoked per person per year in Bulgaria (2793 cigarettes) is sig-
nificantly higher than the average for the European Region (1681 cigarettes) (WHO
2012). Smoking among teenagers in Bulgaria is also among the highest in
Europe—40 % of teenagers smoke (36 % of boys and 44 % of girls) (Tsolova et al.
2010). A 2011 survey found that Bulgaria was fourth out of 36 countries in teenage
smokers (Hibell et al. 2012).
These data are alarming. But additional concern for public health is the effect of
secondhand smoking. The risk of death from coronary heart disease increases 30 %
from exposure to secondhand smoke (American Heart Association 2013).
Secondhand smoke—“passive” smoking—increases a child’s risk of developing
pneumonia, asthma, and other allergic conditions (Naydenov et al. 2007). A survey
of countrywide integrated noncommunicable disease intervention (CINDI)
programme-Bulgaria found more than 80 % of teenagers were exposed to passive
smoking daily (20 % of teenagers were exposed for 1–2 h per day; 50 % were
exposed for more than 2 h per day). Exposure was higher among girls than boys
(43.1 % of boys and 56.7 % of girls were exposed to secondhand smoke for more
than 2 h per day) (Tsolova et al. 2010).
As a member of the EU, Bulgaria has had to harmonize its legislation with
European legislation. The first smoke free legislation in Europe was adopted in
March 2004 in Ireland (Howell 2004). Currently, all EU member countries have
some form of regulation aimed at limiting exposure to secondhand smoke. However,
the scope of these regulations differs widely within the EU (European Public Health
Alliance 2012). First attempts to prohibit smoking in public places in Bulgaria date
back to January 2005. Restaurants and other food and drink places were separated
into zones for smokers and nonsmokers. The Bulgarian society also split into groups
of supporters of the changes and opponents of smoking restrictions.
On November 7, 2005, Bulgaria ratified the World Health Organization
Framework Convention on Tobacco Control. Article 8 of the Convention stipulates
that “effective legislative, executive, administrative and other measures, providing
for protection from exposure to tobacco smoke in indoor workplaces, public trans-
port, indoor public places and, as appropriate, other public places should be taken”
(WHO 2003).
On May 17, 2012, the parliament voted to amend the Bulgarian Health Act pro-
hibiting smoking in public places (Republic of Bulgaria Council of Ministers 2012).
According to the new regulation, which took effect June 1, 2012, smoking was
4
As of 2013, the European Union consisted of 28 member countries (see http://europa.eu/about-eu/
countries/member-countries/).
174 H. Schmidt
prohibited in all indoor public places and workplaces including stadiums, children
playgrounds, kindergartens, and other schools. Still, Bulgarian society remained
conflicted about the issue.
In November 2012, two independent members of the Bulgarian parliament raised
the issue of business losses from the smoking ban. They claimed that 10,000 people
lost jobs due to fewer patrons of food and drink establishments and pleaded for revi-
sion of the law (Todorova 2012). Official data about business losses were not pro-
vided, and such surveys have not been done. Nevertheless, these claims increased
public debate about the smoking bans. On December 10, 2012, the Bulgarian Hotel
and Restaurant Association officially protested the law and insisted it be revised.
The prime minister initially agreed that some revision could be possible but later
supported the minister of health, who opposed changing the law. The minister of
health pointed out that pitting business against health was unacceptable and, instead
of discussing business losses, the government should be discussing the cost of treat-
ing oncological and cardiovascular diseases (Dimitrova 2012). The minister of
economy, energy, and tourism favored a more flexible application of the law.
Eventually, decision making was transferred to parliament’s Economic Committee
with the idea that the ban on smoking could be abolished through the Law of
Tourism, particularly if certain amendments were adopted to allow smoking in spe-
cific areas of bars and restaurants. On December 18, 2012, the Economic Committee
rejected any amendment to the law. Thus, despite the controversy and public
debates, the law prohibiting smoking in public places has survived without change
as of May 2013.
The law prohibiting smoking in public places has been enacted. You are aware of
the public debate and tension surrounding the issue. What would you, as a director
of the regional health inspectorate, do to guarantee the implementation of the law in
the region?
1. When is it acceptable to limit personal autonomy to benefit of the health of

others?
2. How should economic interests be weighed in public health decision making?
Specifically, how should health care expenditures due to smoking-related dis-
eases be weighed against economic losses incurred by the ban on smoking?
3. Law is usually regarded as the strongest measure of public control. Is law the
best approach for influencing health behavior in a society where citizens tradi-
tionally feel no responsibility for their own health or the health of others?
4. What long-term effects could repealing or revising the smoking ban have on the
public’s trust and support?
5. In future years, if a new government decides to revisit the law, what would you,
as an expert in public health, advise the new minster of health? Who are the
relevant stakeholders, and which of their values should the minister of health
consider?
References
American Heart Association. 2013. Heart disease and stroke statistics—2013 update. http://circ.
ahajournals.org/content/127/1/e6.full.pdf+html. Accessed 7 June 2013.
Dimitrova, D. 2012. Smoking prohibition confronted two ministers—The Minister of Economics
Dobrev and the Minister of Health Atanasova. http://dnes.dir.bg/news/zabrana-deljan-
dobrevmerki-srestu-pusheneto-12592161. Accessed 10 Dec 2012.
European Public Health Alliance. 2012. Updated European smoking bans: Evolution of the legis-
lation. http://www.epha.org/a/1941. Accessed 10 Dec 2012.
Hibell, B., U. Guttormsson, S. Ahlström, et al. 2012. The European school survey project on alco-
hol and other drugs: The 2011 ESPAD report, substance use among students in 36 European
countries. http://www.espad.org/Uploads/ESPAD_reports/2011/The_2011_ESPAD_Report_
FULL_2012_10_29.pdf. Accessed 10 Dec 2012.
Howell, F. 2004. Ireland’s workplaces, going smoke free. British Medical Journal 328(7444):
847–848.
Ministry of Health, Bulgaria. 2008. National health strategy: 2008–2013. State Gazette
107/16.12.2008.
Naydenov, K., T. Popov, D. Markov, and A. Melikov. 2007. The influence of smoking on allergy
morbidity among children in Sofia and Burgas at age 2–7 years. Modern Medicine 58(4):
13–20.
Republic of Bulgaria Council of Ministers. 2012. Bulgarian health act. State Gazette 70/10.08.2004
(effective 01.01.2005). Amended 17th May 2012. State Gazette 40/29.05.2012 (effective
01.06.2012 г.). http://lex.bg/laws/ldoc2135489147. Accessed 1 Dec 2012.
Todorova, T. 2012. Parliamentarians require changing the prohibition of smoking. http://dnes.dir.
bg/news/tutunopushene-merki-srestu-pusheneto-kiril-gumnerov-12413757. Accessed 10 Dec
2012.
Tsolova, G., N. Vassilevsky, P. Dimitrov, and A. Manolova. 2010. Surveillance of risk factors for
non-communicable diseases among children aged 14–18 years within the zones of CINDI
programme-Bulgaria 2008. Bulgarian Journal of Public Health 2(3): 35–60.
176 H. Schmidt
Vassilevsky, N., L. Ivanov, G. Tsolova, and P. Dimitrov. 2009. National behavior risk factors sur-
vey among population aged 25–64, 2007. Bulgarian Journal of Public Health Supplement 1(3):
3–42.
Vassilevsky, N., G. Tsolova, P. Dimitrov, and A. Manolova. 2010. Surveillance of risk factors for
non-communicable diseases among population aged 25–64 within the zones of CINDI pro-
gramme- Bulgaria 2007. Bulgarian Journal of Public Health 2(3): 3–32.
World Bank. 1999. Curbing the epidemic: Governments and the economics of tobacco control.
Development in practice. Washington, DC: World Bank. http://documents.worldbank.org/
curated/en/1999/05/437174/curbing-epidemic-governments-economics-tobacco-control .
World Health Organization (WHO). 2003. WHO framework convention on tobacco control.
Geneva: World Health Organization. http://www.who.int/fctc/text_download/en/index.html.
World Health Organization (WHO). 2012. European health for all database. http://data.euro.who.
int/hfadb. Accessed 15 Dec 2012.
Chapter 6
Environmental and Occupational Public
Health
Bruce Jennings
6.1 Environment and Workplace: Key Venues

for Public Health
Environmental health and occupational health and safety have long been established
subfields of public health research, policy, and practice (Frumkin 2010). More so
perhaps than areas such as infectious disease or health promotion, environmental and
occupational health remind us that the health of a society is profoundly affected by
its economic system and economic development. Today, the environmental health
field is largely concerned with a human-made (anthropogenic) environment brought
about by urbanization, the extraction of natural resources, industrial manufacture, the
physical separation of home and workplace, and the transportation systems needed
to support this mode of economy and pattern of living. Economic development alters
the natural environment and sometimes harms ecosystems in terms of the humanly
useful services they provide, their diversity, and their resilience. We are coming to
understand that all of this has significant consequences for human health.
Environmental health has been understood as a public health issue in relation to
air quality, water quality, and exposure to environmental pollutants that are toxic,
carcinogenic, or teratogenic or are chemically bioactive in other ways. The rise of
fossil fuels as the energy base for economic production and transportation, the
industrial-scale advances in mining and metallurgy, and the creation and widespread
presence of synthetic chemical substances have contributed to environmental health
risks throughout the past two centuries. Indeed, these changes have redefined the
meaning of environmental health. For the most part, environmental health involves
B. Jennings, MA (*)
Center for Biomedical Ethics and Society, Vanderbilt University, Nashville, TN, USA
e-mail: brucejennings@humansandnature.org

178 B. Jennings
the domain of chronic illness and disease, and it investigates factors that increase
population risk and susceptibility to patterns of physical and mental illness in vari-
ous forms. Epidemiological investigation is key to public health response to envi-
ronmental health hazards.
If the public health of entire populations is affected in the background by modern-
ization and industrialization in the form of environmental hazards, the personal health
of a large number of individuals—especially people who work in industrial settings or
are otherwise exposed to workplace hazards—is also affected directly in often injuri-
ous ways (Bayer 1988). Despite struggles to protect people in the workplace, the lit-
erature on occupational health is replete with examples of work-related cancers and
pulmonary disease. Moreover, issues of safety and health go hand in hand in the
occupational arena. Occupational accidents and injuries are a substantial factor in the
overall health profile of society. Some occupational sectors remain particularly dan-
gerous due to inherent features of the work environment, the necessary technology
and equipment, or the absence of adequate policies and protections for workers. The
recent emphasis in public health research and policy on personal injury and trauma
may lead to renewed interest in occupational health as a public health issue.
More effective public health policy in regard to environmental and occupational
health is made difficult by the fact that they tend to have distinct regulatory struc-
tures. Each is governed by different authorizing statutes and accumulated bodies of
administrative rules and is overseen by different agencies of varying government
levels (particularly in countries with federal systems). Nonetheless, occupational
health and environmental health should be viewed in relation to each other, since
both ultimately spring from a common root in the recent history of the impact of
science and technology on society. Moreover, the public health responses to these
two areas has varied with different understandings of the appropriate role of the
state and public authority. This is to be expected, given that health matters overall,
though biologically and biochemically connected, raise political, economic, and
social issues. Major disparities in environmental and occupational risk, for example,
stem from race and socioeconomic status (Shrader-Frechette 2005), and thus raise
ethical questions about political and social rights, economic entitlements and wel-
fare safety nets, and the just distribution of risk, wealth, and power.
One additional feature of a contemporary perspective on environmental and
occupational public health should be noted: Our paradigm for understanding the
interrelationships of health, the natural environment, and the workplace environ-
ment is broadening. Lang and Rayner (2012) distinguish among five models for
public health, each with its own historical origins and core ideas. These models are
(1) the sanitary-environmental model; (2) the biomedical model, both individual
and population focused; (3) the social-behavioral model; (4) the techno-economic
model; and (5) the ecological model.
The first four models take an essentially human-centered approach. In these mod-
els, the term “environment” is understood as a mere backdrop or aggregation of condi-
tions and risks for states of human health and illness. By contrast, model five, the
ecological model, understands the natural environment to be comprised of complex
systems, not as an array of separate factors. The environment is the functional and
6 Environmental and Occupational Public Health 179
relational context in which human health and behavior emerge, not just a set of back-
ground conditions. The growing influence of the ecological model of public health is
reorienting the study and regulation of both environmental health and occupational
health, and this model has the potential to bring them into closer alignment.
There are several reasons for this. First, research on the social determinants of
health indicates that distinguishing the social from the natural aspects of an environ-
ment’s health effects is not straightforward. Even in remote wilderness areas, the
natural environment is shaped by human activity. Moreover, the social features of
everyday life include not only psychological effects (happiness and well-being) but
also physiological effects (cardiovascular, hormonal) on the internal biological
environment of the human body.
Second, the growing discussion around the health effects of global climate
change contributes to this reorientation of environmental health by reminding us
that ecosystems are holistic and complex networks of interrelationships and interde-
pendencies. Therefore, hazards to human health take the form of both discrete
threats and general factors that undermine the integrity or functioning of ecosys-
tems upon which the health and functioning of all life ultimately depend. For exam-
ple, a recent literature review on the public health effects of climate change
summarizes the situation as follows:
Impacts of climate change cause widespread harm to human health, with children often suf-
fering the most. Food shortages, polluted air, contaminated or scarce supplies of water, an
expanding area of vectors causing infectious diseases, and more intensely allergenic plants
are among the harmful impacts. More extreme weather events cause physical and psycho-
logical harm. World health experts have concluded with “very high confidence” that climate
change already contributes to the global burden of disease and premature death. IPCC
[Intergovernmental Panel on Climate Change] projects the following trends, if global warm-
ing continues to increase, where only trends assigned very high confidence or high confi-
dence are included: (1) increased malnutrition and consequent disorders, including those
related to child growth and development, (2) increased death, disease and injuries from heat
waves, floods, storms, fires and droughts, (3) increased cardiorespiratory morbidity and mor-
tality associated with ground-level ozone. While IPCC also projects fewer deaths from cold,
this positive effect is far outweighed by the negative ones (Hansen et al. 2013, 8).
Third, the way the built environment is developed can affect not only greenhouse
gas emissions but also lifestyle factors that impinge on human health–for example,
land use and zoning patterns that lead to suburban housing sprawl and automobile
dependency (Frumkin and McMichael 2008).
Environmental health hazards can no longer be thought of simply as discrete entities
(e.g., pathogens, toxic chemicals, carcinogenic substances) within an otherwise health-
neutral field (Kassel and Stephens 2011). Previously environmental health hazards
(even air and water pollution) were viewed on rather narrow local or regional scales and
in close proximity to effected human populations. Now we must view the health haz-
ards emerging from systemic disruptions or dysfunctions as operating on far broader
scales and far more remotely than previously suspected. Deforestation in tropical areas
involves a chain of factors that ultimately affects the quality of life of people with
asthma in Central Asia; changes in the salinity and temperature of the oceans will affect
heat emergency events in Europe. A contaminated well is a localized health risk.
180 B. Jennings
Conversely, environmental changes on the Himalayan plateau that alter the hydrology
of a river spanning miles upon which hundreds of millions depend for fresh water,
represents a different challenge for public health analysis and response. The problem is
global and institutional, which is to say, fundamentally political and economic. The
public health response needs to involve not only specific protections and rules or laws
aimed at individual decisions and behaviors, such as toxic dumping in a particular site,
or the point source pollution of a river, but also the institutional and systemic gover-
nance that alters the structure of power and wealth, and the process by which decisions
and policies are made. The perennial debate between an approach aimed at individual
behavior and one aimed at structural change is endemic to both environmental health
and occupational health and safety.
Because both environmental and occupational public health raise public issues
that involve public perception, a couple of the thorniest ethical problems concern
the concept of acceptable risk and criteria for risk management and risk reduction.
Environmental risks to the public’s health can be managed (or prevented) in multi-
ple ways. The same can be said of workplace risks, especially when conditions put
workers in contact with dangerous machinery or industrial processes; expose work-
ers to harmful substances; and, in the case of health care professionals and biomedi-
cal researchers, expose them to infectious diseases. The debate always concerns
how risk management should be done and at what cost.
6.2 Population Benefits, Individual Rights, and Ethically

Acceptable Risk
The four intriguing cases in this chapter provide examples of policy, decision mak-
ing, and public health practice under specific circumstances. Looming in the back-
ground of each case are fundamental questions about power, equality, and social
justice. The cases indicate the need for a more systemic understanding of environ-
mental and occupational health factors, from the small-scale ecosystem of poten-
tially contagious organisms within the human body to the large-scale natural
ecosystem’s reaction to the effects of mining technology and operations.
Here are the main themes and issues that the cases in this chapter pose for envi-
ronmental and occupational health, especially from the perspective of an ecological
model of public health ethics:
• How should a society democratically set priorities and manage its economic sec-
tors to ensure productivity in the global economy and at the same time protect its
limited natural resources, its core values, and cultural diversity of regional and
ethnic ways of life? Snyder and colleagues address this theme in their case on
mining and health equity.
• How should vulnerable populations, such as hospitalized patients, be protected
from serious infection, and to what extent should those measures impinge on
individual rights and careers of health professionals who are subject to screening
and possible exclusion from clinical practice? This theme is addressed by Rump
and colleagues in their case involving the exclusion of physicians who test posi-
tive for Methicillin-resistant Staphylococcus aureus (MRSA) from performing
patient related interventions.
• How should nongovernmental organizations (NGOs) working on development
projects in resource poor and underserved areas allocate limited resources effec-
tively and equitably? What responsibility does the NGO have when its programs
inadvertently pose health risks to the community that also may threaten its future
capacity to provide services? This theme is addressed in Hayward’s case about
well construction in areas without access to safe drinking water. Hayward com-
pares the health risks and benefits to the cost of different construction methods.
• What are the ethical responsibilities of organizations whose staff and volunteers
do public health work in areas lacking public safety and security resources?
What balance should be struck between outreach to those who need services and
the personal health and safety of the organization’s employees? This case, also
by Hayward, describes how Peace Corps volunteers use motorcycles to reach
otherwise inaccessible areas, which increases their risk of traffic accidents.
As mentioned previously, the forces of economic, scientific, and technological
development brought environmental health and occupational health and safety issues to
the forefront of contemporary public health. Indeed, public health as we know it today
is an outgrowth of the industrial revolution, which has brought about both great
advances and significant disparities of wealth and power. Worldwide, public health
operates amid highly urbanized social systems stratified by class, race, and ethnicity. In
its quest for optimal health outcomes on a population basis, public health is ethically
constrained by individual rights and liberties that may conflict with that goal, just as it
is politically constrained by powerful vested interests. Nonetheless, social inequality is
an obstacle against which public health pushes. For the most part, certainly in the post-
World War II era, the direction of public health has been toward greater access to the
resources and conditions necessary for widespread health and well-being, greater
social and economic equality, and fairness for the most vulnerable and marginalized.
Operating within that trend, decision making about environmental and occupa-
tional health draws primarily on two ethical concepts of public health: One is a utili-
tarian ethic of population well-being, and the other is an ethic of human rights,
dignity, and justice.
Utilitarianism defines the ethical rightness of human acts toward maximizing
aggregate net social benefit (happiness, utility, preference satisfaction). Not surpris-
ingly, utilitarianism is a significant aspect of public health ethics. Its orientation
toward aggregative outcomes befits its concern for populations rather than individ-
ual health—weighing and balancing options rather than delimiting intrinsic value or
ethical absolutes.
Rights- and justice-based ethics focus on intrinsic rightness or wrongness of spe-
cific acts and general actions—not on the consequences of those acts. Actions embody
fundamental values such as respect, dignity, equality, autonomy, and inclusiveness
and therefore have intrinsic rightness. This ethical orientation appeals to cultures with
a heritage of humanitarian concern and to political and legal systems that are simulta-
neously democratically egalitarian and protective of individual liberty.
182 B. Jennings
Utilitarian ethics and rights-based ethics may conflict when situations pit aggre-
gate net population benefits (i.e., health and welfare) against equity and fairness
perspectives that reject discrimination and are unwilling to violate the rights of one,
or a few, to achieve well-being among many. Such dilemmas and trade-offs often
arise in public health practice.
For example, one conflict involving individual rights arises in the case from
Rump and colleagues. In this case, a precautionary policy of exclusion provides
safety for hospitalized patients who have contact with a medical student who is a
carrier of MRSA. But at the same time, the exclusion policy burdens the medical
student who faces personal and professional risk to her livelihood. An individual’s
rights may be violated when health status becomes the basis for discriminatory
treatment or for the loss of liberty or opportunity. A physician or other health care
professional with a condition that poses undue risk to patients illustrates the conflict
between individual rights or freedom and protection of patients health collectively,
or indeed, protection of patient health individually. To resolve such conflict, one
must strike a balance among competing values, informed by factual (biomedical)
knowledge. No individual has the right to intentionally harm an innocent person,
and no physician has a right to deliberately harm a patient. These conflicts typically
arise when facts are uncertain and knowledge is imperfect or probabilistic. Thus, the
question turns not on absolute right and wrong, but on reasonably acceptable risk.
Is a policy that provides a blanket exclusion of health workers who are MRSA posi-
tive appropriate? Or is this policy overly inclusive and cautious? Moreover, how do
we ethically factor in the costs or harms done by exclusion of risk? Perhaps a gifted
physician who poses a low risk of infecting patients may greatly benefit them. If so,
then considerations of nondiscrimination for the individual (physician) and aggre-
gate net benefit for the population (patients) could coincide.
Hayward presents a mirror image in her case on threats to personal safety. This
case involves transportation safety in the developing world, a significant public health
problem to everyone living and working there. Under discussion is a policy that pro-
hibits staff and volunteers from using dangerous forms of travel, such as motorcycles,
even when alternative means of accessing remote areas do not exist. This would affect
many field staff and volunteer health workers who strive to maximize client services
by minimizing transportation time, even at the risk of a traffic accident. The rights-
based question in this case has to do with individual freedom of choice versus pater-
nalistic protection by institutional authorities, again within the context of ethically
acceptable risk. The utilitarian question may be framed as a cost–benefit comparison
of population harm done by the death or injury of health workers (to themselves, their
families, and their clients) and the harm done by suboptimal service delivery (slower,
but safer modes of transportation). A far-reaching consequence may be the loss of
public health and economic development programs that benefit the community.
Risk and harm appear in yet another guise in Hayward’s case on safe water stan-
dards and well construction in rural Africa. An ethical dilemma arises because a less
expensive drilling technique (shallow rather than deep-drilled wells) can produce
more water for more people; however, the risk of contamination and harm to users
will increase. How can decision makers resolve the trade-off between water quan-
tity and quality to benefit the aggregate net population’s health and welfare? In this
instance, an organizational and programmatic risk is also involved. The dilemma

decision makers face has broad implications for future public health initiatives in
the region. If too few wells with a high per unit cost are produced, the community
might perceive that the needs of many are not being considered. Similarly, they
might perceive their health and safety are being neglected if the wells are inexpen-
sive. Decision makers should strive to preserve community trust if they are to gain
cooperation in future public health initiatives.
These three cases illustrate how almost every conceivable approach to risk man-
agement can pose one or more ethical problems. Risk management interventions
may protect some while shifting the exposure and burden of risk to others, raising
serious questions of distributional equity or fairness. Or, interventions to mitigate
risk and protection efforts may supplant or inhibit other programs or public health
activities since intervention is expensive and may lay claim to scarce resources.
Moreover, the concept of risk is seemingly impossible to define in value-neutral
terms and is inherently controversial. Even more ethically charged are the questions
of what level or degree of risk is socially acceptable, who should decide, and how
exposure to risk should be distributed across the affected population. Routine public
health practice in environmental and occupational risk management involves inter-
ventions and policies designed to prevent harm to individuals and to lower health
risks within the population. Interventions include various forms of public health
surveillance—screening and testing—of different groups, with the attendant untow-
ard effect of discrimination or social stigma. Policies may involve regulations with
substantial financial consequences in the form of job loss in regulated industries and
hence higher unemployment rates in the overall economy or higher production costs
and hence higher prices for consumers.
The question of ethically justifiable public health paternalism versus individual
autonomy arises when individuals want to continue engaging in activities that put
themselves, third parties, or the general public at risk. Among the difficult issues
raised about situational ethics are (1) identifying the genuine interests and agendas
of public health authorities who follow seemingly paternalistic programs to reduce
risks and harms; (2) identifying when individuals knowingly (and willingly) expose
themselves to environmental or occupational risks, given the context of inequalities
of power and wealth involved and the lack of employment or residential options
available to these individuals and their families; (3) determining a reasonable level
of acceptable risk in the face of scientific uncertainty; and (4) gauging how a policy
to reduce public health risk will affect public perception and trust.
6.3 Systems and Power: The Ethical Importance

of Ecological and Social Context
We generally know that human health is undermined when the diversity, services,
and functioning of ecosystems are compromised. We also know that various eco-
nomic activities that extract raw materials, manufacture commodities, and provide
jobs often secure these benefits at the expense of the environment. On a local or
184 B. Jennings
regional scale, the health burdens are often felt by people in the immediate area,
whereas the benefits and wealth often accrue to people far removed from the local
environmental disturbances and health risks. When viewed as a manifestation of eco-
nomic systems, environmental health and occupational health are inseparable from
questions of global health justice, and these are very difficult theoretical and practical
questions indeed. Moreover, these dimensions of the ethics of environmental public
health are evolving. Today, given what is known about climate change, we can rea-
sonably say that economic activity virtually anywhere can be environmentally dam-
aging—from oil drilling in the Artic to land clearing in tropical rain forests—and that
such damage affects the health and well-being of people everywhere, not just of
those in the local or regional areas where the environmental damage takes place.
If environmental public health cannot be divorced from economics, neither can it
be understood apart from conditions of governance at international, national, and
local levels. International policies and interventions, including the Millennium
Development Goals and climate change response defined by international protocols
beginning with the Kyoto treaty, are forms of global governance in which environ-
mental public health and public health ethics play indispensable roles.
Questions are no less complex for public health and for ethics at the national
level. In the developing world, particularly countries still experiencing widespread
poverty and lacking fundamental infrastructure and services, economic growth
remains a priority and benefit. Nonetheless, there is a trade-off between short-term
economic gains and long-term national (and global) interest in health, economic
sustainability, and environmental conservation. For example, ecosystems like rain-
forests perform a vital function in absorbing atmospheric CO2. This global function
can be undermined by economically driven decisions about land use and other com-
mercial activities that lead to deforestation. Climate change is only one, albeit dra-
matic, illustration. The collective carbon footprint of developing countries is
growing, often placing the preservation of their ecosystems, biodiversity, and fresh
water at risk. Putting the economic growth of developing nations on a more
sustainable path is not only critical to global control of greenhouse gas emissions, it
is also key to each nation’s economic future and to global public health.
Economic development is no longer simply an issue for each national government
to acknowledge in its internal affairs and domestic policy. In our global market,
external forces impinge on options and resources of individual countries, even
wealthy and powerful ones. Yet in the absence of international governance, it is the
government of each country that remains ethically responsible for the health and
welfare of its citizens and should legislate and regulate its social and economic affairs
accordingly. In a democracy, public participation, debate, and consensus in view-
point and among plural groups are valued and essential components of governance.
The case from Snyder and colleagues provides an opportunity to examine the global
and systemic dimensions of environmental public health ethics and governance. In
Mongolia’s economy, which is heavily dependent on the mining industry and mining
operations, the trade-off between economic growth and environmental protection is
acute. The country clearly needs investment and job opportunities to combat poverty.
But issues of social justice, including health equity, are made complex by the stratifica-
tion of wealth and income and by the uneven development of different regions and
sectors of the society. Mining operations can threaten a complex and fragile ecosystem
and adversely affect health (e.g., toxic waste, air and water pollution). Mining opera-
tions can also create social dislocations (work migration) and change patterns in land
use, especially in areas with a long cultural and economic tradition of pastoralism.
The case by Hayward questions whether to drill expensive deep wells or less
expensive shallow water wells in sub-Saharan Africa. Part of the health risk posed
by the shallow wells requires a change in cultural behavior by preventing livestock
from contaminating the wells and by controlling surface run-off. Thus, any success-
ful public health effort cannot be assessed apart from the capacity of the local soci-
ety to manage and behave toward both its natural and constructed environment in
prudent and sustainable ways. Similarly, but on a larger scale, Mongolia’s regula-
tion of economic growth and its mining industry raise questions of cultural rights
and cultural capacity as well as questions of social equity and institutional capacity
to govern in an effective and socially legitimate fashion.
In summary, environmental and occupational health policy and practice is an
ethical minefield. Overly cautious approaches when predicted outcomes fail to
materialize may reduce the general public’s attentiveness and compliance with pub-
lic health warnings, recommendations, and directives in the future. Insufficient,
cautious responses leading to health consequences that could have been avoided can
carry a heavy political price for officials involved.
As you read and examine the cases in this chapter, pay particular attention to how
public opinion is formed, ethical decisions are justified, and inclusive and participa-
tory deliberation and consensus are achieved. We need effective and meaningful
approaches for engaging the public in health decisions. In particular, we need to find
ways to make a participatory and deliberative form of democracy practical and effec-
tive, especially in the context of environmental and occupational health. Civic educa-
tion about environmental health and ethical literacy will prepare not only stakeholders
but all citizens to make wise decisions about economic interests and the use of tech-
nology. What would motivate genuine deliberation and not simply special interest
advocacy? And civic deliberation is not free-standing; it requires special organiza-
tional forums and needs to move from spontaneity to institutionalized practice if it is
to make a lasting difference. Proper access to information and the cooperation of
experts with specialized technical knowledge are examples of the organizational side
of effective grassroots participation and discussion of key environmental and occu-
pational health issues. How can public health professionals facilitate and contribute
to the formation of civic practice and democratic public judgment in this sense?
References
Bayer, R. (ed.). 1988. The health and safety of workers: Case studies in the politics of professional
responsibility. New York: Oxford University Press.
Frumkin, H. (ed.). 2010. Environmental health: From global to local, 2nd ed. San Francisco:
Jossey-Bass.
186 B. Jennings
Frumkin, H., and A.J. McMichael. 2008. Climate change and public health: Thinking, communi-
cating, acting. American Journal of Preventive Medicine 35(5): 403–410. doi:10.1016/j.
amepre.2008.08.019.
Hansen, J., P. Kharecha, M. Sato, et al. 2013. Assessing “dangerous climate change”: Required
reduction of carbon emissions to protect young people, future generations and nature. PLoS
ONE 8(12): e81648. doi:10.1371/journal.pone.0081648.
Kessel, A., and C. Stephens. 2011. Environment, ethics, and public health. In Public health ethics:
Key concepts and issues in policy and practice, ed. A. Dawson, 154–173. Cambridge:
Cambridge University Press.
Lang, T., and G. Rayner. 2012. Ecological public health: The 21st century’s big idea? British
Medical Journal 345: e5466. doi:10.1136/bmj.e5466.
Shrader-Frechette, K. 2005. Environmental justice: Creating equality, reclaiming democracy.
6.4 Case 1: Assessing Mining’s Impact on Health Equity

in Mongolia
Jeremy Snyder
Faculty of Health Sciences
Simon Fraser University
Burnaby, BC, Canada
e-mail: jcs12@sfu.ca
Craig Janes
School of Public Health and Health Systems
University of Waterloo
Waterloo, ON, Canada
Colleen Davison
Clinical Research Centre and Department of Emergency Medicine
Kingston General Hospital
Kingston, ON, Canada
Department of Public Health Sciences
Queen’s University
Kingston, ON, Canada
Oyunaa Lkhagvasuren
Leading Researchers
Ulaanbaatar, Mongolia
Lory Laing
School of Public Health
University of Alberta
Edmonton, AB, Canada
Meghan Wagler
Simon Fraser University
Burnaby, BC, Canada
6.4.1 Background
Mongolia is a landlocked country bordered by Russia to the north and China to the
south. Although one of the largest countries in Asia in land area (1.56 km2), it has a
small population (2.74 million in 2010). Nearly two-thirds of the population is
urban and reside in provincial capitals and cities. Nomadic pastoralists who tend
mixed herds of animals across the desert and steppe grasslands primarily make up
the remaining third of the population (Central Intelligence Agency 2010).
Beginning in 1990, Mongolia transitioned from a single-party socialist state to a
multiparty democracy, which led to withdrawal of Soviet aid and termination of
trade relations with Soviet bloc countries. The loss of state subsidies and price con-
trols and implementation of trade liberalization caused the economy to falter during
the transition (Stiglitz 2002). Not until 2004 did the gross domestic product (GDP)
return to pre-transition levels (Rossabi 2005). Since then, macroeconomic growth
has been strong, driven by a rapidly expanding mineral sector.
Although resource extraction had been a major economic activity in Mongolia
for some time, the scale of exploration and investment increased markedly in the
early 2000s (Central Intelligence Agency 2010). As of 2008, general mining explo-
ration licenses covered a quarter of the country. Copper, gold, and coal dominate
mining activities, with much of the product exported to neighboring China (The
Economist 2012). The mining industry’s proportion of the total GDP tripled from
11 to 33 % during 2003 through 2007, the sector contributing about one-third of
government tax revenues (World Bank 2013). Propelled by mining and related con-
struction and transportation sectors, in 2011 Mongolia became the world’s fastest
growing economy, reporting annual economic growth of 17 % (World Bank 2011).
Mining in Mongolia occurs in a context of a lower middle-income country with
a GDP of $8.8 billion, rural underdevelopment, and social and economic inequality
(World Bank 2013). Mongolia exhibits significant wealth disparities: more than
one-third of the population lives in poverty, a proportion that has persisted despite
rapid economic growth. Although income poverty levels in rural areas exceed those
in urban areas, both settings have large numbers of vulnerable poor. In rural set-
tings, those lacking sufficient herd animals to sustain livelihoods, especially female-
headed households, rank among the poorest of the poor. Urban areas are inundated
with rural migrants forced into cities by weather disasters and lack of employment.
There they labor in the informal economy, typically living in squatter or “ger” set-
tlements without access to running water, sewerage, or electricity.1
1
A ger settlement, or “yurt,” is a rural parcel of land in Mongolia comprising several detached and
portable dwellings (gers) or shanties. Traditional ger settlements were occupied by pastoralists
(nomadic Mongolian people). Gers typically lack modern conveniences such as water, sewage, and
electricity. Occupants, although mostly self-sufficient, rely on some communal services such as wells.
188 B. Jennings
Although mining potentially can provide employment, improve infrastructure, and

support government services, it also poses substantial social, environmental, and
health risks. Adverse environmental impacts noted in Mongolia include dust pollu-
tion, diminution and degradation of ground and surface water, and loss of traditional
grazing lands by erosion and pollution. Especially concerning is the influx of thou-
sands of mine and construction workers, their families, entrepreneurs, job seekers, and
artisanal miners into rural mining areas (World Bank 2006). This influx, which greatly
strains infrastructure in some areas, can potentially increase the risk of local epidem-
ics of infectious disease, including HIV. As a result, resource development in Mongolia
has become a hotly contested political issue, which has subjected the mining sector to
increased public and regulatory scrutiny (Reeves 2011). Mongolians retain a strong
identity with their pastoralist history and culture, which has manifested itself in strong
pressure to develop resources that benefit the nation while protecting vulnerable
herder populations. Recently, and with international donor support, the government of
Mongolia began addressing some of these concerns. In May 2012, the efforts culmi-
nated in landmark environmental legislation that took into its purview the broad social
and health impacts of mining (Mongolian Mining Journal 2012). This legislation
demonstrates Mongolian interest in mitigating the negative health impacts of mining,
though administering this legislation will be challenging.
Expansion of the Mongolian mining sector raises ethical challenges in three areas.
First, the Mongolian government must assess a proposed mining project’s impact on
Mongolian stakeholders, taking into account the economic, environmental, social, and
health impacts. Because projects will affect stakeholders differently, the assessment
should adopt an equity lens, with differential impacts noted. A wide-ranging assess-
ment of this kind requires that the government determine how equity will be assessed
and how competing negative and positive impacts will be measured and compared.
Second, the Mongolian government must use the assessment to help mitigate potential
negative social and health impacts. Third, however, the government must consider
how regulations could deter mining investments and reduce potential economic ben-
efits of this industry. In a country with a growing population and limited economic
development, the loss of these benefits could impact the country’s welfare signifi-
cantly, limiting modernization and expansion of the health care system.
Before the equity impacts of mining activities can be assessed, stakeholders must
first agree to a standard of equity to prevent misunderstandings. These include equality,
priority to the least advantaged, and sufficiency accounts where the aim is to achieve a
threshold level of well-being for all people. Second, officials must determine whether
any local populations who are particularly vulnerable to mining’s impact merit special
consideration. Third, to meet the diverse needs of the Mongolian people, an impact
assessment must be locally appropriate and assume various forms. For example, differ-
ent remediation requirements may apply to different mine developers, depending on
circumstances. Fourth, one needs to be clear about when differential impacts of mining
become problems of equity. Finally, officials should investigate what requirements for
mitigating equity impacts should be included in any policy (Snyder et al. 2012).
The rapid urbanization and social upheaval brought on by the mining industry and
economic liberalization in Mongolia threaten to destabilize the country and squander
its resources. To avert these threats, Mongolia has already developed robust
legislation to assess the environmental and health impacts of mining. Some
government officials believe that an equity-focused health impact assessment policy
represents the logical next step in the country’s management of its rapid economic
development. Implementation of an equity-focused health impact assessment for
new mining projects could ensure that economic benefits are distributed equitably.
Doing so could improve health and social cohesion without disproportionately
burdening some populations with mining’s adverse consequences (Douglas and
Scott-Samuel 2001). A policy of this kind, while difficult to develop and implement,
is crucial to Mongolia’s future.
A panel that includes public health professionals is being organized to make
recommendations to the Mongolian government on its equity-focused health impact
assessment policy for new mining projects. The agenda for discussion includes the
following three areas:
• How to best include stakeholders in the development of the policy?
• How should health equity be conceptualized?
• How can an equity-focused health impact assessment be applied broadly?
1. Giving a fair hearing to stakeholders in deliberations about issues that affect

them is central to democratic deliberation.
(a) How important or practical is it in Mongolia to give a meaningful voice to all
stakeholders in the deliberations about whether and how a mining project
should be allowed to develop?
(b) What level of consultation constitutes meaningful participation?
(c) Should stakeholders be given veto power over decisions and an equal voice
in a democratic process?
(d) Is consultation by the government without a vote in the final decision
adequate?
2. Equity can be conceptualized differently, leading to various interpretations and
attendant misunderstandings.
(a) Are stakeholders unfamiliar with theories of health equity sufficiently quali-
fied to discuss health equity impacts?
(b) If not, how can they prepare for discussions of this kind?
190 B. Jennings
(c) Should stakeholders undertaking an equity-focused health impact assess-

ment be asked to reach a consensus on a concept of equity?
(d) Is it preferable to supply a single conception of equity?
(e) How can cultural and linguistic differences in understanding concepts such
as equity and fairness be resolved?
3. Some countries are incorporating a health equity assessment component in all
policies.
(a) Is there any unique feature of mining development that sets it apart from
other developments (e.g. road or housing construction)?
(b) Could equity-focused health impact assessment be used more generally to
assess the health equity impacts of projects and policies?
(c) What are the challenges of doing so, especially in a fledgling democracy?
4. Should the panel recommend to the Mongolian government that it apply an
equity-focused health impact assessment policy to new mining projects?
Acknowledgements We thank everyone who participated in a workshop on equity-focused
health impact assessments in Mongolia in October 2010. This workshop was funded through a
Health Equity Catalyst Grant from the Canadian Institutes of Health Research.
References
Central Intelligence Agency. 2010. The world factbook: Mongolia. https://www.cia.gov/library/

publications/the-world-factbook/geos/mg.html. Accessed 21 May 2013.
Douglas, M., and A. Scott-Samuel. 2001. Addressing health inequalities in health impact assess-
ment. Journal of Epidemiology and Community Health 55(7): 450–451.
Mongolian Mining Journal. 2012. The amended law on environmental impact assessment.
September 25. http://en.mongolianminingjournal.com/content/34726.shtml. Accessed 23 Jan
2014.
Reeves, J. 2011. Resources, sovereignty, and governance: Can Mongolia avoid the ‘resource
curse’? Asian Journal of Political Science 19(2): 170–185.
Rossabi, M. 2005. Modern Mongolia: From Khans to Commissars to Capitalists. Berkeley:
University of California Press.
Snyder, J., M. Wagler, O. Lkhagvasuren, L. Laing, C.M. Davison, and C. Janes. 2012. An equity
tool for health impact assessments: Reflections from Mongolia. Environmental Impact
Assessment Review 34: 83–91.
Stiglitz, J.E. 2002. Globalization and its discontents. New York: W. W. Norton.
The Economist. 2012. Booming Mongolia: Mine, all mine. January 21. www.economist.com/
node/21543113. Accessed 23 Jan 2014.
World Bank. 2006. Mongolia: A review of environmental and social impacts in the mining sector.
Washington, DC: World Bank. http://siteresources.worldbank.org/INTMONGOLIA/
Resources/Mongolia-Mining.pdf. Accessed 23 Jan 2014.
World Bank. 2011. Mongolia quarterly economic update—August 2011. www.worldbank.org/en/
news/2011/08/24/mongolia-quarterly-economic-update-august-2011. Accessed 15 May 2013.
World Bank. 2013. Data: Mongolia. http://data.worldbank.org/country/mongolia. Accessed 15
May 2013.
6.5 Case 2: Exceptions to National MRSA Prevention Policy

for a Medical Resident with Untreatable MRSA
Colonization
Babette Rump
Department of Infectious Disease Control
Municipal Health Service Utrecht
Zeist, The Netherlands
e-mail: brump@ggdmn.nl
Carla Kessler
Ethics Institute
Utrecht University
Utrecht, The Netherlands
Ewout Fanoy
Department of Infectious Disease Control
Municipal Health Service Utrecht
Zeist, The Netherlands
National Institute for Public Health and the Environment
Centre for Infectious Disease Control
Bilthoven, The Netherlands
Marjan Wassenberg
Department of Medical Microbiology
Utrecht University Medical Centre
Utrecht, The Netherlands
André Krom
Technology Assessment
Rathenau Institute
The Hague, The Netherlands
Marcel Verweij
Department of Social Sciences, Communication, Philosophy and Technology:
Centre for Integrated Development
Wageningen University
Wageningen, The Netherlands
Jim van Steenbergen
National Institute for Public Health and the Environment
Centre of Infectious Disease Control
Bilthoven, The Netherlands
Leiden University Medical Centre
Centre for Infectious Diseases
Leiden, The Netherlands
192 B. Jennings
6.5.1 Background
Antimicrobial resistance (AMR) is an increasingly serious threat to global public

health. First described in 1961, methicillin-resistant Staphylococcus aureus (MRSA)
is one of the best known antimicrobial resistant (AMR) pathogens. It has become an
increasingly serious cause of health care associated infections worldwide (Boyce
et al. 2005). People infected with MRSA, which resists standard beta-lactam antibi-
otics, can present symptoms or be asymptomatic carriers.
In a community setting, most MRSA carriers have few or relatively minor symp-
toms. In hospitals, however, open wounds, invasive devices, and weakened immune
systems pose a greater risk of infection, making MRSA a serious health problem.
The presence of Panton-Valentine leukocidin (PVL) cytotoxin in a Staphylococcus
aureus has the potential to cause more severe infections, such as pneumonia and
skin infections, although these are rare events considering the number of asymp-
tomatic carriers (Gorwitz 2008).
Worldwide, prevalence of MRSA among the general public and in hospitals var-
ies widely, as do the strategies used to control hospital-acquired MRSA (Boyce
et al. 2005). In the Netherlands and Scandinavia, for example, MRSA causes less
than 1 % of all cases of Staphylococcus aureus bacteraemia. This percentage con-
trasts with percentages of up to 50 % in other European countries (Wertheim et al.
2004). To maintain this low incidence, hospitals in the Netherlands and Scandinavia
follow a strict AMR related search and destroy policy. This policy consists of active
screening of patients and staff for MRSA, strict enforcement of contact precautions,
and judicious use of broad-spectrum antibiotics (Boyce et al. 2005).
In the Netherlands, the Working Party on Infection Prevention (WIP) has incorpo-
rated this search and destroy policy into national MRSA guidelines. The WIP, funded
by the Dutch Ministry of Health, was founded 25 years ago by respective professional
societies of physicians, hygienists, and microbiologists. WIP-issued guidelines are pro-
fessional standards most health professionals and institutes follow (Boyce et al. 2005).
The 2012 WIP guidelines for MRSA prevention in hospital settings involve three
principal procedures, which address both symptomatic and asymptomatic patients,
since carriers can also transmit the infection. First, patients with MRSA are isolated
in single rooms and treated to eradicate MRSA. Isolation procedures require those
entering the patient’s room to wear a gown and mask. Second, hospital patients at
increased risk of being carriers are also placed in isolation until proven MRSA free.
Patients considered potential carriers include all patients (a) transferred from hospi-
tals abroad to Dutch hospitals, (b) transferred from Dutch hospitals with an existing
MRSA condition, and (c) placed in the same room as a patient subsequently detected
unexpectedly with MRSA. Third, hospital staff who care for MRSA patients are
screened for MRSA and treated with antibiotics and mupirocin nasal ointment if
found positive (Boyce et al. 2005).2
Nationally, this search and destroy policy has proved highly successful and effec-
tive at maintaining a low prevalence of MRSA in Dutch hospitals (van der Zee et al.
2013). However, MRSA screening and treatment of health care staff can seriously
affect their lives because they cannot return to work unless testing confirms MRSA-
negative status. Fortunately, MRSA colonization (antibiotic-resistant strain of bac-
teria that lives on skin) is usually temporary, but when persistent, eradication
requires longer-term efforts. Although untreatable colonization is rare, it can neces-
sitate job change (Boyce et al. 2005).
A Dutch medical student has the potentially more virulent Panton-Valentine leukoci-
din (PVL) form of MRSA colonization yet shows no signs or symptoms of infection.
More than a year ago, a routine MRSA screening of health care personnel providing
care for MRSA-positive patients detected the colonization. Since then, the student
has been treated intensively but unsuccessfully in an attempt to decolonize her.
During this decolonization period, the medical student was barred from performing
patient-related interventions, temporarily interrupting her medical residency. After
initial treatment with mupirocin nasal ointment and antibiotics proved ineffective, a
more stringent hygiene regime was added that included hand, nose, hair, and body
scrubbing with disinfecting soap. Additional precautions included simultaneous
treatment of household members and disinfection of the family home. Despite these
efforts, her MRSA status has remained positive. WIP guidelines bar any health care
worker diagnosed with MRSA from performing patient-related interventions. Unable
to complete the residency requirement of at least 1 year of patient care, the medical
student was advised to pursue a career in another profession.
Refusing to accept this verdict, she united with other similarly excluded medical
students to launch a protest that gained media attention. In a press interview, she
acknowledged that potential iatrogenic spreading of MRSA could risk institutional
or community safety. However, she questioned the seriousness of this risk and
argued that the protesting students were being unfairly targeted. She pointed out that
medical staff are not routinely screened for MRSA unless they have cared for a
MRSA-positive patient or have worked in a country with high MRSA prevalence.
Because MRSA can be acquired in the community, potentially many undiagnosed
MRSA-colonized medical staff or residents currently work in hospitals. She also
pointed out that other European countries, despite a higher MRSA prevalence, allow
MRSA carriers to work in health care settings. Despite being persistently MRSA
positive, these professionals can safely work in medical specialties that do not
involve direct patient contact.
2
An English version of the WIP guidelines is available at http://www.wip.nl
194 B. Jennings
As a result of this press coverage, the public has pressured the WIP to reconsider its
guidelines. Because iatrogenic spreading of disease has public health implications, you,
as a public health professional, have been asked to serve on a WIP committee charged
with considering whether the guidelines need to be changed to address these and future
cases. The chair of the committee wants to discuss the following questions.
1. Who are the main stakeholders in this case, and what are their primary interests?
2. What is the ethical rationale for allowing or not allowing medical students who
are MRSA carriers to continue their medical education?
3. What would be your ethical justification for either recommending or not recom-
mending universal screening for all medical students and doctors?
4. How would it change your recommendation if
(a) The MRSA of this student was not PVL positive?
(b) The overall prevalence of MRSA in the Netherlands was high or rapidly
increasing?
(c) There was little or no evidence that excluding colonized health care workers
decreases risks to patients?
(d) The students agreed to pursue medical specialties that do not involve patient care?
5. Although the European Union (EU) is increasingly standardizing its AMR pol-
icy, some EU countries have less stringent regulations than others. Would it be
ethical to advise the medical students in question to finish their education in a
European country with a less stringent MRSA policy?
References
Boyce, J.M., B. Cookson, K. Christiansen, et al. 2005. Meticillin-resistant Staphylococcus aureus.

Lancet Infectious Diseases 5(10): 653–663.
Gorwitz, R. 2008. Understanding the success of methicillin-resistant Staphylococcus aureus
strains causing epidemic disease in the community. Journal of Infectious Diseases 197(2):
179–182. doi:10.1086/523767.
van der Zee, A., W.D. Hendriks, L. Roorda, et al. 2013. Review of a major epidemic of methicillin
resistant Staphylococcus aureus : The costs of screening and consequences of outbreak man-
agement. American Journal of Infection Control 41(3): 204–209.
Wertheim, H.F., M.C. Vos, H.A. Boelens, et al. 2004. Low prevalence of methicillin-resistant
Staphylococcus aureus (MRSA) at hospital admission in the Netherlands: The value of search
and destroy and restrictive antibiotic use. Journal of Hospital Infection 56(4): 321–325.
6.6 Case 3: Safe Water Standards and Monitoring of a Well

Construction Program
Alison Hayward
Department of Emergency Medicine, Yale School of Medicine
Yale University
New Haven, CT, USA
Uganda Village Project
Iganga, Uganda
e-mail: ahs.hayward@gmail.com
institution.
6.6.1 Background
The lack of access to safe drinking water is a serious public health problem affecting
many developing countries. More than 780 million people, mostly located in sub-
Saharan Africa, lack safe drinking water. Sub-Saharan Africa only has coverage
with safe drinking water sources for 61 % of its population, a stark contrast with
regions such as Latin America, northern Africa, and most of Asia, which have all
achieved greater than 90 % coverage (World Health Organization/United Nations
Children’s Fund Joint Monitoring Programme for Water Supply and Sanitation
2012). The Millennium Development Goals (MDGs) have specified that by 2015,
the proportion of people who lack access to safe water and sanitation should be
halved (United Nations 2013). Significant progress has been made towards achiev-
ing this goal; however, vast inequities emerge when comparing populations of rural
areas to urban ones, and of more impoverished communities to those with a higher
socioeconomic status. As such, progress toward achieving access to safe water and
sanitation facilities is not likely to be equitable. As an example, one estimate by the
United Nations Development Program suggests that the world overall will attain the
safe water and sanitation MDGs by 2016 and 2022 respectively, but sub-Saharan
Africa is not projected to attain these goals until 2040 and 2076 (Jimenez and Pérez-
Foguet 2010).
In sub-Saharan Africa, 19 % of the rural population resort to using surface water
collected from streams, rivers, ponds, or other such sources. Unprotected water
sources are particularly dangerous because those who fetch water contaminate the
water source by reaching their hands into the water and wading into it as they fill
their basins and jerrycans. Open defecation and lack of sanitation also contribute to
contamination, as does fecal runoff from livestock wandering through unprotected
water sources. Water that is not contaminated at the source runs a high risk of
196 B. Jennings
becoming contaminated on its way to the drinking cup due to inadequate home stor-
age and dispensing methods that allow children or other household members to
reach into the water while serving it. As a result of this rampant drinking water
contamination, diarrheal disease is common in residents of areas without access to
safe water. Diarrheal disease is deadliest for young children, the elderly, and immu-
nocompromised community members, such as people living with HIV/AIDS. In
children younger than 5 years of age, diarrheal disease is the second leading cause
of death (World Health Organization 2009). With proper access to safe water and
sanitation, most of these deaths would be prevented.
Access to safe water can prevent many other potentially lethal infectious dis-
eases. These include schistosomiasis, intestinal worms, and malnutrition from
repeated diarrheal and intestinal worm infections. Diarrheal disease, however, rep-
resents the bulk of the disease burden contributed by poor sanitation, hygiene, and
drinking water quality (Prüss-Üstün et al. 2008).
The World Health Organization (WHO) publishes a simple set of recommenda-
tions to help small communities with limited water supplies maintain water safety.
One key recommendation calls for the creation of, and adherence to, a Water Safety
Plan (WSP), using illustrated pamphlets to convey the need for preventive mainte-
nance of water supplies. Another recommendation calls for innovative monitoring
strategies such as the use of mobile phones to send data from the field to public
health inspectors (WHO 2010). Water treatment products like chlorine can be added
either at the well, when the water is collected, or at the point of use in the home to
reduce the risk of water contamination (WHO 2011).
The WHO also has detailed guidelines for drinking water quality. These guide-
lines promote the use of health-based targets, which take into account local vari-
ables such as public health status, contribution of drinking water to the transmission
of infectious disease, and social and cultural factors. Some international organiza-
tions set inflexible water quality standards for pathogen concentrations used in ana-
lyzing data from water sources and drinking water. The WHO instead suggests that
such targets be modified to realistic and attainable goals. In order to most appropri-
ately allocate limited resources, the WHO additionally suggests “less stringent tran-
sitional targets supported by sound risk management systems” to achieve a “tolerable
disease burden” for waterborne illness, with incremental improvement in a health-
based transitional target eventually progressing towards tight water quality control,
as resources allow. Such transitional targets can be developed with the aid of risk
management theory. Data collection and advanced statistical modelling may be
challenging in countries with limited resources. Estimations of organisms per liter
in raw water can be combined with information on risk of diarrheal illness from a
given infection, and health outcome targets, to calculate performance targets for
reducing pathogens through water source control or treatment interventions.
Modifiable targets should consider the relevant risks and benefits in a local area to
attain the desired reduction in illness occurrence, and thus, health outcomes, as
measured in disability-adjusted life years per person per year. These targets should
be outlined in the Water Safety Plan (WHO 2011).
You are a managing director for a small nongovernmental organization (NGO) in

rural sub-Saharan Africa. Your organization partners with rural villages to construct
protected shallow wells in areas where residents otherwise need to walk more than
2 km to reach the nearest safe source. This program was designed to be as cost
effective as possible, with village residents volunteering their time and manual labor
for well construction.
Organization members debated whether to use borehole drilling or cheaper, hand-
dug protected shallow wells. Because boreholes draw water from deep underground,
the likelihood of contamination from surface runoff is far less. In contrast, shallow
wells risk contamination, particularly if steps are not taken to address the problem,
such as constructing a fence around the site to keep grazing livestock away. The
nonprofit board concluded that boreholes would be about ten times as expensive to
drill, allowing construction of one-tenth the number of wells for the same funding.
They therefore decided to focus on shallow well construction to reach the greatest
number of communities in need. Still, questions remained about the relative health
risks of an approach prone to contamination. Some members of the organization are
concerned that the shallow well method was pushed, in part, because it was less
expensive and the number of wells constructed would impress donors.
The program was designed in collaboration with the District Water Office for
sustainability. Although the District Water Office agreed to assume responsibility for
testing the water quality of wells being built, its ability to conduct the tests has been
limited by a lack of financial resources. Your organization therefore has undertaken
its own water quality testing of roughly 50 wells constructed in the district. Your well
construction program manager has reported to you the discouraging results of the
water quality tests. Of the wells tested, 20 % have coliform bacteria present in levels
unacceptable to international standard drinking water guidelines, which the staff use
as a target for water quality as part of the program’s monitoring and evaluation plan.
The program manager, who has been in discussions with the District Water Office
and other nonprofits involved in well construction, has several ideas to improve the
well construction process and strengthen protection against coliform contamination
in the wells. He also wants to remediate the wells that failed the testing.
Before committing to any of these ideas, you hold an organizational meeting to
help you decide whether or how to convey these results to the community members
who use the wells, knowing they mistrust both governmental and nongovernmental
programs. You particularly worry about the damage to your organization’s reputation
in trying to convey that the water from wells it has built is dangerous to drink. One
staff member suggests holding community meetings to discuss the issue. Meanwhile,
all heavily contaminated wells would be marked with signs and red tape to indicate
the water is unsafe to drink. Another staffer argues that marking the wells in such a
way might frighten community members and discourage them from drinking from
the wells even after remediation. He notes that if told not to use these sources, com-
munity members might prefer using nearby but similarly (or worse) contaminated
open water sources to walking a long distance to find another protected source.
198 B. Jennings
Although the educational workshops the organization offers have always empha-
sized the need for boiling water or chemically treating it with a chlorination product
to ensure its safety, you know that in practice, many community members consider
water from a protected source to be “safe,” regardless of whether it is boiled or
treated. As you leave the meeting, you realize you have four key questions to resolve.
1. What ethical implications are raised by considering whether or not to publicize

the water quality test results? Which option is more justified, and why?
2. What ethical concerns are raised by the use of shallow well construction, which
allows more wells to be constructed at lower cost but at higher risk of water
contamination?
3. If the water quality test results are publicized, what participatory approach might
best address the problem with water quality?
4. Considering that lower water quality standards could result in more illnesses and
deaths in the community, is the WHO’s risk-benefit approach the most appropri-
ate way to determine what is environmentally, economically, and socially pos-
sible? Would it be better to base one’s strategy on an internationally recognized
standard for acceptable water quality?
References
Jimenez, A., and A. Pérez-Foguet. 2010. Challenges for water governance in rural water supply:
Lessons learned from Tanzania. International Journal of Water Resources Development 26(2):
235–248.
Prüss-Üstün, A., R. Bos, F. Gore, and J. Bartram. 2008. Safer water, better health: Costs, benefits
and sustainability of interventions to protect and promote health. Geneva: World Health
Organization. http://whqlibdoc.who.int/publications/2008/9789241596435_eng.pdf. Accessed
15 May 2013.
United Nations. 2013. Millennium development goals. http://www.un.org/millenniumgoals/.
World Health Organization (WHO). 2009. Diarrhoeal disease fact sheet no. 330. http://www.who.
int/mediacentre/factsheets/fs330/en/index.html. Accessed 15 May 2013.
World Health Organization (WHO). 2010. Small and safe: Investing in small community water
supplies will reduce waterborne disease outbreaks and overall costs. http://www.who.int/
water_sanitation_health/WHS_WWD2010_small_systems_2010_4_en.pdf. Accessed 15 May
2013.
World Health Organization (WHO). 2011. Guidelines for drinking water quality, 4th ed. http://
www.who.int/water_sanitation_health/publications/2011/dwq_guidelines/en/index.html.
World Health Organization/United Nations Children’s Fund Joint Monitoring Programme for
Water Supply and Sanitation. 2012. Progress on drinking water and sanitation. http://www.
unicef.org/media/files/JMPreport2012.pdf. Accessed 15 May 2013.
6.7 Case 4: Implementation of Global Public Health

Programs and Threats to Personal Safety
Alison Hayward
Department of Emergency Medicine, Yale School of Medicine
Yale University
New Haven, CT, USA
Uganda Village Project
Iganga, Uganda
e-mail: ahs.hayward@gmail.com
6.7.1 Background
Many global public health agencies and organizations from high-income countries
conduct programs in locations where the personal safety of workers and volunteers
cannot be guaranteed. Staff and volunteers of nonprofit organizations and govern-
ment aid agencies face a variety of threats. In 2012, aid workers were harmed in 100
discrete incidents involving 187 aid workers, 43 of whom were international aid
workers (Humanitarian Outcomes 2013). These incidents included kidnappings,
murder, and traumatic injury. The profile of deaths amongst aid workers and volun-
teers who serve in conflict zones significantly differs (Sheik et al. 2000). Contrary
to popular belief, tropical infectious diseases rarely cause death in aid workers
(Hargarten et al. 1991). A systematic review of unintentional injury in international
travelers found that only 2 % of traveler deaths were secondary to infectious dis-
ease, whereas injury represented a major cause of death. Motor vehicle accidents
were the leading cause of fatal injury to travelers (McInnes et al. 2002).
According to the World Health Organization’s Global Status Report on Road
Safety, more than 90 % of the world’s road fatalities occur in low and middle-
income countries. The report further notes that the majority of road fatalities in
these countries occur among vulnerable road users—pedestrians, cyclists, and rid-
ers of motorized two-wheeled vehicles (World Health Organization 2009). Little
research has been conducted on health and safety policies and procedures for inter-
national nongovernmental organizations (O’Sullivan 2010). One exception is the
U.S. Peace Corps. A study done of fatalities in the Peace Corps between 1962 and
1983 revealed that unintentional injuries caused 70 % of deaths, with motor vehicle
crashes the top cause of fatality, and motorcycle collisions responsible for 33 % of
the deaths related to motor vehicles (Hargarten and Baker 1985).
After release of the report, the Peace Corps banned motorcycle use in many
countries in which their volunteers serve and mandated a motorcycle safety course
200 B. Jennings
and helmet usage in countries where the use of motorcycles was still permitted. A
follow-up study of fatalities through 2003 concluded that injury prevention mea-
sures instituted as a result of the prior study had significantly decreased the risks
faced by Peace Corps volunteers (PCVs), although, once again, motor vehicle col-
lisions topped the list of causes of death. In the 20 years prior to institution of the
helmet rules, 22 of 105,539 PCVs died in motorcycle collisions. In the following
20 years, another 71,198 PCVs participated in the program, but only 2 died in
motorcycle collisions (Nurthen and Jung 2008). These studies provide evidence that
preventive measures can save the lives of aid workers and volunteers even in low-
income countries with poor transportation safety and infrastructure.
In rural sub-Saharan Africa, you oversee the operations of a nonprofit organization

that provides public health programs to remote communities. Needs assessments
have shown that these areas have the greatest poverty, as well as lack of access to
safe water sources and health care facilities. But the roads leading to the villages,
which become little more than footpaths at some points, pose challenges to travelers
that include erosion, flooding, and large potholes as well as the physical obstacles
of livestock, children, other pedestrians, and bicyclists. The optimal strategy for
reaching the villages is to use a motorcycle.
While working on a grant proposal one afternoon at the office, you receive a cell
phone call from Moses Izimba, a program manager for your nonprofit. Earlier in the
day, several staff and volunteers had taken “boda-bodas” (motorcycle taxis) to a
remote village to offer a sanitation outreach program. Despite passenger warnings
to drive slowly due to the road conditions, the taxi drivers were speeding when a car
that pulled suddenly into their path caused a collision.
One victim is a staff member who had left without his motorcycle helmet as the
group rushed to depart. With a quivering voice, Moses reports that this staff member
did not survive the collision. Another victim is a volunteer who had purchased a
helmet at a local shop, which likely was not safety certified by the Ministry of
Transportation. This helmet now lies shattered near the accident scene, while the
volunteer, still bleeding from a large scalp laceration, is alive but comatose.
The only four-wheeled vehicle on hand for transportation is the car involved in
the accident, which now has a broken windshield, but the driver has offered to trans-
port the victims to a health care facility. You urge Moses to get the injured staff
member to the district hospital quickly. As you end the phone call, shocked by the
tragic news, several thoughts come immediately to mind. Could this accident have
been prevented? How can the organization best deal with a serious trauma to one of
its staff members during fieldwork?
You convene a committee to discuss the ramifications of the accident. The com-
mittee’s pragmatic charge will be to examine staff insurance benefits, including
evacuation coverage and repatriation of remains; organizational policy improve-
ments to minimize the likelihood of riding without a helmet; appropriate standards
for safety equipment; an alert system to warn of hazardous road or transportation

conditions; and innovative strategies to optimize transportation safety under local
conditions. But the committee has also been asked to consider three areas of ethical
challenge the situation has presented.
1. Under what circumstances should you limit humanitarian aid based on the
assessment of risk to workers or volunteers? What is an acceptable level of risk,
and what harms—to the organization, its staff, and the communities being
served—could potentially result from limiting or ending aid?
2. What are the obligations of nonprofits or humanitarian agencies to protect their
workers from safety threats, given that they frequently operate in dangerous
environments where infrastructure is lacking? Do the obligations of nonprofits
differ from the private sector when it comes to protecting the health and safety of
their staff, and if so, how?
3. How can a nonprofit or humanitarian agency best deal with a tragic accident
resulting in the death or serious injury of a volunteer or worker? Consider the
ethical pros and cons of the potential approaches that could be taken to prepare
for risks to aid worker health and safety and address such a situation as it unfolds,
including risk communication.
References
Hargarten, S.W., and S.P. Baker. 1985. Fatalities in the Peace Corps. A retrospective study: 1962
through 1983. Journal of the American Medical Association 254(10): 1326–1329.
Hargarten, S.W., T.D. Baker, and K. Guptill. 1991. Overseas fatalities of United States citizen
travelers: An analysis of deaths related to international travel. Annals of Emergency Medicine
20(6): 622–626.
Humanitarian Outcomes. 2013. Aid worker security database. https://aidworkersecurity.org/inci-
dents/report/summary. Accessed 4 June 2015.
McInnes, R.J., L.M. Williamson, and A. Morrison. 2002. Unintentional injury during foreign
travel: A review. Journal of Travel Medicine 9(6): 297–307.
202 B. Jennings
Nurthen, N.M., and P. Jung. 2008. Fatalities in the Peace Corps: A retrospective study, 1984 to
2003. Journal of Travel Medicine 15(2): 95–101.
O’Sullivan, S.L. 2010. International human resource management challenges in Canadian devel-
opment INGOs. European Management Journal 28(6): 421–440.
Sheik, M., M.I. Gutierrez, P. Bolton, P. Spiegel, M. Thieren, and G. Burnham. 2000. Deaths among
humanitarian workers. British Medical Journal 321(7254): 166.
World Health Organization (WHO). 2009. Global status report on road safety: Time for action.
http://www.who.int/violence_injury_prevention/road_safety_status/2009/en/. Accessed 4 June
2015.
Chapter 7
Vulnerability and Marginalized Populations
Anthony Wrigley and Angus Dawson
7.1 Introduction
Public health practitioners attempt to identify and then remove, or at least reduce,
threats of harm. However, harm does not affect everyone in the same way. Some
people and communities are resilient, whereas others are more susceptible to poten-
tial harm. Much public health work is carried out by, or on behalf of, governments.
Where people or communities are at great risk of harm, government has a clear and
firm responsibility to protect its citizens. One way of describing a potential source
of such a risk of harm is to focus on the idea of vulnerability. This introduction
explores the concept of ‘vulnerability’ and the role that it may play in public health.
Vulnerability is a concept often used in public health ethics and more broadly in
bioethics—but its exact meaning is unclear. Roughly, it indicates that an individual
or group is thought to have a particular status that may adversely impact upon their
well-being, and that this implies an ethical duty to safeguard that well-being because
the person or group is unable to do so adequately themselves. This concept, although
important, consistently eludes precise definition. The difficulty in defining the con-
cept arises from disagreement as to how to characterize the idea of “special status”
and to whom it applies. As a result, more and more categories of individuals and
groups are being classified as vulnerable in an ever-increasing range of situations.
This raises the concern that almost everyone can be classified as vulnerable in some
institutions.
A. Wrigley, PhD
Centre for Professional Ethics, Keele University, Staffordshire, UK
A. Dawson, PhD (*)
e-mail: angus.dawson@sydney.edu.au

204 A. Wrigley and A. Dawson
way and, in turn, that almost every activity now requires this additional attention. If
true, then the concept of ‘vulnerability’ ceases to be useful because if everyone is
vulnerable, then no one is.
There is currently no clear, single, definitive account of this concept that is univer-
sally accepted, although numerous different approaches have been adopted by, for
example, various international bodies in their guidelines. In this chapter, we shall
critically examine some leading definitions of vulnerability and attempt to explain
and classify them to make clear the differences in approach. Then we will offer an
account of vulnerability that seeks to provide a universal basis for the everyday use
of the concept while avoiding the pitfalls associated with the other definitions. Our
approach aims to reduce the concept to a simple role, not as a basic moral concept in
its own right, but as a marker, or signal, to public health practitioners that something
in the situation before them requires ethical attention. The real ethical work is to be
done by the practitioner, not by vague appeal to the idea of vulnerability, but via the
application of other concepts and ethical concerns that are already familiar in public
health and bioethics. We shall use case studies to illustrate how this approach works.
7.2 Different Approaches to the Concept of Vulnerability
Before looking at the approaches taken to define vulnerability, a worthwhile starting

point is to examine the concept that can be derived from the term’s everyday use.
Vulnerability, in line with the etymological root of the word meaning “to wound,” is
widely interpreted as
(V1) Open to harm or under threat of harm.
This basic definition is perfectly adequate, for a range of uses, with context deter-
mining the nature and kind of harm at stake. However, such a definition only captures
a broad background use as to how the concept should be employed. Though this defi-
nition will be sufficient for most purposes, further clarity and greater specificity of the
concept is needed here. In attempting to refine this basic definition, several challenges
arise. First, how we formulate any definition will change whether or not we see some-
one as vulnerable. Therefore, in providing a more substantial definition, one has to
avoid the problem of inadvertently excluding those who should be considered genu-
inely vulnerable or including those who are not vulnerable. Second, if we want the
concept of vulnerability to function as something that generates a duty or responsibil-
ity to prevent harms from befalling people, then we must move beyond a basic, factual
description and include some normative ethical element, something along the lines of
what Goodin characterizes as “the principle of protecting the vulnerable” (1985, 110).
Providing a sound definition of vulnerability that satisfies these elements is more
difficult than might be expected. Hurst (2008) captured this difficulty well by liken-
ing it to the attempts of six blind men trying to describe an elephant. As each blind
man touches a different part of the elephant—the trunk, ear, tusk, tail, etc.—they
cannot agree on how to describe the animal. This analogy maps directly to the chal-
lenge of defining vulnerability. Because different perspectives abound on what con-
7 Vulnerability and Marginalized Populations 205
stitutes the grounds of vulnerability, consensus on the definition is difficult to reach

(Schroeder and Gefenas 2009).
Much of the focus on vulnerability in the bioethics literature has been in research
ethics, where many international guidelines recommend or impose some duty to
provide extra protection for those considered vulnerable. However, these guidelines
generally fail to define the concept (although the Council for International
Organizations of Medical Sciences [CIOMS] (2002) does provide a definition) and,
instead, list groups commonly considered vulnerable (U.S. Department of Health,
Education, and Welfare 1979; World Medical Association 2013; CIOMS 1993).
Although this practice is slowly changing, strategies for analyzing and defining the
concept are usually limited to simply adding or subtracting from a list of properties,
conditions, or categories that typify what it is to be considered vulnerable.
The approaches taken to define vulnerability beyond everyday use (V1) can be
categorized broadly into three basic types:
(V2) Vulnerability is a universal condition that humanity has in virtue of our physi-
cal or social nature (Fineman 2008; Hoffmaster 2006; Turner 2006; Rogers et al.
2012; MacIntyre 1999; International Bioethics Committee of UNESCO [IBC]
2013; and to some extent Hart 1961).
or
(V3) Vulnerability involves one or more specific attributes, contexts, or group types
(Rendtorff 2002; and this is perhaps also the approach taken by the International
Bioethics Committee of UNESCO when it considers what it calls special vulner-
abilities, 2013, 5–6).
or
(V4) Vulnerability involves one (or more) familiar but overarching ethical concept(s)
(Goodin 1985; Wrigley 2010).
Before we critically examine each approach, it is worth noting that all definitions
are perfectly adequate depending on what we want the concept to do or what role
we want it to play. One possible explanation for the failure to produce a single, uni-
versally agreed-upon definition of this concept is that, put simply, those who use the
term have different aims and roles in mind.
7.3 Concerns Surrounding Approach (V2): Universal

Condition
Approaches to the concept along the lines of (V2) use vulnerability to mark every
human as somehow open to harm—including physical injury, dependency on oth-
ers, loss of power, and so forth—just by virtue of being human (Fineman 2008).
Hence, by that logic, everyone is vulnerable because we all have bodies that can be
injured, disabled, and fail through illness and old age. On this view, we are also
vulnerable because whilst we live in social units that require interdependence, high
quality interaction does not always exist.
(V2) is a very particular way of thinking about the concept of vulnerability inas-
much as it motivates and drives discussion of the human condition in general. However,
the major problem with such accounts is that the general truth that we, as humans, are
open to harms of various kinds or that we live in social groups, fails to pick out a spe-
cial category because it applies to absolutely everyone. It becomes difficult to talk of
‘degrees’ or ‘types’ of vulnerability on such accounts. This, in turn, has led to the criti-
cism that such an approach results in the “naturalizing” of the concept, whereby it is
held to be normal or natural to be vulnerable in one way or another (Luna 2009). Of
course, if the idea behind using the term ‘vulnerable’ is (a) to articulate a fundamental
aspect of the human condition, (b), to say something substantive about the interdepen-
dence of humans, and, perhaps, (c) to thereby affirm a natural commitment to human
solidarity, then much substantive (and controversial) content is built into the concept,
and our discussion moves far from the everyday meaning of vulnerability. If we are all
vulnerable, then appealing to this concept as a means to avoid a harm or seek special
protection becomes problematic, as it is hard to see how particular priorities can be set.
This approach makes vulnerability far too broad to serve as anything other than
an underlying presumption about all human beings, and so it is unable to generate
ethical duties beyond what we owe to every human by virtue of being human. As a
result, this approach does not provide an account of vulnerability that can identify
cases where people or groups are potentially open to harm in any special way.
7.4 Concerns Surrounding Approach (V3): Specific

Attributes, Contexts, or Groups
In direct contrast to the approach taken in (V2), (V3) characterizes vulnerability by

identifying it with some specific attribute, context, or group membership. This
approach focuses on vulnerability in terms of something, such as physical vulnera-
bility, social vulnerability, vulnerability in terms of lacking capacity, vulnerability in
terms of belonging to a certain identifiable group, or vulnerability because of
belonging to a marginalized population, etc.
This approach to defining the concept is an excellent way of illustrating the sorts
of conditions that we might want to pick out as requiring special consideration in
terms of susceptibility to harm. As such, (V3) serves as a useful heuristic device
because it gives examples of the sorts of things that are often considered vulnerabili-
ties. However, this check-list approach is to borrow David Lewis’s (1986) phrase, an
attempt at explanation by “way of example,” whereby we provide some key para-
digmatic examples or illustrations of what constitutes vulnerability and state that
vulnerabilities are “these sorts of things.”
This approach does a poor job of defining vulnerability. Listing everything that
falls under a concept, even if it were possible, does not give us a good definition of
that concept. (V3) neither tells us whether the examples listed are appropriate nor
guides our decision making on controversial cases where identifying someone as
vulnerable is unclear. Further, by using the (V3) approach, attention is directed

away from the underlying question of what vulnerability is; and instead, the focus
is on whether or not to add a particular group to a continually expanding unstruc-
tured list of examples (Rogers et al. 2012). Of course, any such list might prove
useful as an aide memoir during, for example, an emergency event. Such a prag-
matic role may be useful, but it should not be mistaken for an ontological category
or conceptual boundary.
The (V3) approach has therefore met with the criticism that it is both too broad
and too narrow to satisfactorily define vulnerability (Levine et al. 2004; Schroeder
and Gefenas 2009; Luna 2009). Concerns about being too broad stem from the list
of vulnerabilities becoming inflated to the point where “virtually all potential human
subjects are included” (Levine et al. 2004). As such, the same concern for (V2)
applies to (V3), since both approaches fail to specify in sufficient detail those who
need additional or special protection from harms.
(V3) is also, potentially, too narrow because it focuses all attention onto specific
or group characteristics and therefore fails to address concerns outside the particular
designated categories (Rogers et al. 2012). It will, therefore, potentially miscatego-
rize certain individuals or groups as not being vulnerable if, for example, they are a
group that has not been encountered previously or if some trait has not made it onto
the list of specified characteristics. Moreover, by focusing on specific or group char-
acteristics, (V3) can stereotype individuals who fall under category headings (Scully
2013). If, for example, we assign names to different categories of vulnerability (e.g.,
‘the elderly’, ‘the disabled,’ or ‘women,’ or ‘the poor’ as categories of vulnerabil-
ity), then many people could be classified as vulnerable without them necessarily
being at any greater risk of harm.
7.5 Concerns Surrounding Approach (V4): Overarching

Concepts
The (V4) approach explains vulnerability in terms of one or more overarching but
more familiar ethical concept(s). Perhaps the best example of this kind is Goodin’s
(1985) account of vulnerability, which builds on the everyday use of the term
(V1)— open to or under threat of harm— but goes a step further by exploring what
the relevant harms might be. This leads Goodin to interpret “harm” in terms of a
person’s “welfare” or “interests” so giving us an initial definition of being vulnera-
ble in terms of ‘being susceptible to harms to one’s interests’(1985, 110–114).
However, as the concepts of ‘welfare’ and ‘interests’ can in turn be open to a
great deal of interpretation, including the possibility of focusing on subjective expli-
cations involving the satisfaction of preferences or desires, further clarification is
needed. To this end, Goodin suggests that a particular sub-group of interests, that
is—people’s “vital interests” or “needs”—are the universally important welfare
considerations that we need to be concerned about. On this view, one is vulnerable
if one’s needs are threatened. And one is most vulnerable if one’s most vital needs
are threatened.
Goodin also adds an explicit normative role to the concept of vulnerability by

imposing an ethical duty to safeguard the potentially vulnerable from harm. This
role is imperative if the concept of vulnerability is to be anything more than a factual
description of an individual’s or a group’s characteristics. Goodin does this by link-
ing his account of vulnerability to the “principle of protecting the vulnerable,”
which is, essentially, an obligation to protect the vital interests of others. Hence
there is a direct link between the classification of someone as being vulnerable, with
a requirement on the part of others to protect them from any potential harms.
Despite being a highly influential account of vulnerability, this approach has
been criticized. One concern is that it potentially promotes widespread paternalism
in an attempt to meet others’ needs (Rogers et al. 2012), thereby characterizing all
vulnerable people as, in some way, being helpless. This criticism misses the mark,
though, because being vulnerable by Goodin’s account does not mean one is power-
less. More telling, however, are the concerns that this account does nothing more
than reduce the concept of vulnerability to the well-recognized concept of needs,
together with a moral theory that demands we aid those in need. In essence, this
implies that the concept of vulnerability is redundant and could be replaced with the
concept of being in (serious) need.
7.6 Simplifying the Concept of Vulnerability (V5):

The Moral-Marker Approach
Rather than continuing this attempt to define vulnerability along the lines of the
approaches already mentioned (V2, V3, and V4), an account of vulnerability can be
offered in much simpler terms. Instead of seeking a substantive definition that tries
to establish conditions for vulnerability, another option is to interpret the word “vul-
nerability” as nothing more than an empty marker or signal for potential moral
concern. This approach can be seen in Hurst’s view of vulnerability as a sign of
“increased likelihood of incurring additional or greater wrong” (2008). However,
this view can be taken further. A formal moral-marker approach simplifies the
account of vulnerability by avoiding any reliance on moral theory or preconceived
wrongs as part of the definition. On this account, vulnerability will simply be
(V5) A marker that additional consideration needs to be given to whatever existing
ethical issues there may be.
It can be seen that what is then in dispute between the different accounts presented
is what sorts of considerations are the relevant ones. However, if we stop at the point
where “vulnerability” is recognized as just a warning marker, we don’t need to
engage with the substantial task of trying to provide a catch-all definition that some-
how incorporates all physical, mental, or emotional, etc. cases that might constitute
vulnerability. Instead, we can focus on substantive ethical concepts such as harm,
consent, exploitation, etc. and explore how each applies to the particular case before
us. On the basis of this approach, “vulnerability” says nothing at all about what gen-
erates the need for any special scrutiny because the substantive ethical weight of the
concern (and how to address it) requires us to engage with these substantive moral
concepts. So, for example, it says little to talk about marginalized populations as
being vulnerable, but if we recognize the ‘moral marker’ of vulnerability here, we
might then explore how exploitation, inequity, and harm are relevant when deliberating
about a particular case. One of the priorities for educating public health professionals
about ethical issues is to seek to increase their sensitivity to the relevant features of
each situation, rather than teach them the formulaic application of rules or vague
concepts such as that of “vulnerability” (Coughlin et al. 2012).
The (V5) approach offers other advantages as well. For example, it avoids stereo-
typing based merely on belonging to a specified category; it avoids exclusion on the
grounds of not already being on the list of vulnerable groups; and it avoids the vacu-
ity of identifying “all” as vulnerable, while maintaining the crucial aspect that the
concept marks out the need for special ethical scrutiny. Trying to provide more
substantial components to the definition of vulnerability diverts scrutiny and energy
from where it matters most—sensitive, rational thought about specific problems—
and instead, promotes a formulaic approach to ethical safeguarding.
Although other writers on vulnerability, such as Levine et al. (2004) and Luna
(2009), criticize this approach claiming generic guidance about paying “special atten-
tion” or giving “special consideration” to something is not useful, the same criticism
could also apply to an account that identifies specific categories or relies on some over-
riding concept. For example, if we try the specific category or context route (V3) so
that, say, we hold “the elderly” vulnerable, how would that guide our actions without
reference to established concerns about, for example, physical harms or exploitation?
The same holds true of (V4) accounts such as Goodin’s focus on vulnerability as being
open to harms to one’s interests, which then requires further analysis of “vital” needs.
The best that can be said for such accounts is that each provides something of a heuris-
tic, teaching anyone who wants to learn ways in which harms or wrongs might arise.
The importance and implications of these issues become apparent as we consider the
various cases in the rest of this chapter. The implications of (V2), the approach focused
on vulnerability as arising from the human condition, is that all are vulnerable, includ-
ing the police and immigration officials in Blight’s and McDougall’s cases, the public
health officials with responsibility for launching national programs to reduce Sudden
Infant Death Syndrome (SIDS) in the Jonas and Haretuku case, and the prison governor
in Christopher et al.’s case. This outcome demonstrates the key problem with this view.
The very concept of vulnerability ceases to have much meaning, although presumably
there might be a retreat to the thought that some individuals and populations are ‘more’
vulnerable than others, although it is unclear how this is to be specified.
Many of the cases could more obviously be used to endorse (V3), the approach
focused on specific groups, contexts, or categories. Many of these cases focus on
marginalized groups within society, such as prison inmates (Christopher et al.),
immigrants, asylum seekers, refugees (McDougall; Blight), substance abusers
(Christopher et al.), minority communities of various kinds (Bernard et al.; Blight;
Jonas and Haretuku), and the poor (Vergès et al.). This is a traditional, influential,
and powerful way of thinking about vulnerability. However, as stated previously,
this approach has its problems. Does it necessarily follow that if you belong to one
of these groups that you are vulnerable? You may well be at increased risk of harm
of various kinds if you belong to such groups. However, you might also be at
increased risk of harm as a recreational drug user, skydiver, or American football
player, although individuals belonging to such groups are not likely to be seen,
intuitively, as being necessarily vulnerable.
The more specific focus on providing a normative explanation for vulnerability pre-
sented in the work of writers such as Goodin (V4), is more useful, in that we can begin
to clearly identify subgroups that are at risk of harm to their vital interests (the girl fed
through a tube and unable to feel pain involved in a forced deportation case: Blight),
rather than just being routinely disadvantaged (the surrogate encouraged to take on that
role because of poverty: Vergès et al.) or at increased risk of harm due to the cultural
traditions or choices of their parents (Jonas and Haretuku). How should we think about
risk factors and vulnerability? Some will think of smoking around children (increasing
the risk of SIDS) as being an individual’s choice. Others will argue that it is unfair to
assume that it is always individuals that are responsible for such choices and the
resultant outcomes, as people may be addicted to nicotine or they may have become
smokers through the influence of norms within their social environment.
The advantage of the ‘moral-marker’ approach (V5) is that it allows us to dive
beneath the surface offered by the label of ‘vulnerability’ and offer more sophisticated
explanations for the situations described in the cases, as well as providing the oppor-
tunity to develop strong normative reasons to respond. For example, all of these cases
are about various kinds of injustice, disadvantage, and inequities in society, and their
impact on individual and community health. They are appropriate issues for those
working in public health to be concerned about precisely because they provide refer-
ence to the identification of various harms at the population-level, and many of the
solutions to these issues will have to come through collective and public action.
As the discussion of the different approaches to defining vulnerability consid-
ered above illustrate, most of the approaches to vulnerability do little more than
encourage us to engage in additional ethical scrutiny using already well recognized
and well understood moral concepts. The final ‘moral-marker’ approach (V5) sug-
gests that this is exactly what the concept should be used for, and nothing more.
References
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epidemiological and clinical research. Public Health Reviews 34(1): 71–83. http://www.publi-
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7.7 Case 1: Reducing Sudden Infant Death Syndrome

in a Culturally Diverse Society: The New Zealand Cot
Death Study and National Cot Death Prevention
Programme
Monique Jonas
School of Population Health, Faculty of Medical and Health Sciences
The University of Auckland
e-mail: m.jonas@auckland.ac.nz
Riripeti Haretuku
Maori SIDS and Research
MauriOra Associates
institutions.
7.7.1 Background
Sudden Infant Death Syndrome (SIDS) involves the death of apparently healthy
sleeping infants, usually within the first year of life. It is a diagnosis of exclusion,
that is, it denotes an unknown cause of death (Willinger et al. 1991; American
Academy of Pediatrics 2011). It is also known as cot or crib death and is classified
as a form of Sudden Death in Infancy (SUDI).
Unlike many public health issues, SIDS unites clinical and forensic considerations,
as this finding of cause of death can determine attribution of criminal (and moral)
responsibility. Police collect evidence and coroners assess the circumstances of the
death and release judgments. This is the method by which a SIDS death is determined.
Context heightens the ethical significance of SIDS diagnosis, research, and prevention.
In 1991, when the New Zealand Cot Death Study (NZCDS) commenced, New
Zealand’s rate of SIDS was high by international standards at 4 deaths per 1,000 live
births (Mitchell et al. 1997) compared, for example, to the Netherlands (1.3/1,000 in
1989) (de Jonge et al. 1989) and Hong Kong (0.3/1,000 in 1986–1987) (Lee et al.
1989). Within New Zealand, SIDS deaths occurred in the indigenous Māori popula-
tion at twice the rate of the non-Māori population (Mitchell et al. 1994). The reason
for this significant disparity was not well understood.
The NZCDS was the first national case-control study designed to identify risk
factors for SIDS. By comparing infants whose deaths were attributed to SIDS with
a representative sample of live births, within a year, the NZCDS had identified a
number of risk factors. The study confirmed an association between increased risk
of SIDS and lower socioeconomic status, along with a range of associated maternal
factors, including fewer years of education, younger age at first pregnancy, greater
number of previous pregnancies, and lower attendance at prenatal classes (Mitchell
et al. 1991). The NZCDS selected three risk factors to address among this range of
findings: lack of breast-feeding, maternal smoking, and placing infants to sleep in a
prone position (Mitchell et al. 1991).
The ensuing national prevention campaign focused on publicizing these risks,
which parents were seen as able to influence. These were categorized as ‘modifiable
risk factors.’ Many parents changed their practices in response to the campaign (Cowan
2010). Abandonment of the prone sleeping position was the most readily and widely
adopted measure and is credited with delivering the largest proportion of the national
reduction in SIDS rates (Mitchell et al. 1997). Factors that were less susceptible to
parental alteration were classified as ‘nonmodifiable risk factors.’ Nonmodifiable fac-
tors included the baby’s sex, the mother’s age, and the family’s socioeconomic status.
Analysis of the second year’s data revealed another risk factor: bed-sharing
(Mitchell et al. 1992). Bed-sharing was categorized as a modifiable risk factor, and
parents were advised to avoid sleeping on the same surface as their baby or allowing
others (for instance, other children) to do so. The study’s findings were immediately
fed into the prevention campaign.
Communicating with parents about this particular risk factor became more prob-
lematic than initially anticipated. The difficulties partly reflected a developing under-
standing about the subtle nature of bed-sharing risk. While early messages counselled
against all bed-sharing, subsequent findings prompted adjustments (Cowan 2010).
Now bed-sharing is not viewed as a significant risk unless coupled with maternal
smoking or with the baby’s bedmate being intoxicated or excessively tired. Other
factors such as the baby’s age, the site, and duration of bed-sharing have also been
identified as affecting the magnitude of risk. These considerations make it difficult to
summarize the risk in a way that is scientifically sound and that parents can easily
understand. Also, the prevention campaign took place against a backdrop of numer-
ous changes in prevailing thought since the 1950s about the causes of SIDS. These
changes were associated with changing advice about parental practices, which cre-
ated uncertainty within families about which advice should be followed.
The cultural significance attributed to bed-sharing meant that there were differ-
ent reactions among groups to advice not to bed-share. While bed-sharing is not
traditional among New Zealand European (Pākehā) families, it is firmly rooted in
Māori and Polynesian child-rearing practices (Tipene-Leach et al. 2000). In these
communities, bed-sharing is seen as positive and beneficial, promoting bonding
between mother and child and enabling mothers to comfort and care for their child
(Abel et al. 2001; Tipene-Leach et al. 2000). The message that bed-sharing is risky
had serious implications, then, for Māori and Polynesian child-rearing practices.
The early years of the SIDS prevention campaign succeeded in reducing the rate
of SIDS, but the tenor of the anti-bed-sharing message alienated many, particularly
indigenous Māori, consequently turning whānau (wider family networks) away
from SIDS prevention messages altogether (Stewart et al. 1993; Tipene-Leach et al.
2000; Cowan 2010). Some interpreted the campaign as blaming Māori for infant
deaths. After an infant death, the involvement of police, pathologists, and a coro-
ner’s court compounds overtones of culpability, intensifying the guilt and grief
associated with the loss of a child (Clarke and McCreanor 2006).
Several years after the ongoing SIDS prevention campaign was launched, rates
of SIDS among Māori remained disproportionately high. In 2009, the rate of SIDS
for Māori was 1.5 per 1,000 live births, compared with 0.6/1,000 for Pacific Peoples,
and 0.3/1,000 for Other, including Pākehā (Ministry of Health 2012).
Several modifiable risk factors for SIDS, including maternal smoking and bed-
sharing, are more prevalent in the Māori community. Māori parents less frequently
attend prenatal classes than non-Māori parents. Along with the modifiable factors,
many nonmodifiable factors are more likely to apply to Māori families, including
lower socioeconomic status, younger age of mother at first pregnancy, greater num-
ber of pregnancies, and fewer years of education (Mitchell et al. 1993). These con-
tributors to rates of SIDS among Māori do not receive the same level of scrutiny in
the media as modifiable parental practices, and prevention campaigns continue to
focus upon altering parental practices.
A sense of injustice and a perception that the state lacks a true commitment to
addressing the societal factors underpinning SIDS prevails in parts of the Māori
community. The prevention campaign’s focus upon discouraging bed-sharing con-
tributes to the community’s sense that the campaign undermines rather than sup-
ports traditional Māori practices. In particular, the coronial process—the
investigations into the cause of death, the invasive process of autopsy, and the slow
return of the body to whānau—cannot easily accommodate the deep-felt need of
whānau to complete the traditional Tangihanga process, the spiritual rituals and
burial proceedings following a death (Clarke and McCreanor 2006; McCreanor
et al. 2004). Nor is the high profile of the bed-sharing risk matched by a commitment
to tackle other risk factors, which may require more resources. Some have therefore
called for examination of the process by which risk factors are categorized as modi-
fiable or nonmodifiable (Tipene-Leach 2010; McManus et al. 2010).
The government has committed substantial resources to culturally appropriate
SIDS prevention for Māori and Polynesian families and is conducting trials of
appropriate supports for families to bed-share safely (Tipene-Leach 2010).
Meanwhile, criminal proceedings against Māori parents relating to the deaths of
their infants while co-sleeping continue to receive media attention (R v Tukiwaho
2012; APNZ 2013). No wonder, then, that the strong sense of parental responsibility
for SIDS deaths, where bed-sharing is a factor, remains. Although inequities under-
write the high exposure of Māori families to both modifiable and nonmodifiable risk
factors, both government-funded health promotion and media coverage of SIDS
remain focused on parental practice.
Following high-profile media coverage of the greater burden of SIDS among Māori,
new funding is available for a SIDS prevention campaign to reduce SIDS in Māori
and Polynesian families. Part of this funding is reserved for the generation of new
guidelines acceptable to Māori. There is also an opportunity to brief the Minister of
Health and the Minister of Social Development about measures that can reduce
rates of SIDS deaths among Māori infants.
1. Evidence suggests that several factors affect the magnitude of risk and that bed-
sharing in the absence of these factors does not significantly increase the risk of
SIDS. But the interplay of risks can be complex and difficult to communicate
effectively in a national campaign. Can a definitive “no bed-sharing” message be
defended, on ethical grounds, if it causes less confusion but overstates the risk to
some groups? What are the most important ethical considerations here?
2. What weight should be attributed to the cultural significance of bed-sharing

when generating guidelines, and why? Should risks that relate to culturally sig-
nificant parental practices, such as bed-sharing, be treated differently from risks
relating to practices that are not held to be culturally significant?
3. Māori and Polynesian families value bed-sharing because of the health and
social benefits they attribute to it. These benefits are not captured in studies
investigating SIDS risk. Should the health and social benefits attributed to
bed-sharing by families who practice it be accorded weight when formulating
guidelines? If so, how much weight? If not, why not?
4. Colonization has imposed and continues to impose an assault upon Māori cul-
ture. Anti-bed-sharing advice might be seen to extend that assault, privileging a
narrow range of health concerns. The inherent beliefs and practices that led
Māori to value bed-sharing, such as bonding between mother and child that pro-
motes strong social bonds, seems particularly worth preserving. How can respect
for Māori social practices and ways of viewing the world inform SIDS-related
health promotion? How much difference does the magnitude of the relevant
health risk make? If the risk is less serious, would you favor a different approach?
5. Consider how risk factors might be categorized as modifiable or nonmodifiable.
What role should fairness play in this process?
6. Consider the role guidelines might play in coroners’ investigations to identify
contributing factors to an infant death. Should this possibility be kept in mind
when guidelines are being drafted? Why? Why not?
7. Does parental responsibility require compliance with child health guidance?
How should parents evaluate conflicting or changing advice about risk?
8. Parents can control some risk factors for SIDS, but others involve broader soci-
etal issues, such as socioeconomic status. Does social justice require that preven-
tion campaigns targeting parental practices be coupled with efforts to tackle
social and economic disparities and inequities? Who should be responsible for
ensuring that this is the case? What should researchers do when they identify a
parental practice as risky if resourcing for broader action is not forthcoming?
Acknowledgements Many thanks to Carol Everard, Dr. Sally Abel, and Dr. David Tipene-Leach
for their patient and generous reflections and sharing of knowledge about SIDS in New Zealand.
Thanks also to Professor Ed Mitchell, Professor Robert Scragg, and Alistair Stewart for their major
contributions.
References
Abel, S., J. Park, D. Tipene-Leach, S. Finau, and M. Lennan. 2001. Infant care practices in New
Zealand: A cross-cultural qualitative stud. Social Science & Medicine 53(9): 1135–1148.
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other sleep-related infant deaths: Expansion of recommendations for a safe infant sleeping
environment. Pediatrics 128(5): 1030–1039. doi:10.1542/peds.2011-2284.
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nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10871515. Accessed 1 June 2015.
Clarke, E., and T. McCreanor. 2006. He wahine tangi tikapa …: Statutory investigative processes
and the grieving of Maori families who have lost a baby to SIDS. Kōtuitui: New Zealand
Journal of Social Sciences Online 1: 25–43.
Cowan, S. 2010. Creating change: How knowledge translates into action for protecting babies
from sudden infant death? Current Pediatric Reviews 6: 86–94.
de Jonge, G.A., A.C. Engelberts, A.J.M. Koomen-Liefting, and P.J. Kostense. 1989. Cot death and
prone sleeping position in The Netherlands. British Medical Journal 298(6675): 722.
Lee, N.N.Y., Y.F. Chan, D.P. Davies, E. Lau, and D.C.P. Yip. 1989. Sudden infant death syndrome
in Hong Kong: Confirmation of low incidence. British Medical Journal 298: 721.
McCreanor, T., D. Tipene-Leach, and S. Abel. 2004. The SIDS care-workers study: Perceptions of
the experiences of Maori SIDS families. Social Policy Journal of New Zealand 23: 154–166.
McManus, V., S. Abel, T. McCreanor, and D. Tipene-Leach. 2010. Narratives of deprivation:
Women’s life stories around Maori sudden infant death syndrome. Social Science & Medicine
71(3): 643–649.
Ministry of Health. 2012. Fetal and infant deaths 2008 and 2009. Wellington: Ministry of Health.
Mitchell, E., R. Scragg, A.W. Stewart, D.M. Becroft, B. Taylor, and R.P. Ford. 1991. Results from
the first year of the New Zealand cot death study. New Zealand Medical Journal 104(906):
71–76.
Mitchell, E.A., B.J. Taylor, R.P. Ford, et al. 1992. Four modifiable and other major risk factors for
cot death: The New Zealand study. Journal of Paediatrics and Child Health
28(suppl 1): S3–S8.
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infant death syndrome in New Zealand. British Medical Journal 306(6869): 13–16.
Mitchell, E.A., J.M. Brunt, and C. Everard. 1994. Reduction in mortality from sudden infant death
syndrome in New Zealand: 1986–92. Archives of Disease in Childhood 70(4): 291–294.
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following the prevention campaign in New Zealand: A prospective study. Pediatrics 100(5):
835–840.
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and UK cot death campaigns. Acta Paediatrica Supplement 82: 119–123.
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Medical Journal 123(1309): 137–138.
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Implications for health messages, infant care services and SIDS prevention in Maori communi-
ties. Pacific Health Dialog 7(1): 29–37.
Willinger, M., L.S. James, and C. Catz. 1991. Defining the sudden infant death syndrome (SIDS):
Deliberations of an expert panel convened by the National Institute of Child Health and Human
Development. Pediatric Pathology 11(5): 677–684.
7.8 Case 2: Medical Tourism and Surrogate Pregnancy:

A Case of Ethical Incoherence
Claude Vergès
Children’s Hospital
University of Panama
Panama City, Panama
e-mail: vergeslopez@hotmail.com
Jorge Rodríguez
Sexual and Reproductive Health, Ministry of Health
Panama City, Panama
Panamanian Family Medicine Association
Panama City, Panama
Raquel de Mock
Adult Health Program, Ministry of Health, University of Panama
Panama City, Panama
institutions.
7.8.1 Background
Advances in biotechnology regularly generate novel ethical challenges that fall

between the cracks of safeguards designed for conventional cases. Innovations—
especially in reproductive technologies—can even create new classes of vulnerable
people. Such novel cases often force us to thoroughly reexamine ethical safeguards
and reveal the legal and ethical gaps.
Panama, like most Latin American countries, divides its health care system into
public and private systems. Public insurance covers roughly 81 % of the population
(Contraloria de la Republica de Panamá 2012). Families lacking permanent work
and unable to afford insurance can find public assistance for health services through
the Ministry of Health (MoH). The MoH by law regulates most health research and
health services, including regulation and supervision of hospitals and public and
private clinics (Asamblea Nacional de Panamá 1947). The private system, although
legally supervised by the Ministry of Commerce, exists mostly free of external con-
trol and relies heavily on self-regulation. Medical doctors, after initial MoH certifi-
cation, are no longer monitored (Decreto de Gabinete 1970).
Like the certification process, the ethical guidance that applies to doctors is not
overseen. Although a Panamanian Medical College code of ethics has applied to
doctors since 2009, its ethics committee meets only to consider malpractice charges
brought against doctors (Colegio Médico 2012). Independent associations for medi-
cal specialties exist, but they focus on academic and social matters, not on public
health issues. Only recently have some associations begun to discuss the ethical,
legal, and social implications of their specialty-related health topics such as trans-
plantation, blood banks, storage of biological tissues, sale of organs for transplant,
and rights and obligations of organ donors and recipients.
In response to a growing burden of maternal mortality, sexually transmitted dis-
eases, and adolescent pregnancy, the World Health Organization in 2000 began a
sexual and reproductive health program (World Health Organization 2000). This
initiative prompted the Panamanian government to begin covering infertility prob-
lems and permitting the public health care system to treat married couples (Ministerio
de Salud 2000). Although the MoH did not include in-vitro fertilization (IVF) and
surrogate pregnancy in this program, a public institution, the Gorgas Institute for
Health Research, announced in 2011 that it would launch an IVF program in 2013
for couples with limited resources (Soto 2012). The government, however, was
silent about IVF, so the regulations governing IVF remain unclear. However, a law
governing organ transplantation, which permits donation of living cells, comes clos-
est to offering legal guidance for IVF. This law requires the donor and recipient to
give written consent but does not permit the donor to receive compensation. Nor
does it protect the health and confidentiality of the donor and recipient or offer treat-
ment of medical complications (Asamblea Nacional de Panamá 2010). Nowhere,
does this law or any other address surrogacy.
Medical tourism is a new and growing industry in Central America, where a
quarter of the world’s medical tourism occurs (Martinez 2011). At 16 %, Costa Rica
commands the largest industry share in Central America; but according to estimates
of its National Science and Technology secretary, Panama will achieve a 12 % share
in 2015 through services offered by its four private hospitals. At these hospitals,
medical tourism may represent nearly 20 % of the patients being treated. The
patients, who come mainly from Canada and the United States, usually seek surgery
for orthopedic problems, infertility, and cardiac disease. Although private advertise-
ments for medical tourism have been appearing since 2007 (Sbwire 2013), lawmak-
ers have not yet created a national legal framework to address the issue.
Couples from neighboring countries or the United States come to Panama seek-
ing infertility treatment because it is inexpensive, is largely unregulated, and per-
formed by Panamanian doctors noted for technical ability. Moreover, anyone who
travels to Panama for treatment is entitled to receive it. IVF using fertilized eggs
from anonymous donors has become standard practice, but surrogacy is not offi-
cially offered. No medical or legal problems with IVF surfaced until 2011 when the
Panamanian MoH was asked to weigh in on a high-profile case of an abandoned
child born with severe birth defects to a Panamanian woman acting as a surrogate
for a foreign couple.
A Panamanian woman, who was married with two children, had a primary school
education. She worked in her own home but was experiencing economic difficulties
because her husband could not find permanent employment. Why she agreed to sur-
rogacy is unknown, but presumably economic considerations played a major role.
Because her first two pregnancies had presented no problems, she signed a surro-
gacy contract to carry the fertilized egg of a married couple who had traveled to
Panama seeking surrogacy services. Little is known about how the foreign couple
and the Panamanian woman came to know each other, because no lawyer
participated in this transaction. Nor did the surrogate’s husband learn of the transac-
tion until after she had signed the contract. Why no one thought to include the hus-
band is a mystery. After signing the informed consent form, the surrogate was
inseminated in a private clinic in Panama. Doctors involved in the case state that
they followed medical recommendations and obtained the informed consent of the
surrogate and the egg donor. Neither the procedure nor the pregnancy presented any
problems, but the surrogate unexpectedly died after severe complications developed
during delivery. These complications, which also caused hypoxia and convulsions
in the newborn, left him with severe cerebral paralysis. As a result of his birth
defects, he will never walk or speak and will require care for the remainder of his
life.
The couple rejected the child, arguing that the contract specified “a healthy
child.” The husband of the Panamanian surrogate also rejected the child claim-
ing it was neither his wife’s, nor his, especially as he had not participated in the
contract. He also pleaded that he now had to cope with his wife’s death and
raising two motherless children. Appealing to the MoH, the clinic sought state
custody of the child. The MoH offered medical assistance, but it declined to
accept long-term responsibility for the child. Instead, the MoH charged a ethics
panel to examine the case and, pending its outcome, sent the child to a religious
orphanage.
The ethics panel has been charged not only with making a ruling on this case, but
in recommending measures to regulate surrogacy in the future, particularly cases
involving medical tourism.
1. In the context of surrogacy and medical tourism, who is responsible for raising
this child, and who should pay for his care and upbringing? What role should
government and professional associations play in these cases? What is the
responsibility of doctors involved in such practices?
2. What measures should the ethics panel recommend to protect vulnerable women
in the future who have agreed to surrogacy?
3. What ethical basis could justify compensation for surrogates or their families in
the case of death or injury to the surrogate?
4. What measures should the ethics panel recommend for protecting medically
compromised and abandoned infants when surrogacy-involved pregnancy or
delivery goes radically wrong? How should informed consent forms be modified
to anticipate such outcomes?
5. Do cases of medical tourism require international regulation of medical tech-
nologies? If not, why not? If so, how should the panel’s ethical arguments be
incorporated into legal agreements between countries to guarantee the protection
of vulnerable populations?
Acknowledgments To Sandra Lopez Vergès and Elizabeth King for their English edits.
References
Asamblea Nacional de Panamá. 1947. Por la Cual se Aprueba el Código Sanitario. Ley 66 de 10
de noviembre de 1947. Gaceta Oficial, 10467. https://www.panamaemprende.gob.pa/descar-
gas/Ley%2066%20de%201947%20-%20Codigo%20Sanitario.pdf. Accessed 13 Aug 2013.
Asamblea Nacional de Panamá. 2010. General de Transplantes de Componentes Anatómicos. Ley
3 de 2 agosto 2010. Gaceta Oficial, 26468-B. http://www.gacetaoficial.gob.pa/
pdfTemp/26468_B/25676.pdf. Accessed 13 Aug 2013.
Colegio Médico. 2012. Código de Ética Panama 2003–2011. http://www.hn.sld.pa/sites/default/
files/upload/CÓDIGO%20DE%20ÉTICA%20COLEGIO%202011.pdf. Accessed 13 Aug
2013.
Contraloria de la Republica de Panamá. 2012. Cuadro 421–02. Población Protegida por la Caja
de Seguro Social Asegurados y Dependientes, Según Provincia y Comarca Indígena: Año 2011.
h t t p : / / w w w. c o n t r a l o r i a . g o b. p a / i n e c / P u b l i c a c i o n e s / P u b l i c a c i o n e s . a s p x ? I D _
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Accessed 13 Aug 2013.
Decreto de Gabinete. 1970. Por el Cual se Establecen los Requisitos para Obtener la Idoneidad y
el Libre Ejercicio de la Medicina y Otras Profesiones Afi nes. 196 del 24-06-1970. Gaceta
Oficial 16639. http://docs.panama.justia.com/federales/decretos-de-gabinete/decreto-degabi-
nete-196-de-1970-jul-3-1970.pdf. Accessed 13 Aug 2013.
Martinez, J.C. 2011. El Turismo Médico en Panama. http://www.panamaqmagazine.com/2011_
May/Medical_tourism_QT_2011_pg1_spanish.html. Accessed 13 Aug 2013.
Ministerio de Salud. 2000. Programa de Salud Sexual y Reproductiva. http://www.minsa.gob.pa/
programa/programa-salud-sexual-y-reproductiva. Accessed 13 Aug 2013.
Sbwire. 2013. PlanetHospital announced today that it has started offering surrogacy in Mexico
forstraight and gay clients. http://www.sbwire.com/press-releases/planethospital-announced-
today-that-it-has-started-offering-surrogacy-in-mexico-for-straight-and-gay-clients-219420.
htm. Accessed 13 Aug 2013.
Soto, G. 2012. Instituto Gorgas aplaza proyecto de fertilidad. Panama America http://www.pana-
maamerica.com.pa/content/instituto-gorgas-aplaza-proyecto-de-fertilidad. Accessed 4 June
2015.
World Health Organization (WHO). 2000. Programa de Salud Sexual y Reproductiva. http://www.
who.int/reproductivehealth/es/. Accessed 13 Aug 2013.
7.9 Case 3: Compulsory Treatment for Injection Drug Use

after Incarceration
Paul Christopher
Department of Psychiatry and Human Behavior, Warren Alpert Medical School
Brown University
Providence, RI, USA
e-mail: paul_christopher@brown.edu
Dora M. Dumont
Division of Community, Family Health and Equity
Rhode Island Department of Health
Providence, RI, USA
Josiah D. Rich
Department of Medicine, Warren Alpert Medical School
Brown University
Providence, RI, USA
institutions.
7.9.1 Background
Injection drug use is a major public health problem, with an estimated 3.5 million
users in the United States (Armstrong 2007) and 15.9 million users worldwide
(Mathers et al. 2008). Between 24 and 36 % of U.S. adults addicted to heroin pass
through the criminal justice system each year (Rich et al. 2005). Compared with the
general population, injection drug users have higher rates of HIV, tuberculosis, hep-
atitis B and C, and sexually transmitted diseases (Baussano et al. 2010; Nelson et al.
2011; Weinbaum et al. 2005). Injection drug use contributes to correctional and
community-level transmission of these conditions and threatens public safety
because users frequently engage in criminal behaviors to support their drug use.
In the United States, more than two million people are incarcerated (Glaze and
Parks 2012), and an estimated 70–80 % of U.S. inmates have at least one substance
abuse problem (Karberg and James 2005; National Center on Addiction and
Substance Abuse at Columbia University 1998). At least 40 % of state and federal
inmates injected drugs in the month before their arrest (National Center on Addiction
and Substance Abuse at Columbia University 1998). Moreover, 95 % of drug users
return to drug use within 3 years of release from prison (Marlowe 2006). Compared
with the general population, prisoners are nearly 13 times more likely to die of any
cause in the 2 weeks after their release and 129 times more likely to die from an
overdose (Binswanger et al. 2007).
Rates of incarceration are also substantially higher among minority groups, with
African American males being more than 6 times as likely, and Hispanics males more
than 2.5 times as likely, to be incarcerated than white males (Carson and Sabol 2012).
African Americans and Hispanics also experience higher rates of conviction for drug-
related offenses than whites (Carson and Sabol 2012) despite comparable rates of
injection drug use between whites and Hispanics and lower rates among African
Americans (Substance Abuse and Mental Health Services Administration 2007).
Although inmates make up only 0.8 % of the U.S. population, about 22–31 % of
Americans with HIV, 40 % with tuberculosis, and 29–43 % with chronic hepatitis C
pass through the correctional system each year (Hammett et al. 2002; Weinbaum
et al. 2005). In the general community and prison population, minority groups bear a
disproportionately high burden of new HIV infections and hepatitis, particularly
among injection drug users (Blankenship et al. 2005; Centers for Disease Control and
Prevention 2013; Estrada 2002). Successful strategies to limit the spread of infectious
disease, therefore, need to include interventions with effective substance abuse treat-
ment that target minority groups, particularly anyone with a criminal background.
Correctional programs that link prisoners to treatment for substance abuse and
related illnesses upon reentry to the community may reduce risky behaviors that
contribute to high post-release mortality rates, bring much-needed care to a vulner-
able and medically and socially disenfranchised population, and interrupt transmis-
sion of infectious diseases to the broader community. However, despite the lack of
widespread access to such services during and after incarceration, perhaps the great-
est obstacle to effectively treating drug users is poor motivation. In the United
States, 95 % of people with untreated substance abuse fail to recognize the need for
treatment (Substance Abuse and Mental Health Services Administration 2012).
When people with substance abuse do present for care, it is often because of exter-
nal, coercive pressure (Fagan 1999). Indeed, coercive strategies have long been used
for treating individuals with substance abuse who do not otherwise seek help (Nace
et al. 2007; Sullivan et al. 2008). One common argument in favor of coerced treat-
ment is that it restores autonomy to people who have lost their ability to control their
addiction (Caplan 2006). Another reason coercion may be necessary, in at least the
initiation phase of treatment, is because permanent cognitive deficits can result from
extended drug use (Sullivan et al. 2008).
The World Health Organization has concluded that legally coerced treatment is
justified if due process and effective and humane treatment are assured (United
Nations 2010). Still, although compulsory substance abuse treatment is frequently
used for pretrial offenders, studies find little evidence that it reduces subsequent drug
use (Perry et al. 2009). Indeed, findings are largely mixed about whether legally
coerced substance abuse treatment—irrespective of a person’s criminal justice
involvement—works in different settings (Klag et al. 2005). Similarly, there are
inconsistent findings on the effectiveness of coerced drug treatment in the U.S. crimi-
nal justice setting and concerns about a lack of experimental controls in those studies
that suggest relative efficiency (Hough 2002; Marlowe 2006; Zhang et al. 2013).
Several reviews conclude that coerced treatment is certainly more effective than
no treatment (Hough 2002; Kelly et al. 2005; Marlowe 2006). Emerging data sug-
gest that coercive substance abuse treatment for parolees reduces rates of reincar-
ceration; however, data are lacking on whether other clinical outcomes are improved
(Zhang et al. 2013).
You serve as the director of Substance Abuse Services (SAS) in a western state in
the United States. Rates of substance abuse, particularly injection drug use, are
higher than the national average. Several large cities in your state have among the
highest rates in the country. SAS shares data and conducts collaborative research
with the Department of Correction (DOC) and other state agencies within the
Department of Health (DOH), of which SAS is a branch. Your research efforts have
identified needle sharing among former prisoners, most of whom are members of
minority groups, as the source of most new community cases of HIV and hepatitis
B and C. You also found that more than half of these infected prisoners do not con-
tinue treatment when released and have high rates of reincarceration.
Following aggressive implementation of a statewide prison-based screening and
treatment program for infectious diseases, your state has experienced a marked drop
in prevalence of these diseases among prisoners. However, for three straight years
rates have increased steadily and disproportionately among injection drug users,
with rates rising faster among minorities.
To confront this problem, you have successfully worked with representatives from
the DOC to offer methadone maintenance programs to opioid-dependent prisoners
and have hired reentry specialists to help parolees get treatment for substance abuse
and infectious diseases upon release. Unfortunately, to date, only 10–15 % of recently
released prisoners who are eligible for these voluntary services have used them.
The governor has issued a directive to think creatively and foster better interagency
collaboration so programs can be developed to reach the other 85–90 % of recently
released prisoners who inject drugs or have infectious illnesses. You have been
appointed to a task force along with other high-level representatives of state agencies,
including the DOH, DOC, Department of Parole, and Department of Mental Health,
to identify and implement other potential solutions. One suggested policy option is to
establish compulsory post-release substance abuse treatment as a condition of parole
that would be linked with voluntary infectious disease screening and treatment. Your
own interagency research suggests a high rate of transmission of HIV and hepatitis
B and C from needle sharing with former prisoners who have been incarcerated multiple
times and have not been treated successfully. Accordingly, the target population would
be recently released prisoners who have two or more incarcerations and at least one
drug-related conviction, a history of injection drug use, and either HIV or hepatitis.
1. Given your research findings that most new community cases of HIV and hepatitis B
and C result from needle sharing with former prisoners, most of whom are minorities,
how would you defend or object to this policy proposal given it will disproportion-
ately subject minority groups to compulsory treatment as a condition of their parole.
2. If such compulsory drug treatment for prison releases is shown to have little
impact on community rates of infectious disease, what effect would the program
need to have on recently released prisoners for you to support its use? Given a
parolee’s vulnerable status in society, would you support the program if it
reduced criminal recidivism alone? If not, what other outcomes are important to
you and why? Would outcomes have to be clinical, or could outcomes reflect a
parolee’s well-being or functioning in society?
3. What are the ethical implications of implementing (and funding) compulsory treat-
ment for released prisoners in a community where availability of (or funding for)
voluntary treatment is currently inadequate? To what extent does lack of access to

voluntary services (and other social determinants of health such as income and
education) contribute to the need for compulsory treatment, particularly among
people who are vulnerable to substance use, incarceration, and infectious disease?
4. Public resources and facilities are already in place to provide involuntary treat-
ment for certain health conditions (e.g., tuberculosis and mental illness). Suppose
that some mental health advocates object to the proposal to introduce compul-
sory drug treatment by arguing that it would divert funds from treating people
with serious mental illness, including those with criminal histories. People with
serious mental illness, they contend, constitute a far more vulnerable prison
group, many of whom have co-occurring substance abuse problems. If true, how
will your thinking about the case be influenced? Why?
5. Suppose someone argues that the compulsory treatment program under consid-
eration is another example of society’s punitive approach to managing substance
abuse. To what extent do you agree or disagree with this argument? Why?
References
Armstrong, G.L. 2007. Injection drug users in the United States, 1979–2002: An aging population.
Archives of Internal Medicine 167(2): 166–173.
Baussano, I., B.G. Williams, P. Nunn, M. Beggiato, U. Fedeli, and F. Scano. 2010. Tuberculosis
incidence in prisons: A systematic review. PLoS Medicine 7(12): e1000381.
Binswanger, I.A., M.F. Stern, R.A. Deyo, et al. 2007. Release from prison—A high risk of death
for former inmates. New England Journal of Medicine 356(2): 157–165.
Blankenship, K.M., A.B. Smoyer, S.J. Bray, and K. Mattocks. 2005. Black-white disparities in
HIV/AIDS: The role of drug policy and the corrections system. Journal of Health Care for the
Poor and Underserved 16(4 suppl B): 140–156.
Caplan, A.L. 2006. Ethical issues surrounding forced, mandated, or coerced treatment. Journal of
Substance Abuse Treatment 31(2): 117–120.
Carson, E.A., and W.J. Sabol. 2012. Prisoners in 2011. Bureau of Justice Statistics. NCJ 239808.
Washington, DC: U.S. Department of Justice, Office of Justice Programs. http://www.bjs.gov/
content/pub/pdf/p11.pdf. Accessed 7 May 2013.
Centers for Disease Control and Prevention. 2013. HIV surveillance report: Diagnoses of HIV
infection in the United States and dependent areas, 2011, vol. 23. http://www.cdc.gov/hiv/
library/reports/surveillance/2011/surveillance_Report_vol_23.html. Accessed 21 May 2015.
Estrada, A.L. 2002. Epidemiology of HIV/AIDS, hepatitis B, hepatitis C, and tuberculosis among
minority injection drug users. Public Health Reports 117(suppl 1): S126–S134.
Fagan, R. 1999. The use of required treatment for substance abusers. Substance Abuse 20(4):
249–261.
Glaze, L.E., and E. Parks. 2012. Correctional populations in the United States, 2011. Bureau of
Justice Statistics Bulletin NCJ 239972. http://www.bjs.gov/content/pub/pdf/cpus11.pdf.
Accessed 23 Jan 2014.
Hammett, T.M., M.P. Harmon, and W. Rhodes. 2002. The burden of infectious disease among
inmates of and releases from US correctional facilities, 1997. American Journal of Public
Health 92(11): 1789–1794.
Hough, M. 2002. Drug user treatment within a criminal justice context. Substance Use & Misuse
37(8–10): 985–996.
Karberg, J.C., and D.J. James. 2005. Substance dependence, abuse, and treatment of jail inmates,
2002. Bureau of Justice Statistics: Special Report. NCJ 209588. Washington, DC: U.S.
Department of Justice, Office of Justice Programs. http://www.bjs.gov/content/pub/pdf/
sdatji02.pdf. Accessed 7 May 2013.
Kelly, J.F., J.W. Finney, and R. Moos. 2005. Substance use disorder patients who are mandated to
treatment: Characteristics, treatment process, and 1- and 5-year outcomes. Journal of Substance
Abuse Treatment 28(3): 213–223.
Klag, S., F. O’Callaghan, and P. Creed. 2005. The use of legal coercion in the treatment of sub-
stance abusers: An overview and critical analysis of thirty years of research. Substance Use &
Misuse 40(12): 1777–1795.
Marlowe, D.B. 2006. Depot naltrexone in lieu of incarceration: A behavioral analysis of coerced
treatment for addicted offenders. Journal of Substance Abuse Treatment 31(2): 131–139.
Mathers, B.M., L. Degenhardt, B. Phillips, et al. 2008. The global epidemiology of injecting drug
use and HIV among people who inject drugs: A systematic review. Lancet 372(9651):
1733–1745.
Nace, E.P., F. Birkmayer, M.A. Sullivan, et al. 2007. Socially sanctioned coercion mechanisms for
addiction treatment. The American Journal on Addictions 16(1): 15–23.
National Center on Addiction and Substance Abuse at Columbia University. 1998. Behind bars:
Substance abuse and America’s prison population. http://www.casacolumbia.org/addictionre-
search/reports/substance-abuse-prison-system-2008. Accessed 7 May 2013.
Nelson, P.K., B.M. Mathers, B. Cowie, et al. 2011. Global epidemiology of hepatitis B and hepa-
titis C in people who inject drugs: Results of systematic reviews. Lancet 378(9791): 571–583.
Perry, A.E., Z. Darwin, C. Godfrey, et al. 2009. The effectiveness of interventions for drug-using
offenders in the courts, secure establishments and the community: A systematic review.
Substance Use & Misuse 44(3): 374–400.
Rich, J.D., A.E. Boutwell, D.C. Shield, et al. 2005. Attitudes and practices regarding the use of
methadone in US state and federal prisons. Journal of Urban Health 82(3): 411–419.
Substance Abuse and Mental Health Services Administration. 2007. The NSDUH report:
Demographic and geographic variations in injection drug use. Rockville: Substance Abuse
and Mental Health Services Administration. http://www.oas.samhsa.gov/2k7/idu/idu.pdf.
Substance Abuse and Mental Health Services Administration. 2012. Results from the 2011
National Survey on Drug Use and Health: Summary of national findings, NSDUH Series H-44,
HHS Publication No. (SMA) 12–4713. Rockville: Substance Abuse and Mental Health
Services Administration. http://www.samhsa.gov/data/nsduh/2k11results/nsduhresults2011.
htm. Accessed 7 May 2013.
Sullivan, M.A., F. Birkmayer, B.K. Boyarsky, et al. 2008. Uses of coercion in addiction treatment:
Clinical aspects. American Journal on Addictions 17(1): 36–47.
United Nations. 2010. From coercion to cohesion: Treating drug dependence through health care,
not punishment. New York: United Nations Office on Drugs and Crime. http://www.unodc.org/
docs/treatment/Coercion_Ebook.pdf. Accessed 7 May 2013.
Weinbaum, C.M., K.M. Sabin, and S.S. Santibanez. 2005. Hepatitis B, hepatitis C, and HIV in
correctional populations: A review of epidemiology and prevention. AIDS
19(suppl 3): S41–S46.
Zhang, S.X., R.E. Roberts, and A.E. Lansing. 2013. Treatment or else: Coerced treatment for drug
involved California parolees. International Journal of Offender Therapy and Comparative
Criminology 57(7): 766–791.
7.10 Case 4: Unanticipated Vulnerability: Marginalizing

the Least Visible in Pandemic Planning
Carrie Bernard
Department of Family and Community Medicine
Toronto, ON, Canada
Department of Family Medicine McMaster University
Hamilton, ON, Canada
e-mail: carrie.bernard@utoronto.ca
Maxwell J. Smith
Toronto, ON, Canada
Frank Wagner
Department of Family and Community Medicine, Faculty of Medicine
Toronto, ON, Canada
Toronto Central Community Care Access Centre and
the University of Toronto Joint Centre for Bioethics
Toronto, ON, Canada
7.10.1 Background
Influenza is a common respiratory pathogen that affects the nose, throat, bronchi
and lungs. The virus is spread through droplets and small particles when people
cough or sneeze. Though influenza regularly affects people worldwide, the emer-
gence of novel influenza virus subtypes has the potential to cause a pandemic (World
Health Organization [WHO] 2008). In such a case, the population’s low immunity
can lead the virus to spread rapidly with high rates of sickness and death. Although
no one can predict when a pandemic will strike, attack rates of 25–45 % have been
suggested with mortality rates varying greatly depending on the virulence of the
strain (WHO 2010).
With a virulent strain of pandemic influenza, many patients will become extremely
ill, and their need for specialized treatment and intensive care may exceed resources.
In addition, front-line health care workers will face great risk of becoming ill, dwin-
dling human resources further and straining the health care system (WHO 2008;
University of Toronto Joint Center for Bioethics 2005). In anticipation of these
human and physical resource shortages, hospitals, public health agencies, and states
have created plans to prepare for an influenza pandemic. Such plans typically include
health services, public health measures, priority setting, and resource allocation and
usually direct surveillance, preparedness, and response (WHO 2010).
Pandemic plans typically aim to minimize serious illness and overall deaths, but
more comprehensive plans also refer to special needs of vulnerable groups. The
term “vulnerable,” however, often is left undefined, and, if specified (e.g., the
elderly), it usually refers to increased biological or medical risk of succumbing to or
transmitting pandemic influenza (Uscher-Pines et al. 2007). Few plans refer to vul-
nerability in social or economic terms (Uscher-Pines et al. 2007). This lack of speci-
ficity raises questions about whether (and how) special consideration ought to differ
for vulnerable conditions, such as being homeless, being immunocompromised, or
living in a remote community. Even when plans do mention such vulnerabilities,
have decision makers or practitioners consulted the people in these categories about
their needs in such situations? (Uscher-Pines et al. 2007) More importantly, has
anyone reconciled the aim of minimizing sickness and death with the oft competing
aim of meeting the needs of the vulnerable?
Meeting the needs of the most vulnerable while being mindful of health equity
and social justice has been a long-standing tradition of public health (Beauchamp
1976; Krieger and Birn 1998). In particular, public health interventions targeting
the social determinants of health have been heralded as an effective way to combat
systemic inequities that lead to disparities in health outcomes (Wilson 2009).
However, some challenge the notion of vulnerability as a static condition that can
be predefined. Broadly defined categories of vulnerability can exclude people not
traditionally seen as vulnerable (such as health care workers), while including peo-
ple thought to be vulnerable who, with the right supports, can actually participate
in the emergency response (e.g., retired older adults) (Mastroianni 2009).
Considering and doing something about the context-specific needs of those who
might be most vulnerable during a pandemic, can easily become a complex, ethi-
cally fraught task.
A further complication is that the interventions taken in response to a pandemic
can unintentionally render some people more vulnerable (Mastroianni 2009). Most
pandemic influenza plans, for example, seem to focus on hospitals, directing atten-
tion to managing intensive care unit (ICU) bed and equipment shortages and distrib-
uting resources in high-acuity settings. Such plans often call for redeploying workers
from community settings to hospital settings. Because many of these workers
already work part-time in the community and hospital sectors, this option is appeal-
ing. But if workers are shifted from community health care settings to hospitals,
people in the community who depend on these workers may become vulnerable
from the intervention.
It has been 1 week since the World Health Organization officially declared the pres-
ence of an influenza pandemic. Person-to-person spread has been confirmed in sev-
eral Canadian cities, and emergency rooms in your large metropolitan city overflow
with influenza patients. Because routine cases usually fill the medical floors and
intensive care units to capacity, there is concern that the surge of influenza admis-
sions will overwhelm resources. To set priorities and possibly reallocate resources
within the health care system, the regional health authority has called a meeting in
anticipation of the surge in admissions. As the lead of the local health emergency
management program, you are asked to attend.
A couple of hours before the meeting, you listen to a call on your answering
machine from Julia, a friend and the director of the local community care access
center (home care agency). This is the largest center in the region, employing 600
and subcontracting 20,000 health and community service workers through other
agencies. Professional services that are subcontracted include in-home nursing,
occupational therapy, physiotherapy, social work, speech and language therapy, and
nutritionists; nonprofessional services include personal support workers and health
care aids and attendants who assist with activities of daily living.
Having become aware of the upcoming meeting with the regional health
authority, Julia wonders why no one from the community-based organizations
that care for people in home settings has been asked to attend. She appreciates the
media focus on the available ventilators and ICU beds in local hospitals, but she
is concerned with the lack of attention on vulnerable populations in the community.
She has heard rumors of plans to reallocate some nursing and personal support
workers from community settings to acute care hospitals and asks if officials have
considered that such a move may require some people, who normally manage
their illness at home, to be hospitalized. Convinced that someone representing the
community should attend priority-setting discussions, she urges you to advocate
for such a presence.
Thinking on various levels about how you would respond to the message even
as you plan for the meeting, you are particularly struck by how such decisions
could adversely affect Julia herself. Her multiple sclerosis is serious enough to
require the daily assistance of a personal support worker to help her get from
home to her office.
1. In what ways does this case challenge conventional notions of who might be
considered vulnerable during a pandemic?
2. What does Julia’s exclusion from the meeting say about the attitude towards
vulnerable populations at the administrative level?
3. How might a decision to shift financial and personnel resources from the com-
munity to the hospital setting deepen the health and social inequities that many
vulnerable populations already face?
4. Would it be fair for Julia to ask her community workers to work more hours
because the needs of the community have increased? What if the workers feel
safer working away from the gravely ill at the hospital and prefer to increase
community work at the expense of hospital work?
5. If the workers remain in their communities with their patients, it could mean they
are able to help fewer members of the population than if they attended their shifts
at the hospital. What is more important, treating more people or giving priority
to the vulnerable or less privileged?
6. Do those who develop pandemic plans have a responsibility to identify people
whose vulnerability might increase during a pandemic? If so, how should plan-
ners identify these people?
7. The document you received before the meeting indicated that one of the discus-
sion topics will be priority setting, particularly the scarce resource of ventilators.
The document proposes that a physical disability should disqualify a person
from having access to a ventilator. How do you balance the need for rationing
scarce acute care resources, like ventilators, with social justice values that advo-
cate for the respect and consideration of those who are vulnerable due to system-
atic social disadvantage? How will you discuss this matter with Julia?
8. In light of Julia’s message, how would you begin to identify systemic barriers
that limit the inclusion of vulnerable populations in planning for a pandemic?
How would you involve these populations in determining if barriers exist that
may significantly limit their access to essential health services available to other
populations during a pandemic?
References
Beauchamp, D.E. 1976. Public health as social justice. Inquiry 13(1): 3–14.
Krieger, N., and A.E. Birn. 1998. A vision of social justice as the foundation of public health:
Commemorating 150 years of the spirit of 1848. American Journal of Public Health 88(11):
1603–1606.
Mastroianni, A.C. 2009. Slipping through the net: Social vulnerability in pandemic planning.
Hastings Center Report 39(5): 11–12.
University of Toronto Joint Centre for Bioethics. 2005. Stand on Guard for Thee: Ethical consid-
erations in preparedness planning for pandemic influenza. http://jcb.utoronto.ca/people/docu-
ments/upshur_stand_guard.pdf. Accessed 24 June 2015.
Uscher-Pines, L., P.S. Duggan, J.P. Garoon, R.A. Karron, and R.R. Faden. 2007. Planning for an
influenza pandemic: Social justice and disadvantaged groups. Hastings Center Report 37(4):
32–39.
Wilson, J. 2009. Justice and the social determinants of health: An overview. Public Health Ethics
2(3): 210–213.
World Health Organization (WHO). 2008. Addressing ethical issues in pandemic influenza plan-
ning: Discussion papers. http://www.who.int/csr/resources/publications/cds_flu_ethics_5web.
pdf. Accessed 8 May 2013.
World Health Organization (WHO). 2010. Pandemic influenza preparedness and response: A
WHO guidance document. http://whqlibdoc.who.int/publications/2009/9789241547680_eng.
pdf. Accessed 8 May 2013.
7.11 Case 5: Can Asylum Seeking Be Managed Ethically?
Karin Johansson Blight

The Policy Institute
Kings College London
London, UK
e-mail: karin.johansson_blight@kcl.ac.uk
institution.
7.11.1 Background
Migration is a challenge managed against the backdrop of international accords and

the social and historic circumstances peculiar to each country. The 1948 Universal
Declaration of Human Rights (UDHR) states “everyone has the right to seek and to
enjoy in other countries asylum from persecution” (United Nations 1948, Article
14). In 1951, the newly established International Organization for Migration (IOM)
began promoting “humane and orderly migration for the benefit of all,” affirming
that all migration can be managed (IOM 2013). The United Nations (U.N.) estimated
221 million migrants worldwide in 2010 (U.N. 2013). EUROSTAT estimated 1.7
million immigrants, including forced migrants, in the European Union (EU) in 2011
(EUROSTAT 2014).
Sweden, a Nordic country that joined the EU in 1995, has a long tradition of moni-
toring the health of its residents. For example, its National Institute of Public Health,
the National Board of Health and Welfare, and Statistics Sweden monitor public
health trends, and a national center monitors suicide and mental illness (the National
Centre for Suicide Research and Prevention of Mental Ill-Health). “Health on equal
terms” is a political priority in Sweden that aligns with the country’s strongly egalitar-
ian and multicultural traditions dating back more than 300 years (Linell et al. 2013;
Westin 2000, 2006). However, social contingencies throughout Sweden’s history have
put pressure on these values and traditions. For example, poor harvests and famine in
the mid- to late-1800s triggered extensive emigration, virtually closing borders when
emigration ended in the 1930s. In the 1940s, the borders reopened first for refugees
from neighboring countries, then, in the 1950s–1960s, for labor immigrants from
European countries. From the 1970s onward, the focus shifted to family reunification
of migrants and refugees from outside the EU. According to Statistic Sweden’s figures
from 2012, of its 9.6 million population, about 15 % are foreign born (Statistics
Sweden 2013). The Swedish Migration Board (SMB) suggests that 16 % of residen-
cies granted in 2012 were on refugee, protection, humanitarian, or similar grounds
(including temporary grounds) (SMB 2014).
The term migration management (MM) was coined in the 1990s, although the
MM field originated in the 1950s (Widgren 1994). The rise of MM coincided with
a time when several factors, including the mechanisms of colonialism and the Cold
War, worked to control and minimize global migration. But other factors also influ-
enced MM, such as resettlements after World War II; efforts to safeguard rights of
refugees and migrant workers rights led by international organizations (e.g., the
International Labour Organization, the United Nations High Commissioner for
Refugees and the International Organization for Migration); and regional initiatives
that removed immigration barriers to improve national economies (e.g., the
Organisation for Economic Co-operation and Development and the Treaty of
Rome). In the mid-1970s to mid-1980s, Western countries jointly attempted to har-
monize entry controls, efforts that the third pillar of the EU’s 1993 Maastricht
Treaty later incorporated (Maastricht Treaty 1992).
Policies enacted since this treaty have focused on deterring unwanted migrants,
arguably to the detriment of human rights and refugee protections (Fekete 2001). By
2002, experts suggested that reducing unwanted and unauthorized immigration could
increase public support for integration assistance for foreign residents in Western
countries (Martin and Widgren 2002). But this focus on reduction had the side effect
of criminalizing “unwanted” migrants. By implying that unwanted migrants could
pose a national security threat, policy instruments such as the 2006 Schengen Borders
Code may have fed xenophobic tendencies (Schengen Borders Code 2010). Article
5 in the code includes, for example, a statement about entry conditions for short-stay,
third-country nationals, that they are not “… considered to be a threat to public pol-
icy, internal security, public health, or the international relations of any of the Member
States.” At any rate, such increased deterrence and control measures do restrict
access to work, housing, health care, and independent legal advice, and even sepa-
rates families (Johansson Blight et al. 2009). Not surprisingly, detention policies
harm health with disproportionately high rates of poor mental health, suicide, and
self-harm amongst detainees (Silove et al. 2000; Cohen 2008). Moreover, evidence
suggests that such controls have resulted in the rejection of asylum claims of torture
survivors and people with severe health problems (Steel et al. 2006; Migration Court
of Appeal 2007; Johansson Blight 2015). The evidence also suggests that controls
led to children suffering due to exacerbated vulnerability in detention and to unac-
counted deaths of forced migrants at Western country borders (Grewcock 2009; Steel
et al. 2011). These injustices prompted repeated appeals to national law, the UDHR,
and the Convention on the Rights of the Child and calls for change to relevant World
Medical Association (WMA) documents such as the Geneva and Lisbon declarations
(Hunt 2007; Bodegård 2014; Johansson Blight 2014; Johansson Blight et al. 2014).
An especially poignant example of the health challenges found among asylum

seekers, especially children, is the condition known as pervasive arousal withdrawal
syndrome (PAWS) (Bodegård 2014). This condition presents as pervasive loss of
functioning and profound social withdrawal and apathy (Söndergaard et al. 2012;
Envall 2013; Bodegård 2014; Johansson Blight 2014; Johansson Blight et al. 2014).
Few children show signs of severe PAWS upon arrival in Sweden; however, routine
data on incidence and prevalence are lacking (Envall 2013). Surveys conducted in
the past 10 years have identified anywhere from 30 to 424 children with this condi-
tion (Envall 2013). Common predictors include exposure to severe persecution,
human rights abuses or other traumatic experiences in the country of origin, and the
prospect of deportation to countries with poor human rights records. Other signs of
distress include suicide attempts (Johansson Blight 2014). PAWS commonly affects
health and functioning gradually, over time rendering a child unresponsive and
unable to eat or drink without support, which makes the condition life-threatening.
Unfortunately, the required health assessment of asylum seekers is insufficient for
detecting PAWS in its early stages (Johansson Blight 2014). Typically, static mea-
sures of health (such as the use of yes/no check boxes) are used, and life events such
as discrimination, traumatizing episodes, or prolonged stress carry little weight in
the health evaluation process requested by the migration authorities. From a health
perspective, broader and more culturally appropriate assessments are recommended
instead, such as illness narratives, family medical history taking, and recording of
past and present social contexts (Bhugra et al. 2010). If adopted, more cases of
PAWS could be identified, prevented, and treated. No cases of children dying with
PAWS have been reported in Sweden, but there has been no systematic follow-up of
children deported from Sweden (Envall 2013).
The Swedish Migration Board (SMB), the ultimate authority on deportation of asy-
lum seekers, announced it no longer deports children with PAWS. After this
announcement, however, the media reported on a rejected asylum seeker, a 14-year-
old Roma girl1 with the condition, deported with her family to their country of ori-
gin (Edquist 2013; Myhrén 2013). During deportation, the girl who had lost all
ability to function, was being fed through a feeding tube, and was unresponsive to
pain. Upon arrival at their home country, the family was refused entry due to the
girl’s advanced illness and was eventually forced to return to Sweden.
A family friend in Sweden said that widespread persecution of Roma people in
the family’s home country had restricted the 14-year-old girl’s life. For example, the
girl had never attended school because her parents feared she would be ostracized,
teased, ridiculed, or even physically hurt. The friend explained that the symptoms of
1
The Roma people are an ethnic group who trace their origin to the Indian subcontinent, some-
times referred to as gypsies.
severe PAWS began the previous month after Swedish police visited the family’s
home in Sweden.
According to the SMB, the police who enforced the deportation reported that when
they first visited the family, the girl was attending school, and although said to be some-
what shy and withdrawn, she appeared relatively healthy. A routine health assessment
of asylum seekers to assess barriers to enforcing deportation found no medical or other
reason to impede deportation. This claim conflicted with the statement of a therapist
working for a human rights organization, who said he had informed the SMB about the
girl’s history of discrimination, trauma, and her state of complete function loss, which
included her inability to communicate and engage in social interaction. In their defense,
police say they followed standard procedures and stand by the initial assessment
regarding deportation, which prompted no grounds for halting deportation.
Upon returning to Sweden, the family was detained in an immigration facility,
where the father at first was separated from the family. At the time of the media
reports, the family had been reunited and was awaiting a new SMB decision on
whether they should again be deported.
You are a member of a commission established to decide the outcome of this case
and come up with ways to improve the asylum and deportation system. Other mem-
bers of the commission include medical officers, public health officials, lawyers,
and former immigration officials.
1. Who are the main stakeholders and organizations in this case? What are their
primary interests and obligations?
2. What bearing does vulnerability or increased risk of harm have on public health’s
obligation to prevent or mitigate harm to an individual? What impact should
legal status have on that obligation?
3. What are the goals of the asylum and deportation process, and what are the val-
ues that drive these goals? How should these values be prioritized?
4. What decision would you make in this case?
5. Based on your prioritization of values, what recommendations would you make
to improve the asylum and deportation system?
References
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Oxford: Oxford University Press.
Bodegård, G. 2014. Comment on the paper ‘Pervasive Refusal Syndrome (PRS) 21 years on—A
reconceptualization and renaming’ by Ken Nunn, Bryan Lask and Isabel Owen, invited com-
mentary. European Child & Adolescent Psychiatry 23: 179–181.
Cohen, J. 2008. Safe in our hands? A study of suicide and self-harm in asylum seekers. Journal of
Forensic and Legal Medicine 15(4): 235–244.
Edquist, K. 2013. Utvisad Apatisk Flicka Tillbaka i Sverige, P4 Dalarna. (Deported Girl with
Apathy Back in Sweden, P4 Dalarna.) Sveriges Radio. http://sverigesradio.se/sida/artikel.aspx
?programid=161&artikel=5500968. Accessed 2 June 2015.
Envall, E. 2013. Barn med Uppgivenhetssyndrom, En Vägledning för Personal inom Socialtjänst
och Hälso- och Sjukvård. ( Children with Depressive Devitalisation, Guidance for Social and
Health Care Personnel. ) Socialstyrelsen. (The National Board of Health and Welfare.) ISBN
978-91-7555-051-0. http://www.socialstyrelsen.se/publikationer2013/2013-4-5. Accessed 2
June 2015.
EUROSTAT. 2014. Further Eurostat information, main tables, immigration (TPS00176). http://
epp.eurostat.ec.europa.eu/statistics_explained/index.php/Migration_and_migrant_population_
statistics. Accessed 2 June 2015.
Fekete, L. 2001. The emergence of xeno-racism. Race & Class 43(2): 23–40.
Grewcock, M. 2009. Border crimes. Australia’s war on illicit migrants, Sydney Institute of
Criminology Series. The Institute of Criminology Series 29. Sydney: Institute of Criminology
Press.
Hunt, P. 2007. Implementation of General Assembly Resolution, 60/251 of 15 March 2006, entitled
“Human Rights Council”: Report of the Special Rapporteur on the Right of Everyone to the
Enjoyment of the Highest Attainable Standard of Physical and Mental Health. Addendum:
Mission to Sweden. District General. Fourth Session, Item 2 of the provisional agenda, A/
HRC/4/28/Add.2, 28 February, Human Rights Council, United Nations.
International Organization for Migration (IOM). 2013. About IOM. http://www.iom.int/about-iom.
Johansson Blight, K. 2014. Medical doctors commissioned by institutions that regulate and control
migration in Sweden: Implications for public health ethics, policy and practice. Public Health
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Johansson Blight, K. 2015. Questioning fairness in Swedish asylum decisions. State Crime 4(1):
52–76.
Johansson Blight, K., S. Ekblad, F. Lindencrona, and S. Shahnavaz. 2009. Promoting mental
health and preventing mental disorder among refugees in Western Countries. International
Journal of Mental Health Promotion 11(1): 32–44.
Johansson Blight, K., E. Hultcrantz, A. D’Orazio, and H.P. Søndergaard. 2014. The role of the
health care services in the asylum process. In Nordic work with traumatised refugees: Do we
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tion detention and temporary protection on the mental health of refugees. The British Journal
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Widgren, J. 1994. Multilateral co-operation to combat trafficking in migrants and the role of inter-
national organizations. Paper presented at the eleventh seminar of the IOM on International
Response to Trafficking in Migrants and the Safeguarding of Migrant Rights, Geneva, 26–28
October.
7.12 Case 6: Tuberculosis Screening, Testing, and Treatment

among Asylum Seekers
Christopher W. McDougall
Institute of Health Policy, Management and Evaluation,
and Joint Centre for Bioethics
Toronto, ON, Canada
e-mail: christopher.mcdougall@utoronto.ca
7.12.1 Background
Tuberculosis (TB), an airborne transmissible bacterial infection that most commonly

affects the lungs, has been dubbed “the greatest killer in history” and one of “human-
kind’s worst enemies” (Selgelid 2008). TB is typically contracted after prolonged
close exposure to the coughing and sneezing of people with active infections.
Although only 5–10 % of people who are infected (but who are not HIV positive)
become sick or infectious at some point during their lives, untreated TB kills about
two-thirds of those it does infect, despite the availability of effective medicines since
the 1950s (World Health Organization [WHO] 2012). Since 1995, the WHO stan-
dard for treatment has been directly observed therapy, short-course (DOTS), which
involves people watching patients swallowing their pills. Treatments delivered
through DOTS are inexpensive and 95 % effective, although 6–9 months may be
required to cure ordinary active or latent strains of the infection (Minion et al. 2013).
Inconsistent or partial treatment—when patients do not take their medicines
regularly for the required period because they start to feel better, because doctors
and health workers prescribe the wrong treatment regimens, or because drug supply
is unavailable due to cost or unreliable due to lack of regulation—has led to TB
strains that resist one or more first-line drugs (i.e., those most effective and least
likely to cause adverse side effects). Drug-resistant TB has been documented in
every country surveyed (WHO 2012). A particularly dangerous form of drug-
resistant TB is multidrug-resistant TB (MDR-TB), defined as the disease caused by
TB bacilli resistant to at least isoniazid and rifampicin, the two standard anti-TB
drugs. Curing MDR strains of the bacteria is much less effective (with a 30–40 %
failure rate in Canada, slightly better than the global average of 52 %, according to
Minion et al. 2013), costs much more, produces reactions that diminish compliance,
and may take as long as 20–24 months (Public Health Agency of Canada. 2014).
MDR-TB accounts for 1.2 % of all TB cases in Canada, for example, and typically
costs five times as much ($250,000 vs $47,290 per patient) (Public Health Agency
of Canada 2014; Menzies et al. 2008).
TB has retained dramatically high levels of incidence, prevalence, and morbidity
and mortality worldwide, especially in developing countries, because social, politi-
cal, and economic factors (rather than simply biological ones) play key roles in infec-
tious disease patterns. Recent global estimates put the numbers at 15 million active,
and perhaps 2 billion latent (asymptomatic) infections, with 9 million new infections
yearly, and 1.5 to 2 million deaths per year (95 % of which occur in sub-Saharan
Africa and Asia) (WHO 2012). TB is the world’s leading cause of preventable death
among young adults, and the leading cause of death among those who are HIV posi-
tive, since the infection tends to affect and progress quickly in those whose immune
systems are compromised by other conditions, particularly HIV but also measles,
malaria, or alcoholism. TB is thus often referred to as a “classic social disease” and
a “disease of poverty” because of its association with overcrowding, malnutrition,
stress, destitution, and rapid social change. TB has also been dubbed the forgotten
plague because it rarely affects the wealthy, who are largely insulated from exposure
(Kim et al. 2005; Ryan 1993). Thus, although TB was extremely common in eigh-
teenth- and nineteenth-century England throughout the industrial revolution, infec-
tion rates declined substantially when housing, sanitation, nutrition, and labor
conditions improved and endemic infections all but disappeared in developed coun-
tries well before effective drugs were widely available (Selgelid 2008).
TB, though relatively uncommon in Canada today with around 1,600 cases
reported annually, is costly ($58 million in direct costs, and $74 million total related
expenditure, in Canada in 2004) (Menzies et al. 2008), frequently results in hospital
admission, and retains an 11 % mortality rate (Greenaway et al. 2011). Foreign-born

persons account for 65 % of active TB, although they make up only 20 % of the
population. Up to half of recent immigrants and refugees to Canada are estimated to
harbor latent TB and are thus at risk of progressing to active infection, and TB in
refugee populations is about double that in other classes of immigrant populations
(Greenaway et al. 2011). Those most at risk domestically are the urban homeless
and aboriginal communities, followed by residents of long-term care and correc-
tional facilities, and then the staff who work in such institutions (Public Health
Agency of Canada 2014).
The cornerstone of TB ethics, according to the WHO, is the protection of indi-
viduals and communities through the proper treatment of infected individuals
(active and latent) and the prevention of new infections. These goals are said to
rely on the promotion of key values including social justice and equity, solidarity,
the common good, autonomy, reciprocity, effectiveness, subsidiarity, participa-
tion, and transparency and accountability (WHO 2010). The WHO also stresses,
in cases where involuntary isolation or detention measures are implemented, the
importance of using the least restrictive means necessary to achieve public health
goals, as set forth in the Siracusa Principles. These principles require states to
ensure that such interventions are proportional to the risk of public harm, neces-
sary and relevant to protecting the public good, and applied without discrimina-
tion (WHO 2010).
On a chilly gray autumn morning, Canadian Coast Guard officials take into cus-
tody 77 people (66 men, and 11 boys between 8 and 16 years of age) after their
vessel, suspected to have been abandoned by human smugglers, is found adrift off
the northwest Pacific coast. All immediately claim refugee status and are trans-
ferred to a provincial prison, the nearest facility judged sufficiently secure to detain
them, review their claims, and physically examine them per immigration proce-
dures. Overcrowding at the criminal correction center, already an issue, becomes
severe with the addition of these individuals, many of whom are housed four or five
to cells designed for only two people, and often in portable trailers parked in the
prison yard. The asylum seekers are subject to the same institutional rules as crimi-
nal detainees: they must wear prison uniforms and are significantly restricted in
making or receiving telephone calls (Nakache 2011). The federal Refugee
Protection Division and provincial health authorities jointly appoint you as a mem-
ber of an ad hoc local public health unit task force responding to the situation.
Canadian immigration law requires asylum seekers in the country to undergo a
medical examination, including screening to assess potential burden of illness,
linked to ongoing surveillance or clinical actions only for TB, syphilis, and HIV
(Gushulak et al. 2011; Gardam et al. 2014). Within 48 h, medical examinations and
chest X-ray results suggest active TB in four of the new detainees: two adults and
two brothers ages 6 and 11. Based on their overall health conditions and patient
histories (to the extent that these can be verifiably ascertained under the circum-
stances) and TB epidemiology in the region of origin, the medical team strongly
suspects all four to be infected with MDR-TB, and cultures are thus ordered. The
tests will take 2 weeks before results can confirm the presence of drug-resistant
strains (6 weeks are needed to confirm negative cultures).
The Canadian Immigration and Refugee Protection Act (IRPA) (Government of
Canada 2001) and accompanying regulations (Government of Canada 2013) stipu-
late that people likely to be a danger to public health or a “public charge” (defined
as likely to make excessive demands on health or social services but likely unable
or unwilling to support themselves) may be deemed inadmissible for refugee sta-
tus. However, considerable discretionary power, particularly for children and oth-
ers in need of protection, is built into the law and related regulations, and initial
decisions by immigration officers are generally subject to appeal (Bailey et al.
2005; Greenaway et al. 2011). Section 249 of the IRPA regulations, moreover, sets
out special requirements for minor refugee claimants, including the duty to con-
sider the availability of local childcare arrangements, of segregated spaces in
detention centers, and of education, counseling, and recreational services
(Government of Canada 2013).
1. Although all 77 refugee claimants have been screened for TB, they have not been
tested for TB. Given the journey and conditions just endured by this group on
board the cramped vessel, should the task force advise local public health author-
ities to test all claimants for active or latent TB? Why or why not?
2. What recommendations should the task force make concerning ongoing detain-
ment conditions? What information should be provided to the current residents
and staff of the regional corrections center?
3. Given the clinicians’ conclusions, should second-line TB treatment be immedi-
ately offered to the four affected refugees? If they refuse treatment, should treat-
ment be compelled? How and why?
4. When news breaks locally of the TB status of the two young brothers, commu-
nity leaders of the same ethnic background offer to shelter the boys and oversee
their treatment. Discuss the relevance of the principle of “least restrictive means”
to such a scenario, and indicate when or whether local public health authorities
should consider community care and support approaches to MDR-TB
treatment.
5. Three months into their detainment, the claims of several refugees are rejected.
Hunger strikes and violence among the detainees ensue. How should the task
force respond?
6. Consider a scenario in which the status of one of the two adults suspected of being
infected by MDR-TB is subsequently confirmed and the patient is denied refugee
status as well. What are the costs and risks of the repatriation of MDR-TB cases
compared with standard TB cases? Do the task force, public health authorities,
and provincial or federal authorities have any obligations under such a scenario?
7. How should the goals of public health and those of immigration policy be
balanced?
References
Bailey, T., T. Caulfield, and N. Ries (eds.). 2005. Public health law and policy in Canada.
Markham: LexisNexis Canada.
Gardam, M., M. Creatore, and R. Deber. 2014. Danger at the gates? Screening for tuberculosis in
immigrants and refugees. In Case studies in Canadian health policy and management, 2nd ed,
ed. R.B. Deber and C.L. Mah. Toronto: University of Toronto Press.
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laws.justice.gc.ca/eng/acts/i-2.5/. Accessed 22 Jan 2014.
Government of Canada. 2013. Immigration and Refugee Protection Regulations. (SOR/2002-227).
http://laws-lois.justice.gc.ca/eng/regulations/SOR-2002-227/. Accessed 22 Jan 2014.
Greenaway, C., A. Sandoe, B. Vissandjee, et al. 2011. Tuberculosis: Evidence review for newly
arriving immigrants and refugees. Canadian Medical Association Journal 183(12): E939–
E951. doi:10.1503/cmaj.090302.
Gushulak, B.D., K. Pottie, J. Hatcher Roberts, et al. 2011. Migration and health in Canada: Health
in the global village. Canadian Medical Association Journal 183(12): E952–E958. doi:10.1503/
cmaj.090287.
Kim, J.Y., A. Shakow, K. Mate, et al. 2005. Limited good and limited vision: Multidrug-resistant
tuberculosis and global health policy. Social Science & Medicine 61: 847–859.
Menzies, D., M. Lewis, and O. Oxlade. 2008. Costs for tuberculosis care in Canada. Canadian
Minion, J., V. Gallant, J. Wolfe, F. Jamieson, and R. Long. 2013. Multidrug and extensively dru-
gresistant tuberculosis in Canada 1997–2008: Demographic and disease characteristics. PLoS
ONE 8(1): e53466. doi:10.1371/journal.pone.0053466.
Nakache, D. 2011. The human and financial cost of detention of asylum-seekers in Canada. UN
High Commissioner for Refugees commissioned report. http://www.socialsciences.uottawa.ca/
sites/default/files/public/dvm/eng/documents/dnakache-finalreport-december2011.pdf .
Public Health Agency of Canada. 2014. Canadian tuberculosis standards, 7th ed. Ottawa: Minister
of Public Works and Government Services Canada. http://strauss.ca/OEMAC/wpcontent/
uploads/2013/11/Canadian_TB_Standards_7th-edition_English.pdf. Accessed 9 June 2015.
Ryan, F. 1993. The forgotten plague: How the battle against tuberculosis was won—And lost.
Boston: Little, Brown.
Selgelid, M. 2008. Ethics, tuberculosis and globalization. Public Health Ethics 1(1): 10–20.
World Health Organization (WHO). 2010. Guidance on ethics of TB prevention, care and control.
Geneva: World Health Organization. http://whqlibdoc.who.int/publica-
tions/2010/9789241500531_eng.pdf. Accessed 3 June 2013.
World Health Organization (WHO). 2012. Tuberculosis, Fact Sheet No. 104. Geneva: World
Health Organization. http://www.who.int/mediacentre/factsheets/fs104/en/index.html.
Chapter 8
International Collaboration for Global Public
Health
Eric M. Meslin and Ibrahim Garba
8.1 Introduction
There is a long tradition of global collaboration in biomedicine and public health.

Examples range from medical outposts in rural communities run by foreign mis-
sionaries (Good 1991) to the early infectious disease programs of the Rockefeller
Foundation (Fosdick 1989) and from medical services and training programs for
indigenous populations set up by colonial authorities (Marks 1997) to the Pan
American Health Organization (PAHO) established by a collective of sovereign
governments (Cueto 2007).
Two complementary sets of factors provide context for understanding collabora-
tion in global public health: first, the factors that inform globalization generally and
global health specifically; second, the factors that shape ethical standards for global
health programs generally and global health research specifically. Good examples
of both factors are reflected in this chapter’s case studies.
The opinions, findings, and conclusions of the authors do not necessarily reflect the official
position, views, or policies of the editors, the editors’ host institutions, or the authors’ host
institutions.
E.M. Meslin, PhD (*)
Indiana University Center for Bioethics, Indianapolis, IN, USA
e-mail: emeslin@iu.edu
I. Garba, MA, JD, LLM
Indiana University Center for Bioethics, Indianapolis, IN, USA
Public Health Law Program, Office of State, Tribal, Local, and Territorial Support,

242 E.M. Meslin and I. Garba
8.2 The Rise of Globalization and Global Health
Collaboration in global health, as we know it today, began taking shape after World
War II when new laws and institutions were established to govern relations among
countries. The war’s end was marked by efforts to establish a body that would
facilitate peaceful relations among member countries. In 1945, the United Nations
(U.N.) was established “to save succeeding generations from the scourge of war”
and to “promote social progress and better standards of life” (U.N. 1945). Various
U.N. agencies were set up to realize these goals—most prominently the World
Health Organization (WHO), founded in 1948 “to act as the directing and
coordinating authority on international health work” (WHO 1948).1 Yet even as
these institutions were being established, their ability to encourage international
collaboration was hampered in two ways.
First, most low- and middle-income countries (LMICs), which bear the bulk of
today’s global disease burden, were under colonial rule for the first decade of the
U.N.’s existence. Hence, these countries were unrepresented in the new organiza-
tion. In later years, the principle of self-determination (i.e., the right of “peoples” to
govern themselves and choose their developmental priorities) and the efforts of
nationalist movements secured political independence and membership in the inter-
national community. In effect, the governments of these countries were authorized
under international law to represent their populations in relations with other govern-
ments, thereby enabling equitable partnerships, even in matters of health.
Second, the escalation of the Cold War in the founding years of the U.N. intro-
duced ideological rivalries into its workings. These rivalries often impeded coordi-
nated actions involving health. For example, the 1950s and 1960s were marked by
the superpowers’ competitive attempts to eradicate specific (often communicable)
diseases (e.g., the United States targeted malaria while the Soviet Union focused on
smallpox) (WHO 2008b). This selective, disease-specific vertical approach con-
flicted with the realization in the 1970s that primary health care was a vital compo-
nent of a national health system. The latter approach defined “health” broadly,
recognizing it as a right and acknowledging the impact of socioeconomic factors on
wellness (WHO 1978). The emphasis on primary health care became critical for
governments of newly independent countries faced with the task of expanding
health systems that under colonial rule had catered to a narrow, privileged segment
of the population (WHO 2008a). However, ideological disputes over government’s
role in society and the policies of the International Monetary Fund (IMF), which
favored privatization of certain public services (Stuckler and Basu 2009), neglected
the primary health care approach (WHO 2008b). The Cold War also influenced pat-
terns of global health collaboration, particularly among members of feuding coali-
tions that continued to support ideologic allies (Feldbaum et al. 2010).
1
Other U.N.-affiliated agencies not directly related to health but influencing collaboration in public
health include the International Monetary Fund, World Bank, and World Trade Organization.
8 International Collaboration for Global Public Health 243
The fall of the Berlin Wall in 1989 and the collapse of the Soviet Union shortly
thereafter marked the end of the Cold War. These events led more countries to adopt
liberal and capitalist principles. Other developments—advances in communications
(most notably, the Internet) and greater trade and travel across borders—intensified
exchanges among national communities. Collectively referred to as the process of
globalization,2 these changes altered the global context for public health
collaboration.
On the one hand, the absence of a drawn-out ideological battle led to constructive
deliberation and global action in public health. For example, in 2000, all members
of the U.N. General Assembly declared their commitment to achieving eight objec-
tives (the Millennium Development Goals) by 2015—half of which pertained to
health. Also significant were widespread efforts to address the HIV/AIDS epidemic
through such mechanisms as the Joint United Nations Programme on HIV/AIDS
(UNAIDS)3 and the more recently established Global Fund to Fight AIDS,
Tuberculosis and Malaria.4
On the other hand, the growing influence of liberal and capitalist principles in the
global environment of the 1990s affected the extent to which governments (espe-
cially those of LMICs) were involved and able to collaborate in public health. These
changes included
… an increasing reliance upon the free market; a significant growth in the influence of
international financial markets and institutions in determining national policies; cutbacks in
public sector spending; the privatization of functions previously considered to be the exclu-
sive domain of the state; and the deregulation of a range of activities with a view to facilitat-
ing investment and rewarding entrepreneurial initiative. These trends serve to reduce the
role of the state in economic affairs, and at the same time increase the role and responsibili-
ties of private (non-state) actors, especially those in corporate business, but also those in
civil society…. (WHO 2002)
Generally associated with neoliberal principles, the changes discussed above

have reduced governments’ public policy role. These developments notwithstand-
ing, there remain compelling arguments for deliberate and sustained engagement by
governments in the interest of global public health. Three are discussed below.
8.2.1 Collective Health
The first argument is that even with their reduced profile in national health systems,
governments continue to bear primary responsibility for population health.
Individual citizens can take responsibility for personal health, but certain health
2
Definitions of globalization vary by disciplinary focus. Richard Labonté (2004) describes global-
ization as “a process by which nations, businesses, and people are becoming more connected and
interdependent across the globe through increased economic integration and communication
exchange, cultural diffusion (especially of Western culture), and travel.”
3
See http://www.unaids.org/en/
4
See http://www.theglobalfund.org/en/
benefits (e.g., clean air, safe roads, potable water) can be secured only through orga-
nized, collective efforts generally involving the exercise of public authority. As
such, in the interest of global health, a country’s public health institutions should be
robust—equipped to protect population health, reduce disease, and administer pro-
grams that save money and lives (Frieden and Koplan 2010). This case needs to be
made for LMICs especially; otherwise, neoliberal principles guiding globalization
may further weaken emergent, poorly governed, or underfunded health systems.
Indeed, the exercise (or failure) of public authority influence all ethical issues
presented by the cases in this chapter. In Jensen and Gaie’s case, an LMIC govern-
ment has neither passed legislation nor provided support that would effectively pre-
vent discrimination against citizens seeking HIV services. In Zinner’s case, an
international aid worker must make difficult decisions about who gets preventive
HIV/AIDS treatment in an African community characterized by a neglected, poorly
funded health system. In Timms’ case, a physician encounters an ethical challenge
brought about by the underdeveloped health infrastructure in India, the govern-
ment’s lax enforcement of research regulations, and the substantial influence of
large foreign pharmaceutical companies on national policy. In List and Boyd’s case,
a foreign researcher must decide whether there is an ethical obligation to expose an
African government’s avoidable failure to prevent a TB medication stock-out.
Under question in Millum’s case is the degree to which both the U.N. (as a collec-
tive body of governments carrying out a humanitarian intervention) and the Haitian
government (as the provider of health infrastructure for its citizens) can be held
morally or legally liable for a cholera outbreak. In Al-Faisal, Hussain, and Sen’s
case, a public health expert testifying before a U.N. Commission must weigh in on
the extent to which (1) foreign governments are obliged to minimize harm to the
health of Syrians and Iraqis when applying sanctions and (2) Syrian and Iraqi gov-
ernments are obliged to conduct a foreign policy that does not jeopardize the health
of their citizens. A U.S.-based researcher grapples in Lee, Kleinfeld, and Glassford’s
case with the question of whether she can ethically justify publishing a paper based
on data obtained from two African countries whose governments have neither insti-
tutional review boards nor national research guidelines.
8.2.2 Coordination
The second argument favoring active engagement of governments in national health

systems is their longstanding ability to enter binding legal agreements with each
other and other stakeholders. A government’s continued involvement is indispens-
able to shaping broad-based and sustainable solutions to the challenges of global
public health. The broad scope of a government’s responsibilities (and authority
associated with performing these responsibilities) enables it to coordinate public
health efforts involving public, private, and civic institutions. The importance of
governmental involvement was crystallized in the words of former WHO Director
General, Gro Harlem Brundtland, as the 2003 WHO Framework Convention on
Tobacco Control was being drafted: “Tobacco control cannot succeed solely through
the efforts of individual governments, national NGOs (nongovernmental organiza-
tions), and media advocates. We need an international response to an international
problem” (Bodansky 1999). Tackling one of the world’s leading causes of prevent-
able death (i.e., smoking), the Framework Convention adopts a comprehensive
strategy that has been signed by the governments of 168 countries.5
With completion of the human genome and development of various technologies
to use it, interest in DNA repositories has surged (Kaye et al. 2009). The develop-
ment and increasing use of biorepositories of DNA, tissues, and other biological
materials in institutions worldwide present far-reaching ethical challenges. Some
challenges, such as those resulting from the collection and use of dried blood spots
(Hendrix et al. 2013) or from regular surveillance like the U.S. Centers for Disease
Control and Prevention (CDC) HIV surveillance projects, are recurrent and famil-
iar.6 When specimens must be shared in the context of collaborative public health
emergency response and planning, the challenges can take on greater urgency. Such
emergency collaborative sharing has occurred with virus strains for pandemic influ-
enza planning7 and with the sequencing of the SARS coronavirus jointly undertaken
by researchers from Canada, Hong Kong, Taipei, the United States, and Vietnam
during the global outbreak (Tong et al. 2004). Similarly, the sharing of data and
health information has long been a source of ethical and legal commentary and is
widely viewed as desirable ethical behavior with demonstrable scientific benefit
(Committee on National Statistics 1985; Benkler and Nissenbaum 2006).
8.2.3 Accountability
The third argument supporting government engagement in global public health is

based on democratic theory. Put simply, a country’s citizens can hold their govern-
ments accountable for failure to meet health commitments. In contrast to govern-
ments that are accountable to their entire populations, NGO stakeholders in global
health answer to narrower constituencies (i.e., corporations to their stockholders,
NGOs to their funders, and foreign health organizations to their home govern-
ments). Because public health is of general concern, a level of accountability is
essential for the entire health system to function properly. The involvement of gov-
ernments is, therefore, critical both to ensure the widest participation possible in
formulating health policies and to sustain such policies despite shifting interests or
diminishing profits of partners.
Setting aside the issue of relative advantages or demerits, the diminished role of
governments in global public health—especially governments of LMICs—creates
5
See http://www.who.int/fctc/signatories_parties/en/index.html
6
See http://www.cdph.ca.gov/programs/aids/Pages/TOASurv.aspx
7
See http://www.ip-watch.org/2013/05/27/world-health-assembly-pandemic-flu-framework-
clears-committee/
room for others to enter the field. Entrants include public institutions (e.g., interna-
tional intergovernmental bodies, governments of emerging economies); NGOs
(e.g., development and relief agencies, academic health partnerships, faith-based
initiatives); private entities (e.g., corporations, philanthropies, individuals); and
hybrid entities that pool resources and expertise from public, nongovernmental, and
private stakeholders (e.g., The Global Fund to Fight AIDS, Tuberculosis and
Malaria). Each entrant to the global health environment plays a unique role. Some
take direct action by providing care, some facilitate and leverage the work of others,
and some effect change in policies to cultivate better and closer collaboration. All
undertake some form of partnership activity.
Essentially, rather than being merely an instrument of foreign policy and diplo-
macy or a means to technical aid between governments, collaboration in health has
grown into a global endeavor involving many actors and stakeholders (Elmendorf
2010). The declining role of governments in public policy presents special chal-
lenges for global public health, and the proliferation of stakeholders makes the for-
mation of partnerships more demanding and critical. As such, effective ethical
frameworks that can serve as guides for planning and also as arbiters between com-
peting values are indispensable.
8.3 Ethics Frameworks for Global Health
Complementing this political history has been an equally comprehensive set of

approaches, each of which provides a moral foundation for defending actions, poli-
cies, and decisions in global health. Foremost among these are principle-based
approaches, human-rights frameworks, and social determinants of health (SDH),
although other approaches have been suggested (Ruger 2009).
8.3.1 Principles and Benchmarks
The debate arising from the 1997 AIDS Clinical Trial Group Study 076 (ACTG-
076) to reduce maternal–fetal transmission of HIV served many purposes. Among
the most useful was the attention focused on how ethical arguments are applied to
substantive problems in global health (Lurie and Wolfe 1997; Varmus and Satcher
1997). Until then, most bioethical reflection had concentrated on domestic topics,
aside from revisions to the Declaration of Helsinki and other documents. ACTG-
076, however, energized discussion about, among other things, the nature of ethical
obligations and commitments to groups, countries, and regions—whether of
researchers to research participants, of science to society, or sponsors to host coun-
tries (Shapiro and Meslin 2001). Accusations of parachute research and double
standards abounded, leading many to rethink the applicability of accepted ethical
principles and practices and to consider new contexts. They also questioned whether
researchers, sponsors, or governments owed any continuing obligation of care to

research participants at the end of a study. The bioethics principles developed over
three decades by Beauchamp and Childress (2009) provided a formidable founda-
tion upon which debates about research and health care could be played out—even
in the face of critiques about their adequacy and sufficiency as moral theory (Clauser
and Gert 1990). Other principles have been recommended by scholars (Lavery et al.
2007) and organizations (United Nations Educational, Scientific and Cultural
Organization [UNESCO] 2005), but even proponents of principle-based approaches
recognized that more was needed to meet challenges in emerging areas of science
(e.g., public health genomics and transborder studies) (Lavery et al. 2007; Emanuel
et al. 2008; Macklin 2008).
Indeed, early in the tenure of the National Bioethics Advisory Commission
(NBAC) that later reported on the ethics of clinical trials (NBAC 2001), Ezekiel
Emanuel proposed that the Commission review the Belmont Report principles. He
urged the Commission to adopt a new principle to its canon of bioethics, namely a
principle of community to accommodate ethical issues arising from the recruitment
of groups. Although the Commission did not adopt this principle, Emanuel’s pro-
posal has since emerged as one of several benchmarks for assessing ethical accept-
ability of clinical research in developing countries (Emanuel et al. 2004). More
relevantly, the concept of community engagement and participation has taken on a
greater role in discussions about the importance of partnerships.
The cases by Timms and by Lee, Kleinfeld, and Glassford illustrate the utility of
using ethical principles to frame the unique challenges of global collaboration in
biomedical research. Timms raises a critical issue about whether a multinational
pharmaceutical company conducting clinical trials in an LMIC is responsible for
harms sustained by research participants during its investigations. The ACTG-076
debate has broadened the question of accountability, recognizing that impoverished
and poorly educated populations living with underdeveloped regulatory, health, and
social service infrastructures must prompt reassessment of a multinational trial
sponsor’s ethical obligations. Such reassessment has focused, naturally, on mea-
sures that prevent exploitation of vulnerable and desperate individuals in LMICs
(e.g., appropriate informed consent, vigilant recruitment practices). But it has also
raised the question of whether foreign sponsors and researchers have an ethical
obligation to the host community or country supplying the large and diverse recruit-
ment pool at comparatively lower cost.
In the case described by Lee, Kleinfeld, and Glassford, a researcher must deter-
mine, apart from questions of scientific validity and potential health utility, whether
proper informed consent was obtained in the acquisition of data and tissue samples
being used for research on which she has been invited to collaborate. These data and
specimens were gathered using various consent methods from six African countries,
none of which had ethics review boards or national research guidelines. Her collabo-
rator assures her that the consent modalities applied, though varying widely, were
appropriate to the settings in which they were used. In deciding whether to coauthor
an article based on acquired data, the researcher must consider how (or whether) the
requirements of informed consent, a foundational principle of ethical research, can
be met in different global settings, particularly those characterized by cultural or

linguistic differences, low health literacy, and absence of regulatory infrastructure.
8.3.2 Human Rights
Human rights constitute a compelling ethical framework for global collaboration.

Based on an ethical vision discernable in early Greco-Roman writings, these prin-
ciples matured in the work of such social contract theorists as Thomas Hobbes,
Jean-Jacques Rousseau, and John Locke. The modern view of human rights presup-
poses that all persons, simply for being human, have inherent dignity. This dignity
constitutes the normative foundation for people having certain inalienable rights.
The terms inherent and inalienable mean such dignity and rights belong to people
naturally and are, certainly, not bestowed by a political authority. According to
human rights theory, a political authority has no ethical basis for arbitrarily depriv-
ing individuals of these rights (not having granted such rights in the first place). But
because some needs are common and not all goals can be met individually, people
choose to surrender certain rights to a public authority established to ensure these
ends are realized. Hence, a government
… exists to ensure the well-being of the individuals who give up certain rights in exchange
for certain protections and benefits […]. The same applies to the community they jointly
establish. From this analysis, the traditional roles of government include such things as col-
lective security, the administration of justice, the protection of property and […] the promo-
tion of the public’s health…. (Meslin and Garba 2011)
This theoretical sketch provides a backdrop to the 1948 U.N. Universal

Declaration of Human Rights (UDHR), the ethical cornerstone of the human rights
system since the end of World War II. Using human dignity as its starting point, the
UDHR codifies a unified ethical vision for preserving a peaceful and just interna-
tional order while also emphasizing “social progress and better standards of life”
(U.N. 1948). Correspondingly, the UDHR contains rights that are broadly political
(e.g., fair trial, free speech, freedom of religion) and others that focus on economic
and social conditions (e.g., housing, education, health).
As discussed previously, however, the Cold War introduced ideological rivalries
into the U.N., rifts that split the unified ethical vision of the UDHR into two treaties:
the International Covenant on Civil and Political Rights (ICCPR) (U.N. 1966a) and
the International Covenant on Economic, Social and Cultural Rights (ICESCR)
(U.N. 1966b).8 The two treaties reflected the priorities of the opposing sides—the
ICCPR advocated by the U.S.-led capitalist alliance and the ICESCR championed
by the U.S.S.R.-led communist bloc. Having two treaties hindered the deployment
of human rights as an effective ethical framework for health collaboration during
the latter half of the twentieth century.
8
Article 12 of the ICESCR codifies the right to health.
As the Cold War abated, the global community adopted a more holistic approach
to human rights, including the right to health. This was captured in the 1993
U.N. Vienna Declaration and Programme of Action, a document that reaffirmed
human rights as “universal, indivisible, and interdependent and interrelated” (U.N.
1993). The Vienna Declaration laid the foundation for the creation of the Office the
United Nations High Commissioner for Human Rights (OHCHR), an agency that
oversees the promotion and protection of human rights throughout the U.N. system.
Moreover, the U.N. Human Rights Council (HRC),9 through its special procedures,
appoints independent experts (or “special rapporteurs”)10 to report on areas of con-
cern, including such health-related themes as food, physical and mental health,
adequate housing and extreme poverty, and healthy and sustainable environments.11
As noted previously, this holistic approach was also reflected in the adoption of the
Millennium Development Goals (most of which are related to health) and exempli-
fied in the coordinated approach to tackling HIV/AIDS. The health and human
rights movement, which gained traction during the global discussion on sexual and
reproductive health, firmly took root once health professionals responded to the
peculiar challenges of treating HIV-positive people facing discrimination (Gruskin
et al. 2007; Mann 1997).
Quite apart from the scarcity of fiscal resources that often plague LMIC govern-
ments, other challenges preclude adopting an integrated approach to the right to
health. For example, a long-standing argument is that the right to health as codified
in the International Covenant on Economic, Social and Cultural Rights attaches to
individuals and is, hence, unsuited for effectively achieving public health objec-
tives, goals that by definition focus on population health (Meier 2006). In addition,
the proliferation of non-state actors in global health mentioned earlier (e.g., relief
agencies, academic health partnerships, corporations, philanthropies) make coordi-
nation and accountability about the right to health more demanding. By and large,
governments are the sole entities authorized to sign health-related human rights
treaties such as the ICESCR. International treaties typically have mechanisms for
ensuring that signatories fulfill legal commitments. But as discussed earlier, the
diminishing role of governments in national policy and the increasing privatization
of public services under globalization (WHO 2002) mean that treaty law will likely
play a correspondingly smaller role in global health collaboration. Although the
influx of new non-state actors allows stakeholders to partner in innovative ways to
address challenges in global health, the stability and accountability of international
human rights law remains a valuable asset in a constantly evolving field.
Most cases in this chapter feature ethical issues that are illuminated but some-
times complicated by the human rights framework. In Jensen and Gaie’s case,
human rights potentially impede a public health strategy for controlling the spread
of HIV/AIDS. The case calls for a public health official to balance the human rights
9
Until 2006, the U.N. Commission on Human Rights.
10
The Human Rights Council also uses working groups.
11
For special procedures of the Human Rights Council, see http://www.ohchr.org/EN/HRBodies/
SP/Pages/Welcomepage.aspx
of individuals (possibly suffering discrimination and stigma-related violence under

routine or mandatory testing policies) against the health of the community, which,
arguably, is better served by precisely such testing regimes.
A distinguishing mark of globalization is the increased influence of transnational
businesses on the policies of LMIC governments. Timms’ case illustrates the impact
of this development. Given the economic and political clout of transnational busi-
nesses, there are continuing discussions on the extent of their human rights obliga-
tions (Weissbrodt and Kruger 2003; Ratner 2001). In this case, even if the
pharmaceutical company conducting research in India is not directly bound by a
human rights treaty, is it obliged to comply with human rights norms on some other
basis (e.g., national laws, industry standards, corporate codes of conduct)?
In 2011, the U.N. Human Rights Council endorsed the Guiding Principles on
Business and Human Rights, a document outlining what has come to be known as
the U.N. “Protect, Respect and Remedy” framework. Guiding Principles recognizes
governments’ duty to protect human rights, acknowledges corporate responsibility
to respect human rights, and requires governments to ensure that people harmed
within their jurisdiction have access to effective judicial and nonjudicial remedies.
List and Boyd’s case questions how one’s freedom of expression (Article 19,
ICCPR) affects public health. Should one be allowed to use the free press to advo-
cate on behalf of fellow citizens? Does the free press furnish a forum for an informed
and representative discussion on public health policy? Are expatriate workers less
likely than nationals to face official retaliation when they use media outlets to criti-
cize government?
Conflict in the Balkans and killings in Rwanda in the early 1990s revived lively
debate on the international community’s obligation to intervene in internal affairs of
member countries to defend human rights (Kardaş 2010; Chopra and Weiss 1992).
Organizing international action to address human rights violations remains a peren-
nial challenge—exemplified by the intractable situation in Syria following major
pro-democracy protests in 2011. But ideological alliances and rivalries during the
Cold War made consensus building around such interventions arduous (Eisner
1993). The Balkan and Rwandan conflicts and a growing atmosphere of cooperation
in the face of global challenges (e.g., environmental degradation, climate change)
contributed to an increase in peacekeeping and humanitarian operations organized
by the international community. These operations, though designed to further
human rights, sometimes undermined the target population’s right to health.
Millum’s case and that of Al-Faisal, Hussain, and Sen raise issues that result,
paradoxically, from increasing adoption of the human rights framework as an inter-
national norm. Millum’s case questions responsibility during a major cholera out-
break originating in a camp occupied by Nepali soldiers on a U.N. peacekeeping
mission in the Caribbean. The Al-Faisal, Hussain, and Sen case considers how the
health of vulnerable groups in Iraq and Syria is affected by economic sanctions
imposed on the two countries’ governments and shows how interventions intended
to protect human rights can still have adverse health consequences.
Increasingly, human rights are being used to frame responses to global public health
challenges (Adorno 2009; Mann 1997). Human rights are a pervasive transcultural and
normative discourse. Issues once relegated to bioethics are now cast as human rights
concerns (Adorno 2009; Faunce 2005). For example, UNESCO adopted three declara-
tions that use human rights to frame health challenges: the Universal Declaration on
the Human Genome and Human Rights (1997), the International Declaration on
Human Genetic Data (2003), and the Universal Declaration on Bioethics and Human
Rights (2005). Each declaration codifies the principle of informed consent—a princi-
ple at stake in the case cited by Lee, Kleinfeld, and Glassford and, to a lesser degree,
the case by Timms. The cross-fertilization of concepts and concerns between bioethics
and human rights is a salutary consequence of public health partnerships forged in an
increasingly interconnected and complex world.
8.3.3 Social Determinants of Health
The social determinants of health (SDH) framework is based on social justice (Lee
2004). The guiding principle of SDH is equity. As with public health, SDH empha-
sizes population health and prevention. However, SDH goes beyond traditional pub-
lic health approaches because, in addition to deploying interventions aimed at
reducing population mortality and morbidity, SDH targets “the social context and
conditions in which people live” (Blas et al. 2011). These contextual factors and
conditions that affect health outcomes in a given population are called social deter-
minants of health.12 These include such factors as housing, education, transporta-
tion, employment, insurance coverage, and access to health care (Brennan Ramirez
et al. 2008).
The SDH framework stands on 40 years of research demonstrating that clinical
care alone cannot improve health outcomes unless social factors are addressed
(WHO 2007). Statistical associations between social disadvantage and poor health
became increasingly clear, impelling the inference that closing the gap in health
status between populations required corresponding improvements in the social con-
texts of disadvantaged populations.
The ethical norm underlying efforts to eliminate these preventable health differ-
ences is the principle of equity. Health inequities are differences “socially produced;
systematic in their distribution across the population; and unfair” (WHO 2007). On
the other hand, health equity is “the absence of unfair and avoidable or remediable
differences in health among population groups defined socially, economically,
demographically, or geographically” (WHO 2007). These definitions highlight two
aspects of SDH. First, the differences in health are not merely descriptive but pre-
scriptive as well, implying an ethical obligation in favor of their elimination. Second,
the focus on social context and conditions means that policy and action must be
intersectoral, involving actors and spheres outside the health field (WHO 2007).
12
The social determinants of health have also been characterized as “the conditions in which peo-
ple live and work that affect their opportunities to lead healthy lives” (Labonté and Schrecker
2007).
Health disparities among populations in different parts of the world motivate

public health interventions and assist the development of useful analytical tools for
global health. A case in point would be the gaps in infant mortality rates and life
expectancy between countries with strong economies and LMICs. These gaps pro-
vide moral stimulus for elimination and benchmarks for setting goals and assessing
progress (e.g., the health-related Millennium Development Goals).
The SDH framework faces several challenges and limitations. Most people do
not realize the impact of social and contextual factors on health outcomes. Political
orientations and worldviews further impede the acceptance of SDH as a viable pol-
icy alternative (Gollust et al. 2009). Some argue that variations of SDH oversimplify
the link between wealth and health, thereby failing to consider other causes of health
disparities (Poland et al. 1998). Even though statistical links have been made
between social context and ill health, scientific questions remain on the mechanisms
that account for these associations. This is especially critical in the field of mental
health, where attempts have been made to clarify associations between SDH and
psychological well-being (Marmot et al. 1997; Bovier et al. 2004; Fisher and Baum
2010; Paananen et al. 2013).
Aside from the availability of HIV/AIDS health services and medication, the
Jensen and Gaie case and Zinner case demonstrate how social factors affect health.
In Jensen and Gaie, advocates of client-initiated voluntary testing (vigilant, rights-
based) offer compelling reasons to minimize the potential for discrimination and
stigma-related violence against people living with HIV. As the case points out, the
risk of violence or discrimination is particularly high in LMIC societies where
social, cultural, and legal protections are nonexistent or being developed.
Although HIV-positive status can have adverse social consequences, Zinner illus-
trates how social factors increase the risk of infection in the first place. In this case, an
international anti-AIDS program administering pre-exposure prophylactic medica-
tion is deciding whether to budget small sums of money to educate young girls in the
community. Investing in education should reduce their likelihood of getting infected
in unequal liaisons with older men (sugar-daddy relationships) while creating open-
ings in the program for other at-risk groups to participate. In effect, the program is
considering medical intervention (i.e., a pre-exposure prophylactic drug) and social
determinants of health (i.e., girl–child education) in making its allocation decisions.
Both Timms’ and Lee, Kleinfeld, and Glassford’s cases show how social deter-
minants (e.g., gender, caste, economic status, literacy) influence the effectiveness of
informed consent for vulnerable LMIC populations participating in drug research.
Less direct but equally critical, these cases also show how geographic disparities in
social conditions establish context for global health research. The challenge of
ensuring that drug research is conducted ethically in LMICs derives from such con-
textual factors as greater disease burdens in these regions due to underdeveloped
health systems, lax regulation of biomedical research due to ineffective governance
structures, and economic and social vulnerability of most potential research partici-
pants (Barlett and Steele 2011).
In the context of SDH, empowerment “is inseparably linked to marginalized and
dominated communities gaining effective control over the political and economic
processes that affect their well-being” (WHO 2007). List and Boyd’s case demon-
strates how citizens of LMICs can use mass media to influence their governments
on public health topics. A physician-national in an East African country fears retali-
ation if she talks to the media about a TB medication stock-out potentially due to
government corruption and misuse of public funds. Her fears underscore the risks
and responsibilities associated with the role of health workers as advocates for the
socially and politically marginalized in their communities (Pérez and Martinez
2008; Farmer 2004; Geiger and Cook-Deegan 1993). Also pertinent from a global
SDH perspective is the likelihood that an expatriate whistleblower, especially a citi-
zen from a higher-income country, would not face as serious a risk.
8.4 Summary
The approaches and methods for collaborating in global public health are diverse—
just like the cases in this chapter. These cases reflect the rich and multifaceted con-
text for global public health while also emphasizing the role that different ethical
standards (and the foundations for those standards) play. In so doing, the cases offer
a fresh and innovative perspective on the ethics of public health.
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8.5 Case 1: The Ethics of HIV Testing Policies
Kipton E. Jensen
Department of Philosophy and Religion
Morehouse College
Atlanta, GA, USA
e-mail: kipton.jensen@morehouse.edu
Joseph B.R. Gaie
Department of Theology and Religious Studies
University of Botswana
Gaborone, Botswana
institutions.
8.5.1 Background
The global public health community has significantly advanced our understanding
of the biology of the human immunodeficiency virus (HIV) and developed reliable
diagnostic tests and effective antiretroviral treatments. Despite these advancements,
the rate of prevalence and transmission, especially in low- and middle-income coun-
tries, remains alarmingly high. HIV prevention, often considered better than a cure,
remains the mainstay of our collective response to the epidemic. By all accounts,
HIV testing plays a pivotal role in treatment and prevention, yet in low- or middle-
income countries, only 10 % of those who have been exposed to HIV infection may
have access to counseling and testing (UNAIDS/WHO 2004; Centers for Disease
Control and Prevention 2012). In general, HIV testing policies range from voluntary
or client-initiated counseling and testing to provider-initiated approaches (e.g., rou-
tine testing, mandatory HIV screening). Most policy makers and health workers
have promoted voluntary HIV testing, although routine HIV counseling and testing
increasingly is being adopted. Notably, however, the global health community has
adamantly discouraged mandatory HIV testing (UNAIDS/WHO 2004).
Resource-poor countries may be unable or unwilling to ensure social and medical
infrastructures adequate for safeguarding the human rights of people seeking ser-
vices. As a result, global health officials have encouraged countries to adopt volun-
tary or client-initiated counseling and testing policies opposed to routine or
provider-initiated policies. Even in settings in which voluntary counseling and testing
is readily available, few people take advantage of these services. Stigmatization per-
sists as an obstacle to HIV counseling and testing, which, by all accounts, is vital to
effectively treat people living with HIV and AIDS and to reduce further infection.
Many public health ethicists recommend that policy makers and health workers
carefully consider the ethical consequences of routine testing policies, especially
for people in locales that lack protections against discrimination and stigma-related
violence (Rennie and Behets 2006). To protect individuals against HIV-related dis-
crimination and threat of violence, advocates of the human-rights approach vigi-
lantly oppose the application of standard methods of disease control, which include
mandatory testing and partner notification. But this vigilant rights-based approach
to HIV prevention, an approach that Bayer (1991) labelled AIDS exceptionalism,
can undermine society’s ability and indeed responsibility to control the epidemic.
And although public health officials are a minority, some argue for mandatory HIV
testing (Schuklenk and Kleinsmidt 2007), seeing it as the only way to control the
HIV epidemic. Failure to apply standard methods of disease control, some argue,
devalues public health and social justice (Frieden et al. 2005; De Cock et al. 2002).
By treating HIV/AIDS differently than other infectious diseases, AIDS exceptional-
ism may inadvertently increase stigmatization rather than reduce it (De Cock et al.
2002). Proponents of testing point to its potential to reduce stigma by raising aware-
ness, preventing transmission, expanding treatment, and empowering individuals
(Crepaz et al. 2004).
HIV testing policy recommendations from the global international public health
community can also challenge if not undermine the authority of the indigenous
knowledge system or indigenous ethical codes (Chilisa 2005; Dube 2006; Jensen
and Gaie 2010). These recommendations typically stipulate ethical preconditions
within voluntary HIV testing policies, such as strict confidentiality, informed con-
sent, and competent pre- and post-test counseling. Some argue that preconditions
constitute a Western approach that blocks local efforts to control the epidemic.
Although many believe that the context of provider-initiated HIV testing preserves
“sufficient voluntariness,” others have criticized this approach. Critics maintain
that opting-out from provider-initiated HIV testing differs significantly from
client-initiated or voluntary HIV counseling and testing (Kenyon 2005). In either

case, all agree, medical practitioners and policy makers cannot guarantee ideal or
even adequate social and institutional support services (Weiser et al. 2006).
These disputes are by no means merely theoretical. In Botswana, for example,
policy has shifted within the past 5 years from a client-initiated to a provider-
initiated or routine HIV diagnostic counseling and testing strategy (Botswana
Ministry of Health 2012). More recently, in response to a parliamentary-approved
public health bill presently being contested as unconstitutional (Botswana Network
on Ethics, Law and HIV/AIDS 2012), the debate has shifted to whether certain
conditions render mandatory testing ethically permissible.
The Minister of Health of a sub-Saharan nation has asked you, a public health official
and physician from a Western country, to recommend an effective HIV testing policy.
The sub-Saharan nation is among the hardest hit by the HIV epidemic (e.g., the HIV
prevalence rate among pregnant women aged 15–49 is >25 %). In this resource-poor
nation, people with HIV and AIDS are commonly stigmatized despite national cam-
paigns to reduce stigma. Even if the nation were to adopt a policy of voluntary HIV
counseling and testing, more than 50 % of people living with HIV and AIDS are unaware
of their serostatus. Although HIV treatment is currently unavailable, international donors
have promised to provide free or inexpensive antiretroviral therapies (ART).
You have sought the input of your colleagues in global public health only to dis-
cover they are contentiously divided. Some vigorously oppose enhanced HIV test-
ing policies that would move from voluntary to routine HIV testing to protect the
community against discrimination or stigma-related violence. They also oppose in
principle Western-based interventions, which, they say, undermine traditional loci
of authority and indigenous systems of medical knowledge. Other colleagues insist
that human rights-based approaches undermine public health’s ability, as well as
responsibility, to control the HIV epidemic. They are for moving beyond client-
initiated approaches and vigorously support mandatory HIV testing. These
colleagues feel that the only way to control the HIV epidemic is to apply the stan-
dard methods of disease control.
Given these divergent views, you hope to be able to recommend a HIV policy
that strikes a balance between the Hippocratic ideal of doing no harm and the
equally compelling mandate to protect if not improve public health.
1. How might an emphasis on protecting human rights in HIV prevention reduce

the importance of public health and social justice?
2. Is opting in, or not opting out, as part of the routine testing strategy, ethically
equivalent to acquiring consent within a voluntary testing site? What are the
necessary and sufficient conditions, ethical or otherwise, for “adequate informa-

tion” or “sufficient voluntariness” in cases of HIV testing?
3. Is there an ethical conflict between one’s duty, whether as a physician or a public
health official, whether as the minister of health or simply as a person, to adopt
what are considered to be effective methods of controlling disease, e.g., HIV, and
the obligation to respect indigenous knowledge systems and approaches to pub-
lic health? If there is a conflict, which duty should take precedent?
4. What policy would you recommend under these circumstances? And what ethi-
cal principles guided your recommendation?
5. How would your recommendation provide, if at all, protections against discrimi-
nation and stigma-related violence?
References
Bayer, R. 1991. Public health policy and the AIDS epidemic: An end to HIV exceptionalism? New
England Journal of Medicine 324(21): 1500–1504.
Botswana Ministry of Health. 2012. Routine HIV Testing (RHT). Gaborone, Botswana: Department
of HIV and AIDS Prevention & Care.
Botswana Network on Ethics, Law and HIV/AIDS. 2012. Public health bill shocking and regres-
sive. Press Release, December 6. http://www.bonela.org/index.php?option=com_k2&view=ite
m&Itemid=223&id=104:06-december-2012. Accessed 17 July 2013.
Centers for Disease Control and Prevention. 2012. Strategic plan, division of HIV/AIDS prevention
(2011–2015). http://www.cdc.gov/hiv/pdf/policies_DHAP-strategic-plan.pdf. Accessed 23 Jan
2014.
Chilisa, B.C. 2005. Educational research within postcolonial Africa: A critique of HIV/AIDS
research in Botswana. International Journal of Qualitative Studies in Education 18(6):
659–684.
Crepaz, N., T.A. Hart, and G. Marks. 2004. Highly active antiretroviral therapy and sexual risk
behavior: A meta-analytic review. Journal of the American Medical Association 292(2):
224–236.
De Cock, K.M., D. Mbori-Ngacha, and E. Marum. 2002. Shadow on the continent: Public health
and HIV/AIDS in Africa in the 21st century. Lancet 360(9326): 67–72.
Dube, M.W. 2006. Adinkra! Four hearts joined together: On becoming healing-teachers of African
indigenous religion/s in HIV & AIDS prevention. In African women, religion, and health:
Essays in honor of Mercy Amba Ewudziwa Oduyoye, ed. I.A. Phiri and S. Nadar, 131–156.
Maryknoll: Orbis Books.
Frieden, T.R., M. Das-Douglas, S.E. Kellerman, and Henning K. J. 2005. Applying public health
principles to the HIV epidemic. New England Journal of Medicine 353(22): 2397–2402.
Jensen, K., and J.B. Gaie. 2010. African communalism and public health policies: The relevance
of indigenous concepts of personal identity to HIV/AIDS policies in Botswana. African Journal
of AIDS Research 9(3): 297–305. doi:10.2989/16085906.2010.530187.
Kenyon, K. 2005. Routine HIV testing: A view from Botswana. Health and Human Rights 8(2):
21–23.
Rennie, S., and F. Behets. 2006. Desperately seeking targets: The ethics of routine HIV testing in
low-income countries. Bulletin of the World Health Organization 84(1): 52–57.
Schuklenk, U., and A. Kleinsmidt. 2007. Rethinking mandatory HIV testing during pregnancy in
areas with high HIV prevalence rates: Ethical and policy issues. American Journal of Public
Health 97(7): 1179–1183.
UNAIDS/WHO. 2004. UNAIDS/WHO policy statement on HIV testing. Geneva: World Health
Organization. http://www.who.int/ethics/topics/en/hivtestingpolicy_who_unaids_en_2004.pdf.
Accessed 17 July 2013.
Weiser, S.D., M. Heisler, K. Leiter, et al. 2006. Correction: Routine HIV testing in Botswana: A
population-based study on attitudes, practices, and human rights concerns. PLoS Medicine
3(10), e395. doi:10.1371/journal.pmed.0030395.
8.6 Case 2: Just Allocation of Pre-exposure Prophylaxis

Drugs in Sub-Saharan Africa
Susan Zinner
School of Public and Environmental Affairs
Indiana University Northwest
Gary, IN, USA
e-mail: szinner@iun.edu
institutions.
8.6.1 Background
During the summer of 2012, the U.S. Food and Drug Administration (FDA)
announced the approval of Truvada (emtricitabine/tenofovir disoproxil fumerate)
for use in pre-exposure prophylaxis programs (PrEP) for people at high risk of HIV
infection (FDA 2012). After successful use of antiretroviral therapy (ART) drugs to
treat HIV/AIDS-infected populations, researchers found that daily prophylactic use
of these drugs in uninfected individuals who engaged in high-risk activities was also
effective in reducing their risk of HIV/AIDS. The U.S. Centers for Disease Control
and Prevention (CDC) noted that PrEP could reduce HIV rates for men having sex
with men if those at high risk of HIV infection were targeted and if PrEP was used
as part of a comprehensive set of preventive services, including regular monitoring
of HIV status, adherence, and risk behaviors (CDC 2011). Candidates for Truvada
should first be tested for HIV to ensure that they are in fact HIV negative before
beginning the PrEP program.
This innovative prophylactic approach to reducing the likelihood of contracting
HIV holds great promise. One study found that Truvada reduced the risk of HIV
infection 42 % compared with men taking placebos and having sex with other men
(Grant et al. 2010), whereas a second study found that risk fell by up to 75 % com-
pared with serodiscordant couples taking placebos (Baeten et al. 2012). However,
Truvada is associated with some side effects, including nausea and vomiting (CDC
2011) and possible decreases in bone mineral density (Grigsby et al. 2010).
Furthermore, Truvada is contraindicated for anyone with decreased kidney function.

Regular testing of kidney function is recommended for those people taking this
medication (CDC 2011).
Truvada has been tested only in serodiscordant couples—not in women. Its effi-
cacy in the general population of women, in sex workers, and in young girls in
sugar-daddy relationships (i.e., young girls in unequal relationships with older
males) is unknown.
Sub-Saharan Africa has been hit especially hard by HIV/AIDS. An estimated
two-thirds of people affected by HIV worldwide are concentrated in this area,
although significant variations exist in different parts of the continent (Kalipeni
et al. 2004). Unfortunately, the distribution and availability of ART drugs have
exposed the inadequacies of some African national health systems, such as the neg-
ative effects of a long-neglected health sector, economic challenges, declining pub-
lic expenditures, and decentralized funding (Schneider et al. 2006).
Many international aid groups help fund public health programs, including pro-
grams to reduce the spread of HIV/AIDS. Programs such as PEPFAR (The United
States President’s Emergency Plan for AIDS Relief), the Global Fund, the World
Bank, the United Nations, and the Gates Foundation have all contributed large sums
of money for this purpose.
African groups at high risk of contracting new infections (and thus good poten-
tial candidates for PrEP) include sex workers, men having sex with men, serodiscor-
dant couples, and girls in sexual sugar-daddy relationships. The latter group poses
specific ethical issues. These girls, typically teenagers, may be coerced into sexual
relationships with men old enough to be their fathers or even grandfathers through
the offering of gifts or money. These sugar daddies generally engage in multiple
sexual relationships, possibly with a spouse and several young women, while put-
ting the girls at risk of HIV. Every averted case of HIV increases economic produc-
tivity, lowers the risk of social unrest, strengthens the labor force, and improves the
investment climate (Over 2011).
You are the head of an international anti-AIDS effort currently stationed in a com-
munity of 40,000 in sub-Saharan Africa, where the HIV prevalence rate is 21 %. You
have received funding from different world organizations, including some based in the
United States. Your organization is piloting the use of Truvada in populations that are
at high risk of HIV. The organizations funding this project will allow you and the two
health workers assigned to assist you to make all allocation decisions.
The cost of Truvada for one patient is about $500 per year. Those living in this
community are poor, and none could afford this drug without the existence of your
program. Many populations in the community are at high risk of HIV infection,
including homosexual and bisexual men who routinely engage in sex with other
men, girls in sugar-daddy relationships, sex workers, and serodiscordant couples.
You have been given enough Truvada to treat and monitor 100 patients for a year.
The funding organizations have indicated that they are likely to provide more
Truvada if you find its use results in no or few new infections during the year among
the 100 selected patients. The community of 40,000 people include the following:
• 80 men who have sex with other men;
• 80 girls in sugar-daddy relationships;
• 40 sex workers; and
• 30 serodiscordant couples (60 people; noninfected partner receives Truvada
while the infected partner is not medically eligible for ART).
One challenge you face is that many feminist organizations and child health advo-
cates are pressuring you to include all girls in the group because ample research shows
that girls in sugar-daddy relationships are relatively powerless and cannot ask their
partners to wear a condom, virtually ensuring that these girls will become infected.
There is some evidence, however, that simply paying girls a small amount of money
to attend school (and thus dramatically reducing the possibility of these relationships)
is cost effective. If you adopt this approach, you could use the Truvada for the other
groups. You may need to consider whether to request more money from the funding
organizations if you adopt this approach. One of your organization’s goals is to respect
cultural norms and beliefs if the health of those at risk of HIV/AIDS is not jeopar-
dized. You have been asked to allocate the PrEP drugs in your community.
1. What role should the community play as you make your allocation decisions?
How do you remain culturally sensitive when implementing this program?
2. Create a rubric to help you consider each group for inclusion in the PrEP pro-
gram. What factors will you weigh in making allocation decisions? If you do not
pick an entire group, what criteria do you use to select individuals in that group?
How would your criteria differ if you were distributing ART drugs to infected
individuals (and not to those who are at risk but not infected)?
3. What role should the likelihood of patient adherence play in your allocation
decision? Keep in mind that patients are expected to take their medication daily
on a strict time schedule.
4. How will you determine if your program is successful? How will you determine
whether your allocation decisions are just and fair?
References
Baeten, J.M., D. Donnell, P. Ndase, et al. 2012. Antiretroviral prophylaxis for HIV prevention in
heterosexual men and women. The New England Journal of Medicine 367(5): 399–410.
doi:10.1056/NEJMoa1108524.
Centers for Disease Control and Prevention (CDC). 2011. Interim guidance: Preexposure prophy-
laxis for the prevention of HIV infection in men who have sex with men. Morbidity and
Mortality Weekly Report 60(3): 65–68. http://www.cdc.gov/mmwr/preview/mmwrhtml/

mm6003a1.htm. Accessed 5 May 2013.
Food and Drug Administration (FDA). 2012. FDA approves first drug for reducing the risk of sexu-
ally acquired HIV infection. FDA News Release July 16. http://www.fda.gov/NewsEvents/
Newsroom/PressAnnouncements/ucm312210.htm. Accessed 15 May 2013.
Grant, R.M., J.R. Lama, P.L. Anderson, et al. 2010. Preexposure chemoprophylaxis for HIV pre-
vention in men who have sex with men. The New England Journal of Medicine 363(27): 2587–
2599. doi:10.1056/NEJMoa1011205.
Grigsby, I.F., L. Pham, L.M. Mansky, R. Gopalakrishnan, and K.C. Mansky. 2010. Tenofovir-
associated bone density loss. Therapeutics and Clinical Risk Management 6: 41–47.
Kalipeni, E., S. Craddock, and J. Ghosh. 2004. Mapping the AIDS pandemic in Eastern and
Southern Africa: A critical overview. In HIV & AIDS in Africa: Beyond epidemiology, ed. E.
Kalipeni, S. Craddock, J.R. Oppong, and J. Ghosh, 58–69. Malden: Blackwell Publishing.
Over, M. 2011. Achieving an AIDS transition: Preventing infections to sustain treatment.
Washington, DC: Center for Global Development.
Schneider, H., D. Blaauw, L. Gilson, N. Chabikuli, and J. Goudge. 2006. Health systems and
access to antiretroviral drugs for HIV in Southern Africa: Service delivery and human resources
challenges. Reproductive Health Matters 14(27): 12–23.
8.7 Case 3: Drug Trials in Developing Countries
Olinda Timms
Department of Health and Humanities
St. Johns Research Institute
Bangalore, Karnataka, India
e-mail: olindatimms@gmail.com
institutions.
8.7.1 Background
Clinical trials outsourced to India offer, in addition to business opportunities for

clinical research management, the prospect of health infrastructure development
and collaborative research. Since 2005, drug trials in India have increased as foreign
drug companies eagerly take advantage of the favorable research environment
(British Broadcasting Corporation [BBC] News 2006; Russia Today 2010; Overdorf
2011; John 2012). These advantages include highly qualified English-speaking
doctors, a large and diverse population, and lower costs and relative freedom from
burdensome regulations for privately funded research trials (World Health
Organization 2008). As a result, clinical research organizations working on behalf
of pharmaceutical companies frequently approach doctors in private or government
practice to recruit patients for drug trials, often offering attractive payouts per recruit
and promising coauthorship and publication credits as incentives.
For vast sections of its demographic, India grapples with inadequate access to
health services and high rates of infant mortality and communicable diseases
(Government of India Planning Commission 2011). Only a small slice of the popu-
lation can afford the high-end private and corporate hospital care in urban pockets
of the nation. Though extremely deferent to physicians, the Indian population is
insufficiently informed about the risks and benefits of clinical trials. Illiterate,
impoverished, and unaware of the implications of participation, many drug trial
recruits are vulnerable to exploitation (Srinivasan and Nikarge 2009). With limited
health care options, some gladly enroll in a drug trial, considering themselves fortu-
nate to receive medical attention, food, and compensation for local travel. Such
circumstances compromise the intent behind freely giving informed consent.
The media has drawn attention to several high-profile cases. These involved poor
people from lower castes who enrolled in drug trials without adequate consent,
resulting in severe adverse effects, including death (Lloyd-Roberts 2012). Citing
data for 2005–2012, the BBC reported that 2,000 clinical trials took place in India.
The death count among people enrolled in these clinical trials was 288 in 2008,
637 in 2009, 668 in 2010, and 438 in 2011 (Lloyd-Roberts 2012). The media also
raised concerns about inadequate regulation of private trials, inconsistent applica-
tion of informed consent requirements, and irregularities in ethics reviews (The
Hindu 2011; The Indian Express 2012).
Although officials have been responsive to these concerns, their efforts still leave
the vulnerable unprotected. In 2000, the Ministry of Health and Family Welfare
established legal guidelines regulating the conduct of research in India that align
with international guidelines on research ethics including the International
Conference on Harmonisation of Good Clinical Practice (ICH-GCP) (1996), the
Declaration of Helsinki (World Medical Association 2008) and Council for
International Organizations of Medical Sciences (CIOMS) guidelines (2002). The
Indian Council of Medical Research also developed guidelines specifically for clini-
cal trials (2006). Further, the Drugs and Cosmetics Rules were amended to require
review and registration of trials and to compensate trial participants or their families
in the event of an adverse event (Government of India 2005). Unfortunately, adverse
events go grossly underreported. Few recruits receive compensation, and hardly any
investigations result in convictions for unethical research practices.
Sharada, a 45-year-old woman of a low social caste in an impoverished town in India,

lives on less than 2 U.S. dollars a day. She has access only to the government hospi-
tal system that provides free health care to underserved citizens. Complaining of
chest pains, she is taken to the nearest government hospital and diagnosed with heart
and renal failure. Pharmakon, a multinational pharmaceutical company, happens to
be conducting a trial for a drug that has renal-protective effects in cardiac failure.
From a colleague serving as a site investigator for this trial, Sharada’s cardiologist
hears that pilot testing of the drug has shown promising results. But he also learns that
his colleague’s compensation is tied to the number of subjects he enrolls in the study.
Worse, Pharmakon has a history of enrolling patients without ensuring they fully
understand they will be participating in a research project. Despite misgivings about
this history and his colleague’s financial incentive to enroll patients, Sharada’s cardi-
ologist recommends that she enroll in the drug trial. He emphasizes that enrollment
offers the only way to obtain an expensive drug necessary to save her life that would
otherwise be unaffordable. Given the family’s lack of education, he is uncertain how
much they understood, yet they seem grateful for the prospect of immediate care and
treatment. While on this medication, Sharada develops cardiac arrhythmias, is taken
off the drug, and is discharged from the hospital in a few days. Almost a month later,
she succumbs to cardiac arrest at home. Soon thereafter, the high number of serious
drug-related complications forces discontinuation of the drug trial.
1. Who are the stakeholders in this case, what is at stake for each of them, and what
values does each bring to the situation?
2. What are the risks and benefits of enrolling impoverished, uneducated patients
living in developing countries in clinical drug trials? What are the barriers to
obtaining true informed consent from these patients, and what can be done to
overcome these barriers?
3. What are the ethical implications of tying a researcher’s compensation to the
number of subjects enrolled? Should this practice be permitted?
4. Are multinational pharmaceutical companies that benefit from cost-effective
drug trials in developing countries obligated to improve the lives of people living
in those countries?
5. Who should be held responsible for adverse events due to a drug trial conducted
by a multinational company in a country where there is limited health insurance,
no social security, and poor enforcement of regulations? What international or
grassroots efforts might help ensure accountability for adverse events?
References
British Broadcasting Corporation News. 2006. Drug trials outsourced to Asia. April 22. http://
news.bbc.co.uk/2/hi/south_asia/4932188.stm. Accessed 27 June 2013.
Council for International Organizations of Medical Sciences (CIOMS). 2002. For biomedical
research involving human subjects. http://www.cioms.ch/publications/layout_guide2002.pdf.
Government of India. 2005. Drugs and cosmetics rules: Schedule Y. http://dbtbiosafety.nic.in/act/
Schedule_Y.pdf. Accessed 23 Jan 2014.
Government of India Planning Commission. 2011. Report of the working group on National Rural
Health Mission (NRHM) for the Twelfth Five Year Plan (2012–2017). New Delhi: Government of
India. http://planningcommission.nic.in/aboutus/committee/wrkgrp12/health/WG_1NRHM.pdf.
Indian Council of Medical Research. 2006. Ethical guidelines for biomedical research on human
participants. New Delhi: Indian Council for Medical Research. http://icmr.nic.in/ethical_
guidelines.pdf. Accessed 27 June 2013.
International Conference on Harmonisation of Good Clinical Practice (ICH-GCP). 1996.
International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use. Good clinical practice. http://ichgcp.net/. Accessed 27 June
2013.
John, S. 2012. Trial and error: India can attract 5–10% of the global market for drug trials. Times
of India, October 22. http://timesofindia.indiatimes.com/business/india-business/Trial-and-
Error-India-can-attract-5-10-of-the-global-market-for-drug-trials/articleshow/16910327.cms.
Lloyd-Roberts, S. 2012. Have India’s poor become human guinea pigs? BBC News Magazine,
November 1. http://www.bbc.co.uk/news/magazine-20136654. Accessed 27 June 2013.
Overdorf, J. 2011. India: Deadly drug trials. GlobalPost, June 19. http://www.globalpost.com/
dispatch/news/regions/asia-pacific/india/110618/india-health-drug-trials. Accessed 27 June
2013.
Russia Today. 2010. India becomes global drug trial ground for pharmaceuticals. October 23.
http://rt.com/news/india-drug-trial-pharma/. Accessed 27 June 2013.
Srinivasan, S., and S. Nikarge. 2009. Ethical concerns in clinical trials in India: An investigation.
Mumbai: Centre for Studies in Ethics and Rights. http://www.fairdrugs.org/uploads/files/
Ethical_concerns_in_clinical_trials_in_India_An_investigation.pdf. Accessed 27 June 2013.
The Hindu. 2011. Opinion/editorial: A shockingly unethical trial. May 15. http://www.thehindu.
com/opinion/editorial/a-shockingly-unethical-trial/article2021657.ece. Accessed 27 June
2013.
The Indian Express. 2012. 10 die per week in drug trials in India. July 8. http://indianexpress.com/
article/india/regional/10-die-per-week-in-drug-trials-in-india/. Accessed 27 June 2013.
World Health Organization (WHO). 2008. Clinical trials in India: Ethical concerns. Bulletin of the
World Health Organization 86(8): 581–582. doi:10.2471/BLT.08.010808.
World Medical Association. 2008. Declaration of Helsinki—Ethical principles for medical
research involving human subjects. http://www.wma.net/en/30publications/10policies/b3/
index.html. Accessed 27 June 2013.
8.8 Case 4: Ethical Issues in Responding to International

Medication Stock-Outs
Justin List
Robert Wood Johnson/VA Clinical Scholars Program
University of Michigan
Ann Arbor, MI, USA
e-mail: justin.list@gmail.com
Andrew Boyd
Department of Medicine, Section of Hospital Medicine
Columbia University
New York, NY, USA
institutions.
8.8.1 Background
The World Health Organization (WHO) maintains a list, updated every 2 years, of
medications it considers essential—medications that a given country should have on
hand to distribute to its citizens (WHO 2015). In functioning health systems, the
intent is to have essential medicines of assured quality available at all times in ade-
quate amounts, in appropriate dosage forms, and at an affordable price (WHO
2015). Among those medications are treatments for tuberculosis (TB), a ubiquitous,
slow-growing bacteria that kills 1.4 million people annually (WHO 2012).
Control of TB requires the availability of medication for months of treatment.
Procurement of TB medication requires an intact and predictable supply chain.
Ideally, ministries of health in low-income countries forecast accurately the number
and types of medications needed to treat the local burdens of disease. Then govern-
ments typically purchase medications to store in a central facility for regional distri-
bution. Inefficiencies in drug supply forecasting; stocking practices; storage
capabilities; transportation capacity; and timely funding, procurement, and delivery
can lead to a breakdown in a supply chain.
One barrier to TB control in low-resource countries, as well as in the United
States, is intermittent unavailability of TB medication, an occurrence known as a
stock-out (Centers for Disease Control and Prevention 2013). Medication stock-
outs often result in delayed treatment, an increased risk of drug resistance in incom-
pletely treated people, and the potential for untreated or incompletely treated people
to infect others. Stock-outs occur for different reasons, including budget constraints,
poor drug procurement policies and distribution networks, and political corruption
slowing drug availability (Stop Stock-outs Campaign 2010).
Although 80 % of national ministries of health reporting to WHO have an unin-
terrupted supply of first-line TB medications, 45 % of the 20 highest-burden coun-
tries report stock-outs (WHO 2009). More recently, 14 countries experienced
anti-TB drug stock-outs in 2011 (Stop TB Partnership 2011). To contend with
recurrent stock-outs, the Stop TB Partnership provides technical support and drug
procurement avenues to resource-poor nations through its Global Drug Facility
(GDF) and Green Light Committee (GLC) (Stop TB Partnership 2011). Although
GDF and GLC are essential players in ensuring at-risk nations have adequate drug
supplies, both are limited in how quickly they can respond to stock-outs.
Advocacy groups and nongovernmental organizations can generate widespread
public attention in hope of quicker resolution of stock-outs. A paucity of literature
covers the ethical roles of expatriate health workers in stock-outs. The model of
“ethics of engaged presence” in health practice for expatriate health workers in low-
income countries may offer a framework of solidarity with local people (Hunt et al.
2012). This nondirective framework broadly centers on the moral dimensions of

expatriate involvement in humanitarian health work undertaken with local individu-
als. Still, limited ethical guidelines exist for expatriates who seek to enter foreign
political and social forays to affect change—leaving the problem of essential TB
medication stocks-outs unresolved.
You are a visiting researcher in an East African country investigating TB case-finding

detection strategies in an urban area. This country has one of the highest TB burdens
in the world. Its government funds the national medical stores to stock anti-TB drugs
per WHO’s essential medication list. On occasion, you work in the TB clinic at the
local hospital treating TB patients, some of whom have multidrug-resistant TB. You
know that your research participants are guaranteed TB drugs through your study’s
funding. Potential participants who do not qualify for the study but have active TB
infection are referred to a local clinic.
After months living and working in this country, you learn that many of the urban
and rural clinics carry an inadequate supply of anti-TB medications. You speak with
local doctors about the anti-TB drug shortage. They are frustrated and speculate as
to why there have been stock-outs. Some suspect corruption and misuse of funds by
the ministries of finance and health are to blame. Others blame drug manufacturers
for unreliable supplies.
You search for drug stock-outs in this country using Internet search engines and
come across stock-outs for other drugs but find no mention of anti-TB drug stock-
outs. You return to a weekly clinic meeting and note that the news has not covered
the stock-outs your colleagues are experiencing at their clinics. You ask if any of
them will push the ministry of health to fix the shortage. One physician says he
heard that the ministry will “provide the TB drugs again shortly.” You suggest that
one of the physicians contact someone from a media outlet to raise attention. After
a period of silence, a physician says she fears that the government will somehow
retaliate if this issue is raised.
After further conversations with colleagues, you decide to attract media attention
to this issue. Your local colleagues support you, even saying they will provide you
with data about the stock-out. Contacts in your U.S.-based sponsoring organization
feel ambivalent about your working with the media to raise attention but will not
prohibit it so long as you do not mention your affiliation.
You decide to contact an international health and human rights organization about
the stock-out, and its staff puts you in touch with a local partner organization. The
local partner wants you to speak, along with local human rights advocates, at a stock-
out conference and interview with newspaper reporters. Despite your wanting to help
those dependent on the national drug supply for their TB treatment, you are conflicted
about your participation and its possible repercussions. Before committing, you tell
the local partner that you need to think the matter through thoroughly.
1. What are some risks and benefits of your involvement with the stock-out confer-
ence and contact with the media? What ethical concepts should inform your
decision? Would your decision change if your colleagues or sponsoring organi-
zation urged you to say nothing?
2. How does your limited understanding of local institutional hierarchy and gover-
nance inform your ethical analysis of whether or not to engage in advocacy
around stock-outs? If you conclude you should engage, are there ways to do so
besides public testimony?
3. Does it matter ethically if the stock-out pertained to antimalarial medications; that
is, a medication outside your research area (TB medication)? Why or why not?
4. In terms of perceptions and consequences from the media and government min-
istries, how might your public reporting of the stock-out differ from a local offi-
cial reporting it? What different types of impact might result from each? How
might your ability to work with local health professionals in the future be affected
if you report the alleged stock-out?
5. Knowing that you have ready access to anti-TB medication for research partici-
pants, should you broaden the inclusion criteria to allow more patients to receive
guaranteed treatment? Why or why not?
6. Should you attempt to bring the stock-out to the attention of the global health
international community by inviting members of the international media to the
stock-out conference? If not, why not? If so, what approaches might interna-
tional and local nongovernmental organizations, World Health Organization
departments, and patient advocacy groups employ to effectively publicize and
resolve stock-outs? If not, why not?
7. Do you have an ethical duty to report the stock-out if local health officers will not
do so?
Acknowledgements Dr. List thanks staff members of the National Institutes of Health/Fogarty
International Clinical Research Scholars program, Physicians for Human Rights, and Action Group
for Health, Human Rights and HIV/AIDS (AGHA-Uganda) for advice on this case study’s content.
Both authors thank the leadership of the Yale/Stanford Johnson & Johnson Global Health Scholars
Program for training medical residents in ethics before their clinical work assignments in Rwanda.
References
Centers for Disease Control and Prevention. 2013. Interruptions in supplies of second-line antitu-
berculosis drugs—United States, 2005–2012. Morbidity and Mortality Weekly Report. http://
www.cdc.gov/mmwr/preview/mmwrhtml/mm6202a2.htm. Accessed 24 Mar 2013.
Hunt, M.R., L. Schwartz, C. Sinding, and L. Elit. 2012. The ethics of engaged presence: A frame-
work for health professionals in humanitarian assistance and development work. Developing
World Bioethics. doi:10.1111/dewb.12013.
Stop Stock-outs Campaign. 2010. What are stock-outs? http://stopstockouts.org/stop-stock-out-

scampaign/what-are-stock-outs/. Accessed 28 Dec 2012.
Stop TB Partnership. 2011. Global drug facility annual report 2011. http://www.stoptb.org/assets/
documents/gdf/whatis/GDF_Annual_Report_2011_web_lowres.pdf. Accessed 28 Dec 2012.
World Health Organization (WHO). 2009. Global tuberculosis control 2009: Epidemiology, strat-
egy, financing, 37. Geneva: World Health Organization.
World Health Organization (WHO). 2012. Global tuberculosis report 2012: Executive summary. http://
apps.who.int/iris/bitstream/10665/75938/1/9789241564502_eng.pdf. Accessed 3 June 2015.
World Health Organization (WHO). 2015. Essential medicines. http://www.who.int/topics/essen-
tial_medicines/en/. Accessed 24 June 2015.
8.9 Case 5: Transmitting Cholera to Haiti
Joseph Millum
Clinical Center Department of Bioethics and Fogarty International Center
National Institutes of Health
Bethesda, MD, USA
e-mail: joseph.millum@nih.gov
institutions.
8.9.1 Background
Cholera is caused by infection with Vibrio cholerae bacteria, which colonize the
small intestine and produce cholera toxin. The disease is characterized by sudden
onset of severe, watery diarrhea and vomiting. Left untreated, cholera rapidly leads
to dehydration and shock. Severe cholera can be fatal in more than 50 % of cases.
Prompt treatment reduces the case fatality rate to less than 1 % (Boore et al. 2008).
Treatment primarily addresses the loss of fluids: patients should be aggressively
treated with oral rehydration solution or, if severely dehydrated, through intrave-
nous fluids. Treatment with antibiotics shortens the course of the disease.
Cholera is transmitted through contaminated food or water. In developing coun-
tries, where most infections and deaths occur, inadequate sanitation is frequently the
cause of the spread of V. cholerae, as untreated fecal matter from cholera sufferers
leaks into the water supply. Each year, 3–5 million cases of cholera occur, leading
to about 120,000 deaths (Harris et al. 2012).
Cholera is endemic in more than 50 countries. In many places, cholera outbreaks
are seasonal—flaring up during the rainy season and dying down again during dry
periods. Outbreaks can be prevented or contained by properly treating sewage, pro-
moting rigorous hygiene practices, and sterilizing drinking water. Two oral cholera
vaccines are commercially available but not included in most cholera control
programs, although the World Health Organization (WHO) recommends them for
use in outbreaks and for high-risk populations (WHO 2010). Before 2010, Haiti had
not experienced cholera for at least a century.
Haiti, a country of ten million people, occupies the western portion of the island
of Hispaniola in the Caribbean. Although its per capita gross domestic product
(GDP) is about $1,200 (Central Intelligence Agency 2012),13 a tiny elite controls
most of the country’s wealth. With 80 % of the population living below the poverty
line, Haiti is the lowest-ranked country in the Americas on the United Nations
(U.N.) Human Development Index (UNDP 2011). The economy depends heavily
on remittances from Haitians working abroad and on foreign aid.
Life expectancy in Haiti is 62 years, while infant mortality is 52 per 1,000 live
births (UNDP 2011). Sixty-four percent of Haitians have access to an improved
water source (i.e., one that is protected from outside contamination), but just 26 %
have access to improved sanitation (i.e., a facility that separates human excreta from
human contact) (WHO/UNICEF 2013). Communicable diseases, including HIV/
AIDS, tuberculosis, diarrheal diseases, and malaria remain substantial causes of
disability and death. There are severe shortages of physicians, nurses, hospital beds,
and essential medicines. About 6 % of GDP is spent on health, of which three-
quarters is private expenditure. Out-of-pocket spending on health care is extremely
high (UNDP 2011).
Haiti has a long history of political instability, characterized by multiple coups, for-
eign interference and occupation, and extended periods of dictatorship, notably under
François Duvalier (Papa Doc) and his son Jean-Claude Duvalier (Baby Doc) between
1957 and 1986. Following a coup in 2004, the U.N. stationed peacekeepers in Haiti. The
U.N. Stabilization Mission in Haiti (MINUSTAH) has been in Haiti ever since.
In January 2010, a magnitude 7.0 earthquake struck Haiti. Hundreds of thousands
of people died and up to a million were left homeless. International aid agencies,
donor governments, and nongovernmental organizations (NGOs) mobilized rapidly
in response, and substantial amounts of money and aid were promised to assist in
rebuilding.
In mid-October 2010, upstream of the Artibonite River, a sudden rush of people

began presenting at the local hospital with acute diarrhea, signaling the first cholera
cases. People living nearby use the river extensively for washing, bathing, and
drinking water; farmers downstream use it for irrigation. Within days, the spread of
cholera to the Artibonite River Delta and settlements on the coast had overwhelmed
local clinics and hospitals. The facilities lacked cholera cots that allow patients to
defecate hygienically from their beds, while insufficient space for all patients pre-
vented isolation of cholera victims. For the thousands of sufferers, the supply of
13
Purchasing power parity in 2011 U.S. dollars.
doctors, nurses, and rehydration packs proved inadequate. The epidemic exploded
across Haiti. Since cholera was not endemic, the population lacked immunity.
Within months, thousands of people had died and hundreds of thousands had been
sickened.
NGOs and some international donor agencies, including from the U.N., who
were already in Haiti dealing with the aftermath of the earthquake, diverted resources
to combat cholera. They distributed medical supplies, organized educational cam-
paigns on cholera prevention, trucked clean drinking water and water purification
tablets across the country, and worked with local hospitals to institute rigorous
infection control measures.
The Haitian and international response to the cholera outbreak rapidly brought
the case fatality rate from around 9 % to less than 1 %. Although the outbreak died
down, the aid efforts failed to rectify the dire state of Haiti’s water and sanitation
infrastructure. During the rainy season, cases would spike again, exposing the dif-
ficulty of improving the Haitian health care system so that it could respond to new
outbreaks without external assistance.
Haiti had been cholera-free for more than a century—so how had cholera got
there? Almost as soon as the outbreak started, rumors circulated blaming U.N.
peacekeepers. A contingent of soldiers from Nepal, where cholera is endemic, had
arrived in October 2010. They were stationed at a camp on a tributary of the
Artibonite River near where the outbreak began. Waste management at the base was
rumored to be inadequate and had allowed sewage to flow into the river.
Initially, U.N. officials denied responsibility for bringing cholera to Haiti. But
rumors and public protest persisted, fueled by independent investigations suggest-
ing the camp as the source (Piarroux et al. 2011). Finally, the U.N. Secretary General
convened an independent panel of experts charged with determining the source of
the cholera outbreak. The panel completed its report in May 2011. It argued that the
evidence from the Artibonite River’s tributary system, the epidemiological timeline,
and genetic analyses of Haitian V. cholerae bacteria indicated that the outbreak
resulted from contamination of the river with feces carrying a strain of the current
South Asian bacterium. Moreover, the report noted that the “haphazard” plumbing
construction in the main toilet and showering area offered significant potential for
cross-contamination, and that heavy rains could cause the open septic pit into which
black water was deposited to overflow into the tributary (Cravioto et al. 2011).
The report offered a series of recommendations to prevent similar occurrences
and concluded
The introduction of this cholera strain as a result of environmental contamination with feces
could not have been the source of such an outbreak without simultaneous water and sanita-
tion and health care system deficiencies. These deficiencies, coupled with conducive envi-
ronmental and epidemiological conditions, allowed the spread of the Vibrio cholerae
organism in the environment, from which a large number of people became infected.
The independent panel concludes that the Haiti cholera outbreak was caused by the
confluence of circumstances as described above and was not the fault of, or deliberate
action of, a group or individual (Cravioto et al. 2011).
Since the initial outbreak, more than 7,500 Haitians have died from cholera and
more than 600,000 have been sickened. Subsequent independent genetic analysis
confirmed that the Haitian strain was almost identical with the strain currently cir-
culating in South Asia (Hendriksen et al. 2011).
Many commentators believe that the systemic deficiencies that enabled the out-
break are partly the fault of the Haitian government. It failed to take appropriate
measures to protect its population from disease, such as improving drinking water
and sanitation, investing in health care infrastructure, and so forth. The Independent
Panel concluded that the introduction of cholera by the U.N. mission was therefore
not the fault of the U.N. An alternative view is that multiple actors were at fault for
this tragedy, including the Haitian government, the U.N., and foreign governments
whose policies affect Haiti.
A distinct issue is whether and how the victims of the outbreak should be compen-
sated. One option is to make compensation the responsibility of those at fault, although
the difficulties in assigning fault may make this option challenging. An alternative is
to establish a no-fault scheme that would compensate anyone affected, but determin-
ing who must pay is also problematic. Donors working on earthquake relief in Haiti,
for example, arguably should not have to divert funds to remedy a problem they did
not create. In November 2011, a legal suit was brought against the U.N. seeking com-
pensation for the victims of the cholera outbreak (Sontag 2012). In February 2013, the
U.N. invoked legal immunity against such suits and refused to provide
compensation.
1. Which parties’ interests are affected by the cholera outbreak? Which parties
might have some responsibility to respond to the outbreak?
2. The U.N.’s Independent Panel of Experts concluded that “the Haiti cholera out-
break was caused by the confluence of circumstances … and was not the fault of,
or deliberate action of, a group or individual.” Assume that they are correct about
the facts. Does it follow that no one is morally at fault? Explain why or why not.
3. Imagine that you are providing recommendations for compensating the victims
of infectious disease outbreaks, like Haiti’s. Should individual actors be held
accountable, or should a no-fault compensation scheme be put in place? If the
latter, who should provide compensation? Explain the reasons for your responses.
(Douglas 2009 discusses “no-fault” compensation in another context.)
4. If the Haitian government has neglected its responsibilities to its citizens, does
this make any difference to the help that international aid agencies should pro-
vide to Haiti? Explain why or why not.
5. One possible concern with seeking compensation for the people who contracted
cholera is that it may have a “chilling effect” on international assistance. For
example, if aid agencies believe they are at risk of being sued for unintentionally
transmitting disease, they may be deterred from working in a country in the first
place. Should the Haitian government or the lawyers representing the victims
take this concern into account? Why or why not?
References
Boore, A., M. Iwamoto, E. Mintz, and P. Yu. 2008. Cholera and other vibrioses. In Control of com-
municable diseases manual, 19th ed, ed. D.L. Heymann, 113–127. Washington, DC: American
Public Health Association.
Central Intelligence Agency. 2012. The world factbook. https://www.cia.gov/library/publications/
the-world-factbook/. Accessed 29 May 2013.
Cravioto, A., C.F. Lanata, D.S. Lantagne, and G.B. Nair. 2011. Final report of the independent
panel of experts on the cholera outbreak in Haiti. http://www.un.org/News/dh/infocus/haiti/
UN-cholera-report-final.pdf. Accessed 29 May 2013.
Douglas, T. 2009. Medical injury compensation: Beyond ‘no fault’. Medical Law Review 17(1):
30–51. doi:10.1093/medlaw/fwn022.
Harris, J.B., R.C. LaRocque, F. Qadri, E.T. Ryan, and S.B. Calderwood. 2012. Cholera. Lancet
379(9835): 2466–2476. doi:10.1016/S0140-6736(12)60436-X.
Hendriksen, R.S., L.B. Price, J.M. Schupp, et al. 2011. Population genetics of Vibrio cholerae
from Nepal in 2010: Evidence on the origin of the Haitian outbreak. mBio 2(4): e00157–
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Piarroux, R., R. Barrais, B. Faucher, et al. 2011. Understanding the cholera epidemic, Haiti.
Emerging Infectious Diseases 17(7): 1161–1168.
Sontag, D. 2012. In Haiti, global failures on a cholera epidemic. New York Times, March 31.
United Nations Development Programme (UNDP). 2011. Human development report 2011:
Sustainability and equity: A better future for all. http://hdr.undp.org/en/content/humandevelop-
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WHO/UNICEF Joint Monitoring Programme (JMP) for Water Supply and Sanitation. 2013. Data
and estimates. http://www.wssinfo.org/data-estimates/table/. Accessed 29 May 2013.
World Health Organization (WHO). 2010. Cholera vaccines: WHO position paper. Weekly
Epidemiological Record 85(13): 117–128. http://www.who.int/wer/2010/wer8513.pdf?ua=1.
8.10 Case 6: Perilous Path to Middle East Peace:

The Sanctions Dilemma
Waleed Al-Faisal
Department of Family and Community Medicine, Faculty of Medicine
Damascus University
Damascus, Syrian Arab Republic
Primary Health Care
Dubai Health Authority
Dubai, United Arab Emirates
Hamid Hussain
Faculty of Medicine
University of Baghdad
Baghdad, Iraq
Dubai Residency Training Program and Public Health Consultant

Dubai Health Authority
Dubai, United Arab Emirates
e-mail: hussainh569@gmail.com
Kasturi Sen
Global Public Health, Wolfson College (Common Room)
University of Oxford
Oxford, UK
institutions.
8.10.1 Background
During the last century, public health practices have greatly improved the health of
individuals and societies in the Middle East and North Africa (MENA) region
through successful interventional programs like expanded immunization for chil-
dren and universal salt iodization programs. The major challenge for public health
in the twenty-first century is to simultaneously maintain and upgrade the infrastruc-
ture created to improve peoples’ lives.
Currently, the MENA region faces multiple challenges to its public health achieve-
ments, one of which is the impact of sanctions being used against MENA countries to
influence political behavior. Sanctions—defined as mostly economic but also political
and military penalties introduced to alter political/military threats and behavior—are
employed by the United States and other countries to discourage the proliferation of
weapons of mass destruction and ballistic missiles, bolster human rights, end terror-
ism, thwart drug trafficking, discourage armed aggression, promote market access,
protect the environment, and replace governments (Haass 1998). Sanctions often
involve economic measures, such as restricting or eliminating foreign assistance,
freezing countries’ assets, imposing export and import limitations, and revoking most-
favored-nation trade status (World Health Organization 2003).
Empirical evidence indicates that sanctions have profound long- and short-term
public health impact on the health of citizens in the affected countries, with the great-
est harm affecting the elderly, women, and children (Garfield 1999; Ali and Shah
2000). This impact goes far beyond problems with medical supplies or other health-
specific resources. Public health services depend on a safe water supply, a functioning
sanitation system, and a reliable power infrastructure; on availability of equipment
such as ambulances, X-ray machines, and refrigerators for storing vaccines; on the
public having resources to access health care (e.g., transportation, financial resources);
and on human resources, the trained staff who use the equipment.
Two examples of the use of sanctions were those imposed by the United Nations
(U.N.) against Iraq in the 1990s and against Syria beginning in 2011.
8.10.2 The Case of Iraq
To assess the health impact of the Iraq sanctions, the U.N. Children’s Fund
(UNICEF), in collaboration with the World Health Organization and local health
authorities surveyed child health in Iraq during February through May 1999
(UNICEF 1999a, b). Between 1984 and 1989, infant mortality in Iraq was 47 per
1,000 live births (Ali and Shah 2000). In southern and central Iraq, the infant mor-
tality rate almost tripled, rising to 108 per 1,000 live births during 1994 through
1999. The under-5 child mortality rate also drastically increased (more than dou-
bled) from 56 to 131 per 1,000 live births for the same period (Ali and Shah 2000).
Yet in the autonomous northern region of Iraq, infant mortality declined from 64 to
59 per 1,000 live births and under-5 mortality fell from 80 to 72 per 1,000 live births
for the same period. These differences were attributed to better food and resource
allocation due to Western support for an autonomous region and the nonapplication
of universal sanctions (UNICEF 2002).
Other studies of the health impact of sanctions on Iraq have similar negative find-
ings (Armijo-Hussein et al. 1991; Hurwitz and David 1992; Central Statistical
Organization, Iraq 1996, 1997). Table 8.1 summarizes data from these studies and
shows the change in health indicators once sanctions were imposed in 1990.
8.10.3 The Case of Syria
Since May 2011, economic sanctions against Syria significantly affected the
exchange rate, devaluing its Syrian Lira (SL). The exchange rate of 45 SL for every
U.S. dollar increased to more than 200 SL and had serious economic ramifications.
The cost of living essentials such as gas, eggs, milk, bread, and cooking oil more
than tripled over the past 2 years. At the same time, the purchasing power of
Table 8.1 Health status indicators before and after the 1990 sanctions against Iraq
Indicator 1985 1991 1996
Infant mortality rate 52 42 97
Under-5 mortality rate 64 42 126
Chronic malnutrition (%) 18 18 32
Stunting (%) 12 29 26
Maternal mortality per 100,000 – 121 294
births
Diarrhea episodes per child per year – 3.8 14.4
Births below 2.5 Kg (%) 5–9 4.5 12
Note. A dash indicates that reliable data are not available
salaries was halved. Families, nearing starvation, were forced out of work, and
more than 20 % of the working population was unable to purchase living essentials
(Zarzar 2013; Food and Agriculture Organization of the United Nations 2013). The
collapse of the exchange rate increased the cost of health services and of medicines.
Despite the emphasis of sanctions on economic measures, they prevented entry of
essential medical supplies into the country, including those for chronic diseases
such as cancer, diabetes, and heart disease, which are not produced locally. Local
drug production, an area in which Syria had been 90 % self-sufficient before the
sanctions and conflict, largely collapsed. This opened channels for counterfeit
drugs and corruption among those who smuggled supplies through the country’s
porous borders. The high cost of heating and electricity during 2 years of conflict
compounded the adverse effects of Syria’s extreme winter and summer tempera-
tures. Most notably, the cold chain of vaccines were destroyed, contributing to the
virtual collapse of the once successful vaccination programme (Al Faisal et al.
2012a, b). The combination of price increases, job losses, and lower salaries devas-
tated families, especially those with children or members who were pregnant or
elderly (United Nations Office for the Coordination of Humanitarian Affairs 2013).
Millions of small businesses collapsed in Syria. Many were small-scale and home-
based, run by women providing invaluable income to cope with price inflation and
to purchase food, school books and uniforms for children, and essential medicines
and emergency medical care.
8.10.4 Ethical Considerations
Before World War I, economic sanctions were considered acts of warfare that, like
military sieges, inflicted suffering on entire populations. Viewed this way, economic
sanctions appear ethically suspect from a number of perspectives. Sanctions violate
the just war ban on targeting noncombatants, the Kant’s philosophy not to use peo-
ple as means to an end, and the negative right of populations not to be deprived of
their means of subsistence (Gordon 1999; United Nations 2005). However, after
World War I when the League of Nations was created, economic sanctions came to
be viewed as a peaceful, diplomatic alternative to war that could prevent military
intervention (Gordon 1999). This viewpoint holds that to justify sanctions, the ben-
efits of avoiding the presumably far greater harms caused by war, civil war, or long-
term political oppression must outweigh the harms sanctions impose on a populace.
But this grim utilitarian calculus must also consider the probability of the success of
sanctions, which generally is low. Pape (1997), for example, estimates that sanc-
tions lead to political compliance less than 5 % of the time. More optimistically,
Hufbauer et al. (2009) judge sanctions effective in 34 % of situations used. However,
they stress that the success of sanctions depends on many factors including the pur-
pose; the relative economic instability of the country receiving sanctions; whether
the country receiving sanctions is part of a broad array of diplomatic, economic,
military, and covert measures; and whether the sanctions are being imposed in the
context of a broader international coalition (Hufbauer et al. 2009).
You are a public health official from a country in the Middle East researching the
impact of economic sanctions on the health of populations. You have seen first-hand
the impact sanctions have had on vulnerable populations. You also have expertise in
public health ethics and have written extensively about ethics in the use of economic
sanctions. You have been invited by a United Nations commission to testify on the
health impact of sanctions. The commission values your opinion on whether sanc-
tions are ever ethical and justified.
1. What are the range of ethical considerations for and against the use of economic
sanctions? Are there ways of imposing economic sanctions that can avoid forms
of collective punishment and minimize subsequent adverse health impact on
individuals and populations?
2. In extreme situations where many human lives are at stake, such as emergency
disaster relief, doctors and public health officials often revert to simple utilitarian
calculations of lives lost or saved (e.g., triage decisions). To what extent is the
ethical logic surrounding economic sanctions similar or dissimilar to the ethical
logic of emergency disaster relief?
3. Can economic sanctions be ethically justified
(a) as an alternative to long-standing political oppression and human rights
violations?
(b) to prevent civil war?
(c) to avert war?
(d) to effect regime change?
References
Al Faisal, W., Y. Al Saleh, and K. Sen. 2012a. Syria: Public health achievements and sanctions.
The Lancet 379(9833): 2241. doi:10.1016/S0140-6736(12)60871-X. http://www.thelancet.
com/journals/lancet/article/PIIS0140-6736(12)60871-X/fulltext. Accessed 5 July 2013.
Al Faisal, W., K. Sen, and Y. Al Saleh. 2012b. Syria: Public health achievements and the effect of
sanctions. Indian Journal of Medical Ethics 9(3): 151–153.
Ali, M.M., and I.H. Shah. 2000. Sanctions and childhood mortality in Iraq. Lancet 355(9218): 1851–
1858. http://www.thelancet.com/journals/lancet/article/PIIS0140673600022893/. Accessed 4
July 2013.
Armijo-Hussein, N.A., E. Benjamin, R. Moodie, et al. 1991. The effect of the Gulf Crisis on the
children of Iraq. New England Journal of Medicine 325(13): 977–980. doi:10.1056/
NEJM199109263251330.
Central Statistical Organization, Iraq. 1996. The 1996 Multiple Indicator Cluster Survey: A survey
to assess the situation of children and women in Iraq. Final Report with Results from South/
Centre Governorates. Iraq, UNICEF Ref IRQ/97/288, August.
Central Statistical Organization, Iraq. 1997. The 1996 Multiple Indicator Cluster Survey: A survey
to assess the situation of families in Iraq. Final Report with Results from Northern Governorates.
Iraq, UNICEF, Rep/97/166, May.
Food and Agriculture Organization of the United Nations. 2013. Four million Syrians are unable
to produce or buy enough food. http://www.fao.org/news/story/en/item/179446/icode/.
Accessed 6 July 2013.
Garfield, R. 1999. The impact of economic sanctions on health and well being, Relief and
Rehabilitation Network, Paper 31, 1–4. London: Overseas Development Institute.
Gordon, J.A. 1999. A peaceful, silent, deadly remedy: The ethics of economic sanctions. Ethics &
International Affairs 13(1): 123–142. doi:10.1111/j.1747-7093.1999.tb00330.x.
Haass, R.N. 1998. Economic sanctions: Too much of a bad thing. Brookings Policy Brief Series.
http://www.brookings.edu/research/papers/1998/06/sanctions-haass. Accessed 21 Apr 2013.
Hufbauer, G.C., J.J. Schott, K.A. Elliott, and B. Oegg. 2009. Economic sanctions reconsidered,
3rd ed. Washington, DC: Peterson Institute for International Economics.
Hurwitz, M., and P. David. 1992. The state of children’s health in pre-war Iraq. London: Centre
for Population Studies, London School of Hygiene and Tropical Medicine.
Pape, R.A. 1997. Why economic sanctions do not work. International Security 22(2): 90–136.
United Nations. 2005. Economic, social and cultural rights: Handbook for national human rights
institutions, Professional Training Series No. 12. New York: United Nations. http://www.ohchr.
org/Documents/Publications/training12en.pdf. Accessed 8 July 2013.
United Nations Office for the Coordination of Humanitarian Affairs. 2013. Syria Humanitarian
Assistance Response Plan (SHARP, 1 January–30 June 2013). http://www.unocha.org/cap/appeals/
humanitarian-assistance-response-plan-syria-1-january-30-june-2013. Accessed 21 Apr 2013.
UNICEF. 1999a. Iraq surveys show ‘humanitarian emergency.’ UNICEF Newsline. August 12.
UNICEF. 1999b. Questions and answers for the Iraq child mortality surveys. August 16. http://
www.casi.org.uk/info/unicef/990816qa.html. Accessed 9 Feb 2014.
UNICEF. 2002. Nutritional Survey 2002: Overview of nutritional status of under-fives in South/
Central Iraq. http://www.casi.org.uk/info/unicef/0211nutrition.pdf. Accessed 9 Feb 2014.
World Health Organization (WHO). 2003. Health situation in Iraq prior to March 2003. WHO/
EMRO: 5/2003: 47. Diaz, J., and R. Garfield. 2003. Iraq Watching Briefs: Health and Nutrition.
http://www.google.ae/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=1&ved=0CCcQ
FjAA&url=http%3A%2F%2Fwww.corpwatch.org%2Fdownloads%2FIraqiHealthWatching_
Brief.doc&ei=Sxj3Ut7mCqip0AXUyoDwCg&usg=AFQjCNGKtg9iCFecdctGW6U-7Gt94E
8Hnw&sig2=EB5Zjewajg3mr6F0pse29g. Accessed 9 Feb 2014.
Zarzar, A. 2013. The ballooning cost of living in Damascus. Al-Akhbar. http://english.al-akhbar.
com/node/14624. Accessed 9 Feb 2014.
8.11 Case 7: Advancing Informed Consent and Ethical

Standards in Multinational Health Research
Drew E. Lee
Department of Family Medicine
Advocate Lutheran General Hospital
Park Ridge, IL, USA
e-mail: drewleemd@gmail.com
Sarah A. Kleinfeld
Department of Psychiatry
Medstar Georgetown University Hospital
Washington, DC, USA
Rachel M. Glassford
School of Public Health and Health Services
George Washington University
Falls Church, VA, USA
institutions.
8.11.1 Background
In the United States, regulations for informed consent largely came about during the
1950s through 1970s not only in response to unethical human experiments carried
out in Nazi Germany, but also to those within U.S. borders (Beecher 1966).
Experiments like the U.S. Public Health Service Tuskegee Syphilis Study (Jones
1981) prompted Congress to enact human research regulations, initially through the
1974 National Research Act. Subsequently, other research guidelines have been
developed and revised (World Health Organization 2000; Council for International
Organizations of Medical Sciences 2002; The International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use 1996; World Medical Association 2008), fostering expansion of ethics
commissions and review boards and making informed consent an integral compo-
nent of health research (Meslin and Johnson 2008). Yet, half a century later, many
countries still lack adequate human research regulations or regulatory authorities.
These regulatory gaps leave research participants, their families, and communities at
risk for great harm through sociocultural discrimination, research-related illness, dis-
ability, and death and post-experimental medical abandonment. In Nigeria, Pfizer
tested an unapproved drug on infants and children (Abdullahi v. Pfizer Inc. 2002); in
India, Johns Hopkins tested cancer drugs on patients without proper consent (Sharma
2001); and other such incidents have been reported (LaFraniere et al. 2000). Even the
U.S. National Institutes of Health failed to produce consent forms for experiments on
HIV-positive women in developing countries (Public Citizen 1998).
On a practical and ethical level, debate continues over human research and
informed consent (Tri-Council 2010; Marshall 2008; Nuffield Council on Bioethics
2002). While some argue for a single ethical standard for human research (Lurie
and Wolfe 1997; Angell 1997), others believe that imposing a global ethical stan-
dard irrespective of cultural differences would amount to ethical imperialism
(Resnik 1998). The New England Journal of Medicine “has taken the position that
it will not publish reports of unethical research regardless of their scientific merit”
(Angell 1997). But like other scientific journals, it has found difficulty in determin-
ing what is unethical versus what is culturally appropriate research in different
settings.
There are many challenges to obtaining informed consent. Some involve illiter-
acy; noncomprehension of information; language and communication barriers; or
unfamiliarity with certain scientific, medical, or ethical concepts. Other challenges
are attributable to complex sociocultural, psychological, or structural elements,
such as shared decision making by community members, rather than by an indi-
vidual (Marshall 2000, 2008). Some studies, however, take the stance that such
challenges do not preclude an individual’s ability to understand or voluntarily par-
ticipate in research studies (Pace et al. 2003). Consequently, in order to ensure that
research participation is voluntary, it is important to safeguard a participant’s right
to refuse or withdraw from a study at any time.
One practical solution to obtaining appropriate consent is by implementing cul-
turally acceptable methods such as oral consent, video documentation, or commu-
nity meetings (Tri-Council 2010; Nuffield Council on Bioethics 2002; Dawson and
Kass 2005). Another is to require foreign researchers to receive dual approval
through a local review board and their own institutional review board (IRB) (World
Health Organization 2000; Council for International Organizations of Medical
Sciences 2002; Tri-Council 2010). Nevertheless, multinational collaborations in
research, especially those originating in regions that lack adequate research regula-
tions, can be problematic because research “approval” may not provide adequate
protections.
De-identified data and information14 pose an additional complication for obtain-
ing proper informed consent. These can include “x-rays, endoscopic images, images
of organs or tissues taken during an autopsy, still or video recordings of surgical
procedures, and microscopic images” (Tranberg et al. 2003). As long as these remain
de-identified, researchers need not obtain informed consent (European Union 1995;
U.S. Department of Health and Human Services 2009; National Institutes of Health
2007). However, in countries lacking adequate research ethics infrastructures, waiv-
ing informed consent is problematic at several levels. First, verifying if appropriate
consent was obtained becomes virtually impossible. Second, the lack of consent can
be medically dangerous for research participants and have legal repercussions for
researchers (Flory et al. 2008). Finally, it can complicate the research process by
compromising the utility of research samples and data (Wendler 2008).
Continued globalization, international development and increased accessibility
to data through electronic medical records and online databases will increase multi-
national human research. As multinational research becomes more common, the
need to find appropriate ethical standards and informed consent policies will become
more urgent. Ultimately, the goal of such standards and policies should be to ensure
that research participants and their information are safeguarded at the origin and
throughout every step of the research process.
14
De-identification involves stripping data and information of personal identifiers (e.g. names,
addresses, birth dates, photos, or any unique identifiers), such that an individual’s identity remains
anonymous and cannot be retraced.
You are an infectious disease specialist working at a university in a high-income

country and are interested in researching cervical cancer in immunocompromised
patients. Because you collaborate regularly with colleagues worldwide, other
researchers commonly seek your input. An African colleague e-mails you for advice
on a multinational cervical cancer study she is conducting with several other research-
ers in seven different African countries. This study began 3 years ago to address the
local population’s health needs and has been funded by local hospitals and organiza-
tions. This colleague, a public health professional, has compiled the research data in
an online database. The information she sends you includes an electronic copy of the
preliminary report, de-identified data set, and pathology slides of cervical specimens.
After reviewing her preliminary findings, you agree that her research could posi-
tively impact the health outcomes of individuals in her community.
Excited by this initial review, your colleague invites you to coauthor an upcom-
ing manuscript on the study. You carefully review the methods section of the pre-
liminary report, focusing on how consent was obtained. In one research country,
consent was provided via video documentation; in two others, it was obtained
through a standardized consent form; and in a fourth, through verbal consent of
male community leaders before seeking consent from individual participants, a
practice in line with local cultural norms. For the remaining three countries, no
consent documentation exists.
You follow-up with your colleague about the various consent methods. She indi-
cates that none of the countries involved in the project have IRBs or national
research guidelines, but that consent methods were typical for research projects in
these countries. Regarding the three countries lacking consent documentation, she
believes that some form of consent was obtained from the research participants,
although she lacks supporting evidence.
Although the information you received was de-identified, you wonder about the
lack of uniformity in the consent process but attribute it to respect for differing cul-
tural norms. Based on all information provided, you believe the research has scien-
tific merit and the data collected is scientifically valid. You also believe the study
should be published, as it could significantly improve the health of the region and
advance future research.
1. Who would you turn to in your institution for guidance regarding your involve-
ment in the research, coauthorship of the manuscript, and other contributions to
this research study?
2. What are some appropriate ways to obtain informed consent when conducting
research in areas with culture or language different from yours? Name some pros
and cons to each approach.
3. Does the use of multiple methods to obtain consent raise questions about the
reliability of the data or validity of the research project? Without confirmation of
informed consent, would you consider the publication of this research study to
be scientific misconduct?
4. What are some appropriate ways to obtain informed consent for research con-
ducted in countries with different consent standards and requirements? Are there
instances when one set of requirements should take priority over another?
5. Given the multiple methods used to obtain consent, are you willing to coauthor
your colleague’s paper? Why or why not?
References
Abdullahi v. Pfizer, Inc., (“Abdullahi I”). 2002. U.S. Dist. LEXIS 17436 (S.D.N.Y., 17 Sep).
Angell, M. 1997. The ethics of clinical research in the Third World. New England Journal of
Medicine 337(12): 847–849.
Beecher, H.K. 1966. Ethics and clinical research. New England Journal of Medicine 274(24):
1354–1360.
lines for biomedical research involving human subjects. Geneva: Collaboration with the World
Health Organization. http://www.cioms.ch/publications/layout_guide2002.pdf. Accessed 3 Jan
2013.
Dawson, L., and N.E. Kass. 2005. Views of US researchers about informed consent in international
collaborative research. Social Science & Medicine 61(6): 1211–1222.
European Union. 1995. Directive 95/46/EC of the European Parliament and of the Council on the
protection of individuals with regard to the processing of personal data and on the free move-
ment of such data. http://ec.europa.eu/justice/policies/privacy/docs/95-46-ce/dir1995-46_
part1_en.pdf. Accessed 3 Jan 2013.
Flory, J.H., D. Wendler, and E.J. Emanuel. 2008. Empirical issues in informed consent for research.
In The Oxford textbook of clinical research ethics, ed. E.J. Emanuel, C. Grady, R.A. Crouch, K.
Lie, F.G. Miller, and D. Wendler, 645–660. Oxford: Oxford University Press.
International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use. 1996. The ICH Harmonised tripartite guideline: Guideline
for good clinical practice. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/
Guidelines/Efficacy/E6/E6_R1_Guideline.pdf. Accessed 3 Jan 2013.
Jones, J.H. 1981. Bad blood: The Tuskegee syphilis experiment. New York: Free Press.
LaFraniere, S., M.P. Flaherty, and J. Stephens. 2000. The dilemma: Submit or suffer ‘Uninformed
Consent’ is rising ethic of the drug test boom. The Washington Post. http://www.washington-
post.com/wp-dyn/content/article/2008/10/01/AR2008100101150.html. Accessed 27 Mar 2013.
Lurie, P., and S.M. Wolfe. 1997. Unethical trials of intervention to reduce perinatal transmission of
the human immunodeficiency virus in developing countries. New England Journal of Medicine
337(12): 853–856.
Marshall, P.A. 2000. Informed consent in international health research: (1) Cultural influences on
communication, (2) The protection of confidentiality. In Biomedical research ethics: Updating
international guidelines, ed. A. Consultation, R.J. Levine, S. Gorovitz, and J. Gallagher, 100–
134. Geneva: World Health Organization.
Marshall, P.A. 2008. “Cultural competence” and informed consent in international health research.
Cambridge Quarterly of Healthcare Ethics 17(2): 206–215.
Meslin, E.M., and S. Johnson. 2008. National bioethics commissions and research ethics. In The
Oxford textbook of clinical research ethics, ed. E.J. Emanuel, C. Grady, R.A. Crouch, R.K. Lie,
F.G. Miller, and D. Wendler, 187–197. Oxford: Oxford University Press.
National Institutes of Health. 2007. How can covered entities use and disclose protected health
information for research and comply with the Privacy Rule? http://privacyruleandresearch.nih.
gov/pr_08.asp. Accessed 3 Jan 2013.
Nuffield Council on Bioethics. 2002. The ethics of research related to healthcare in developing
countries. London: Nuffield Council on Bioethics. http://www.nuffieldbioethics.org/wp-con-
tent/uploads/2014/07/Ethics-of-research-related-to-healthcare-in-developing-countries-I.pdf.
Pace, C., C. Grady, and E.J. Emanuel. 2003. What we don’t know about informed consent. http://
www.scidev.net/en/opinions/what-we-dont-know-about-informed-consent.html. Accessed 14
Apr 2013.
Public Citizen. 1998. Health group fi les suit over NIH experiments on HIV-positive women in
developing countries. http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=241.
Accessed 27 Mar 2013.
Resnik, D.B. 1998. The ethics of HIV research in developing nations. Bioethics 12(4): 286–306.
Sharma, D.C. 2001. Johns Hopkins and RCC face drug trial allegations. Lancet Oncology 2(9):
530.
Tranberg, H.A., B.A. Rous, and J. Rashbass. 2003. Legal and ethical issues in the use of anony-
mous images in pathology teaching and research. Histopathology 42(2): 104–109.
Tri-Council. 2010. Tri-Council policy statement: Ethical conduct for research involving humans.
Canadian Institutes of Health Research, National Sciences and Engineering Research Council
of Canada, and Social Sciences and Humanities Research Council of Canada. http://www.eth-
ics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf. Accessed 3 Jan 2013.
U.S. Department of Health and Human Services. 2009. Title 45 (Public Welfare), Code of Federal
Regulation, Part 46 (Protection of Human Subjects). http://www.hhs.gov/ohrp/policy/ohrp-
regulations.pdf. Accessed 3 Jan 2013.
Wendler, D. 2008. Research with biological samples. In The Oxford textbook of clinical research
ethics, ed. E.J. Emanuel, C. Grady, R.A. Crouch, R.K. Lie, F.G. Miller, and D. Wendler, 290–
297. Oxford: Oxford University Press.
World Health Organization (WHO). 2000. Operational guidelines for ethics committees that
review biomedical research. http://www.who.int/tdr/publications/documents/ethics.pdf.
World Medical Association. 2008. Declaration of Helsinki. http://www.wma.net/
en/30publications/10policies/b3/. Accessed 3 Jan 2013.
Chapter 9
Public Health Research
Drue H. Barrett, Leonard W. Ortmann, Natalie Brown,

Barbara R. DeCausey, Carla Saenz, and Angus Dawson
9.1 Introduction
Having a scientific basis for the practice of public health is critical. Research leads
to insight and innovations that solve health problems and is therefore central to
public health worldwide. For example, in the United States research is one of the ten
essential public health services (Public Health Functions Steering Committee 1994).
The Principles of the Ethical Practice of Public Health, developed by the Public
Health Leadership Society (2002), emphasizes the value of having a scientific basis
The opinions, findings, and conclusions of the authors do not necessarily reflect the official
position, views, or policies of the editors, the editors’ host institutions, or the authors’ host
institutions.
D.H. Barrett, PhD (*) • L.W. Ortmann, PhD
Office of Scientific Integrity, Office of the Associate Director for Science,
Office of the Director, Centers for Disease Control and Prevention, Atlanta, GA, USA
e-mail: dbarrett@cdc.gov
N. Brown, MPH
Human Research Protections Office, Office of Scientific Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease Control and Prevention,
Atlanta, GA, USA
B.R. DeCausey, MPH, MBA
Clinical Research Branch, Division of Tuberculosis Elimination, National Center for HIV/
AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention,
Atlanta, GA, USA
C. Saenz, PhD
Regional Program on Bioethics, Office of Knowledge Management, Bioethics, and Research,
Pan American Health Organization, Washington, DC, USA
A. Dawson, PhD

286 D.H. Barrett et al.
for action. Principle five specifically calls on public health to seek the information
needed to carry out effective policies and programs that protect and promote health.
This chapter presents ethical issues that can arise when conducting public health
research. Although the literature about research ethics is complex and rich, it has at
least two important limitations when applied to public health research. The first is that
much of research ethics has focused on clinical or biomedical research in which the
primary interaction is between individuals (i.e., patient-physician or research partici-
pant-researcher). Since bioethics tends to focus on the individual, the field of research
ethics often neglects broader issues pertaining to communities and populations,
including ethical issues raised by some public health research methods (e.g., the use
of cluster randomized trials to measure population, not just individual, effects).
However, if our discussion of public health research ethics begins by examining pub-
lic health activities, it becomes apparent that the process of gaining consent involves
more than individuals. We must consider that communities bear risks and reap bene-
fits; that not only individuals but also populations may be vulnerable; and that the
social, political, and economic context in which research takes place poses ethical
challenges. Public health research, with its focus on intervention at community and
population levels, has brought these broader ethical considerations to researchers’
attention, demonstrating how ethics guidance based on biomedical research may
limit, if not distort, the ethical perspective required to protect human subjects.
The second limitation has to do with how guidelines and regulations are con-
ceived and used. As described in Chaps. 1 and 2 of this casebook, research ethics has
mostly evolved out of concern for research abuses. Consequently, the intent of many
guidelines and regulations is to strengthen the ethical practice of research with
human subjects. These ethical guidance documents include the Nuremberg Code
(1947); the Universal Declaration of Human Rights (United Nations 1948); the
Declaration of Helsinki (World Medical Association 1964, last revised in 2013); and
two documents developed by the Council for International Organizations of Medical
Sciences (CIOMS) in collaboration with the World Health Organization (WHO):
International Ethical Guidelines for Biomedical Research Involving Human Subjects
(CIOMS 2002) and the International Ethical Guidelines for Epidemiological Studies
(CIOMS 2009). In the United States, the primary ethical guidance for protecting
human subjects is Title 45, Part 46, of the Code of Federal Regulations
(U.S. Department of Health and Human Services 2009). The ethical principles of
respect for persons, beneficence, and justice have often framed the discussion on
ethical conduct of research with human subjects. These principles were first articu-
lated by the U.S. National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research (1979) in the Belmont Report and expanded
upon by Beauchamp and Childress (1979) in Principles of Biomedical Ethics.
Such guidelines and regulations often represent a consensus on landmark issues and
show ways to consider ethical issues. However, consensus documents can pose obsta-
cles if used uncritically with overgeneralized rules applied blindly. For example, such
documents seem to assume that the randomized controlled trial is the gold standard of
research methodology, obscuring the fact that all research methods may raise ethical
issues. In addition, it is debatable whether these guidelines adequately capture commu-
nity- and population-oriented values and issues central to public health (Verweij and
Dawson 2009). A general concern is that overreliance on guidance documents encour-
9 Public Health Research 287
ages a legalistic or compliance approach to ethics, rather than encouraging reflection

and analysis (Coughlin et al. 2012). Coughlin and colleagues argue that to be success-
ful, research oversight needs to focus on moral judgment and reflection, not on strict
rule-like adherence to regulations documented on a checklist. Though formal training in
ethics is desirable, moral judgment and discernment are developed by making ethical
judgments. This highlights a problem inherent in research oversight. Review of research
protocols requires scientific and ethical expertise. However, members of ethics review
committees are often unpaid and uncompensated for service time and are frequently
asked to perform review duties in addition to their normal work. This lack of regard for
their service often results in considerable turnover among committee members and does
not allow sufficient time for new members to develop moral discernment. Review of
research protocols for human subjects should include consideration of the wider ethical
implications of the research and not just focus on compliance with ethics regulations.
When inappropriate, guidance should be adapted or even set aside.
Chapter 1 of this casebook provides an account of public health ethics that builds
upon the disciplines of both ethics and public health. Following a similar approach, this
chapter advances a view of public health research ethics that builds upon concepts of
research ethics and public health research. As a result, many ethical issues discussed
apply to all health research, including public health research. However, once we exam-
ine public health examples, we see that something beyond the traditional resources of
current research regulations is needed. We will discuss these ethical issues by reflecting
upon traditional research tenets and studying their limitations in a public health context.
We will conclude by illustrating via the case studies included in this chapter how ethical
challenges arise in public health research. It is impossible to closely analyze all possible
ethical issues that may arise either in health research or public health research; thus our
intent is to highlight some of the major ethical challenges and considerations.
9.2 What Is Different About Public Health Research?
The community and population perspective of public health, especially when address-
ing health issues in resource-poor contexts or in marginalized populations, frequently
brings ethical challenges into focus. In public health, research typically occurs out-
side of the controlled environment that is characteristic of biomedical research.
Instead, in public health, research often occurs in real world settings in a particular
social, political, and economic context. It may involve interventions with whole com-
munities or populations impacted by catastrophic public health emergencies.
9.2.1 Can Public Health Research Be Clearly Distinguished

from Public Health Practice?
Distinguishing between public health practice and public health research is chal-
lenging. Many of the tools and methods are similar. Both involve systematic collec-
tion and analysis of data that may lead to generalizable knowledge. Public health
research can take forms ranging from descriptive approaches (e.g., correlational
studies and cross-sectional surveys) to analytic epidemiologic approaches (e.g.,
case control studies and cohort studies, including clinical trials). These same
approaches can characterize methods for collecting information as part of public
health practice.
A common way to define research is on the basis of its goal to develop gener-
alizable knowledge. For example, the International Ethical Guidelines for
Biomedical Research Involving Human Subjects (CIOMS 2002) defines research
as “… a class of activity designed to develop or contribute to generalizable knowl-
edge. Generalizable knowledge consists of theories, principles or relationships, or
the accumulation of information on which they are based, that can be corroborated
by accepted scientific methods of observation and inference.” Similarly, in the
United States, research is defined as “…a systematic investigation, including
research development, testing and evaluation, designed to develop or contribute to
generalizable knowledge” (U.S. Department of Health and Human Services
2009).
In jurisdictions with legal requirements governing research activities, such as
the United States, determining what is and is not research becomes critical.
Sometimes, however, the line between research and practice-related activities is
blurry. One way to identify if an activity is research is to look at intent. The primary
intent of public health research is to yield generalizable knowledge. Key character-
istics of public health research include (1) benefits beyond the needs of the study
participants, (2) collection of data exceeding what is needed to care for study par-
ticipants, and (3) generation of knowledge with relevance outside the population
from which data were collected. In contrast, the primary intent of activities that
constitute public health practice are to “… prevent or control disease or injury and
improve health, or to improve a public health program or service …” (Centers for
Disease Control and Prevention [CDC] 1999, 2010). Key characteristics of public
health practice include (1) benefits that focus on activity participants, (2) collection
of data needed to improve the activity or the health of the participants, and (3)
generation of knowledge that does not go beyond the scope of the activity (CDC
1999, 2010).
Some researchers suggest that the difficulty in distinguishing public health
research from public health practice emerges from a deeper conceptual issue relat-
ing to the impossibility of satisfactorily defining “research” and related categories
(Fairchild and Bayer 2004). For example, public health surveillance might involve
identical interventions and risks for public health research as for practice. This has
led many public health professionals to call for reorienting ethical review around an
activity’s level of risk, which applies to activities in both public health research and
practice (Willison et al. 2014). Jurisdictions that do not yet have legal structures or
have more flexibility to govern research activities than the United States might have
an advantage. Whereas other jurisdictions might need to modify their approach to
correlate ethical review with risk instead of on whether something falls under a slip-
pery concept such as research.
9.3 Ethical Considerations for Protecting the Public

during Health Research
This section outlines core aspects of research ethics and not only explains their
relevance to public health, but also delves into why research ethics principles might
need to be applied differently to public health research than to biomedical research.
9.3.1 Informed Consent
Informed consent is often treated as the primary means of protecting research par-
ticipants. Although informed consent can be defined in different ways, it is foremost
an active agreement made by someone with the capacity to understand, on the basis
of relevant information, and in the absence of pressure or coercion. The common
ethical justification for seeking informed consent is an appeal to the notion of auton-
omy, which holds that individuals have values and preferences and thus should vol-
untarily decide whether to participate in research. However, gaining consent can
result from a more direct appeal to beneficence or to general welfare. Many research
ethics guidelines and regulations require an interactive process between the investi-
gator and research participant to best provide information and ensure
comprehension.
Some potential research participants will always lack capacity to look after their
own interests (e.g., children, people with dementia, the unconscious) and thus cannot
provide consent. To protect people with diminished autonomy, informed consent is
usually obtained from a parent, guardian, or legal representative. While it is clear that
research participants with diminished capacity need extra protection, empirical evi-
dence shows that even research participants with full cognitive capacity may not
understand information presented as part of the consent process (Dawson 2009). For
this reason, informed consent cannot be the only mechanism for protecting research
participants. For instance, a research ethics committee can protect participants by
assessing risks and benefits. Requiring approval by a research ethics committee
might be considered a paternalistic judgment, but not an obviously wrong one
(Garrard and Dawson 2005; Miller and Wertheimer 2007). Research ethics commit-
tees routinely consider waiving informed consent. This is true in public health
research where the risk can be less than in biomedical research. Reliance on the judg-
ments of research ethics committees presupposes that members have a high level of
professional trustworthiness and have the skills for ethical deliberation and analysis.
Cultural or social influences can challenge the ideal model of informed consent
when conducting public health research. Marshall (2007) provides an excellent
overview of challenges with obtaining informed consent, especially in resource-
poor settings. These challenges include cultural and social factors that affect com-
prehension, communication of risks, and decisional authority for consent to do
research. Language barriers and low literacy, mistaken beliefs about the benefits of
participation, especially when access to health care is limited, and the need to com-
municate complex scientific information may reduce comprehension of study pro-
cedures, benefits, and risks. Marshall (2007) emphasizes the importance of engaging
community leaders and soliciting and considering the opinions of community resi-
dents when identifying project goals and procedures and establishing consent pro-
cesses. She notes that in many communities, relying solely on individual consent
may not be culturally appropriate. In these situations, adding family or community
consent is fitting.
Some research cannot be conducted if the standards of autonomous informed
consent are always applied. A good example is emergency research when uncon-
scious victims of head trauma may be randomized to different promising treatments,
but the relative effectiveness of each treatment option is unknown. Some countries
allow such research via waivers of informed consent if relevant conditions are met
(e.g., minimal risk, and the research could not otherwise be carried out)
(U.S. Department of Health and Human Services 2009). A public health research
method for which it sometimes may be appropriate not to seek informed consent is
the cluster randomized trial. By design, a cluster randomized trial compares inter-
ventions that target a group (i.e., social entity such as village or town, or a popula-
tion). Various characteristics of these clusters are matched to ensure a robust
comparison of interventions (including no intervention). In some cluster trials,
obtaining individual informed consent can seem prohibitively expensive, damaging
to achieving study goals, or even impossible to attain (Sim and Dawson 2012;
McRae et al. 2011b). Where consent is impossible to attain, is it right to require it at
the expense of not doing the research? Attempts have been made to justify research
without first attaining individual consent by appealing to an ethics committee for
review, soliciting viewpoints from the community about whether the research is
acceptable, or even seeking some form of community consent.
Dickert and Sugarman (2005) make a distinction between community consent
and community consultation. Consent means seeking approval, whereas consulta-
tion means seeking ideas and opinions. They note, however, that this distinction
gets blurred in practice, and that community consultation should not be approached
as a box to check off without scrutinizing the input. They identify four ethical goals
for any community consultation: enhanced protection, enhanced benefits, legiti-
macy, and shared responsibility. Adherence to these goals may ensure that risks are
identified and protections put into place; that the research benefits not only the
researchers, but also the participants and communities being studied; and that the
legitimacy of the findings is increased. However, this does not constitute a direct
parallel to the individual model of informed consent described previously.
Community consent involves meeting with legitimate community representatives
empowered to permit researchers to conduct studies involving community members
(Weijer and Emanuel 2000; Dickert and Sugarman 2005). The involvement of com-
munity representatives in public health research is most clearly seen in community-
based participatory research (CBPR). In CBPR, authorities are involved at all levels
of research—from initiation of ideas and projects through data collection, analysis
and interpretation, and use of research findings to prompt community change
(Flicker et al. 2007).
9.3.2 Risk/Benefit Analysis
A central concern for research ethics is the weighing of expected benefits against
possible harms. The commonly employed criteria for assessing risk to human sub-
jects who participate in health research are that risks are minimized and reasonable
in relation to the anticipated benefits. For example, one can argue that procedures
used in research are justifiable when already being used for diagnosis or treatment
and the risks are proportional to the importance of the knowledge reasonably
expected to result from the research. However, one problem in such a determination
is the uncertainty of all judgments about risks and benefits. Such determinations
have to be made carefully and fairly and on the basis of the best possible evidence.
Research participants may encounter several types of risks. One obvious risk is
physical harm, which may include discomfort, pain, or injury from interventions
such as drug regimens or medical procedures. Another risk is psychological harm.
Research participants may experience stress, anxiety, embarrassment, depression,
or other negative emotions. These emotions, which can occur during or after partici-
pation in the research, are common in research involving sensitive topics such as
sexual preferences or behavior. Social and economic harms are another type of risk.
Participants in research that focuses on mental illness, illegal activities, and even
certain diseases such as HIV may risk being labeled or stigmatized if precautions
are not taken to provide adequate privacy and confidentially. A person’s economic
status may be affected if costs are incurred for participating (e.g., transportation
expenses to and from the study site) or by loss of employment (present or future) if
a breach of confidentiality occurs (e.g., an employer discovers an employee is being
treated for substance abuse).
One common problem—about which ethics guidelines are typically silent—is how
we should conceptualize study participants (McRae et al. 2011a). Consider, for exam-
ple, that cluster randomized designs and cohort studies commonly compare a group
receiving active intervention with a parallel group receiving no intervention. Does the
term “participant” apply to those receiving no intervention? This question has far-
reaching consequences. If people who do not receive intervention count as participants,
researchers may have obligations to them that otherwise would not exist. Another way
to think about this is to identify who might be at increased risk, rather than who is a
participant. For example, the U.S. National Bioethics Advisory Commission (NBAC)
recommends that whenever researchers anticipate that risks will extend beyond study
participants, researchers should try to minimize risks to nonparticipants (NBAC 2001).
The benefits of health research are any favorable or positive outcome received as
a direct result of the research. Put simply, without the research, the outcome would
not exist. Sometimes the benefits of health research extend beyond study partici-
pants to society; other times, however, research participants do not benefit. And in
other instances, only a few participants might benefit. Researchers should thor-
oughly consider what to do in all these scenarios and how benefits could be pro-
vided to those in need. Sometimes research involves reimbursement, incentives, or
other tangible goods. Although such items may be provided when someone agrees
to participate in research, these items should not be considered benefits arising from
the research procedures. In some contexts, such as prisons, offering anything in
return for participation in research may be viewed as pressure to participate and
therefore should be carefully considered.
The risks of research must be reasonable when compared to the anticipated ben-
efits. This can be difficult to assess because risks will vary depending on the study
population. For example, research procedures considered safe for healthy adults
may be risky for adults with compromised health or for vulnerable populations such
as children, pregnant woman, or seniors. Even if the potential benefits are the same,
if the risks differ, the risk/benefit balance is affected. Another consideration for
evaluating risks and benefits is the expected result of the research. A higher level of
risk may be acceptable if the research can reasonably be expected to benefit the
participants. If there is no expectation that the research participants will benefit, the
same level of risk may be unacceptable.
Foreseeing the benefits and harms in a study can be challenging. Striking a bal-
ance between the two can be difficult and, at times, controversial. A good example
of this is the discussion generated by a series of studies conducted in Baltimore that
assessed different methods for reducing the exposure of children to lead paint in
older rented properties (Mastroianni and Kahn 2002). In this case, the fact was
already known that exposure of children to lead is dangerous. However, due to the
high cost of removing lead-based paint (the known, best solution), the researchers
assessed the effectiveness of cheaper, partial methods of abatement for reducing or
even removing the risk of exposure. If found to be effective, these alternative meth-
ods would allow treatment of more homes at the same cost, potentially benefiting
more children. Monitoring during the study found that some children in the alterna-
tive abatement options had elevated blood lead levels. Some health officials believe
that the research should not have gone ahead because of this likelihood. Others
think that the research was justified because the children were not exposed to any
greater level of lead, and in most cases, significantly less than if the research had not
been conducted. In other words, no child was put at greater risk through participa-
tion, and all children benefited from blood monitoring. This study demonstrates the
complexities of evaluating risks and benefits in public health research.
9.3.3 Protection of Vulnerable Populations
Although all segments of society should have the opportunity to participate in

research, vulnerable populations may need additional protections to prevent coercion
or exploitation. The definition of what it is to be vulnerable is contested (Chap. 7).
However, NBAC (2001) defines vulnerability in the context of research as a condition,
either intrinsic (e.g., mental illness) or situational (e.g., incarceration), that increases
some participants’ risk of being harmed. Regardless of how we define vulnerability,
it is often interpreted to require special protections for the safety and well-being of
populations such as children, prisoners, pregnant women, mentally disabled people,
and economically or educationally disadvantaged people. The CIOMS (2002)

international guidelines suggest that special justification is required for inviting
vulnerable people to serve as research subjects and, if they are selected, the means of
protecting their rights and welfare must be strictly applied. The history of research is
replete with examples of unethical treatment of vulnerable populations (Chap. 2).
Despite such worries about protecting vulnerable populations, a strong equity-
based argument can be made for ensuring that they are appropriately represented in
health research, unless the rationale for not including them is clear and compelling
(CDC 1996). To exclude vulnerable populations violates the spirit of the principle
of justice, which requires fair distribution of risks and benefits of research. Inclusion
of vulnerable populations may require accommodations to address the specific
nature of the vulnerability; however, once these accommodations are in place, vul-
nerable people with the cognitive capacity to provide informed consent should exer-
cise autonomous choice about their participation. For example, it seems arbitrary to
exclude pregnant women from research as a matter of course rather than making a
decision based on an assessment of risk levels, the ability to control risks, and the
likelihood of direct benefit to the participant.
9.3.4 Returning Research Results
Public health research tends to focus on population-level research questions. In

some cases, for example where data have been anonymized, even when an issue
relevant to the clinical care of one or more individuals in the data set is discovered,
there is nothing that can be done about it. However, in other cases, public health data
sets or surveillance data might hold information that could be crucial to the care of
individuals.
When and how should individual-level data, including incidental and secondary
findings, be communicated to research participants? The primary argument for an
ethical imperative to offer participants research findings, both summary and indi-
vidual results, rests on the principle of respect for persons; however, the principles
of beneficence and justice are also frequently cited (Presidential Commission for
the Study of Bioethical Issues 2013; Miller et al. 2008; Fernandez et al. 2003). The
word “offer” is important because giving people the right to decline results is also
an expression of respect for persons. The ethical justification for a “duty to disclose
research results,” especially individual-level data, has been challenged due to the
potential harms of disclosure (Miller et al. 2008). Miller and colleagues argue that
the lack of consistent policy guidance for disclosures and the ambiguity about what
to disclose undermines any generalized ethical duty to disclose. Clearly, before
making a decision to return results, especially individual-level data, the potential
benefits and harms from disclosure must be carefully assessed.
The research consent process should describe plans for returning results or pro-
vide an option for not receiving results. The consent process should explain the
potential harms and benefits associated with receiving research results, the possible
strengths and limitations of the results, and the options for follow-up and support if
unanticipated consequences occur. If a decision is made to return results, careful
considerations must be given to how the results will be returned (e.g., in person,
over the telephone, through a letter), whether opt-in or opt-out procedures will be
used, and when the results should be returned. Fernandez and colleagues (2003)
argue that “research results should, in general, be delayed until the results are pub-
lished or until they have undergone peer review and been accepted for publication.”
This recommendation is based on the need to ensure the integrity of the interpreta-
tion of the data and to prevent disclosure of inaccurate information.
To illustrate the diversity of opinion about sharing research data, some research-
ers have taken the obligation for disclosure further by advocating that research par-
ticipants be granted access to their raw data via a data repository before these data
are analyzed (Lunshof et al. 2014). Lunshof and colleagues suggest that access to
raw personal data would increase transparency, personal choice, and reciprocity.
Further, such access could equalize the relationship between those who donate data
and those who use data for research. However, this rather utopian view raises issues
with potential breaches of confidentiality, so more discussion is needed. More dis-
cussion is also needed about participants increasingly sharing information about
research studies through social media, which can result in breaches of confidential-
ity and further challenge the integrity of research (Lipset 2014).
9.3.5 Conflicts of Interest
The potential for conflicts of interest occurs when an individual or group has mul-
tiple interests, one of which can compromise the integrity or impartiality of the
other. Research involving human subjects often creates this potential when research-
ers are also involved with participants in the role of health care providers or through
engagement with communities in the context of public health research. In resource-
poor contexts, the economic impact of the research enterprise can be of such mag-
nitude that it has sociopolitical ramifications or complexities with potential to spur
conflicts of interest. Discussion about conflicts of interest raises issues about integ-
rity in public health and even the very concept of public health as an activity
(Coughlin et al. 2012).
Shrinking budgets for public health activities have led many health departments,
even those in resource-rich countries, to explore alternative approaches to financing
public health research, leading to questions about what constitutes an appropriate
partnership and to concerns about real or perceived conflicts of interest. For exam-
ple, should governments collaborate with vaccine manufacturers to research poten-
tial adverse effects of a vaccine? Should researchers collaborate with soda
manufactures to study the association between sugar-sweetened beverages and obe-
sity? The U.S. Institute of Medicine (IOM) Committee on Conflicts of Interest in
Medical Research, Education, and Practice defines conflict of interest as “a relation-
ship that may place primary interests (e.g., public well-being or research integrity)
at risk of being improperly influenced by the secondary, personal interests of the

relationship (e.g., financial, professional, or intellectual gains)” (IOM 2009). When
Bes-Rastrollo and colleagues (2013) studied systematic reviews of the association
between sugar-sweetened beverages and weight gain, they found instances where
conflicts of interest influenced scientific findings. The systematic reviews that iden-
tified sponsorship or conflicts of interest with food or beverage companies were five
times more likely to report “no positive association” between consumption of sugar-
sweetened beverages and weight gain or obesity than the reviews that reported hav-
ing no industry sponsorship or conflicts of interest. These findings point to the need
for guidance on how to identify and avoid conflicts of interest with potential to
influence outcomes of public health research, especially when the research shapes
public policy (IOM 2014).
9.3.6 Conducting Research during Public Health Emergencies
Sometimes the traditional elements of research ethics are inappropriate frameworks

for decision making. Let’s consider, for example, a decision being contemplated to
conduct research during a public health emergency. The research is deemed vitally
important to analyze what happened during the emergency, to plan for future sce-
narios, and to prevent death and illness during disasters. However, such research
raises concerns, including the appearance that health officials are more interested in
expanding knowledge than in responding to the disaster and that researchers are
insensitive to more urgent needs of affected individuals. Still, the case can be made
for a strong, ethical imperative that obligates public health officials to conduct
research that could yield data useful in preventing future death and illness during
disasters (London 2016). The chief ethical task for conducting research during a
disaster is to secure future benefits for people without sacrificing the rights or inter-
ests of research subjects (Jennings and Arras 2008; WHO 2015). So to justify
research during a disaster, public health officials must first demonstrate a real need
for the research, which includes its social and scientific value (anticipated results).
Generally speaking, research that can be conducted in a nonemergency setting
should not be conducted during an emergency response.
If the decision is made to conduct research during a public health emergency,
some unique ethical concerns must be considered: the research should not detract
resources and personnel from emergency response activities; research activities
should be prioritized by highest social and scientific value; and, as people in an
emergency are often affected physically and psychologically, and sometimes trau-
matized, they should be considered a vulnerable population (Jennings and Arras
2008; WHO 2015). At the very least during an emergency, keep in mind that some
people may not be able to make reasoned, informed decisions to participate in the
research. Consequently, adequate means of protection for participants must be in
place. The procedures for an ethics committee review may need to be modified for
disaster research projects (Lurie et al. 2013). Possible approaches for ensuring
appropriate review include developing just-in-case protocols and establishing cen-

tralized or specialized ethics review committees that can approve disaster research
protocols quickly (Médecins Sans Frontières 2013).
9.4 How Ethical Challenges Can Arise in Public Health

Research: Lessons Learned from Cases
The cases presented in this chapter illustrate some of the ethical challenges raised
by public health research. These challenges range from compliance with research
ethics guidelines to the need to address the economic and political implications
from the wider societal context in which public health research occurs. Social, eco-
nomic, and political factors can directly lead to ethical challenges or may affect a
researcher’s ability to comply with ethical guidelines.
The case by Boulanger and Hunt illustrates how well-intentioned international
efforts to improve access to health care in resource-poor countries can have unin-
tended consequences that present ethical complications. The case raises various
interconnected issues that have to do with researchers’ responsibilities and obliga-
tions and with conflicts between individual and public goods. Within a collaborative
international public health research project, such conflicts can easily arise when
local investigators find themselves serving multiple roles that create potential con-
flicts of interest. Boulanger and Hunt provide an excellent summary of the respon-
sibilities and obligations of researchers, including to
• Protect participants from harm and ensure they benefit from the research when-
ever possible;
• Support and protect research staff, especially students;
• Support and respect research collaborators, building local capacity when possi-
ble; and
• Support the research enterprise, which includes building public trust, maximiz-
ing the relevance and usefulness of the research, and disseminating findings.
Central to this case is a local researcher’s uncovering of how informal fees for
obstetric care are being diverted to senior hospital administrators. The local
researcher has a dilemma. If he reveals this ethically dubious informal fee structure,
he will not only jeopardize his standing at the hospital, but he could also undermine
the availability of obstetric care to women in his community. The director of the
research program must ethically weigh the research goal of improving access to
health care services with supporting the interests of the research staff while also
maintaining good relations with local health agencies. In many contexts, this case
would be a clear-cut whistleblower issue demanding revelation. However, where
informal fees are standard practice, part of the political culture, or the health infra-
structure is already fragile or minimal, the issue becomes complicated, forcing one
to prioritize competing values and moral considerations.
The case by Makhoul and colleagues involves research on mental health con-
cerns among youth in a Palestinian refugee camp. The case highlights cultural and
social factors that may influence the consent process, especially the power dynam-
ics within communities. Beyond addressing central bioethical and medical princi-
ples of trust and respect for persons, the case points to the need for considering
broad public health concepts such as respect for community values, empowerment,
and advocacy. This case also illustrates how researchers are almost always drawn
into a community’s political dynamics by the economic influence of research in
resource-poor settings. Efforts by community members to avoid alienating groups
that contribute resources to the community may act as a subtle form of pressure to
participate in the research.
The case by Kasule and colleagues illustrates the difficult practical choices that
resource-poor countries face in processing the increasingly complex volume of
research to be ethically reviewed. In these countries, public health officials struggle
to complete basic administrative and regulatory aspects of research review and
oversight, let alone provide conditions for careful, conscientious ethical analysis.
This scenario questions the adequacy of training for members of ethics review com-
mittees. Failure to adequately train committee members and fund research oversight
will result in lost opportunities and revenues, setting back a resource-poor country’s
research or health infrastructure for years. But funding an organization to develop
research oversight may divert funds from other more urgent public health needs.
Trading short-term public health solutions for long-term research funding presents
a classic case of resource allocation and prioritization. Kasule and colleagues con-
sider the pros and cons of reliance upon outside ethics review committees, which
might save money at the expense of having less control of oversight.
The case by Kanekar describes the use of an Internet-delivered safe sex health
promotion intervention for young black men who have sex with men. This case
raises a number of practical and ethical considerations and questions that arise in
public health research. How does one differentiate research from public health prac-
tice? What approaches are required to serve vulnerable populations? How can one
use innovative techniques to target hard-to-reach populations? What are the best
ways to protect the privacy of participants and ensure confidentiality of data? How
can one reconcile or accommodate conflict among research partners who perceive
their primary role or function in radically different ways (e.g., medical provider
versus epidemiologist)?
9.5 Conclusions
Many ethical issues can arise in public health research. The social, economic, and
political context within which the research enterprise functions further complicates
the ethical landscape. Traditional approaches for considering research ethics issues
emerged from biomedical research and initially emphasized ethical considerations
at an individual level. However, research in public health demonstrates why this
traditional approach to ethics should be expanded. A public health approach to

research ethics is apt because it considers community values, the interdependence
of citizens, social or population benefit, and social justice. However, as explained in
Chap. 1, there is more to ensuring ethical conduct and scientific integrity in public
health research than having an ethical review committee apply rule-based guide-
lines. Researchers need to be familiar with the ethical considerations unique to pub-
lic health and have sufficient training and experience to exercise moral judgment in
all phases of research.
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9.6 Case 1: To Reveal or Not to Reveal Potentially Harmful

Findings: A Dilemma for Public Health Research
Renaud F. Boulanger
Biomedical Ethics Unit
McGill University
Montréal, QC, Canada,
Matthew R. Hunt
School of Physical and Occupational Therapy
McGill University
Montréal, QC, Canada
Centre for Interdisciplinary Research on Rehabilitation
Montréal, QC, Canada
e-mail: matthew.hunt@mcgill.ca
institutions.
9.6.1 Background
In 1987, African health ministers met in Mali to address access to quality primary
health care, particularly in rural areas (Anonymous 1988). The resulting Bamako
Initiative promoted universal accessibility, though it drew some early criticism for
its support of user fees (McPake et al. 1993). For the next decade, user fees were
implemented in many African countries to finance health care services. The World
Bank supported the measure as part of its Structural Adjustments Programs, which
also included austerity measures, trade liberalization, and privatization (McIntyre
et al. 2006). However, user fees have since been shown to create access barriers that
tend to affect the poor disproportionately (Macha et al. 2012), suggesting that many
vulnerable individuals have been prevented from accessing needed health care ser-
vices. Against this backdrop, mounting international pressure led to the reform of
many user-fees programs, particularly in the last decade. One primary strategy for
increasing health care access has been the introduction of selective exemptions of
user fees for specific groups (Ben Ameur et al. 2012; Meessen et al. 2011; Ridde
et al. 2012). Although this strategy was originally planned in the Bamako Initiative,
it was not uniformly implemented. Given the scale of the changes that user fees
removal implies for health care systems, there is ongoing research to evaluate their
impact (Lagarde and Palmer 2011). Health system investigations such as these may
raise ethical questions (Hyder et al. 2014), especially since they involve the study of
a public health intervention, often focus on individuals in extreme poverty, and tend
to be international and collaborative in nature.
Collaborative international public health research offers the opportunity to build
local capacity (Mayhew et al. 2008). However, such research raises a number of issues
about researchers’ obligations and responsibilities. First is the responsibility to protect
research participants from harm, an obligation recognized by all research ethics
guidelines. This duty of protection is heightened when the research participants are
from vulnerable populations (Hurst 2008), especially when they are recruited from
extremely impoverished populations. Researchers’ responsibilities toward research
participants also include ensuring that they benefit from the results of the research
whenever possible. For example, the International Ethical Guidelines for Biomedical
Research Involving Human Subjects directs that “any intervention or product devel-
oped, or knowledge generated, will be made reasonably available for the benefit of
that population or community” (Council for International Organizations of Medical
Sciences 2002, guideline 10). A second researcher responsibility is to support students
and staff hired as part of the research project and to protect them from harm (Wilson
1992). This responsibility can be thought of both as the duty of an employer and the
fiduciary duty of an academic supervisor and must extend to situations of whistle-
blowing. Third, researchers involved in collaborative research have a responsibility to
colleagues and collaborators, especially given that research may play a crucial role in
capacity building (Garcia and Curioso 2008). Although partnerships with local
researchers have been touted as highly valuable (Costello and Zumla 2000), these ties
may also result in unexpected ethical dilemmas for local researchers if conflicts arise
between their research activities and their established local obligations and responsi-
bilities (Richman et al. 2012). A fourth responsibility of researchers is dedication to
the research enterprise. The conduct of public health research can have significant
implications for the well-being of large segments of the population, but it requires the
trust of the public and of relevant authorities. Endangering the relationship of trust in
the context of one specific public health study may jeopardize or ruin other research
initiatives (Corbie-Smith et al. 1999). Finally, a fifth responsibility of publicly funded
researchers is their duty to the public in whose name they conduct research. Good
stewardship requires that researchers strive to maximize the relevance and usefulness
of their efforts and that they disseminate their findings (Arzberger et al. 2004).
Researchers conducting collaborative international public health research may
encounter ethically challenging conflicts among these five lines of responsibilities.
Dr. Milena A. is the principal investigator of a large research program that is exam-
ining approaches for decreasing inequities in access to health care services in a
low-resource setting. She works for an American university, and her research is
funded by a U.S. agency. One member of her research team, Dr. Timothy N., is a
local physician studying toward a public health degree at Milena’s institution. He is
back in his country after finishing his coursework and is ready to conduct fieldwork
research. Timothy has taken leave from his position at a local hospital to pursue his
studies and, although he wants to continue his clinical work at the hospital, he also
wants to expand his focus to include population-level health issues and, eventually,
work with his country’s ministry of health. His studies are co-funded by Milena’s
research grant and by the ministry of health.
Timothy’s research consists of an examination of the impact of his country’s
recent abolishment of health care user fees for children younger than 5 years. User
fees had been implemented uniformly in the 1990s without special consideration for
poorer families with young children. Initial indicators suggest that health care ser-
vices continue to be underused in some districts, especially by poor children, despite
the recent removal of user fees. Despite the limited uptake, the ministry of health
touts the policy abolishing user fees for children younger than 5 years as an impor-
tant success. Timothy is conducting his study at several urban health centers, includ-
ing the hospital from which he is currently on leave. The research project has received
ethics approval from Milena’s institution and from the relevant local review boards.
Recently, Timothy requested a meeting with Milena saying that he needed
advice. He reports that he has identified a system of informal fees that undermines
the ministry of health’s official policy by making health care once again too expen-
sive for many families with young children. From what Timothy understands, the
fees are levied primarily to fund better obstetric care locally, but some indicators
point toward senior administrators keeping a small share for themselves. Timothy
worries that making his findings public is too risky for him, especially since his
involvement in this fieldwork is well-known. He does not think it possible to share
his findings without identifying himself as the source of the information. His hos-
pital is one of the sites where he has identified the system of informal payments. He
also has good reasons to believe that some members of the ministry of health are
already aware of the situation but have not taken action to address it. Disseminating
his results will jeopardize his employment at the hospital, his relationships with
government officials, and, potentially, the plans to improve obstetric care.
Milena is also conflicted. She recognizes that she has multiple roles, responsi-
bilities, and interests, and that individual and communal goods are at stake.
Identifying and seeking to address informal payment structures could improve
accessibility of health care services for children, which is the primary goal of her
research program. However, the team has responsibilities to Timothy as their stu-
dent and colleague. Demanding that he upend his career, either for their benefit or
for the improvement of health care accessibility, might fail to respect him as an
individual. In addition, bringing the situation to light could embarrass the ministry
of health. Because the research program depends on the ministry of health’s autho-
rization, tensions in relationships could lead to premature termination of the
research. Such an event would have unpredictable outcomes on the careers of every-
one on the research team and on the future of health care accessibility locally.
1. How should Milena and Timothy prioritize their responsibilities, and what
should they ultimately do?
2. What preemptive actions could the research team have taken to limit the likeli-
hood that the situation described above would happen?
3. How should the fact that, aside from Timothy, the research team members are not
citizens in the country where they are conducting research be considered in the
assessment of their obligations?
4. Is this a case where developing partnerships with local researchers might be
counterproductive? Or, could a more robust partnership with local researchers
have positioned the team to better address this issue?
5. How would the ethical analysis differ if, instead of identifying unequal access
due to informal fees, Timothy had observed that those exempted from the fees
were being offered a lower standard of care than patients whose fees were not
waived?
References
Anonymous. 1988. The Bamako initiative. Lancet 2(8621): 1177–1178.

Arzberger, P., P. Schroeder, A. Beaulieu, et al. 2004. Promoting access to public research data for
scientific, economic, and social development. Data Science Journal 3: 135–152.
Ben Ameur, A., V. Ridde, A.R. Bado, M.G. Ingabire, and L. Queuille. 2012. User fee exemptions
and excessive household spending for normal delivery in Burkina Faso: The need for careful
implementation. BMC Health Services Research 12: 412. doi:10.1186/1472-6963-12-412.
Corbie-Smith, G., S.B. Thomas, M.V. Williams, and S. Moody-Ayers. 1999. Attitudes and beliefs
of African Americans toward participation in medical research. Journal of General Internal
Medicine 14(9): 537–546.
Costello, A., and A. Zumla. 2000. Moving to research partnerships in developing countries. British
Medical Journal 321(7264): 827–829.
lines for biomedical research involving human subjects. http://www.cioms.ch/publications/
layout_guide2002.pdf. Accessed 27 Dec 2012.
Garcia, P.J., and W.H. Curioso. 2008. Strategies for aspiring biomedical researchers in resource
limited environments. PLoS Neglected Tropical Diseases 2(8): e274. doi:10.1371/journal.
pntd.0000274.
Hurst, S.A. 2008. Vulnerability in research and health care: Describing the elephant in the room?
Bioethics 22(4): 191–202. doi:10.1111/j.1467-8519.2008.00631.x.
Hyder, A.A., A. Rattani, C. Krubiner, A.M. Bachani, and N.T. Tran. 2014. Ethical review of health
systems research in low- and middle-income countries: A conceptual exploration. American
Journal of Bioethics 14(2): 28–37. doi:10.1080/15265161.2013.868950.
Lagarde, M., and N. Palmer. 2011. The impact of user fees on access to health services in low- and
middle-income countries. Cochrane Database of Systematic Reviews 4: CD009094.
doi:10.1002/14651858.CD009094.
Macha, J., B. Harris, B. Garshong, et al. 2012. Factors influencing the burden of health care financ-
ing and the distribution of health care benefits in Ghana, Tanzania and South Africa. Health
Policy and Planning 27(suppl 1): i46–i54.
Mayhew, S.H., J. Doherty, and S. Pitayarangsarit. 2008. Developing health systems research
capacities through north–south partnership: An evaluation of collaboration with South Africa
and Thailand. BMC Health Research Policy and Systems 6: 8. doi:10.1186/1478-4505-6-8.
McIntyre, D., M. Thiede, G. Dahlgren, and M. Whitehead. 2006. What are the economic conse-
quences for households of illness and of paying for health care in low- and middle-income
country contexts? Social Science & Medicine 62(4): 858–865.
McPake, B., K. Hanson, and A. Mills. 1993. Community financing of health care in Africa: An
evaluation of the Bamako initiative. Social Science & Medicine 36: 1383–1395.
Meessen, B., D. Hercot, M. Noirhomme, et al. 2011. Removing user fees in the health sector: A
review of policy processes in six sub-Saharan African countries. Health Policy and Planning
26(suppl 2): ii16–ii29. doi:10.1093/heapol/czr062.
Richman, K.A., L.B. Alexander, and G. True. 2012. Proximity, ethical dilemmas, and community
research workers. American Journal of Bioethics Primary Research 3(4): 19–29. doi:10.1080/
21507716.2012.714837.
Ridde, V., E. Robert, and B. Meessen. 2012. A literature review of the disruptive effects of user fee
exemption policies on health systems. BMC Public Health 12: 289.
doi:10.1186/1471-2458-12–289.
Wilson, K. 1992. Thinking about the ethics of fieldwork. In Fieldwork in developing countries, ed.
S. Devereux and J. Hoddinott, 179–199. New York: Harvester Wheatsheaf.
9.7 Case 2: Ethical Challenges in Impoverished

Communities: Seeking Informed Consent
in a Palestinian Refugee Camp in Lebanon
Jihad Makhoul, Rima Afifi, and Rima Nakkash
Department of Health Promotion and Community Health,
American University of Beirut
Beirut, Lebanon
e-mail: ra15@aub.edu.lb
institutions.
9.7.1 Background
Beginning in 1948, the United Nations Relief and Works Agency (UNRWA)
established camps in Lebanon to house refugees from Palestine. As of 2013, 12
camps remained (UNRWA 2013). The typical UNRWA camp houses three
generations of refugees, most of whom are unemployed and face economic hardships
from state-imposed legal and political restrictions (Chaaban et al. 2010). Camp
housing is substandard, usually lacking adequate health care and educational
infrastructures. A household survey of camp residents older than 15 years found
that the mean length of school attendance is 6–7.5 years, the mean yearly household
income is below $3,000, and more than half the respondents consider themselves
poor (Makhoul 2003; Khawaja et al. 2006).
Family structures in the camp vary, ranging from matriarchal families, extended
families, and traditional patriarchal families to even modern families where parents
jointly make decisions. These family structures also include complex formations
where, for example, a remarried father lives with his new wife and stepchildren. In
such complex families, children often have several guardians or authority figures.
Sociocultural conceptions shared by parents and social workers stress the reliance
of children on parental decisions—parents know what is best for children, while
children know they must obey parental decisions.
In resource-poor settings like the camps, many nongovernmental organizations
(NGOs) supplement UNRWA services, thereby gaining influence. The perceived
power that the local Palestinian NGOs hold in the community derives from years of
providing supplemental economic and social services to residents. Not surprisingly,
if an NGO is politicized, it also will hold political power. In this context, if an NGO
agrees to participate in a project, residents may agree to participate without paying
close attention to the details or the scope of work. They participate either because
they trust the NGO to decide on their behalf or because they want to avoid being
perceived as opposing an organization that provides them with needed services.
Similarly, international NGOs hold perceived power by providing essential services
and distributing needed supplies, especially during emergencies. Universities can
acquire such power, even unintentionally, not only from the prestige and status that
educational institutions generally enjoy, but also from the potential benefits that
research projects bring to the camps. Intentional or not, exercising such power can
raise unanticipated problems for the research enterprise.
To protect research participants, some national and international commissions
have published guidance documents about equitable distribution of benefits and
respect for autonomy, beneficence, and social justice. These documents include the
Nuremberg Code (1947), the Declaration of Helsinki (World Medical Association
1964), The Belmont Report (National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research 1979), and the International
Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for
International Organizations of Medical Science 2002). Even though these interna-
tional guidelines acknowledge the need to consider culture and community, they
lack adequate guidance for community-based public health research (Racher 2007;
Bledsoe and Hopson 2009). In addition, these guidelines are difficult to apply in
nonbiomedical research contexts in community settings. This difficulty could be
attributed to applying guidelines without first considering local contexts (Dawson
and Kass 2005; Benatar 2002; Chilisa 2009). Many community-oriented practitio-
ners find the principles too limiting to guide public health research ethics in com-
munity settings and recommend incorporating broader conceptions of respect, trust,
inclusion, diversity, participation, empowerment, and advocacy (Racher 2007;
Bledsoe and Hopson 2009).
Biomedical guidelines often clash with community interactions, especially in the
nonindustrialized world (Bledsoe and Hopson 2009; Matsumoto and Jones 2009;
Chilisa 2009). One such clash occurs between individual-oriented societies and
more collectivist societies that view personhood and individual decision making
through the lens of a person’s relation to society (Marshall and Baten 2003). Another
clash occurs between the artificially impersonal character of research environments
and the centrality of relationships and partnerships in communities. Randomized
clinical trials (RCTs), for example, require control of all possible confounders, a
nearly impossible standard to achieve in close-knit and dense community settings
(Makhoul et al. 2013). Implementing ethical guidelines in the context of power
dynamics (Marshall and Baten 2004), like the pronounced power that males wield
over females in patriarchal societies, can instigate numerous clashes. In communi-
ties like refugee camps that offer few economic or career opportunities, the per-
ceived power that NGOs and, even more so, academic institutions wield is a force
that must be taken into account. In such restricted settings, the power dynamics
between researchers and research subjects can take on a subtle coercive character.
These same tensions, challenges, and dynamics will emerge in any efforts to
obtain informed consent to participate in research. The emergence may stem from
failure to appreciate the unique complexity of local familial, cultural, and political
structures, or it may represent limitations in the principles being applied.
A community coalition, initiated by researchers from a nearby university, has been

meeting for more than a year to prioritize health concerns for youth in a Palestinian
refugee camp near Beirut, Lebanon. The camp is a typical UNRWA camp and
includes six elementary schools. The coalition comprises camp residents including
youth (17–25 years), UNRWA representatives, camp NGO workers, and members
of the university research team. The coalition has decided to focus on the mental
health of younger adolescents (11–13 years) in this Palestinian refugee camp and to
develop a research intervention on this issue. Cross-sectional studies and evaluation
of interventions that link social and life skills to mental health outcomes strongly
support the view that these skills enhance the mental health of youth; however, most
of the evidence comes from industrialized settings.
The goal of the intervention is to enhance positive mental health by increasing
the social and life skills of young adolescents, who will be recruited through the
schools. The six elementary schools have comparable resources and student pro-
files. Each school has been randomly assigned either to the intervention or to the
control arm of the study, and only fifth and sixth graders will participate. Participating
students in the intervention group will receive 45 extracurricular sessions of 1½ h
each over 9 months and gain skills in solving problems, making decisions, building
self-esteem, and enhancing relationships with peers, parents, and teachers. Parents
of the students in the intervention group will receive 15 1-h group sessions, and
teachers in the intervention schools will be offered six workshops addressing the
same topics. Students randomized to the control group will receive 10 sessions over
the course of 9 months, but their parents will not participate in the program.
However, because teachers often work in more than one camp school, some teachers
at the control schools may participate in the intervention workshops. All partici-
pants in either the intervention or control condition must complete pre- and post-
assessment questionnaires that measure mental health and social and life skills
before and after the intervention and at 6 months follow-up.
Recruitment into the research project will unfold in phases. Toward the end of
the school year preceding the intervention, parents will be invited to an informa-
tional session about the project that will take place in one of the camp schools. After
the informational session, meetings will take place with individual families in their
homes to recruit students entering grades 5 and 6. Some youth (ages 17–23 years)
who live in the camp will receive training to become part of the recruitment team.
These youth will visit the homes of all potential intervention and control partici-
pants to explain the study and to obtain parental consent. If the parents consent,
students will be invited to the school for further discussion (to ensure confidentiality
and autonomy of decision making). Once the study has been explained to them,
they’ll be asked individually to give their assent.
You are a member of the university research team leading the effort to obtain
informed consent. You would like to obtain consent and assent in accordance with
standard international procedures, but you realize their application may need to be
adjusted to the context of the camp. In particular, you have considered what role
principles such as trust, inclusion, diversity, and broad community participation
should play in the research project. That is why you chose to have older youth from
the camp obtain both parental consent and student’s assent, but you are concerned
about potential problems that this approach may encounter. Also, given the power
dynamics and conditions in the camp, you would like the research team to consider
how this project can be used to spearhead a discussion with the community coalition
about larger issues of empowerment and advocacy. With this in mind, you plan to
address the following questions with your research team.
1. How could the history of Palestinian refugee camps potentially impact the
informed consent process and the success of this intervention?
2. Who are the stakeholders in this case, and what stake, for or against, do they have
in the research project? How would you deal with those who believe the project
is not in their or the community’s interests?
3. What are the advantages and potential disadvantages of using older youth to
obtain parental consent and student’s assent? What other steps could be taken to
enhance the informed consent seeking process in such social contexts?
4. What incentives, if any, should be given for participation? To whom should these
incentives be given? Given the limited opportunities for the inhabitants of the
refugee camps and the perceived power of NGOs, at what point would incentives
become compulsive to encourage participation?
5. How do relationships of power influence the application of informed consent
procedures specifically, in this context? What steps can be taken to minimize the
effects of power?
6. What bearing, positive or negative, does the background of the researchers have
on the researcher-participant interaction, especially for researchers who have
never lived in such camp settings and would be considered outsiders to the camp
community?
7. Beyond the informed consent process, are the researchers simply teaching the
adolescents how to adjust to an oppressive arrangement instead of exploring,
providing and validating strategies to transform the situation? If so, what are
some alternative intervention strategies that could foster the latter?
8. By almost any measure, the camp environment is abnormal for a developing ado-
lescent. Given that social determinants severely challenge the health of all members
of the camp community, how should the researchers take into account the unusual
and extreme circumstances of the adolescents as they implement and evaluate inter-
ventions that aim to change individual-level circumstances and attributes?
References
Benatar, S.R. 2002. Reflections and recommendations on research ethics in developing countries.
Social Science & Medicine 54(7): 1131–1141.
Bledsoe, K.L., and R.K. Hopson. 2009. Conducting ethical research and evaluation in underserved
communities. In The handbook of social research ethics, ed. D.M. Mertens and P.E. Ginsberg,
391–406. Thousand Oaks: Sage Publications.
Chaaban, J., H., Ghattas, and R.R., Habib, et al. 2010. Socio-economic survey of Palestinian refu-
gees in Lebanon. American University of Beirut (AUB) and the United Nations Relief and
Works Agency for Palestine Refugees in the Near East (UNRWA). http://fafsweb.aub.edu.lb/
aub-unrwa/files/AUB_UNRWA_report_final_draft.pdf. Accessed 3 Jan 2013.
Chilisa, B. 2009. Indigenous African-centered ethics: Contesting and complementing dominant
models. In The handbook of social research ethics, ed. D.M. Mertens and P.E. Ginsberg, 407–
425. Thousand Oaks: Sage Publications.
lines for biomedical research involving human subjects. http://www.cioms.ch/publications/
layout_guide2002.pdf. Accessed 18 Feb 2014.
Dawson, L., and N.E. Kass. 2005. Views of US researchers about informed consent in international
collaborative research. Social Science & Medicine 61(6): 1211–1222.
Khawaja, M., S. Abdulrahim, R.A. Soweid, and D. Karam. 2006. Distrust, social fragmentation
and adolescents’ health in the outer city: Beirut and beyond. Social Science & Medicine 63(5):
1304–1315.
Makhoul, J. 2003. Physical and social contexts of the three urban communities of Nabaa, Borj el
Barajneh Palestinian Camp and Hay el Sullum. Unpublished report. CRPH, American
University of Beirut, Lebanon.
Makhoul, J., R. Nakkash, T. Harpham, and Y. Qutteina. 2013. Community based participatory
research in complex settings: Clean mind–dirty hands. Health Promotion International 29(3):
510–517. doi:10.1093/heapro/dat049.
Marshall, A., and S. Batten. 2003. Ethical issues in cross-cultural research. In CONNECTIONS’03,
ed. W.M. Roth, 139–151. http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&
cd=1&cad=rja&uact=8&ved=0CCEQFjAAahUKEwjO7JWKuujIAhXK7CYKHdNyANc&u
rl=http%3A%2F%2Fejournal.narotama.ac.id%2Ffiles%2FEthical%2520Issues%2520in%252
0Cross-Cultural%2520Research.pdf&usg=AFQjCNG04xJ3QFK7bIjX_EQUvwrwZRacxg.
Marshall, A., and S. Batten. 2004. Researching across cultures: Issues of ethics and power. Forum
Qualitative Sozialforschung/Forum: Qualitative Social Research 5(3): Article 39. http://nbnre-
solving.de/urn:nbn:de:0114-fqs0403396. Accessed 3 June 2015.
Matsumoto, D., and C.A.L. Jones. 2009. Ethical issues in cross-cultural psychology. In The hand-
book of social research ethics, ed. D.M. Mertens and P.E. Ginsberg, 323–336. Thousand Oaks:
Sage Publications.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral
human subjects of research. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html.
Control Council Law No. 10, Vol. 2, pp. 181–182. Washington, DC: U.S. Government Printing
Office, 1949. http://www.hhs.gov/ohrp/archive/nurcode.html. Accessed 23 Feb 2014.
Racher, F.E. 2007. The evolution of ethics for community practice. Journal of Community Health
Nursing 24(1): 65–76.
United Nations Relief and Works Agency (UNRWA). 2013. Lebanon. http://www.unrwa.org/
etemplate.php?id=65. Accessed 4 June 2013.
World Medical Association. 1964. Declaration of Helsinki: Ethical principles for medical research
involving human subjects. http://www.wma.net/en/30publications/10policies/b3/. Accessed 23
Feb 2014.
9.8 Case 3: Improving Review Quality and Efficiency

of Research Ethics Committees to Enhance Public
Health Practice in Africa
Mary Kasule
Office of Research and Development
University of Botswana
Gaborone, Botswana
e-mail: mary.kasule@mopipi.ub.bw
Douglas Wassenaar
South African Research Ethics Training Initiative, School of Applied
Human Sciences
University of KwaZulu-Natal
Pietermaritzburg, South Africa
Carel IJsselmuiden
Council on Health Research for Development
Geneva, Switzerland
School of Applied Human Sciences, South African Research Ethics
Training Initiative, University of KwaZulu-Natal, Pietermaritzburg, South Africa
Boitumelo Mokgatla
Africa Office for Council on Health Research for Development
Gaborone, Botswana
Mapping African Research Ethics Review and Medicines Regulatory Capacity,
Gaborone, Botswana
mokgatla@cohred.org
institutions.
9.8.1 Background
Many low- to middle-income countries in Africa face a tremendous burden of infec-

tious diseases. Tuberculosis (TB) causes particular concern, with incidence rising
and the greatest prevalence in children. Compounding this concern is the lack of an
easy-to-use and accurate diagnostic test (World Health Organization 2012). To
address these challenges, the World Health Organization’s (WHO) 2011 global plan
to stop TB by 2050 urgently calls for more research to develop diagnostics, drugs,
and vaccines. WHO’s call reinforces the 2008 Global Ministerial Forum on Research
for Health held in Mali, which recommended that each country allocate 2 % of
health ministry funds to health care research (Yazdizadeh et al. 2010). All research
involving human subjects will require review by institutional review boards (IRBs)
or, as they are generally known in Africa, research ethics committees (RECs). But
to expedite the process of high-quality ethical reviews necessary to keep pace with
these new research initiatives, a corresponding investment in REC funding and
training should be made.
In TB-endemic areas of Africa, the volume and complexity of research have
increased without a corresponding strengthening in the capacity of local RECs
(WHO 2011). At least 190 RECs operate throughout Africa, but the quality and
capacity of each vary widely (IJssemuiden et al. 2012). Although some RECs still
lack adequate research regulatory frameworks, the major challenge to strengthening
capacity is lack of funding (Kass et al. 2007). This means, for example, that few, if
any, African RECs have tools like electronic information management systems to
coordinate submissions efficiently. It also means that few have trained REC admin-
istrators, a gap rightly identified as the missing link to improved quality and through-
put of ethical review (IJsselmuiden et al. 2012). These factors can delay ethical
reviews and create problems with quality and consistency (Milford et al. 2006; Kass
et al. 2007). Whenever significant research funds are wasted on managing ineffi-
cient RECs, fewer funds are available to study ways to improve public health care
services (Tully et al. 2000). This waste of resources on inefficient ethical review
affects the timeliness of health services, which, in turn, affects subsequent health
care policy and decision making. Ironically, such wastefulness poses an unethical
barrier to potentially beneficial public health research activities. Worse, these inef-
ficiencies can cost research institutions a chance to compete for grants that require
prior ethical review of research proposals by the country’s internal REC.
In Africa, external grants are often used to fund health research activities, whereas
REC funding typically is either nonexistent or constrained by more pressing health
care needs. Attempting to prioritize and allocate resources for activities with out-
comes linked to funding puts policy makers in a dilemma. On the one hand, diverting
funds from the immediate treatment of life-threatening diseases to a weak, inefficient
REC can waste critical resources. On the other hand, not allocating funds to
strengthen RECs can lead to the loss of external research funding, the very research
that could reduce the burden of disease in the long run. Moreover, external funding,
though filling a critical gap, often heightens the tensions at play in prioritizing
between immediate needs for health care and long term needs for research and RECs.
A multinational pharmaceutical company put out a call for proposals to research

institutions in sub-Saharan Africa to apply for a research grant. The 3-year grant,
which provides 500,000 U.S. dollars per year to develop an effective paediatric TB
diagnostic tool, would involve conducting clinical trials in five African TB-endemic
countries. Successful award of the grant is contingent upon timely review of the
proposal by the applicant’s national REC.
In one country eligible for the grant, the ministry of health (MoH) encouraged its
National Tuberculosis Research Centre to apply. The grant funding would have
boosted the country’s long-term efforts to strengthen the capacity of its public health
research by restructuring its TB treatment protocol. The Research Centre promptly
submitted a proposal to the national REC, which levies 10 % of the grant as over-
head to sustain the REC.
Despite the overhead funding, the country’s national REC lacks an administrator
formally trained in research ethics and a robust ethics review structure. Although
the REC receives more than 100 applications annually, it only meets every 3 months,
often missing deadlines, because it cannot afford essential tools to coordinate sub-
missions efficiently. To have a proposal reviewed; applicants have to submit 20 hard
copies of the research application form and 10 copies of all other study materials.
The review procedure typically forces the principal investigator of a clinical trial to
submit nearly 20 kg of paper copies, a considerable sum in supplies and manpower.
Despite its high profile, the TB Research Centre’s grant application does not prove
to be an exception to the notoriously slow review process.
Professor Y, a highly capable public health specialist, directs the public health
department in the local MoH. She also lectures at a local medical school, serves as
Principal Investigator (PI) of an ongoing TB clinical trial in the country, and has
extensive experience at all levels of REC activity and oversight. Unfortunately,
Professor Y has never had formal training in research ethics, which is critical for
anyone involved in managing REC activities. Because of her background, Professor
Y became aware of the delays in reviewing the TB Research Centre’s application.
Recognizing its importance to the country, Professor Y offered to serve as the pri-
mary reviewer for the proposal. Professor Y called an ad hoc REC meeting. At this
meeting, the other members, who had only received copies of the grant application
form to prepare for their review, unanimously agreed to outsource review of the pro-
tocol because they lacked the expertise to evaluate the application. Amid these delays,
institutions in other countries competing for the same grant, having already received
ethical clearance from their RECs, were awarded the grant. Not only did the delays
cost the country a funding opportunity to enhance its public health research capacity,
but preparing the application also wasted precious time and scarce resources.
In response to this bungled opportunity, the MoH set up a task force to analyse
the situation and offer recommendations. In its report, the task force recommended
allocating more resources to RECs to strengthen capacity. Due to budget constraints,
the MoH had to divert the money allocated to RECs from the antiretroviral program.
Meanwhile, the MoH recommended temporarily outsourcing all REC services to a
U.S. based clinical research organization.
1. What ethical tension or challenges could result from the insufficiencies in REC
capacity that forced the MoH’s decision to divert funds from the antiretroviral
program to strengthen REC capacity?
2. How should a country prioritize between the need to foster research, which can
have significant long-term impact and immediate health care needs?
3. Funding for the research grant and temporary outsourcing of ethical reviews will
come from multinational or U.S. based partners. What are the advantages and
disadvantages for developing countries to accept such funding? What impact
does accepting such funding have on a country’s ability to determine its own
health priorities?
4. Professor Y has public health credentials, TB expertise, and extensive experi-
ence as an REC administrator. The case suggests that had she followed the pro-
cedures for the review process, the grant application might have been successful,
even though she apparently lacks formal ethics training.
(a) According to international research ethics regulations, what procedures
should Professor Y have followed when distributing the proposal for review,
allocating reviewers, and setting up the REC meeting?
(b) How critical is formal ethics training to serving on an REC or to overseeing
the development of REC capacity nationwide?
(c) Is it a good use of time for someone like Professor Y to be serving adminis-
tratively on an REC?
(d) Would you recommend that the MoH create a permanent position for a
trained research ethics administrator solely responsible for REC administra-
tion issues instead of allowing volunteers like Professor Y, who have multiple
roles and responsibilities, to oversee the activity?
5. Given the cultural and economic differences between developed Western nations that
sponsor research and African host countries, should formal ethics training to prepare
for serving on an REC be modelled on Western training or on some other model?
6. Keeping the interests and values of all stakeholders in mind, consider the best
ways to address the strengthening of REC capacity in African low- to middle-
income countries at the local and global levels.
References
IJssemuiden, C., D. Marias, D. Wassenaar, et al. 2012. Mapping African ethical review committee
activity onto capacity needs: The MARC initiative and HRWEB’s interactive database of
RECSs in Africa. Developing World Bioethics 12(2): 74–86.
Kass, N.E., A.A. Hyder, A. Ajuwon, et al. 2007. The structure and function of research ethics com-
mittees in Africa: A case study. PLoS Medicine 4(1): e3. doi:10.1371/journal.pmed.0040003.
Milford, C., D. Wassenaar, and C. Slack. 2006. Resources and needs of research ethics committees
in Africa: Preparations for HIV vaccine trials. IRB: Ethics & Human Research 28(2): 1–9.
Tully, J., N. Ninis, R. Booy, and R. Viner. 2000. The new system of review by multi-centre research
ethics committees: Prospective study. British Medical Journal 320(7243): 1179–1182.
World Health Organization (WHO). 2011. An international road map for tuberculosis research:
Towards a world free of tuberculosis. Geneva: World Health Organization.
World Health Organization (WHO). 2012. Global tuberculosis report 2012. Geneva:World Health
Organization. http://apps.who.int/iris/bitstream/10665/75938/1/9789241564502_eng.pdf.
Yazdizadeh, B., R. Majdzadeh, and H. Salmasian. 2010. Systematic review of methods for evaluat-
ing healthcare research economic impact. Health Research Policy and Systems 8: 6.
doi:10.1186/1478-4505-8-6.
9.9 Case 4: Internet-Based HIV/AIDS Education

and Prevention Programs in Vulnerable Populations:
Black Men Who Have Sex with Men
Amar Kanekar
Department of Health, Human Performance and Sport Management
University of Arkansas at Little Rock
Little Rock, AR, USA
e-mail: axkanekar@ualr.edu
institution.
9.9.1 Background
Since surfacing more than 30 years ago, the HIV/AIDS pandemic has devastated
populations worldwide. Various factors have contributed to this epidemic, such as
lack of awareness of HIV status, stigma, homophobia, negative perceptions about
HIV testing, socioeconomic factors, behavioral risk factors, and high prevalence of
sexually transmitted diseases (Centers for Disease Control and Prevention 2015). In
the United States, one goal of the national HIV/AIDS strategy is to reduce HIV-
related health disparities. Any reduction in the collective risk of acquiring HIV will
require behavior change interventions in communities with the highest HIV preva-
lence. However, extending the reach of HIV/AIDS preventive interventions in
remote areas with limited access to HIV testing and prevention services has proved
difficult (Office of National AIDS Policy 2012).
The challenge of reaching some populations has led many practitioners to con-
sider innovative intervention methods that rely on technologies such as the Internet
and mobile telephones. Public health professionals are using these technologies to
deliver health education to vulnerable populations in big cities, small towns, and
hard-to-reach rural areas. In particular, the past decade has seen more health com-
munication efforts using the Internet to prevent HIV and sexually transmitted dis-
eases (Bull et al. 2007, 2009; Rietmeijer and McFarlane 2009). Studies of
interventions that use Internet chat rooms, online modules, and health intervention
websites show promising results that bode well for the future of these technologies
(Chiasson et al. 2009; Moskowitz et al. 2009).
Studies conducted with marginalized and vulnerable populations such as black
men who have sex with men (MSM) can pose difficulties. On the technology front,
many difficulties reflect the Internet’s relative novelty for conducting studies and
the consequent lack of clarity in dealing with the rules, language, and norms of a
virtual community culture compared with a traditional community culture (Loue
and Pike 2010). On the allocation front, having limited resources usually implies
that tailoring interventions to a specific group will mean forgoing benefits to another
group. Still, in promoting the health of populations, public health professionals
must strive to distribute resources fairly while responding to the specific needs of
racial, ethnic, and cultural groups. These concurrent goals require maintaining a
delicate balance between targeted and population interventions. On the ethics front,
because some projects straddle the line between research and practice, public health
professionals can become unsure about whether the ethical guidelines of research or
of community work should govern their actions. They must bear in mind that trust,
which is essential for conducting community-based participatory research, becomes
more crucial when working with vulnerable populations, which tend to show a high
degree of mistrust (Loue and Pike 2010). Those who study vulnerable populations
need to negotiate community entry either by developing trust or by working closely
with local practitioners and building upon established trust.
In the United States, the HIV/AIDS epidemic has hit the African-American pop-
ulation hardest, with black men accounting for 70 % of new HIV infections.
Between 2006 and 2009, new HIV infections increased 48 % among black 13- to
24-year-old MSM (Centers for Disease Control and Prevention 2015); by 2009,
37 % of new HIV cases among black men were from black MSM. Given this high
prevalence, before the end of 2015, the U.S. national HIV/AIDS strategy calls for a
20 % increase in the proportion of African Americans diagnosed with HIV who
have an undetectable viral load (Office of National AIDS Policy 2012). Already,
information about HIV issues affecting young MSM (Mustanski et al. 2011) is
widely available on the Internet, including messages about how to reduce risk
(Hightow-Weidman et al. 2011) and interventions to prevent HIV risk behaviors
among MSM (Rhodes et al. 2010) and blacks who inject drugs (Washington and
Thomas 2010). Studies show that online delivery of HIV counseling and behavioral
interventions for MSM at high risk for HIV are successful, suggesting that the
future holds great promise for Internet-delivered interventions for this vulnerable
population (Chiasson et al. 2009; Moskowitz et al. 2009).
Dr. Albert, a social scientist, and Dr. Baines, a community worker, are employed by
a public health agency in a medium-size U.S. town. The agency has asked them to
determine whether a skill-based, Internet-delivered intervention to promote safer
sex among young Black MSM will increase HIV knowledge and increase the fre-
quency of using safer-sex practices.
Project participants will be recruited via the Internet in gay chat rooms and be
verified electronically by using Internet Protocol and Microsoft Access usernames
and passwords (Bull 2011). Participants will be surveyed before they begin the
training modules and again at 1- and 6-week intervals after completing the modules.
Participants will be randomly assigned to control and experimental arms. Those in
the control arm will receive 6 h of online training about health and well-being (e.g.,
nutrition, physical activity, stress reduction). The experimental arm will receive a
6-h online program including two 1-h modules on each of the following topics: (a)
HIV/AIDS-related knowledge; (b) development and improvement of safe sex skills,
such as partner communication and monogamous sexual relationships; and (c) self-
efficacy in using condoms. The modules will include automated reminders for HIV
testing. The study will measure improved knowledge on HIV/AIDS, partner com-
munication about safer sex, and condom usage self-efficacy. Data will be analyzed
using statistical software.
Dr. Albert thinks the results could be generalized not only to black MSM in the
community but also to black MSM overall. He plans to write an article describing
the results for publication in a scientific journal. Although Dr. Baines knows the
impact of education on health, especially in underprivileged communities, she
wants to educate only a subset of the community they will reach. Besides, since
their work is for a public health agency, she believes the intervention ought to reach
as many community members possible. She claims the project’s goal is to provide a
vulnerable and disadvantaged population with much needed education on health
matters and health-promoting behavior and doubts their project constitutes research.
Dr. Albert worries that, because his colleague lacks academic rigor and underap-
preciates the role of evidence, she fails to appreciate the project’s rationale and
design and, as a result, is indifferent to the challenges the Internet poses (e.g.,
technology-induced bias, protection of confidentiality). Conversely, Dr. Baines
believes Dr. Albert has missed the boat and is wasting resources, spuriously intro-
ducing statistical analysis of experimental and control arms into what the agency
clearly had intended as an education intervention.
1. Is this a research project? Should approval from an ethics review committee be

obtained? Or should the project be considered nonresearch because it will
improve the health of the population? How should you decide?
2. Does the fact that the project is funded by a public health agency play a role in
this discussion? Should public health agencies conduct studies to generate evi-
dence about HIV education and prevention interventions? Should agencies focus
on the delivery of interventions based on the existing evidence?
3. How is this black MSM population vulnerable, and how should this vulnerability
be addressed in research and nonresearch interventions?
4. Do Dr. Albert and Dr. Baines have ethical obligations to other community popu-
lations? On what basis is the public health agency justified in advancing inter-
ventions that target only a subgroup of the community?
5. How should research studies on Internet-based interventions be conducted to
ensure scientific validity, given the difficulties of knowing, for example, whether
the participant meets the study’s inclusion criteria? Which measures should be
taken to protect the privacy and confidentiality of participants?
6. How should you decide what level and type of evidence you need to back a pub-
lic health educational intervention? Should public health professionals always
use science to validate educational interventions?
References
Bull, S. 2011. Technology-based health promotion. Thousand Oaks: Sage Publications.

Bull, S.S., S. Phibbs, S. Watson, and M. McFarlane. 2007. What do young adults expect when they
go online? Lessons for development of an STD/HIV and pregnancy prevention website.
Journal of Medical Systems 31(2): 149–158.
Bull, S., K. Pratte, N. Whitesell, C. Rietmeijer, and M. McFarlane. 2009. Effects of an Internet
based intervention for HIV prevention: The Youthnet trials. AIDS and Behavior 13(3): 474–
487. doi:10.1007/s10461-008-9487-9.
Centers for Disease Control and Prevention. 2015. HIV Among African Americans. http://www.
cdc.gov/HIV/risk/racialethnic/aa/index.html. Accessed 2 June 2015.
Chiasson, M.A., F.S. Shaw, M. Humberstone, S. Hirshfield, and D. Hartel. 2009. Increased HIV
disclosure three months after an online video intervention for men who have sex with men
(MSM). AIDS Care 21(9): 1081–1089. doi:10.1080/09540120902730013.
Hightow-Weidman, L.B., B. Fowler, J. Kibe, et al. 2011. HealthMpowerment.org: Development of
a theory-based HIV/STI website for young black MSM. AIDS Education and Prevention 23(1):
1–12. doi:10.1521/aeap.2011.23.1.1.
Loue, S., and E.C. Pike. 2010. Case studies in ethics and HIV research. New York: Springer.
Moskowitz, D.A., D. Melton, and J. Owczarzak. 2009. PowerON: The use of instant message
counseling and the Internet to facilitate HIV/STD education and prevention. Patient Education
and Counseling 77(1): 20–26. doi:10.1016/j.pec.2009.01.002.
Mustanski, B., T. Lyons, and S.C. Garcia. 2011. Internet use and sexual health of young men who
have sex with men: A mixed-methods study. Archives of Sexual Behavior 40(2): 289–300.
doi:10.1007/s10508-009-9596-1.
Office of National AIDS Policy. 2012. National HIV/AIDS strategy: Update of 2011–2012 federal
efforts to implement the national HIV/AIDS strategy. http://www.aids.gov/federal-resources/
national-hiv-aids-strategy/implementation-update-2012.pdf. Accessed 2 June 2015.
Rhodes, S.D., K.C. Hergenrather, J. Duncan, et al. 2010. A pilot intervention utilizing Internet chat
rooms to prevent HIV risk behaviors among men who have sex with men. Public Health
Reports 125(suppl 1): 29–37.
Rietmeijer, C.A., and M. McFarlane. 2009. Web 2.0 and beyond: Risks for sexually transmitted
infections and opportunities for prevention. Current Opinion in Infectious Diseases 22(1):
67–71. doi:10.1097/QCO.0b013e328320a871.
Washington, T.A., and C. Thomas. 2010. Exploring the use of Web-based HIV prevention for injec-
tion-drug-using black men who have sex with both men and women: A feasibility study. Journal
of Gay & Lesbian Social Services 22(4): 432–445. doi:10.1080/10538720.2010.491747.
Index
A Aristotle, 14, 15
ACA. See Patient Protection and Affordable ART. See Antiretroviral therapy (ART)
Care Act (ACA) Assent, 22, 307
Acceptable risk, 180–183 Asylum seekers, 209, 232, 233, 235–239
Access to care, 95, 99–100 Autism, 104, 106
Accountability, 15, 245–247, 249, 265 Autonomy, 13, 16, 17, 19–21, 23–26, 37–39,
Accountability for reasonableness, 28 53, 95–97, 100, 116, 150, 168, 169,
A1C Registry, 39, 50–54 181, 183, 222, 237, 289, 306, 307
Adolescent mental health, 307 AVA. See Anthrax Vaccine Adsorbed (AVA)
Adverse events, 41, 264, 265
Advertising, 53, 148, 154–156, 159
Advocacy, 185, 267, 269, 297, 306, 308 B
Africa, 121, 148, 182, 310–313 Bacillus anthracis, 126
African-Americans, 45, 165, 221 Bamako Initiative, 301
Aggregate population health, 65. See also Behavioral health. See Behavioral health
Population health treatment
AIDS, 314 Behavioral health treatment, 75, 77, 78
AIDS exceptionalism, 257 Belmont report, 21, 22, 49, 247, 286, 306
Alabama, 38, 44–50, 53, 54 Beneficence, 19, 22, 23, 49, 286, 289, 306
Allocation, 62–70, 72, 73, 101, 227, 252, Bioethics, 4, 19–23, 28, 37, 47, 48, 81, 170,
260–262, 276, 315 203–205, 219, 247, 251, 286
AMR. See Antimicrobial resistance (AMR) Biomedical research, 20, 25, 180, 247, 252,
Anthrax attack, 126 286–289, 297, 301, 306
Anthrax disease, 126. See also Inhalation Biotechnology (ethical challenges
anthrax of), 21, 217
Anthrax vaccine, 101, 125–128 Bioterrorism, 101, 133
Anthrax vaccine adsorbed (AVA), 126 Bloodspot screening, 97, 111–114
Antibiotic resistance, 130, 193 Bloomberg, M., 53
Antibiotics, 126, 127, 192, 193, 270 Breast cancer, 142
Antimicrobial resistance (AMR), 192 Breast-feeding, 212
Antiretroviral therapy (ART), 109, 258, Breast screening, 143
260–262 Buck v. Bell, 43, 44
Anti-vaccination movement, 104 Built environment, 179
Anxiety, 112, 291 Bulgaria, 150, 172–175
Apathy, 232 Bulgarian Health Act, 173

Public Health Ethics Analysis 3, DOI 10.1007/978-3-319-23847-0
320 Index
C Collective health, 32, 243–244

Canadian Immigration and Refugee Protection Colom, A., 49
Act (IRPA), 238 Colombia, 66, 72, 73
Case-control study, 212 Colonial rule, 242
Casuistry, 38, 39 Commercial sex work, 46, 47, 121, 123. See
Cataract, 66 also Prostitution
CBPR. See Community-based participatory Common morality, 13
research (CBPR) Common rule, 20, 21
CDC. See Centers for Disease Control and Commonwealth v. Henning Jacobson, 41
Prevention (CDC) Communicable disease, 129
CEA. See Cost-effectiveness analysis (CEA) Communitarian values, 71
CEDAW. See Convention on the Elimination Community-based participatory research
of All Forms of Discrimination against (CBPR), 290, 315
Women (CEDAW) Community health, 4, 6, 10, 26, 39,
Centers for Disease Control and Prevention 210, 227
(CDC), 4, 31, 38, 39, 44, 45, 50, 109, Community participation, 71, 308
120, 121, 126, 137, 158, 164, 222, 245, Comparative effectiveness research
257, 260, 267, 288, 293, 314, 315 (CER), 63, 64
Central America, 218 Compensation, 102, 133, 218, 264, 265, 273
CER. See Comparative effectiveness research Compliance, 15, 18, 19, 72, 100, 102, 133,
(CER) 185, 236, 277, 287, 296. See also
Childbirth, 100, 116, 117 Noncompliance
Child health, 262, 276 Compulsory treatment program, 224
Childhood obesity, 149, 158–161 Conditional cash incentive scheme, 116–118
Childhood vaccination, 97, 105 Conflict, 12, 13, 18, 21, 27, 31, 40, 66–68, 73,
Children, 10, 29, 31, 40, 41, 43, 48, 73, 75–78, 85, 93, 96, 146, 168, 169, 174, 181,
96, 97, 101, 148, 149, 154–156, 182, 199, 242, 250, 259, 268, 277, 294.
158–161, 164, 168, 169, 174, 179, 196, See also War and warfare
200, 210, 213, 218, 231, 232, 238, 275, Conflicts of interests, 21, 142, 149, 294–296
277, 280, 289, 292, 302, 305, 310 Consent, 20, 22, 23, 25, 30, 31, 48, 169, 218,
Chile, 129 219, 247, 258, 264, 280–283, 286, 289.
Choice See also Informed consent
healthy, 160 Consumers, 71, 146–148, 168, 183
personal, 23, 25, 26, 111–114, 294 Convention on the Elimination of All Forms of
voluntary, 140, 158 Discrimination against Women
Cholera and outbreak, 244, 250, 270, 272 (CEDAW), 122
Cholera vaccines, 270 Coordination, 133, 134, 244–245, 249
Chronic disease prevention, 137, 138, Corporate social responsibility, 148
140–151, 153–165, 167–170, 172–175 Cost(s), 11, 15, 17, 29, 45, 61, 63, 65, 68, 71,
Chronic diseases, 38, 137–140. See also 72, 75, 76, 78, 86, 137–139, 144, 151,
Noncommunicable diseases 155, 158, 160, 161, 165, 168, 169, 174,
Cigarette use, 173 180, 236, 238, 247, 261, 263, 276, 277,
CIOMS. See Council for International 291, 292, 311, 312. See also
Organizations of Medical Sciences Cost benefit; Cost effective;
(CIOMS) Cost saving
Climate change, 179, 184, 250 Cost benefit, 17, 182
Clinical ethics, 4, 19–24, 37–39 Cost effective, 66, 67, 86, 88, 142, 144, 196,
Clinical guidelines, 72, 88 261, 265
Clinical trials, 40, 247, 263, 264, 288, 312 Cost effectiveness, 11, 15, 64, 66, 68, 72,
Cluster randomized trials, 286, 290 141, 150
Cold War, 231, 242, 243, 248–250 Cost-effectiveness analysis (CEA), 63
Coliform bacteria, 197 Cost savings, 17
Collaboration(s), 7, 20, 23, 24, 32, 81, 82, 123, Council for International Organizations of
197, 223, 241–243, 245–249, 263, 276, Medical Sciences (CIOMS), 20, 205,
281, 282, 286 264, 280, 281, 293, 301, 306
Index 321
Counseling and testing, 257, 258 Duties, 15–18, 23, 53, 54, 97, 98, 102, 138,
Crib death, 212 203, 204, 206, 208, 238, 250, 287, 293,
Criminalization of infectious disease 301, 302
transmission, 98
Criminal laws, 120, 121
Culturally appropriate research, 280 E
Cutler, J.C., 47 Economic analysis, 63
Economic development, 137, 157, 177, 182,
184, 189
D Economic measures, 275, 277
DALY. See Disability-adjusted life year Economic systems, 177, 184
(DALY) Ecosystems, 177, 179, 180, 183–185
Decision-making process, 11, 67, 69–70, 72, Effectiveness, 6, 10, 26, 29, 40, 45–47, 53, 63,
73, 149, 150, 169 64, 67, 144, 163, 168, 222, 237, 252,
Declaration of Helsinki, 20, 44, 246, 264, 290, 292. See also Cost effectiveness
286, 306 Efficiency, 6, 62–66, 68, 72, 169, 222,
De-identified data, 281, 282 310–313
Denormalization, 163 Efficiency frontiers, 63
Dental caries, 168–170 Emanuel, E., 247
Deportation, 210, 232, 233 Emergency model, 112
Detention policies, 231 Emergency response, 95, 101–102, 227,
Diabetes, 39, 50–54, 137, 141, 160, 277 245, 295
Diarrheal diseases, 40, 196, 271 Emergency Use Authorization (EUA), 126
Dilemmas, 13, 72, 99, 100, 121, 156, Emigration, 230
159, 182, 274–278, 296, Empowerment, 99, 252, 297, 306, 308
300–303, 311 Enforcement, 18, 41, 70, 98, 133, 192, 244
Directly observed therapy, short-course Environmental hazards, 178
(DOTS), 236 Environmental health, 38, 177–181, 184, 185
Disability-adjusted life years (DALYs), Environmental health risks, 177. See also
64, 172, 196 Environmental hazards
Discrimination, 8, 9, 98, 100, 109, 158, 182, Equity, 4, 8–9, 22, 23, 27–29, 53, 66, 67, 71,
183, 232, 233, 237, 244, 249, 250, 252, 73, 86, 91, 141, 182, 183, 188, 209,
257, 258, 280 237, 251
Disease burdens, 8, 10, 68, 137, 150, 172, 196, Essential public health services, 6, 44, 54, 285
242, 252 Ethical conduct of research with human
Disease prevention and control, 5, 96–102, subjects, 286
104–107, 109–114, 116–118, 120–123, Ethical reviews, 20, 48, 288, 298, 311
125–135 Ethical standards, 13, 15, 241, 253, 279–283
Disease screening, 95, 97–98, 223 Ethics (difference from morality), 4, 10, 13, 14
Disincentives, 98, 159 Ethics frameworks, 4, 26, 38, 52, 53, 96,
Disparities, black-white, 67 246–253
Disparities, health, 8, 67, 252, 314 Ethics review, 20
Distributive and social justice, 163 Ethics review committees, 20, 287, 296, 297
Distributive justice, 29 EUA. See Emergency Use Authorization
Diversity, 14, 105, 106, 177, 180, 183, 294, (EUA)
306, 308 European Region, 104, 172, 173
Division of Venereal Disease, 45 European Union (EU), 173, 230, 281
DOTS. See Directly observed therapy, Evacuation, 102, 132–135, 200
short-course (DOTS)
Drinking water quality, 196
Drug resistance, 97, 100, 267 F
Drug supply, 236, 267, 268 Fair chances, 62–65
Drug trials, 20, 263–265 Fair distribution, 9, 293
322 Index
Fairness, 28, 44, 47, 64, 65, 70, 91, 133, Health-adjusted life-year measures, 64
181–183. See also Fair chances; Fair Health-based targets, 196
distribution; Fair outcomes Health care access, 122, 301, 303
Fair outcomes, 71 Health care associated infections, 192
Fluorides, 150, 168. See also Water Health care costs, 138, 158, 160
fluoridation Health care personnel, 131, 193
Food and beverage marketing, 153–157. See Health care staff, 193
also Food promotion Health care worker(s), 130, 193, 226, 227.
Food promotion, 154, 156 See also Health care personnel; Health
Food and beverage preferences, 154 care staff
Foreign assistance, 275 Health communication, 315
Framework convention on tobacco control, Health disparities, 8, 67, 252, 314
148, 244–245 Health equity, 4, 8–9, 22, 23, 29, 53, 164, 165,
Free choice, 16, 17, 23, 25, 70 180, 184, 186–190, 227, 251
Freedom, 22, 30, 41, 42, 76, 101, 102, 107, Health impact assessment, 189
138, 139, 182, 248, 250, 263. See also Health inequities, 8, 9, 22, 251
Free choice; Free will Health interventions, 7, 10, 17, 23, 24, 27, 39,
Free will, 16 43, 50, 53, 63, 66, 163–165, 170, 227,
252, 301, 315
Health maximization, 65, 67, 68
G Health outcomes, 9, 63, 64, 66, 72, 116, 150,
Gates Foundation, 261 154, 163, 181, 196, 227, 251, 252,
Gender inequality, 121 282, 307
Generalizable knowledge, 287, 288 Health priorities and resource allocation,
Global collaboration, 241, 247, 248 61, 63–73, 75–78, 80–82, 84,
Global Fund, 243, 246, 261 85, 87–92
Global health, 99, 184, 241–253, 257, 269 Health promotion, 9, 66, 71, 73, 137, 138,
Globalization, 241–246, 249, 250, 281 140–151, 153–165, 167–170, 172–175,
Global public health, 32, 109, 151, 184, 192, 177, 214, 297
199–201, 241–253, 256–265, 267–273, Health promotion incentives, 95, 100–101
275–278, 280–283 Health reform, 71
Goodin, R.E., 204, 205, 207–210 Health risk assessments, 141
Government(s), 7, 9, 10, 25, 32, 40, 43–47, 49, Health status indicators, 276
50, 52, 53, 76, 78, 81, 140, 144–148, Helmet rules, 200
150, 154, 155, 158–160, 169, 170, 174, Hepatitis, 221, 223
178, 184, 187–189, 199, 203, 214, 218, HIV/AIDS, 20, 64, 121, 196, 243, 244, 249,
219, 241–245, 247–250, 253, 263, 264, 252, 257, 258, 260–262, 271, 315, 316
267–269, 271, 273, 275, 294, 303 among African-American men, 315
Greece, 150, 167–170 education, 314–317
Guatemala STD studies, 38, 44–50 Hobbes, T., 248
Guideline(s), 5, 13, 18, 20, 44, 48, 88, 142, Human dignity, 248
192, 193, 196, 197, 204, 205, 214, 215, Human immunodeficiency virus (HIV), 31, 49,
244, 247, 264, 268, 280, 282, 286, 289, 98, 99, 109, 120–122, 188, 221, 223,
293, 296, 306, 315 236, 237, 244–246, 252, 256–261, 291,
Guiding Principles on Business and Human 314–316
Rights, 250 criminalization, 98, 120–124
infections, 109, 121, 122, 221, 260,
261, 315
H prevention, 109, 122, 256–258, 314
Haiti, 270–273 surveillance, 122
Harm principle, 25, 26, 159 testing, 97, 98, 109, 121–123, 257–259,
Harms, 39, 43, 47, 48, 53, 143–145, 148, 156, 314, 316
159–161, 168, 177, 182, 183, 201, 204, testing policy, 256–259
206, 207, 209, 210, 244, 247, 250, 275, transmission, 98, 99, 108–110, 121, 223
277, 280 Human research regulations, 280
Index 323
Human-rights, 9, 29, 99, 101, 121, 122, 181, International collaboration, 8, 241–253,
231–233, 246, 248–251, 257, 258, 268, 257–265, 267–273, 275–278, 280–283.
275. See also Human rights See also Global collaboration
frameworks; Human rights theory International Conference on Harmonisation
Human rights abuses, 232 of Good Clinical Practice
Human rights frameworks, 246, 249, 250 (ICH-GCP), 264
Human rights theory, 248 International Covenant on Civil and Political
Hurst, S.A., 204, 208, 301 Rights (ICCPR), 248, 250
International Covenant on Economic, Social
and Cultural Rights (ICESCR),
I 145, 248, 249
ICER. See Incremental cost-effectiveness International Declaration on Human Genetic
ratio (ICER) Data, 251
Immigration, 30, 97, 209, 231, 233, 237 International Ethical Guidelines for
Incarceration, 220–224, 292 Biomedical Research Involving
Incidental and secondary findings, 293 Human Subjects (CIOMS), 20, 286,
Inclusion, 68, 262, 269, 293, 306, 308 288, 301
Incremental cost-effectiveness ratio International Ethical Guidelines for
(ICER), 64 Epidemiological Studies, 286
India, 100, 116–118, 244, 250, 263, 264, 280 International Monetary Fund (IMF), 242
Indian Council of Medical Research, 264 Internet-delivered interventions, 315, 316
Individual behavior, 138, 140, 164, 180 Intersectoral, 7, 24, 155, 251
Individualism, 22, 24, 42, 43, 49, 54 Intervention ladder, 146, 147
Individual liberty, 27, 31, 42, 43, 50, 96, 181 Investigational new drug (IND), 126
Individual rights, 26, 37, 43, 101, 180–183 In-vitro fertilization (IVF), 218
Inequalities, 67, 116, 163, 164, 169, 183 IOM. See U.S. Institute of Medicine (IOM)
Infant mortality, 67, 252, 264, 271, 276 Iraq, 250, 276
Infants, 109, 112, 212–214, 280 IRPA. See Canadian Immigration and Refugee
Infection (active and latent), 236, 237 Protection Act (IRPA)
Infectious diseases, 30, 38, 39, 41, 45, 50, 96, IVF. See In-vitro fertilization (IVF)
98, 99, 177, 179, 180, 188, 196, 199,
222, 223, 236, 241, 257, 273, 282, 310
Influenza, 226, 228 J
Information, 4, 29, 31, 32, 37, 53, 102, 105, Jacobson, H., 38, 41–44, 50, 53, 54
112–114, 127, 138, 139, 141, 142, 148, Jacobson v Massachusetts, 38–44
156, 159, 185, 196, 245, 259, 281, 282, Janani Suraksha Yojana (JSY), 116–118
286, 288–290, 293, 294, 303, 311 Jenner, E., 40
Informed choices, 112, 160 Jew Ho v. Williamson, 43
Informed consent, 20–23, 46–49, 95, 97, 98, Justice, 7, 8, 13, 20, 22, 23, 29, 44, 47, 49, 53,
101, 120, 126, 127, 219, 247, 251, 252, 86, 164, 165, 169, 181, 215, 222, 248,
257, 264, 265, 279–283, 289, 290, 293, 286, 293. See also Injustice
305–308. See also Consent
Informed consent (in STD experiments),
47, 49 K
Inhalation anthrax, 126 Kant, I., 15, 16
Injection drug use, 220–224 Knowles, John H., 138, 139
Injustice, 8, 210, 214, 231
Inmates, 209, 221
Institutional review board L
(establishment of), 48 Lang and Rayner models for public health
Institutional review boards (IRBs), 20, 49, biomedical model, 178
244, 281, 282, 311 ecological model, 178
Interdependence, 7, 24, 25, 27, 206, 298 sanitary-environmental model, 178
International aid workers, 199, 244 social-behavioral model, 178
International Bioethics Committee of techno-economic model, 178
UNESCO [IBC], 205 Latin America, 71, 116, 168, 195
324 Index
Law, 4, 6, 10, 12, 16–18, 23, 28, 31, 38, Mental illness, 68, 73, 75, 76, 178, 224, 230,
41–43, 76, 77, 87, 88, 146, 148, 150, 291, 292
174, 180, 217, 218, 231, 237, 242, Men who have sex with men (MSM), 262,
249, 250 297, 314–317
Least infringement, 26, 29, 53 Methicillin-resistant Staphylococcus aureus
Lebanon, 305–308 (MRSA), 181, 182, 191–194
Lewis, David, 113, 206 Middle East and North Africa (MENA) region,
Liberty, 17, 22, 25, 26, 28, 41, 43, 54, 96, 101, 275. See also Middle East
133, 145, 182 Migration, 185, 230–232
Lifestyles, 50, 73, 138–140, 159, Migration management (MM), 231
163–165, 179 Millennium development goals (MDGs), 184,
LMICs. See Low- and middle-income 195, 243, 249, 252
countries (LMICs) Mill, J.S., 15, 25
Locke, J., 248 Minimal/least infringement principle, 26, 53
Low- and middle-income countries (LMICs), Minimal risk, 290
137, 150, 168, 199, 242–245, 247, 249, Mining, 177, 180, 184, 186–190
250, 252, 253, 256, 310 Mining health and social impacts, 139
Modifiable risk factors, 212, 213
Mongolia, 184–190
M Morality, 10, 13, 14. See also Common
Maastricht Treaty, 231 morality
Managed competition, 71 Moral marker of vulnerability, 209
Mandatory notification, 129 Mother-to-child HIV transmission (MTCT),
Mandatory treatment, 95–97, 100 108–110
Mandatory vaccination, 40, 43, 95–97, Motorcycles, 181, 182, 199, 200
102–107. See also Childhood Motor vehicles, 199. See also Motorcycles
vaccination MRSA. See Methicillin-resistant
Māori, bed-sharing, 213, 214 Staphylococcus aureus (MRSA)
Māori population, 212 MSM. See Men who have sex with men
Marginalized populations, 133, 204–215, (MSM)
217–219, 221–224, 226–233, Multidrug-resistant TB (MDR-TB), 29, 130,
236–239, 287 236, 268
Market(s) (and regulations), 146 Multinational, 157, 247, 264, 265, 281, 312
Massachusetts, Board of Health, 41 Multinational research, 279–283
Mass evacuation, 102, 132–135. See also Multiple sclerosis (MS), 66, 228
Evacuation
Maternal-child health, 67
Maternal mortality, 116, 217, 276 N
Maximizing strategy, 65. See also Health Nanny state, 53, 144
maximization National Bioethics Advisory Commission
MDGs. See Millennium Development Goals (NBAC), 247, 291
(MDGs) National Commission for the Protection of
Measles, 96, 102–107, 236 Human Subjects of Biomedical and
Media campaigns, 149, 158–161 Behavioral Research (National
Medicaid, 51, 68, 160 Commission), 21, 48, 49, 286, 306
Medical tourism, 216–219 National Institute of Clinical and Health
Medication(s), 30, 100, 130, 140, 244, 252, Excellence (NICE), 65
253, 261, 262, 265–269. See also NBAC. See National Bioethics Advisory
Medicines Commission (NBAC)
Medicines, 21, 22, 25, 37, 61, 127, 236, 265, Needle sharing, 223
271, 277 Negative right of populations, 277
Mental health, 68, 131, 158, 231, 249, 252, Neoliberal concerns, 73. See also Neoliberal
297, 307. See also Mental illness values
Index 325
Neoliberal values, 71 Organisation for Economic Cooperation and

Net benefits, 17, 22, 182 Development (OECD), 158, 159, 231
Netherlands, 113, 192, 212 Overweight, 137, 140, 158, 161
Newborn bloodspot screening (NBS),
97, 111–114. See also Bloodspots
screening; Residual bloodspots P
Newborns, 30, 31, 219 PAHO. See Pan American Health Organization
New York City Department of Health and (PAHO)
Mental Hygiene (NYC DOHMH), 51 Palestine, 305
New Zealand, 213 Palestinian, 307
New Zealand Cot Death Study (NZCDS), Palestinian refugee camp, 297, 305–308
211–215 Panama, 217, 218
NICE. See National Institute of Clinical and Pan American Health Organization (PAHO),
Health Excellence (NICE) 104, 129, 130, 241
Nonbiomedical research, 306 Pandemic(s), 20, 27, 28, 67, 68, 226, 227, 314
Noncommunicable diseases, 39, 50, 52, 54, Pandemic influenza, 62, 101, 245
68, 137, 154, 172 Pandemic planning, 226–229
Noncompliance, 18, 100, 131, 133 Parental consent, 30, 31, 114, 307, 308
Nongovernmental organizations (NGOs), 32, Parents, 4, 10, 15, 30, 31, 76, 77, 140, 149,
181, 197, 199, 245, 267, 269, 271, 156, 157, 159–161, 210, 212–214, 232,
305, 306 289, 305, 307
Nonmaleficence, 19, 22, 23 Parity between mental and physical health
Nonmodifiable risk factors, 212 coverage, 76
Non-paternity, 112 Parran, T., 47
Nonprofit organizations, 199, 200 Participant, 293
Norms, 19, 25–29, 31, 32, 38, 148, 160, 210, Participation, 5, 7, 29, 44, 46, 49, 62, 71, 121,
250, 251, 262, 282, 315 170, 184, 185, 237, 245, 247, 264, 268,
Nuffield Council on Bioethics, 146, 159, 168, 281, 290–293, 306
169, 280, 281 Paternalism, 21, 25, 95, 96, 150, 159, 168,
Nuremberg Code, 20, 44, 286, 305 169, 183, 208
Paternalistic, 21, 26, 100, 146, 182, 183, 289
Paternity, 112. See also Non-paternity
O Patient Protection and Affordable Care Act
Obesity, 26, 68, 82, 140, 143, 149, 150, 154, (ACA), 63, 68, 76, 77
158–165. See also Childhood obesity; Patriarchal societies, 306
Obesity costs; Obesity prevention PAWS. See Pervasive arousal withdrawal
Obesity costs, 159 syndrome (PAWS)
Obesity prevention, 149, 157, 159–161 PCSBI. See Presidential Commission for the
Obligations, 8, 11, 15–18, 21, 22, 26, 32, 38, Study of Bioethical Issues (PCSBI)
52, 62, 63, 98, 123, 133, 138, 148, 170, Peace Corps, 181, 199, 200
208, 217, 244, 246, 247, 250, 251, 259, Penalties, 72, 98, 122, 140, 141, 275
291, 294, 296, 301, 302 PEPFAR (The United States President’s
Occupational health and safety, 177, 180, 181 Emergency Plan for AIDS Relief), 261
OECD. See Organisation for Economic Personal autonomy, 21, 22, 25–26, 47, 174
Co-operation and Development Personal responsibility, 138, 139, 141, 145,
(OECD) 150, 163–165. See also Individual
Office the United Nations High behavior
Commissioner for Human Rights Personal safety, 182, 199–201
(OHCHR), 249 Pervasive arousal withdrawal syndrome
Opt out/opt in, 30, 52, 53, 112, (PAWS), 232
113, 294 Pharmaceutical companies, 244, 247, 250,
Oral diseases, 150, 168, 169 263–265, 312
Oral health care, 169 PHS, 6, 21, 38, 44–50, 53, 54, 65, 112, 275,
Oral health policies, 168 280, 285
326 Index
Points of dispensing (PODs), 127 Principles, 4, 7, 10, 11, 13–24, 26, 27, 32, 37,
Policy, 10, 12, 13, 15, 21, 30, 39, 43, 48, 49, 38, 42, 43, 49, 53, 54, 65, 68, 78, 80,
51, 53, 54, 62–64, 66–68, 78, 84, 85, 81, 86, 138, 141, 151, 168, 242–244,
90, 91, 138–141, 144, 146, 148, 149, 246–248, 251, 258, 259, 285, 286, 288,
151, 154–157, 159, 162, 167–170, 172, 293, 306, 308
177, 180, 182–184, 188, 191–194, 200, Principles of Biomedical Ethics, 286
242–246, 249–252, 257–260, 263, 267, Principles of the Ethical Practice of Public
270, 273, 275, 281, 293, 302, 311 Health, 285
Policy interventions, 139, 155 Principlism, 20–23
Political, 8, 10, 11, 18, 19, 22, 24–27, 29, 31, Prioritizes, 4, 7, 12, 18, 21, 37, 73, 169, 296,
32, 37–39, 42, 44, 54, 68, 76, 78, 81, 307, 311
138, 143, 146, 148, 150, 160, 169, 170, Priority setting, 62–73, 227, 228
178, 180, 181, 185, 188, 230, 236, 242, Priority setting in health care, 87–89. See also
246, 248, 250, 252, 267, 268, 271, 275, Health priorities and resource
277, 278, 286, 287, 296, 297, 305, 307 allocation
Population, 4–10, 23, 26, 31, 37–39, 44, 47, Prisoners, 46, 47, 221–223
49–54, 62, 65–69, 73, 80, 82, 85, 89, Privacy, 29, 30, 39, 52–54, 97–99, 113, 114,
141, 143, 144, 150, 156, 163, 164, 168, 291, 297
173, 178, 180–183, 187, 188, 195, Procedural justice, 29, 169
241–243, 245, 247, 249–252, 260, 261, PROCET. See Program for Control a
263, 264, 271–273, 277, 278, 282, nd Eradication of Tuberculosis
286–288, 292 (PROCET)
benefits, 23, 180–183, 298 Profession(al), 13, 15, 19, 21, 22, 24, 27, 32,
health, 6, 27, 50, 61, 62, 66–69, 96, 137, 38, 47, 50, 54, 72, 81, 141, 143, 144,
138, 148, 156, 243, 244, 249, 251 149, 157, 169, 180, 182, 185, 189, 192,
health interventions, 38 194, 209, 219, 228, 249, 269, 282, 288,
Population health, 6, 27, 50, 61, 62, 66–69, 96, 289, 314, 315
137, 138, 148, 156, 243, 244, 249, 251 Program for Control and Eradication of
Poverty-reduction, 116 Tuberculosis (PROCET), 129
Power, 25, 26, 41, 43–45, 54, 148, 178, 180, Proportionality, 29, 96
181, 183, 275, 276 Prostitution, 98, 120, 121, 123
perceived power, 306, 308 Public health (definition of), 5, 37
political power, 305 Public health emergencies, 106, 245, 287,
power dynamics, 297, 306, 307 295, 296
Perilous path to peace, 274–278 Public Health leadership Society, 7, 15, 285
Practical ethics, 3, 19 Public health policies, 23, 53, 69, 95, 97, 98,
Precedents, 9, 29, 50, 54, 259 100, 101, 113, 178, 250
Pre-exposure prophylaxis programs Public health research, 38, 44–46, 48, 49, 177,
(PrEP), 260 178, 286–297, 301–303, 305–308,
Pregnancy, 19, 109, 116, 212, 213, 216–219 310–316
PrEP, 260–262 Public health research vs public health
Presidential Commission for the Study of practice, 38
Bioethical Issues (PCSBI), 45–47, Public health service model, 112
126, 293 Public health services, 23, 65, 275
Presumptive norm, 25, 26, 28, 29, 31 Public health surveillance, 39, 40, 51, 183, 288
Presumptive values, 25–27, 31 Public hospitals, 71–73
Prevention, 5, 7, 38, 39, 45, 50, 71, 73, 78, 80, Public-private partnership(s), 68
81, 84, 87, 138, 142, 144, 145, 147,
149, 154, 158–161, 165, 168–170, 192,
200, 212, 213, 215, 222, 237, 251, 272, Q
314–317 QALY. See Quality-adjusted life year (QALY)
Prevention vs. treatment, 257 Quality-adjusted life year (QALY), 17, 64–66
Primary prevention, 38, 141, 143 Quality assurance, 112
Index 327
R S
Racism, 46, 49 Safe deliveries, 116
Randomized controlled trials, 141, 142, 286 Safe drinking water, 181, 195
Refugees, 209, 231, 237, 305–307 Safety, 5, 6, 11, 12, 21, 41–43, 221
Regulations, 6, 18, 20, 21, 23, 28, 38, 40, 42, Safe water, 182, 195–198. See also Safe
43, 49, 66, 70, 113, 121, 129, 146, 148, drinking water; Drinking water quality
155, 173, 179, 183, 185, 188, 217, 218, Sanctions, 133, 244, 250, 274–278
236, 238, 244, 252, 263–265, 280, 281, Sanitation, 5, 39, 45, 50, 144, 195, 196, 200,
286, 287, 289 236, 270–273, 275
Reproductive technology, 217 Scandinavia, 192
Research, 5, 7, 12, 18, 20–22, 25, 38–40, 44, Schools, 37, 43, 82, 146, 155, 159, 160, 168,
45, 47–49, 51, 53, 54, 72, 88, 141, 142, 174, 218, 232, 233, 262, 277
150, 154, 205, 222, 223, 241, 244, 246, Screening, 29–31, 76, 141, 142, 164, 257
247, 250–252, 262–265, 268, 269, Secondary prevention, 39, 50, 141–143
279–283, 288, 289, 292–295, 311, 315. Secondhand smoke, 161, 173
See also Research funding Self-determination, 29, 52, 242
Researchers’ obligations and Self-regulation models, 149
responsibilities, 301 Self-regulatory approaches, 155
Research ethics, 4, 18–23, 37–39, 47, 264, 281 Self-regulatory codes, 155. See also Self-
Research ethics committees (RECs), regulatory approaches
289, 310–313 Sequential Organ Failure Assessment (SOFA)
Research funding, 312 scores, 91
Research oversight, 287, 297 Serodiscordant couples, 260–262
Residual bloodspots, 114 Sexually transmitted infections (STI),
Resource allocation, 227, 276, 297 121, 122
Resource allocation decisions, 61–63, 70 SIDS. See Sudden Infant Death Syndrome
Resource allocation (in public health versus (SIDS)
medicine), 61, 63–68, 70–73, 75–78, Siracusa principles, 237
80–82, 84, 85, 87–92 Smoke free legislation, 173
Resource shortages, 227 Smoking, 138–141, 148, 150, 151, 160, 161,
Respect, 7, 9, 12, 13, 16, 19, 22–25, 29, 30, 163, 172–175, 210, 212, 213, 245
48, 181, 250, 259, 262, 282 bans, 160, 174
Respect for persons, 19, 22–24, 48, 49, 286, in public places, 150, 172–175
293, 297 Smoking-related causes of death, 172
Returning research results, 293, 294 Social-compact theory, 42
Revisability condition, 69 Social conditions, 9, 164, 248, 252
Right to health, 4, 8, 16, 99, 100, 122, 138, Social consensus, 11, 23, 27
145, 249, 250 Social contract theory, 24, 248. See also
Risk(s), 8, 11, 12, 17, 20, 22, 28, 30, 31, Social-compact theory
47–52, 54, 61, 67, 72, 78, 137, 138, Social determinants, 8, 158–159, 165, 252
140–143, 146, 148, 150, 155, 158, 160, Social determinants of health (SDH), 8–9,
163, 165, 169, 170, 172, 173, 178, 181, 123, 179, 227, 246, 251–253
252, 253, 260–262, 264, 265, 267, 269, Social equity, 185
273, 280, 292, 293, 315 Social gradient, 163
benefit analysis, Social justice, 4, 8–9, 21–23, 53, 180, 184,
291, 292 227, 237, 251, 257, 298, 306
management, 180, 183, 196 Social norms, 19, 27, 149, 160
reduction, 180 Social welfare, 117
Road safety, 199 Socioeconomic conditions, 163
Rockefeller Foundation, 241 Socioeconomic disparities, 133
Roma people, 232 Solidarity, 7, 8, 24, 26–29, 31, 71, 169, 170,
Rousseau, J.-J., 248 206, 237, 267
Rule-based guidelines, 298 Spain, 68, 96, 102, 105, 106, 168
Ryan White Care Act, 120 Sponsorship, 156, 295
328 Index
Stakeholder(s), 4, 10–13, 19, 26, 28–32, 37, 142, 168, 169, 244, 256–258, 265,
62, 67, 69, 73, 78, 82, 149, 150, 155, 267–270
169, 170, 175, 233, 244–246, 249, 265, Triage, 67, 68, 278
308, 313 Trust, 7, 21, 32, 40, 47, 49, 98, 175, 183, 296,
Standards, 4, 6, 9–13, 15, 18, 27, 30, 42, 43, 297, 302, 306, 308, 315
51, 65, 66, 68, 76, 86, 88, 139, 148, Truvada, 260–262
154, 159, 172, 241, 242, 246, 248, 250, Tuberculosis (TB), 29, 40, 51, 81, 96,
253, 257, 258, 279–283 129–131, 221, 310. See also TB
Standards of care, 98 incidence and prevalence; TB
STD Prevention, 120–124 medication; TB treatment
Stigma, 68, 75. See also Stigmatization and screening, 29, 235–239
obesity stigma testing, 235–239
Stigmatization and obesity stigma, 98, 99, treatment, 235–239
162–165, 257 Tuskegee syphilis study, 46, 49. See also U.S.
Stock-outs, 244, 253, 266–269 Public Health Service Syphilis Study at
Storage, 111–114, 196, 217, 267 Tuskegee
Structural intervention, 120
Structural reform, 72
Students, 105, 182, 193, 296, 301, 303, 307 U
Sub-Saharan Africa, 110, 121, 185, 195, 197, U.K. Food Standards Agency, 154
200, 236, 260–262, 312 U.N. Human Development Index, 271
Substance abuse, 123, 138, 221–223, 291 U.N. Human Rights Council (HRC),
Sudden infant death syndrome (SIDS), 209, 249, 250
211–215 Unintentional injury, 199
Surrogacy and egg donor, 219 United Kingdom, 65, 147, 168
Surrogate pregnancy, 218. See also Surrogacy United Nations (U.N.), 81, 145, 230, 231, 242,
and egg donor 261, 271, 276–278
Surveillance, 5, 7, 95, 97–98, 106, 121, 227, United Nations Educational, Scientific and
237, 245, 293 Cultural Organization (UNESCO), 247
Sweden, 41, 230–233 United Nations Relief and Works Agency
Syphilis, 21, 31, 44–49, 237, 280 (UNRWA), 305
Syria, 250, 276–277 United States, 20, 22, 30, 39–41, 44, 45,
47–51, 54, 61, 63, 67, 75, 84, 85, 137,
147, 148, 150, 158, 160, 163, 164, 168,
T 218, 221, 222, 242, 245, 261, 267, 275,
TB incidence and prevalence, 29, 97, 129, 280, 315
130, 310 Universal access, 23, 122, 301
TB medication, 244, 253, 267–269 Universal Declaration on Bioethics and
TB treatment, 96, 130, 131, 237, 268, 311 Human Rights, 251
Terrorism, 101, 126, 275. See also Universal Declaration on the Human Genome
Bioterrorism and Human Rights, 251
Title 45, Part 46, of the Code of Federal Unprotected water sources, 195
Regulations, 286 UNRWA. See United Nations Relief and
Tobacco, 137, 139, 140, 146–148, 160, Works Agency (UNRWA)
172, 173 U.N. Universal Declaration of Human Rights
Trades, 65, 139, 146, 169, 187, 243, 275, 301 (UDHR), 99, 230, 248, 286
Transparency, 15, 28, 29, 62, 90, 168, 170, U.N. Vienna Declaration and Programme of
237, 294 Action, 249
Transparent, 91. See also Transparency U.S. Advisory Committee on Immunization
Transportation safety, 182, 200, 201 Practices, 126
Trauma, 178, 200, 233, 290 U.S. Department of Health and Human
Treatment, 23, 29, 30, 45–49, 63, 64, 66, 68, Services, 18, 20, 21, 48, 49, 140, 281,
75–77, 81, 87, 88, 90, 92, 137, 141, 286, 288, 290
Index 329
U.S. Department of Homeland Security populations, 44, 47, 49, 134, 149, 180,
(DHS), 126 228, 278, 292, 293, 295, 297, 301,
Use of incentives for research, 263 314–317
User fees, 301, 302
U.S. Food and Drug Administration (FDA),
126, 260 W
U.S. Institute of Medicine (IOM), 6, 154, 294 Waivers of informed consent, 290
U.S. Public Health Service, 21, 38, 44–50, 280 War and warfare, 126, 277
U.S. Public Health Service Syphilis Study at Water contamination, 196
Tuskegee, 21, 281 Water fluoridation, 150, 167–170
Utilitarianism, 15, 17, 91, 181. Waterhouse, B., 40
See also Utility Water quality testing, 197
Utility, 17, 26, 27, 29, 93, 123, 141, 143, 181, Water Safety Plan (WSP), 196
247, 282 Well construction, 181, 182, 195–198
Western, 3, 22, 222, 231, 243, 257, 258,
271, 276
V WHO, 173
Vaccination, 6, 40–42, 73, 92, 277 WIP. See Working Party on Infection
Vaccine(s), 20, 39–41, 80, 270, 275, 277 Prevention (WIP)
Vaccine coverage, 104–106, 127 Working Party on Infection Prevention (WIP),
Values, 4, 7–13, 18, 19, 25–27, 31, 32, 37, 38, 192–194
43, 53, 54, 63, 64, 71, 73, 78, 82, 88, Workplace hazards, 178
91, 93, 141, 144, 150, 168, 170, 175, World Bank, 137, 172, 187, 188, 242,
246, 265, 278 261, 301
Vertical transmission, 109 World Health Organization (WHO), 5, 49, 75,
Vibrio cholera, 269, 272 (see also Cholera and 80, 84, 90, 91, 137, 154, 158, 168, 173,
outbreak) 196, 199, 242, 263, 267, 269, 271, 275,
Victim blaming, 140 276, 280, 281, 286
Voluntary, 18, 30, 40, 140, 142, 148, 155, 159, World Health Organization Framework
252, 257, 258, 281 Convention on Tobacco Control, 173
Voluntary counseling and testing and HIV, 122 WSP. See Water Safety Plan (WSP)
Voluntary vs. mandatory evacuation, 102
Vulnerability (definition of), 204, 209
Vulnerability, 252 Y
Vulnerable, 180, 181, 187, 188, 199. See also Youth, 149, 153–157, 297, 307, 308
Vulnerability
groups, 48
and marginalized groups, 162–165 Z
and marginalized populations, 133 Zucht v. King, 43

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What is the purpose and scope of this book series?

What is the purpose and scope of this book series?

What topics will be covered in the volumes of this book series?

What topics will be covered in the volumes of this book series?

Public Health Ethics Analysis 3

Series Editor: Michael J. Selgelid

Drue H. Barrett · Leonard W. Ortmann

More information about this series at http://www.springer.com/series/10067

Public Health Ethics:

Angus Dawson Carla Saenz

ISSN 2211-6680 ISSN 2211-6699 (electronic)

Library of Congress Control Number: 2015960197

Printed on acid-free paper

This Springer imprint is published by Springer Nature

Atlanta, GA, USA Drue H. Barrett, PhD

Section I Introduction to Public Health Ethics

Section II Topics in Public Health Ethics

3.4 Decision-Making Process .............................................................. 69

4.14 Case 6: Ethics of Administering Anthrax Vaccine to Children ..... 125

6.6 Case 3: Safe Water Standards and Monitoring

8.6 Case 2: Just Allocation of Pre-exposure Prophylaxis

Index ................................................................................................................. 319

Dhrubajyoti Bhattacharya, JD, MPH, LLM Department of Population Health

Juan Laguna-Sorinas, MD, MPH Department of Epidemiological Surveillance,

Raquel de Mock, MD Adult Health Program, Ministry of Health, University of

Babette Rump, MD Department of Infectious Disease Control, Municipal Health

Jo A. Valentine, MSW Division of STD Prevention, National Center for HIV/

Leonard W. Ortmann, Drue H. Barrett, Carla Saenz, Ruth Gaare Bernheim,

© The Author(s) 2016 3

guidance yet sufficiently flexible and encompassing to adapt to global contexts.

1.2 Public Health

Individuals in society stand in complex relations of interdependence, competition,

1.2.1 Core Values

1.2.2 Health Equity, Social Justice, and Social Determinants

Anthropologists, however, view morals as customs that govern social interactions,

1.3.1 Scientific Facts and Ethical Values

Public health practice increasingly requires appreciation of the complementary

granted. Standard interventions, then, generally require no more justification than

1.3.2 Ethics and Morality

1.3.3 Ethical Principles

1.3.4 Ethical Theories

As used here, an ethical framework refers to a tool or approach for practically

Table 1.1 Ethical theories

1.3.5 Law Versus Ethics

leaving their compliance up to individual prerogative. An ethical rule’s enactment as

1.4 Public Health Ethics

1.4.1 Research Ethics, Clinical Ethics, and Bioethics:

1.4.2 Contrast between Clinical Ethics and Public Health

1.4.3 Individual Versus Relational Autonomy

1.4.4 Personal Autonomy as a Presumptive Value of Liberal

1.5 Ethical Frameworks

or in context. The three-step framework that follows is a straightforward tool to help

1.6 A Three-Step Approach to Public Health Decision

1.6.1 An Approach to Ethical Analysis and Justification

Lisa M. Lee, Kayte Spector-Bagdady, and Maneesha Sakhuja

© The Author(s) 2016 37

2.2 Case Study: Jacobson v. Massachusetts

By the turn of the twentieth century, public health campaigns—including improved

2.2.2 Case Description