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bioethics
Developing World Bioethics ISSN 1471-8731 (print); 1471-8847 (online)
Volume 15 Number 1 2015 pp 8–17
doi:10.1111/dewb.12030
ENGAGING DIVERSE SOCIAL AND CULTURAL WORLDS:
PERSPECTIVES ON BENEFITS IN INTERNATIONAL CLINICAL
RESEARCH FROM SOUTH AFRICAN COMMUNITIES
OLGA ZVONAREVA, NORA ENGEL, ELEANOR ROSS, RON BERGHMANS, AMES DHAI
AND ANJA KRUMEICH
Keywords
benefit sharing,
bioethics,
South Africa,
clinical trials,
culture,
local perspectives
ABSTRACT
The issue of benefits in international clinical research is highly controversial.
Against the background of wide recognition of the need to share benefits of
research, the nature of benefits remains strongly contested. Little is known
about the perspectives of research populations on this issue and the extent
to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low-income
South African communities on benefits in international clinical research.
Twenty-four individuals with and without experience of being involved in
clinical research participated in in-depth interviews. Respondents felt that
ancillary care should be provided to clinical research participants, while a
clinical study conducted in particular community should bring better health to
its members through post-trial benefits. Respondents’ perspectives were
grounded in the perception that the ultimate goal of international clinical
research is to improve local health. We argue that perspectives and understandings of the respondents are shaped by local moral traditions rather than
clinical research specificities and require attention as valid moral claims. It is
necessary to acknowledge such claims and cultural worlds from which they
emerge, thus building the foundation for equal and embracing dialogue to
bridge different perspectives and handle contradicting expectations.
INTRODUCTION
Clinical research is expanding globally. The numbers of
international clinical studies, conducted in lower-income
countries and funded by organizations from wealthier
countries, have been growing, accompanied by a proliferation of ethical debates which have focused on preventing exploitation, promoting social value of research and
designing legitimate regulatory regimes.1 One of the most
pronounced controversies arose around research benefits.
At the heart of this controversy is the concern that
populations of lower-income countries bear burdens of
international clinical research, while benefits accrue to
other parties, including researchers who achieve career
enhancement, sponsors who are recognized for their scientific profile and may obtain financial profits and citizens of wealthier countries where more developed,
although still imperfect, infrastructure exists for translating research results into health-care practices.2 Against
1
S. Benatar. Reflections and Recommendations on Research Ethics in
Developing Countries. Soc Sci Med 2002; 54: 1131–1141; R. Macklin.
After Helsinki: Unresolved Issues in International Research. Kennedy
Inst Ethics J 2001; 11: 17–36; E.J. Emanuel et al. What Makes Clinical
Research in Developing Countries Ethical? The Benchmarks of Ethical
Research. J Infect Dis 2004; 189: 930–937.
2
S.R. Benatar, A.S. Daar & P.A. Singer. Global Health Challenges:
The Need for an Expanded Discourse on Bioethics. PLoS Med 2005; 2:
e143. doi:10.1371/journal.pmed.0020143; C. Hayden. Taking as Giving:
Bioscience, Exchange, and the Politics of Benefit-sharing. Soc Stud Sci
2007; 37: 729–758.
Address for correspondence: Olga Zvonareva, Department of Health, Ethics and Society, Maastricht University, Postbus 616, Maastricht Limburg
6200 MD, Netherlands, Email: o.zvonareva@maastrichtuniversity.nl.
Conflict of interest statement: No conflicts declared
© 2013 John Wiley & Sons Ltd
9
Olga Zvonareva et al.
the background of wide recognition of the need to
share benefits arising from international clinical
research there is still no agreement over what exactly, if
anything, is owed to those participating in international
clinical research and their communities.3 This study
brings in viewpoints and experiences of actual and
potential participants in international clinical research
and adds to the growing body of literature calling for
their equal inclusion in this debate as well as in wider
discussions about the ethics of international clinical
research.4
This article starts by positioning the study in current
debates on benefits in international clinical research.
Following a description of the methodology, the results
based on data obtained through in-depth interviews
with low-income members of South African communities with and without experience of being involved in
clinical studies, are presented in 3 steps: 1) the respondents’ views on clinical research; 2) the respondents’ perspectives on benefits in clinical research; 3) the views
and experiences of the respondents who had been
involved in clinical research and whose expectations
regarding their involvement were not met. Further we
discuss how perspectives and understandings put
forward by the respondents are grounded in local moral
traditions and argue against attributing their views to
lack of knowledge about clinical research and its activities. Finally, the article elaborates on the normative significance of the local perspectives, speaking to wider
debates on the design of regulatory regimes for international clinical research and the need for a greater dialogue between diverse socio-cultural worlds open to
different framings.
For the purpose of clarity, throughout this article the
term ‘respondent’ refers to the individuals who participated in interviews for our study. The term ‘participant’
refers to hypothetical clinical research participants who
are referred to by the respondents.
3
Participants in the 2001 Conference on Ethical Aspects of Research in
Developing Countries. Fair Benefits for Research in Developing Countries. Science 2002; 298: 2133–2134; Participants in the 2001 Conference
on Ethical Aspects of Research in Developing Countries. Moral Standards for Research in Developing Countries: from ‘Reasonable Availability’ to ‘Fair Benefits’. Hast Cent Rep 2004; 34: 17–27; Participants in
the 2006 Georgetown University Workshop on the Ancillary-Care Obligations of Medical Researchers Working in Developing Countries.
The Ancillary-Care Obligations of Medical Researchers Working in
Developing Countries. PLoS Med 2008; 5: e90. doi:10.1371/journal.
pmed.0050090; A.J. Ballantyne. How to Do Research Fairly in an
Unjust World. Am J Bioeth 2010; 10: 26–35.
4
P. Tindana et al. Grand Challenges in Global Health: Community
Engagement in Research in Developing Countries. PLoS Med 2007; 4:
e273; C. Weijer & G. LeBlanc. The Balm of Gilead: Is the Provision of
Treatment to those who Seroconvert in HIV Prevention Trials a Matter
of Moral Obligation or Moral Negotiation? J Law Med Ethics 2006; 34:
793–808.
BACKGROUND
Providing benefits to international clinical research participants and their communities has been widely recognized as an important means to minimize exploitation
and promote social value of research. One approach
advocates post-trial access to an intervention shown to be
effective in a clinical study and other benefits.5 It is
endorsed by international research guidelines,6 including
the Declaration of Helsinki, which stipulates that at the
conclusion of the study research participants are entitled
‘to share any benefits that result from it, for example,
access to interventions identified as beneficial in the study
or to other appropriate care or benefits’7 and states that
research protocol should describe ‘arrangements for
post-study access by study subjects to interventions
identified as beneficial in the study or access to other
appropriate care or benefits’.8 Further, there is a wide
agreement in the policy documents that not only research
participants but also their communities should benefit
from research.9 However, existing regulations leave
important questions open, including who is responsible
for ensuring that benefits are available as well as to whom
exactly, when and which types of benefits should be provided. This uncertainty complicates realization of benefit
sharing in practice.10
Within the academic debates the prominent topic has
been the fairness of distribution of research benefits. The
‘fair benefits’ framework also considers various forms of
research benefits, besides access to the developed intervention, for example the construction of health care
facilities, public health measures and health services
beyond those required as part of the research that should
be made available to participants and their communities,
and, importantly, emphasizes community engagement by
offering that host populations themselves point to the
benefits that are of value for them and are fair, taking
into account burdens, relative contributions and benefits
to others.11 However, disagreement persists about
whether fairness of benefits should be determined based
5
D. Schroeder & E. Gefenas. Realizing benefit sharing – the case of
post-study obligations. Bioethics 2012; 26(6): 305–14.
6
See, for example, UNESCO, Universal Declaration on Bioethics and
Human Rights 2005, Article 15.
7
World Medical Association, Declaration of Helsinki 2008, Guideline
33.
8
World Medical Association, Declaration of Helsinki 2008, Guideline
14.
9
CIOMS, International Ethical Guidelines for Biomedical Research
Involving Human Subjects 2002 Guideline 10, 51. See also World
Medical Association, Declaration of Helsinki 2008, Guideline 17, stating
that research is only justified ‘if there is a reasonable likelihood that
[research] population or community stands to benefit from the results of
the research’.
10
Participants, op. cit. note 3; D. Schroeder & E. Gefenas, op. cit. note
5.
11
Ibid.
© 2013 John Wiley & Sons Ltd
Benefits in International Clinical Research
on the micro-level transactional justice or whether it
should take the broader macro level disparities into
account, as well as about how benefit-sharing should be
organized in practice.12
Several counter-arguments focusing on benefit sharing
as a key dimension of ethical research conduct have been
articulated, cautioning against conflating research with
other types of activities. Taken together these arguments
essentially claim that research as ‘an activity designed to
test a hypothesis, permit conclusions to be drawn, and
thereby to develop or contribute to generalizable knowledge’13 does not have an aim to provide health care or
restore global inequalities.14 This conflating of research
with clinical care and/or development work, it is argued,
leads to erroneous ethical judgments.15 Furthermore,
within the regulatory field much attention is given to
limiting ‘excessive’ offers that can possibly distort
decision-making of potential research participants, thus
constituting undue inducement.16 Paradoxically, strict
prohibitions against undue inducements, especially when
research is performed among low-income populations,
limit benefit sharing possibilities and threaten the protection from exploitation as disproportional distribution of
benefits.17 Finally, there is lack of examples of good practice in providing benefits to research participants and
host communities.18
Several studies on the perspectives of research populations themselves on the issue of benefits in international
clinical research have been published to date. Few studies
were conducted on perceptions of and experiences with
12
A. London & J. Zollman J. Research at the Auction Block: Problems
for the Fair Benefits Approach to International Research. Hast Cent
Rep 2010; 40(4): 34–45; A.J. Ballantyne. op. cit. note 3; R. Macklin. Fair
Benefits in Developing Countries: Maximin as a Good Start. Am J
Bioeth 2012; 10(6): 36–37; U. Schuklenk. For-profit Clinical Trials in
Developing Countries – Those Troublesome Patient Benefits. Am J
Bioeth 2010; 10(6): 52–54; B. Pratt & B. Loff. Justice in international
clinical research. Dev World Bioeth 2011; 11(2): 75–81.
13
The Belmont Report, 1978; 3.
14
P. Litton & F.G. Miller. A Normative Justification for Distinguishing the Ethics of Clinical Research from the Ethics of Medical Care. J
Law Med Ethics 2005; 33(3): 566–574.
15
F.G. Miller. Research Ethics and Misguided Moral Intuition. J Law
Med Ethics 2004; 32(1): 111–116; F.G. Miller & H. Brody. A Critique of
Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical
Trials. Hast Cent Rep 2003; 33(3): 19–28.
16
See, for example, CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects 2002; Guideline 7, 45,
stating ‘The payments should not be so large, however, or the medical
services so extensive as to induce prospective subjects to consent to
participate in the research against their better judgment (“undue
inducement”)’.
17
G. Arnason & A. Van Niekerk. Undue Fear of Inducements in
Research in Developing Countries. Camb Q Healthc Ethics 2009; 18(2):
122–129.
18
E.R.M. Cohen et al. Reporting of Informed Consent, Standard of
Care and Post-Trial Obligations in Global Randomized Intervention
Trials: A Systematic Survey of Registered Trials. Dev World Bioeth
2008; 9(2): 74–80.
© 2013 John Wiley & Sons Ltd
10
benefits in international clinical research among stakeholders in developing countries19 and even fewer explicitly focus on perspectives of research participants and
their communities,20 while most of the latter are devoted
to HIV-related studies.21 Consequently, little is known
about the extent to which research ethics discourses and
guidelines are salient to the expectations and aspirations
existing on the ground. The debates described above have
been taking place mainly among academics and scientists
from the economically rich countries of the West.22
However, it is crucially important that research populations inform discussions on this key ethical question.
Views of people from culturally diverse and lower-income
settings, who are confronted with ethical complexities
introduced by international clinical research in real life,
can reframe the debate by exposing overlooked issues,
showing which arguments are particularly relevant, as
well as by switching focus away from concerns which
appear to have little relevance in practice settings. This
exploratory study contributes to filling this void by
examining perspectives of people in low-income South
African communities on benefits in international clinical
research and arguing for their equal inclusion into related
discussions.
METHODS
The qualitative exploratory study was conducted in
South Africa, a country with increasing numbers of international clinical research sites23 and with about 50% of
the population living below the national poverty line
of $121 (PPP).24 The study, inspired by the methodology
19
G.M. Lairumbi et al. Forms of Benefit Sharing in Global Health
Research Undertaken in Resource Poor Settings: A Qualitative Study
of Stakeholders’ Views in Kenya. Philos Ethics Humanit Med 2012; 7: 7.
17 January 2012; S. Molyneux et al. Benefits and Payments for
Research Participants: Experiences and Views from a Research Centre
on the Kenyan Coast. BMC Med Ethics, 2012; 13: 13. 22 June 2012.
20
C. Grady et al. op cit. note 12.
21
D.N. Shaffer et al. Equitable treatment for HIV/AIDS clinical trial
participants: A focus group study of patients, clinical researchers, and
administrators in western Kenya. J Law Med Ethics 2006; 32: 55–60;
C.R. Thiessen et al. Personal and community benefits and harms of
research: views from Rakai, Uganda. AIDS 2007; 21(18): 2493–501; N.
Barsdorf et al. Access to Treatment in HIV Prevention Trials: Perspectives from a South African Community. Dev World Bioeth 2010; 10(2):
78–87.
22
P.W. Geissler & R. Pool. Editorial: Popular Concerns about Medical
Research Projects in Sub-Saharan Africa – A Critical Voice in Debates
about Medical Research Ethics. Trop Med Int Health 2006; 11(7): 975–
982.
23
J. Karlberg. Sponsored Clinical Trial Globalization Trends. Clinical
Trial Magnifier 2008; 1(2): 13–18; J. Karlberg. The establishment of
Emerging Trial Regions. Clinical Trial Magnifier 2011; 4(1): 7–23.
24
M. Leibbrandt et al. Trends in South African Income Distribution
and Poverty since the Fall of Apartheid. OECD Social, Employment and
Migration Working Papers 2010; 101.
11
Olga Zvonareva et al.
of grounded moral analysis, combined empirical and normative enquiry.25 The research process was open, responsive and organized in interaction with the respondents,
permitting methodological decisions such as directing
sampling strategy, selecting issues that required further
exploration and determining the point of saturation to be
taken along the way.26
Respondents
The study involved 24 respondents (7 men and 17 women
in the age range 22–62), 9 of whom had experience with
participating in clinical research. Originally the cleaning
staff at one of the South African universities was invited
to participate. This decision was based on the rationale
that it is relatively safe to assume a low economic status
for them as their salaries do not exceed R2000 (240 US
dollars) per month. 19 members of the cleaning personnel
were included in the study, among whom only 4 had an
actual experience in clinical research. This relative lack of
lived experiences among the respondents directed the
sampling further. 5 more individuals were included, who
were enrolled in a Phase III randomized controlled trial
designed to assess the safety and effectiveness of a vaginal
microbicide in the prevention of a HIV Type 1 infection
in women. Economic status of the trial participants was
not assessed directly. However, according to the research
staff involved in the trial the community where the trial
was conducted has historically been underprivileged and
is still rather poor.
Instrument and procedure
The first author conducted in-depth individual interviews. This allowed for an understanding of why
respondents expressed certain opinions and for the exploration of values and worldviews behind these. In the
course of interviews, the respondents were encouraged to
bring in issues related to international clinical research
which in their opinion were relevant. The original interview guide was informed by the available literature and
involved the following topics: experiences in clinical
research, views on purpose of clinical research, on role of
participants in it and on appropriate benefits and monetary payments to participants. The perspectives, which
emerged in the interviews with the respondents, were then
used to refine the interview guide and direct further
research, considering relevant theoretical arguments.
Thus, the topics of motives for (non)participation and
perceptions of possible risks for participants were
25
M. Dunn et al. Toward Methodological Innovation in Empirical
Ethics Research. Camb Q Healthc Ethics 2012; 21: 466–480.
26
J. Ives & H. Draper. Appropriate Methodologies for Empirical
Bioethics: It’s All Relative. Bioethics 2009; 23: 249–258.
incorporated into the interview guide; within the original
topic of benefits two main points of focus were suggested
by the respondents: medical care in clinical research and
post-trial benefits; finally, the originally prominent topic
of monetary payments came to be a less substantial part
of the interview.
A pilot interview was conducted to adjust wording as
English was not the first language of the respondents. All
interviews were conducted by the first author over a 3
month period from May to July 2012. 10 interviews were
conducted completely in English, the remaining fourteen
required the involvement of a translator. The degree of the
translator’s involvement varied from assisting with communicating difficult concepts such as risk, to the translation of the entire interview to the native languages of the
respondents – isiZulu, isiXhosa, Sesotho and Sesotho sa
Leboa. The interviews lasted between 30 and 60 minutes
and were audiotaped and transcribed verbatim.
Data analysis
Over the course of data collection, data analysis and
interpretation were continuously performed. The interviews were read and discussed by the members of the
research team. The first author identified text units relevant for the study purpose and coded them using the
concepts derived from the data and preexisting theoretical frameworks. The codes were checked for consistency
by other members of the research team in order to obtain
consistency and congruency was observed. Further, the
themes were developed drawing from the codes of similar
content and underlying meanings ‘that are theorized as
underpinning what is actually articulated in the data’.27
All investigators participated in reviewing and refining
data interpretation and analysis. During data collection,
quality was ensured through continuous review of tapes
and transcripts to improve interview methods. While analyzing the data, concepts and emerging patterns were
continuously cross-checked within and across interviews
to challenge or support the respondents’ and investigators’ accounts and interpretations.
Ethical considerations
The study was approved by the Human Research Ethics
Committee – Medical (HREC) of the University of the
Witwatersrand. Informed consent and permission to
record the interview was obtained from all respondents.
The confidentiality of the respondents was ensured by the
separation of data from identifiable individuals, secure
storage of the codes linking data to individuals and
27
V. Braun & V. Clarke. Using Thematic Analysis in Psychology. Qual
Res Psychol 2006; 3: 77–101: 85.
© 2013 John Wiley & Sons Ltd
Benefits in International Clinical Research
anonymizing individuals in this paper. No compensation
was provided to the respondents.
RESULTS
‘May be it will bring good results to our
nation’: views on clinical research
This section presents respondents’ attitudes towards
international clinical research, perceptions of risks
involved in participation, ideas about reasons to participate in clinical studies and, finally, perceptions of the
relationship between researchers and participants.
Respondents generally expressed a positive and welcoming attitude towards international clinical research. It
was seen as a search for ways to address health problems
prevalent in South African communities with the HIV/
AIDS epidemic being mentioned most often. Clinical
research possessed a high social value for the respondents, which was firmly situated in the local health conditions. A woman who, not having the experience of
participating in a clinical study, knows several individuals
who had been involved in research, stated:
‘Here we’ve got a dangerous sickness, a virus . . . we
haven’t got a medicine here to help. . . . But you can
come and make this research, . . . may be it will bring
back good results to help our nation.’ (A, 56-year-old).
And a woman currently enrolled in the Phase III
microbicide trial echoes this statement:
‘I just wanted to take part in this research because we all
need medicines for HIV, so if we don’t test it, don’t
research about it, we won’t know whether it is working or
not. So that’s why I joined.’ (O, 37-year-old).
The large majority of the respondents acknowledged
the risks involved in clinical research participation. They
presented clinical research as inherently unsafe for participants. To explain this position they most often
referred to the novelty of the intervention and unpredictability of its effects. For example, when asked about how
safe the enrolment in a medical study would be, a woman
who described clinical research as being very beneficial
for her community, replied:
‘I don’t know how it will be on me. It might be dangerous.
I don’t know about it. Nobody knows.’ (E, 54-year-old,
no personal experience in clinical research).
Acknowledgement of risks did not seem to discourage
participation. A woman enrolled in a clinical trial for the
first time described procedures associated with participation and their possible negative consequences:
‘Then you have to insert gel and then afterwards they see
that gel may react some other way in your body and they
© 2013 John Wiley & Sons Ltd
12
will have to check and see that this gel may be is damaging.’ (P, 28-year-old female).
Another woman (also involved in clinical research for
the first time) refers to the process of weighing personal
risks against societal benefits, with societal benefits overweighing personal risks:
‘I don’t see a problem because of I know that at that
stage there will be risk. And if I do it and then I get sick
or I get ill, I will be proud of that I will say ok I was doing
it for people.’ (Q, 22-year-old female, has personal
experience in clinical research).
Moreover, the respondents often brought up the idea
of participation in clinical research as a duty, although a
potentially dangerous one. This was rooted in the view of
clinical research as a process that produces results, which
at the end bring better health to communities where
research was conducted. The feeling of personal responsibility to make a contribution was expressed with
varying degrees of explicitness.
‘You know, to be fair, if I say no, how do we know that
this drug is working? I must say yes, because I want to
know its working. Because it is also about our lives.’ (E,
54-year-old female, no personal experience in clinical
research).
Some respondents extended the duty to participate
beyond themselves to others in the community as well:
‘I think that medication is good. Us, we need to participate, all, because of, you know, helping. So these projects
I think is good.’ (T, 47-year-old female, no personal
experience in clinical research).
These statements point to the tendency to link closely
clinical research and better health, but not through perceiving research procedures as directly beneficial for
participants’ own health. Respondents linked clinical
research and practice through the perception of clinical
research results being translatable into advances in
locally available health care and, thus, a healthier society.
Besides presenting clinical research as locally relevant
and beneficial, the respondents often stressed the equal
importance of the input of clinical research participants
and that of researchers. The respondents commonly
referred to everyone involved in a process of clinical
research as ‘we’, highlighting the presumed collaborative
nature and common goals. Explaining why he would take
part in a clinical study, a respondent said:
‘I can do it because I can see we want to help people and
see if this thing is working’. (X, 53-year-old male, no
personal experience in clinical research).
The respondents constructed the relationship between
researchers and participants in international clinical
13
Olga Zvonareva et al.
studies as a form of collaborative partnership, within
which the participants were thought of as active contributors. The respondents made sense of participation in
international clinical research through envisioning a positive image of research as in a long run bringing better
health to their communities. The vivid feature of
respondents’ narratives was the perception of medical
research as a public good to which responsible people
should contribute. The perspectives presented in this
section provide a background for understanding the
respondents’ views on benefits in international clinical
research.
‘Partnership and mutuality’:
Perspectives on benefits
When speaking of benefits in international clinical
research the respondents focused on ancillary care and
post-trial benefits as their core expectations. Their views
in this regard are presented in this section. Although the
respondents did not think that financial payments should
be provided to research participants (and in ethics literature financial payments usually are not regarded as
research benefits), the general ideas about payments in
clinical research articulated by the respondents are presented at the beginning of this section to better illustrate
their aspirations.
Monetary payments
Deliberating on what should be offered to clinical
research participants, the respondents themselves did not
put forward financial reward. The logic of their riskbenefit calculus somewhat departed from the logic of the
established theoretical debate, which assumes that financial reward may constitute undue inducement, thus
‘blinding’ participants to risks. Acknowledging that clinical research entails risk, the respondents conveyed that
the risk of damaging their health in a context of hardly
accessible healthcare, decisively outweighed personal
benefit of obtaining even a considerable sum of money:
‘I won’t go for money. Money can’t do anything. If my
health is suffered, then what? I am going to eat that
money?’ (O, 37-year-old female, has personal experience in clinical research).
However, while money was not presented as a valid
reason to take risks, health improvements for one’s community could well be such a reason.
The common thread was that motivation of gain,
including financial gain, was not appropriate for participation in clinical research. Since clinical research, according to the respondents, was intended to improve health in
the communities where it was conducted, the respondents
felt it was not right to want something in return for
helping their own communities (including future generations). One respondent compared participation in clinical
research with blood donation, claiming that one could
accept a reward but should not be motivated by the prospect of its reception:
‘It’s like blood donation, it’s like you feel that you are
doing blood donation, it is from your heart. And if you
feeling to do it, if government can say that now all the
people who are doing blood donation we are going to give
them money. So much, what. Even that it is not a
problem. But only if you feel to donate you can go.’ (G,
32-year-old male, no personal experience in clinical
research).
Overall the respondents expressed indifference towards
monetary rewards.
Ancillary care
Most respondents mentioned healthcare as something
they would welcome, accept and actually expect from
researchers conducting clinical studies. The respondents
currently enrolled in the clinical trial stressed the importance of ancillary care (health care beyond the measures
to ensure scientific validity, prevent study-related harms
or address study related injuries), in the context of hardly
accessible medical help in the following way:
‘So the healthcare should be high. If they find that something is happening in my body, they don’t just taking me
to the public hospital. Public hospitals . . . You’ll go and
die there. They have to take you somewhere where they
know you will be taken care of. That way it is fine.’ (O,
37-year-old female, has personal experience in clinical
research).
Within the perceived relationship of partners working
together towards finding ways to improve local health,
described in the previous section, researchers and participants were seen by the respondents as bound by mutual
responsibilities towards each other. Respondents felt that
clinical research participants made a valuable and important contribution by providing their bodies and risking
health, while researchers, in turn, were expected to be
concerned about the wellbeing of participants and, in the
long run, the study population. This mutuality was
summed up by one of the respondents:
‘I know if I help them, they will help me and the other
people.’ (A, 56-year-old female, no personal experience
in clinical research).
It should be stressed that the described perception of
the relationship between researchers and participants did
not lead to the thinking that the purpose of research was
to help research participants personally. The respondents
© 2013 John Wiley & Sons Ltd
Benefits in International Clinical Research
were well aware of the ‘research’ nature of clinical studies;
however it was important for them to know that those
who conduct research were not indifferent towards participants’ wellbeing and would reciprocate by making an
effort to assist when a participant needed health care.
Post-trial benefits
Unanimously expressed was the hope that the output of
international clinical research would benefit the host
community. In the bioethics literature and international
guidelines this topic has been framed as the post-trial
benefits. Some respondents stressed that an intervention
shown effective in the course of a clinical study should be
provided to the ones who participated in research:
‘If there is a cure [found in the course of a clinical study]
they should give it to me.’ (G, 32-year-old male, no
personal experience in clinical research).
Most of the respondents assumed that the intervention
shown effective in the clinical study would be available
for wider communities.
‘If it [tested intervention] helps her, it means that most
of our nation they will get help.’ (A, 56-year-old female,
no personal experience in clinical research).
At the same time many respondents did not focus on
single clinical studies, taking instead a broader view of
clinical research as a process consisting of multiple trials
and errors that sooner or later would yield beneficial
results, which would be used for the betterment of those
who need them in host communities.
‘But about this kind of research. At the end it will be
helping us, people on the ground.’ (I, 38-year-old male,
no personal experience in clinical research).
The respondents found it quite natural that some clinical research studies failed to deliver results or were very
early-stage projects. However they still presented the
totality of research processes and agendas as directed
towards concrete outcomes such as new and better treatments. In the view of the respondents, any outputs of
international clinical research must be used for the benefit
of host communities, otherwise it exposes participants to
risks for no good reason. It was important for the
respondents to be able to conceive the participation in
clinical research as a contribution to the common good.
‘No, I won’t agree to participate’:
Facing realities of clinical research
This section presents accounts of the respondents who
hold a negative attitude towards clinical research and
their experiences that shaped this attitude, illustrating the
importance of engagement with research participants and
their perspectives.
© 2013 John Wiley & Sons Ltd
14
Two respondents in this study expressed a negative
attitude towards clinical research as such. This attitude
was shaped by their previous experiences in clinical
research. As clinical research participants they expected
to be fully informed about a clinical study, their contribution in it as well as study results, and would like to
establish equal and reciprocal relationships with a
research team. However, these expectations were not met.
One of them explained his dissatisfaction with participating in a clinical study conducted after 2000:
‘So maybe you will take hair from me and you will never
come back to explain that this helped you by this, this and
this. Because they don’t come back to us and explain to us
what really-really they are needing from us . . . So when
they took blood from me and gave me little money it was not
good, because those people they took blood from us and we
don’t know why they are taking blood from us.’ (F, 28-yearold male, has personal experience in clinical research).
The second respondent echoed this story, but referred
to events which took place in the 1960s in a rural area of
South Africa:
‘In the area where I grew up they used to come and take
blood from people . . . In those old days they would just
come and take blood and will never explain to us what
they are doing.’ (D, 62-year-old male, has personal
experience in clinical research).
Consequently, the respondents did not perceive clinical
research as locally beneficial and were suspicious about
its goals:
‘No, I won’t not agree to participate. Because I do not
understand why people want to test anything. And I
would not allow my children to do that.’ (D, 62-year-old
male, has personal experience in clinical research).
For both respondents these experiences resulted in
disappointment and a negative perception of clinical
research and researchers, with a corresponding reluctance to take part in clinical research anymore.
‘I won’t do anything, even if they come and ask for blood
I won’t go there. And not because I am afraid.’ (F,
28-year-old male, has personal experience in clinical
research).
‘So if ever they are testing this medicine I will say no,
even if they offer those thousands of rands or whatever
they are offering.’ (D, 62-year-old male, has personal
experience in clinical research).
The willingness to participate in clinical research was
rooted in perceived local beneficence of research, which
also laid the crucial foundation for communication
between researchers and participants. The views and
experiences described in this last section show that doubts
15
Olga Zvonareva et al.
about the beneficial nature of research resulting from
unmet expectations of involvement and acknowledgement erodes the willingness to participate.
MAKING SENSE OF INTERNATIONAL
CLINICAL RESEARCH
The results of this study show that the respondents redefined the meaning of being involved in clinical research,
constructing it as a contribution towards achieving better
local health. Underlying this interpretation was the
implicit assumption that international clinical research
was conducted in South Africa due to the poor local
health status with the purpose of finding ways to improve
it. Consequently the respondents perceived research as
having high social value for their communities. Researchers and participants were thought to share concerns over
the poor health in many South African communities and
were expected to form partnerships to work together
towards achieving the common goals. The indifference
towards payments and expectations of ancillary care and
post-trial benefits for the host communities were
grounded in the described interpretation.
The respondents held essentially a relational understanding of international clinical research and the corresponding benefits. For them the relationship between
researchers and participants was not shaped by a study
protocol and regulated through informed consent to
uphold the distanced position of a researcher as contrasted with the personal character of the doctor-patient
relationship and to safeguard autonomy of an individual
research participant.28
The assumption that the way participants understand
clinical research can be determined by means of the effective communication of research aims and procedures has
been relatively prominent in research ethics.29 It is reasoned that, when discrepancies arise, this must be a matter
of inefficient communication and general ignorance, and
ways to address them would be limited to such measures as
instrumental improvements in consent forms (simplifying
language, shortening forms) and improvements in the
process of obtaining consent (addressing power dynamics,
repeated administration of informed consent procedures
and the assessment of comprehension).30
28
O. Corrigan. Empty Ethics: The Problem with Informed Consent.
Sociol Health Illness 2003; 25: 768–792; 13: 87–106; K. Stewart &
N. Sewankambo. Okukkera Ng’omuzungu (Lost in Translation): Understanding the Social Value of Global Health Research for HIV/AIDS
Research Participants in Uganda. Global Public Health 2010; 5: 164–180.
29
U. Felt et al. Refusing the Information Paradigm: Informed Consent,
Medical Research, and Patient Participation. Health (London) 2009.
30
There is a vast bulk of the literature on ‘improving participant comprehension’, see, for example, E. Cohn & E. Larson. Improving Participant Comprehension in the Informed Consent Process. J Nurs
Scholarship 2007; 39: 273–280.
However, medical anthropologists and ethnographers
have been skeptical of reducing diverging perspectives to
mere misinterpretation or misunderstanding due to ineffective communication and participants’ ignorance of
science and its processes, attributing them rather to more
fundamental differences in how clinical research is
framed and interpreted within particular cultural horizons and actor groups.31 Also ideas in support of this
critique are presented in the works of science and technology scholars, who see science and its ways as embedded socio-cultural practices, as much (in)valid as any
other ways of finding sense.32
The perspectives of the respondents in this study and
their expectations regarding benefits were influenced
heavily by the indigenous accounts of right and wrong,
which have hardly been articulated in the field of research
ethics as the local moralities do not speak the language
of this field. Discussing African33 moral traditions,
Tangwa34 says: ‘For the most part, of course, African
philosophy is not set out in monographs and journals;
rather, it is manifested in, held by, African peoples themselves’. Some scholars, drawing on anthropological inputs
and their own cultural backgrounds as members of indigenous communities, have attempted to describe the rich
and long standing ethical heritage of Africa with its diverse
populations.35 They do not claim that cultures with ideas
about morality ingrained in them exist for centuries in a
static and unchanged manner and/or being held uniformly
by all African people. This literature, nevertheless, provides a helpful context for understanding the perspectives
and expectations put forward in this study.
African moral traditions are relational in nature. Their
cornerstone is Ubuntu, a traditional philosophy and way
of life of communities in South Africa and Sub-Saharan
Africa in general.36 It is commonly accepted that Ubuntu
derives from the word muntu, which means a person,
human being.37 It is Ubuntu that constitutes the very
31
Geissler & Pool, op. cit. note 22; J. Fairhead, M. Leach & M. Small.
Public Engagement with Science? Local Understandings of a Vaccine
Trial in the Gambia. J Biosoc Sci 2006; 38: 103–116; J. Fairhead,
M. Leach & M. Small. Where Techno-Science Meets Poverty: Medical
Research and the Economy of Blood in The Gambia, West Africa. Soc
Sci Med 2006; 63: 1109–1120.
32
S. Jasanoff. Technologies of Humility. Nature 2007; 450: 33.
33
Speaking about African moral traditions we refer to thought, values
and practices of people who culturally belong to indigenous communities of Sub-Saharan Africa.
34
G.B. Tangwa. The Traditional African Perception of a Person: Some
Implications for Bioethics. Hast Cent Rep 2000; 30: 39–43: 41.
35
G.B. Tangwa. Bioethics: An African Perspective. Bioethics 1996; 10:
183–200; T. Metz. African and Western Moral Theories in a Bioethical
Context. Dev World Bioeth 2010; 10: 49–58.
36
M. Munyaka & M. Motlhabi. 2009. Ubuntu and its Socio-moral
Significance. In African Ethics. An Anthropology of Comparative and
Applied Ethics. M.F. Murove, ed. Scottsville: University of KwaZuluNatal Press: 63–84.
37
Ibid.
© 2013 John Wiley & Sons Ltd
Benefits in International Clinical Research
essence of being human, it is an inner state that makes
one feel and behave as a true human being. And behaving
according to human nature is identified with contributing
to the wellbeing of others and the community and promoting harmonious relations within society.38 Achieving
a state of being a human or having Ubuntu is possible
only through relating positively with others as expressed
in the widespread maxim ‘A person is a person through
other persons’.39
Such mutuality in African moral traditions allows one
to distinguish between more human and less human. That
is the more one promotes harmonious relations, the more
morally virtuous and the more of a person one is. To
become personally complete as a human being one has to
engage more and more deeply in community with others.40 Whereas if one harms others or is even just indifferent to them, then one lacks Ubuntu, literally becoming
‘not a person’.
Reflecting on the fundamental value of harmonious
(communal) relationships, Metz41 suggests that such relationships involve identifying and exhibiting solidarity
with each other. He describes identity as ‘to think of
themselves as members of the same group, that is, to
conceive of themselves as a “we”, as well as for them
to engage in joint projects, coordinating their behavior to
realize shared ends’; while exhibiting solidarity would
mean ‘to engage in mutual aid, to act for the sake of one
another (ideally, repeatedly over time)’.42
Ethics not only regulates behavior, but construes it,
through interpretive power which is rooted in culture.43
Accordingly, clinical research was interpreted by the
respondents through the lens of local moral traditions.
The value of identity was expressed by them through
relating to researchers as their partners and a desire to
help the community. Solidarity was seen in the conceptualization of clinical research as a common quest towards
better health and in expectations of care and results
sharing on the part of researchers.
Such an interpretation was necessary for international
clinical research to be judged as morally right; impartial
transaction-like research, that did not contribute to the
betterment of the host communities (beyond the mere
purposes of research) had no chance of being accepted,
since within described social and cultural worlds it would
be viewed as lacking humanity, violating harmonious
relations within society and, therefore, as morally wrong.
38
Ibid
Metz, op. cit. note 35.
40
A. Shutte. 2001. Ubuntu: An Ethic for the New South Africa. Cape
Town, South Africa: Cluster Publications.
41
Metz, op. cit. note 35.
42
Metz, op. cit. note 35, p 51.
43
N.A. Christakis. Ethics are Local: Engaging Cross-Cultural Variation in the Ethics for Clinical Research. Soc Sci Med 1992; 35: 1079–
1091.
39
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16
The few respondents in this study who viewed clinical
research negatively confirmed this by pointing to the
detached attitude of researchers and absence of engagement with and concern about participants and their communities, which led them to a moral conclusion that
clinical research ‘is not a good thing’.
CONCLUSION
The voices of the respondents in the present study
require serious attention. Their accounts were shaped
not by clinical research specificities but by the broader
indigenous moral systems and cannot be ‘corrected’
with more and/or differently presented information.
Respondents’ perspectives stem from the local social
and cultural worlds and represent legitimate and valid
moral claims, which require equal engagement with
research participants and their communities as well as
provision of ancillary care and post-trial benefits in settings with hardly accessible medical care for international clinical research to be judged as morally right.
These claims are consonant with a growing body of
ethics literature advocating collaborative partnerships
and social value as important aspects of international
clinical research.44
It is necessary to acknowledge local moral claims and
cultural worlds from which they emerge, thus building
the foundation for equal and embracing dialogue to
bridge different perspectives and handle contradicting
ethical expectations. Awareness of and respect for the
legitimate ethical expectations of participants and host
communities in international clinical research are crucial
for sustainability of clinical research in South Africa
and other developing countries. The necessity of a dialogue was stressed by the respondents who developed
antagonistic attitudes towards clinical research after
experiencing a clash between their expectations and
actual research practices. The present exploratory study
confirmed the need for more research on local moral
perspectives on benefits and other issues in international
clinical research, which would lay a foundation for
further broader engagement. Attention also needs to be
given to further development of the mechanisms of
inclusion and practices of engagement to ensure that
these are not orchestrated in favour of powerful actors
and that local needs and perspectives are truly heard
and taken seriously.
44
E.J. Emanuel et al. op. cit. note 1; V.M. Marsh et al. Working with
Concepts: The Role of Community in International Collaborative Biomedical Research. Public Health Ethics 2011; 4(1): 26–39; C.P. Gikonyo
et al. Taking Social Relationships Seriously: Lessons Learned from the
Informed Consent Practices of a Vaccine Trial on the Kenyan Coast.
Soc Sci Med 2008; 67: 708–720.
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Olga Zvonareva et al.
Acknowledgements
The authors are grateful to the people who took part in the interviews
for this study and colleagues at the Steve Biko Centre for Bioethics and
Maastricht University for their useful comments and suggestions during
the conduct of this study and development of this manuscript. We thank
Human Research Ethics Committee – Medical (HREC) of the University of the Witwatersrand, Setshaba Research Centre and personally
Professor Peter Cleaton-Jones, Dr Khatija Ahmed, Dr Mookho
Malahleha, Dr Itumeleng Funani and Dr David Buso for their invaluable assistance. We also thank the reviewers for their helpful and
insightful comments.
Biographies
Olga Zvonareva is a Research Assistant at the Department of Health,
Ethics and Society, Maastricht University, the Netherlands, and honorary research associate at the Steve Biko Centre for Bioethics, University of the Witwatersrand, South Africa. She holds the Kootstra Talent
Fellowship and obtained MSc in Global Health from Maastricht University. Her research interests lie in research ethics.
Nora Engel is an Assistant Professor at the Department of Health,
Ethics and Society at Maastricht University, The Netherlands. Her
research draws on Science and Technology Studies and Innovation
Studies to examine innovation dynamics related to global health
challenges.
Eleanor Ross is a Professor of Social Work and a former Head of the
Social Work Department at the University of the Witwatersrand (Wits).
She was elected to serve on the South African Council for Social Service
Professions and is currently affiliated to the Steve Biko Centre for
Bioethics at Wits Medical School.
Ron Berghmans, PhD, is an Assistant Professor at the Department of
Health, Ethics and Society, CAPHRI School for Public Health and
Primary Care at Maastricht University, The Netherlands. He was
trained as a psychologist and bioethicist. His major areas of interest are
psychiatric ethics, research ethics, ethics in elderly care and end-of-life
decision-making.
Amaboo Dhai is Director of the Steve Biko Centre for Bioethics, Head
of Bioethics at the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg. She is also Co-Chair of the Human
Research Ethics Committee (Medical) and Deputy Chair of the
National Health Research Ethics Council.
Anja Krumeich, PhD, is an Assistant Professor and Programme Director MSc Global Health at the Department of Health, Ethics and
Society. She studied Cultural Anthropology at the University of
Amsterdam, majoring in Medical Anthropology. Her research interests
include social differentiation, health and diversity, health and culture,
health and poverty, international health, health promotion, and dialogical ethnography.
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