Journal of the International AIDS Society, Nov 1, 2021
IntroductionA major change in the ethics framework for preventive HIV vaccine trials worldwide is... more IntroductionA major change in the ethics framework for preventive HIV vaccine trials worldwide is the release of the UNAIDS 2021 ethical considerations in HIV prevention trials. This new guidance comes at an exciting time when there are multiple HIV vaccine efficacy trials in the field. Research Ethics Committees (RECs) or Institutional Review Boards are a most likely audience for these guidelines. Our objective is to highlight shifts in ethics recommendations from the earlier 2012 UNAIDS guidance.DiscussionWe review recommendations related to four key issues, namely standard of prevention, post‐trial access to safe and effective vaccines, enrolment of adolescents and enrolment of pregnant women. We outline implications and make recommendations for the ethics review process, including suggested lines of inquiry by RECs and responses by applicants.ConclusionsThere have been several shifts in the UNAIDS ethics guidance with implications for HIV vaccine researchers submitting applications for initial ethics review or re‐certification, and for RECs conducting such reviews. This review may assist RECs in a more efficient and consistent application of ethics recommendations. However, additional tools and training may further help stakeholders comply with new UNAIDS ethics recommendations during protocol development and ethics review.
Malaria vector studies are a very important aspect of malaria research as they assist researchers... more Malaria vector studies are a very important aspect of malaria research as they assist researchers to learn more about the malaria vector. Research programmes in various African countries include studies that assess various methods of preventing malaria transmission including controlling the malaria vector. Various institutions have also established mosquito colonies that are maintained by staff from the institutions. Malaria vector research presents several dilemmas relating to the various ways in which humans are used in the malaria vector research enterprise. A review of the past and present practices reveals much about the prevailing attitudes and assumptions with regard to the ethical conduct of research involving humans. The focus on the science of malaria vector research has led some researchers in African institutions to engage in questionable practices which reveal the ethical tensions inherent in the choice between science and the principles of justice, nonmaleficence and respect for individuals. The analysis of past and present choices in malaria vector research has relevance to broader questions of human dignity and are in line with the current emphasis on ethical research worldwide.
Background: Despite an increase in health research conducted in Africa, there are still inadequat... more Background: Despite an increase in health research conducted in Africa, there are still inadequate human resources with research ethics training and lack of local long-term training opportunities in research ethics. A research ethics training program named United States-Mali Research Ethics Training Program (US-Mali RETP) was established through a partnership between the George Washington University Milken Institute School of Public Health (GWSPH), USA and University of Sciences, Techniques & Technologies of Bamako (USTTB), to address the critical need for improved bioethics training, leadership, and policy in Mali. Methods: The aims of the capacity building programme are achieved by leveraging US and Africa-based expertise to strengthen research ethics education and capacity through: (1) intensive faculty development to design ethics training curricula; (2) development of a research ethics specialization within the existing Masters of Public Health program (MPH); and (3) establishi...
According to international guidelines [1,2] and several nations ’ laws [3–5], research with human... more According to international guidelines [1,2] and several nations ’ laws [3–5], research with humans requires independent ethics committee review. In the United States, committees are called institutional review boards (IRBs) [6]; elsewhere they generally are called research ethics committees (RECs). Committees are designed to: provide third party review, thereby minimizing conflicts of interest; protect the welfare of research participants through attention to risks, benefits, and informed consent; and avoid exploitation of vulnerable individuals and populations. Most literature examining RECs comes from wealthier countries. One US study found “serious concerns” with the quality of 14 % of IRB reviews [7]. Another found that IRBs focused predominantly on consent documentation, spending less time examining voluntariness, selection of participants, and risk [8]. Many US [9– 15] and international [16–18] studies have found that different research ethics committees reach different conclu...
ObjectivesThis paper explores industry influence on public health using a specific case study and... more ObjectivesThis paper explores industry influence on public health using a specific case study and applies an established ethical framework based on eleven principles to explore Commercial Determinants of Health (CDoH). It demonstrates an application of these principles to evaluate the ethical integrity of industry strategies and practices and their impacts on public health.MethodsUsing eleven a priori, deductive, ethical principles as codes, this paper conducted an in-depth analysis of 19 e-mail chains and accompanying documents made publicly available through the Freedom of Information Act (FOIA) from U.S. Right to Know (USRTK) sent between Coca-Cola representatives, lobbyists, academics, and the International Life Sciences Institute (ILSI), founded by former Coca-Cola executives.ResultsThe three principles violated most frequently amongst the documents were consumer sovereignty (n = 22), evidence-informed actions (n = 21), and transparency (n = 20). Similarly, codes that featured ...
This paper seeks to contribute toward a better understanding of commercial determinants of health... more This paper seeks to contribute toward a better understanding of commercial determinants of health by proposing a set of ethical principles that can be used by researchers and other health actors in understanding and addressing Commercial Determinants of Health (CDoH). The paper is mainly based on a systematic review and qualitative analysis of the existing literature on CDoH and public health ethics frameworks. We conducted searches using selected search engines (Google Scholar and Pubmed). For ethical challenges relating to CDOH, our searches in Google Scholar yielded 17 papers that discussed ethical challenges that affect CDoH. For ethical frameworks relevant for CDOH, our searches in Google Scholar and Pubmed yielded 15 papers that clearly described bioethical models including relevant ethical principles. Additionally, we consulted eight experts working on CDoH. Through these two methods, we were able to identify ethical challenges as well as norms and values related to CDoH that we offer as candidates to comprise a foundational ethics framework for CDoH. Discussing risk factors associated with CDH frequently brings public health into conflict with the interests of industry actors in the food, automobile, beverage, alcohol, ammunition, gaming and tobacco industries including conflict between profit-making and public health. We propose the following candidate ethical principles that can be used in addressing CDoH: moral responsibility, nonmaleficence, social justice and equity, consumer sovereignty, evidence-informed actions, responsiveness, accountability, appropriateness, transparency, beneficence and holism. We hope that this set of guiding principles will generate wider global debate on CDoH and help inform ethical analyses of corporate actions that contribute to ill health and policies aimed at addressing CDoH. These candidate principles can guide researchers and health actors including corporations in addressing CDoH.
This paper examines ways that moral considerations come to bear on HIV/AIDS care and treatment in... more This paper examines ways that moral considerations come to bear on HIV/AIDS care and treatment in limited resource countries. We highlight various ethical issues that relate to access to antiretroviral therapy within limited resource countries as well as some of the questions that HIV/AIDS treatment programme managers have to think about when designing HIV/AIDS treatment programmes in limited resource countries in order to ensure fairness in terms of access to treatment. The paper includes recommendations on how to increase access to antiretroviral therapy in limited resource countries and how to overcome or minimise some of the ethical problems relating to access to care.
This study entailed conducting extensive qualitative interviews of mothers who had been invited t... more This study entailed conducting extensive qualitative interviews of mothers who had been invited to have their infants participate in the Kilimanjaro Intermittent Preventive Treatment of Malaria in Infants (Kili IPTi) trial, designed to assess the efficacy of intermittent preventive malaria chemoprophylaxis for infants. Our study sought to explore whether there was a relationship between the mothers' understanding of the research and the decision to enroll their infants or to decline. Such empirical data is necessary to address widely voiced concerns that limited understanding of research or exploitive inducement may undermine informed consent among clinical trial recruits in developing countries. The most striking result of the study was that, in general, those who declined to have their children participate in the trial had a better understanding of the trial than those who agreed to have their children participate. Decliners were more likely to understand the experimental natu...
ABSTRACT Introduction Vaccination is the most effective strategy to mitigating COVID-19 and resto... more ABSTRACT Introduction Vaccination is the most effective strategy to mitigating COVID-19 and restoring societal function. As the pandemic evolves with no certainty of a herd immunity threshold, universal vaccination of at-risk populations is desirable. However, vaccine hesitancy threatens the return to normalcy, and healthcare workers (HCWs) must embrace their ambassadorial role of shoring up vaccine confidence. Unfortunately, voluntary vaccination has been suboptimal among HCWs in the United States, a priority group for whom immunization is essential for maintaining health system capacity and the safety of high-risk patients in their care. Consequently, some health systems have implemented mandates to improve compliance. Areas covered This article discusses the ethical and practical considerations of mandatory COVID-19 vaccination policies for HCWs utilizing some components of the World Health Organization’s framework and the unique context of a pandemic with evolving infection dynamics. Expert opinion COVID-19 vaccine mandates for universal immunization of HCWs raise ethical and practical debates about their appropriateness, especially when the vaccines are pending full approval in most jurisdictions. Given the superiority of the vaccines to safety and testing protocols and their favorable safety profile, we encourage health systems to adopt vaccination mandates through participatory processes that address the concerns of stakeholders.
Journal of the International AIDS Society, Nov 1, 2021
IntroductionA major change in the ethics framework for preventive HIV vaccine trials worldwide is... more IntroductionA major change in the ethics framework for preventive HIV vaccine trials worldwide is the release of the UNAIDS 2021 ethical considerations in HIV prevention trials. This new guidance comes at an exciting time when there are multiple HIV vaccine efficacy trials in the field. Research Ethics Committees (RECs) or Institutional Review Boards are a most likely audience for these guidelines. Our objective is to highlight shifts in ethics recommendations from the earlier 2012 UNAIDS guidance.DiscussionWe review recommendations related to four key issues, namely standard of prevention, post‐trial access to safe and effective vaccines, enrolment of adolescents and enrolment of pregnant women. We outline implications and make recommendations for the ethics review process, including suggested lines of inquiry by RECs and responses by applicants.ConclusionsThere have been several shifts in the UNAIDS ethics guidance with implications for HIV vaccine researchers submitting applications for initial ethics review or re‐certification, and for RECs conducting such reviews. This review may assist RECs in a more efficient and consistent application of ethics recommendations. However, additional tools and training may further help stakeholders comply with new UNAIDS ethics recommendations during protocol development and ethics review.
Malaria vector studies are a very important aspect of malaria research as they assist researchers... more Malaria vector studies are a very important aspect of malaria research as they assist researchers to learn more about the malaria vector. Research programmes in various African countries include studies that assess various methods of preventing malaria transmission including controlling the malaria vector. Various institutions have also established mosquito colonies that are maintained by staff from the institutions. Malaria vector research presents several dilemmas relating to the various ways in which humans are used in the malaria vector research enterprise. A review of the past and present practices reveals much about the prevailing attitudes and assumptions with regard to the ethical conduct of research involving humans. The focus on the science of malaria vector research has led some researchers in African institutions to engage in questionable practices which reveal the ethical tensions inherent in the choice between science and the principles of justice, nonmaleficence and respect for individuals. The analysis of past and present choices in malaria vector research has relevance to broader questions of human dignity and are in line with the current emphasis on ethical research worldwide.
Background: Despite an increase in health research conducted in Africa, there are still inadequat... more Background: Despite an increase in health research conducted in Africa, there are still inadequate human resources with research ethics training and lack of local long-term training opportunities in research ethics. A research ethics training program named United States-Mali Research Ethics Training Program (US-Mali RETP) was established through a partnership between the George Washington University Milken Institute School of Public Health (GWSPH), USA and University of Sciences, Techniques & Technologies of Bamako (USTTB), to address the critical need for improved bioethics training, leadership, and policy in Mali. Methods: The aims of the capacity building programme are achieved by leveraging US and Africa-based expertise to strengthen research ethics education and capacity through: (1) intensive faculty development to design ethics training curricula; (2) development of a research ethics specialization within the existing Masters of Public Health program (MPH); and (3) establishi...
According to international guidelines [1,2] and several nations ’ laws [3–5], research with human... more According to international guidelines [1,2] and several nations ’ laws [3–5], research with humans requires independent ethics committee review. In the United States, committees are called institutional review boards (IRBs) [6]; elsewhere they generally are called research ethics committees (RECs). Committees are designed to: provide third party review, thereby minimizing conflicts of interest; protect the welfare of research participants through attention to risks, benefits, and informed consent; and avoid exploitation of vulnerable individuals and populations. Most literature examining RECs comes from wealthier countries. One US study found “serious concerns” with the quality of 14 % of IRB reviews [7]. Another found that IRBs focused predominantly on consent documentation, spending less time examining voluntariness, selection of participants, and risk [8]. Many US [9– 15] and international [16–18] studies have found that different research ethics committees reach different conclu...
ObjectivesThis paper explores industry influence on public health using a specific case study and... more ObjectivesThis paper explores industry influence on public health using a specific case study and applies an established ethical framework based on eleven principles to explore Commercial Determinants of Health (CDoH). It demonstrates an application of these principles to evaluate the ethical integrity of industry strategies and practices and their impacts on public health.MethodsUsing eleven a priori, deductive, ethical principles as codes, this paper conducted an in-depth analysis of 19 e-mail chains and accompanying documents made publicly available through the Freedom of Information Act (FOIA) from U.S. Right to Know (USRTK) sent between Coca-Cola representatives, lobbyists, academics, and the International Life Sciences Institute (ILSI), founded by former Coca-Cola executives.ResultsThe three principles violated most frequently amongst the documents were consumer sovereignty (n = 22), evidence-informed actions (n = 21), and transparency (n = 20). Similarly, codes that featured ...
This paper seeks to contribute toward a better understanding of commercial determinants of health... more This paper seeks to contribute toward a better understanding of commercial determinants of health by proposing a set of ethical principles that can be used by researchers and other health actors in understanding and addressing Commercial Determinants of Health (CDoH). The paper is mainly based on a systematic review and qualitative analysis of the existing literature on CDoH and public health ethics frameworks. We conducted searches using selected search engines (Google Scholar and Pubmed). For ethical challenges relating to CDOH, our searches in Google Scholar yielded 17 papers that discussed ethical challenges that affect CDoH. For ethical frameworks relevant for CDOH, our searches in Google Scholar and Pubmed yielded 15 papers that clearly described bioethical models including relevant ethical principles. Additionally, we consulted eight experts working on CDoH. Through these two methods, we were able to identify ethical challenges as well as norms and values related to CDoH that we offer as candidates to comprise a foundational ethics framework for CDoH. Discussing risk factors associated with CDH frequently brings public health into conflict with the interests of industry actors in the food, automobile, beverage, alcohol, ammunition, gaming and tobacco industries including conflict between profit-making and public health. We propose the following candidate ethical principles that can be used in addressing CDoH: moral responsibility, nonmaleficence, social justice and equity, consumer sovereignty, evidence-informed actions, responsiveness, accountability, appropriateness, transparency, beneficence and holism. We hope that this set of guiding principles will generate wider global debate on CDoH and help inform ethical analyses of corporate actions that contribute to ill health and policies aimed at addressing CDoH. These candidate principles can guide researchers and health actors including corporations in addressing CDoH.
This paper examines ways that moral considerations come to bear on HIV/AIDS care and treatment in... more This paper examines ways that moral considerations come to bear on HIV/AIDS care and treatment in limited resource countries. We highlight various ethical issues that relate to access to antiretroviral therapy within limited resource countries as well as some of the questions that HIV/AIDS treatment programme managers have to think about when designing HIV/AIDS treatment programmes in limited resource countries in order to ensure fairness in terms of access to treatment. The paper includes recommendations on how to increase access to antiretroviral therapy in limited resource countries and how to overcome or minimise some of the ethical problems relating to access to care.
This study entailed conducting extensive qualitative interviews of mothers who had been invited t... more This study entailed conducting extensive qualitative interviews of mothers who had been invited to have their infants participate in the Kilimanjaro Intermittent Preventive Treatment of Malaria in Infants (Kili IPTi) trial, designed to assess the efficacy of intermittent preventive malaria chemoprophylaxis for infants. Our study sought to explore whether there was a relationship between the mothers' understanding of the research and the decision to enroll their infants or to decline. Such empirical data is necessary to address widely voiced concerns that limited understanding of research or exploitive inducement may undermine informed consent among clinical trial recruits in developing countries. The most striking result of the study was that, in general, those who declined to have their children participate in the trial had a better understanding of the trial than those who agreed to have their children participate. Decliners were more likely to understand the experimental natu...
ABSTRACT Introduction Vaccination is the most effective strategy to mitigating COVID-19 and resto... more ABSTRACT Introduction Vaccination is the most effective strategy to mitigating COVID-19 and restoring societal function. As the pandemic evolves with no certainty of a herd immunity threshold, universal vaccination of at-risk populations is desirable. However, vaccine hesitancy threatens the return to normalcy, and healthcare workers (HCWs) must embrace their ambassadorial role of shoring up vaccine confidence. Unfortunately, voluntary vaccination has been suboptimal among HCWs in the United States, a priority group for whom immunization is essential for maintaining health system capacity and the safety of high-risk patients in their care. Consequently, some health systems have implemented mandates to improve compliance. Areas covered This article discusses the ethical and practical considerations of mandatory COVID-19 vaccination policies for HCWs utilizing some components of the World Health Organization’s framework and the unique context of a pandemic with evolving infection dynamics. Expert opinion COVID-19 vaccine mandates for universal immunization of HCWs raise ethical and practical debates about their appropriateness, especially when the vaccines are pending full approval in most jurisdictions. Given the superiority of the vaccines to safety and testing protocols and their favorable safety profile, we encourage health systems to adopt vaccination mandates through participatory processes that address the concerns of stakeholders.
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Papers by Paul Ndebele