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Apr-Jun2001-9(2)
REPORT
The Global Forum for Bioethics
in Research: report of a meeting
Bebe Loff, Karen Hofman,
Vasantha Muthuswamy
Over the past decade, funding for international
research in low and middle-income countries has grown. As research
activities have increased, so has the number of complex questions concerning the
social and ethical dimensions of collaborative research. While the
scientific and lay press have begun to take note of these concerns (1, 2,
3), until recently no platform existed for individuals from the developing world
who are responsible for the ethical conduct of research in their countries, to
engage in dialogue about how these issues might be approached in their own
countries and in international collaborative research.
This report describes the activities of the Second
Global Forum on Bioethics in Research (4), the most recent in a series of
colloquia designed to examine conceptual and practical challenges arising from
cross-cultural research and to provide guidance in improving institutional
capabilities in bioethics in the developing world. Working with the US
National Institutes of Health, the United Kingdom's Medical Research Council,
the South African Medical Research Council and other international agencies, the
meeting was hosted in Bangkok, Thailand, in October 2000 by the World
Health Organization. At both the inaugural meeting held in 1999 (5) and
the Bangkok meeting, the predominant representation was from the developing
world.
The focus of the meeting in Bangkok was
on:
- Capacity building for ethics review in developing countries,
- the benefit of the process and products of research to the host country; and
- the impact of international and national intellectual property rights frameworks.
This report provides background on these issues and
a sense of the discussion in Bangkok.
Capacity building for ethical
review
If countries hosting collaborative research are to
be full partners in the research process, it is crucial that they have their own
capacity to conduct a thorough ethical review of research proposals. This
may not be so simple, since the precise elements that constitute capacity are
not clear. Some say that adequate capacity requires a properly constituted
ethics review committee that follows fair and transparent procedures. For
example, the WHO's operational guidelines for ethics committees that review
biomedical research (6) states that "Ethics Committees should be
multidisciplinary and multi-sectorial in composition, including relevant
scientific expertise, balanced age and gender distribution, and laypersons
representing the interests and concerns of the community." These
guidelines go on to specify a series of requirements for review of applications
including assessment of the nature of community involvement prior to and during
research, and the extent to which the community will benefit as a consequence of
the research.
A panel discussion at the Bangkok meeting
highlighted some of the shortcomings of improving ethics review capacity
alone. Even within the confines of an ethics committee, serious ethical
debate could be problematic in social and cultural milieu lacking a tradition of
egalitarianism or in an environment in which challenging authority is
unusual. In settings in which unfounded but strongly held discriminatory
presumptions operate with respect to gender, caste or race, it seems unrealistic
to expect that ethical review will redress this. The self-interest of
governments, of researchers and the privileged few who may become members of
these committees might influence the committees' deliberations and judgements,
and without transparency could be difficult to regulate. Corruption or
bias may be blatant or may be manifested in understandable loyalties to family,
clan or region. Committees are not independent from economic and social
pressures. These issues represent a significant challenge for capacity building
in developing countries.
Benefiting the community
One common criticism of the conduct of medical
research in developing countries is that those who ought to benefit as a result
of research frequently do not. This is particularly true of participants
in resource-poor settings. The indirect benefits of research may include
provision of training, facilities, building capacity for independent scientific
and ethical review, the creation of collaborative research opportunities and the
recognition of community contribution in publications and research forums.
Beyond the indirect benefits, however, the obligation to make successful
interventions available to participants, and even more broadly to their
communities and populations, is still hotly debated. However, the
principle of reciprocity of benefit between those performing the studies and
those volunteering as participants is increasingly being accepted as a
requirement of ethical research, though there is no consensus on the appropriate
scope of the obligation.
The Global Forum on Bioethics in Research in
Bangkok contributed to the on-going debate on this issue by presenting three
case studies that illustrated different approaches to negotiating and providing
benefits to the community in three different setting at three stages in the
research process. The cases were subsequently discussed in small breakout
sessions during the meeting. The first case illustrated an elaborate
process of negotiation between industry and the government of Thailand before
initiating research on an AIDS vaccine. The second case illustrated
lengthy negotiations about drug pricing, in this case medication for river
blindness, a product that had been available for many years for veterinary
purposes. A neutral body, in this instance the World Health Organization,
acted as mediator. The final case illustrated the complexities of prior
agreements. The Africa Centre for Population and Reproductive Health in
South Africa presented a video documenting the difficulties and the detailed
negotiations required after the research had begun because the perceptions and
expectations of the community were changed during the process of
participating.
Following the breakout sessions, during which small
groups examined the merits of each case, a panel discussion centred on the value
of prior agreements to a draft template for conceptualising and negotiating
community benefits in advance of trials. Some participants expressed
concern that such a requirement might delay or prevent research being carried
out in developing countries, and that promising access to a product at the end
of trial can raise the question of undue inducement. An attempt to provide
some guidance on this point is furnished by recent UNAIDS guidelines on vaccine
research (7), which state that "The research protocol should outline the
benefits that persons participating in HIV preventive vaccine trials should
experience as a result of their participation. Care should be taken so
that these are not presented in a way that unduly influences freedom of choice
in participation." It was acknowledged that discussion is centered on
community benefit agreements during the course of clinical research, and
that it might be different when performing epidemiological, genetic and social
sciences research. A number of related issues were raised including the
question of who ought to be party to the agreement and its prospective
enforceability. Further discussion is still needed to clarify who might
bear responsibility for reviewing benefit-sharing agreements and in particular
whether or not an ethics review committee is an appropriate body to perform this
role.
The subject of intellectual property is frequently
raised in the context of international health research and this was also on the
agenda in Bangkok. Lamentably, in this arena ethical discussion seems
least developed. There is debate amongst AIDS treatment activists about
compulsory licensing and some writing about patenting of genetic
material.
Conclusion
Capacity building is a key first step in promoting
ethical conduct and all efforts to do so should be encouraged to continue.
These include efforts such as the Forum for Ethical Review Committees in the
Asian and Western Pacific Region that could be used as a model for other
regions, funding by donor governments such as the grant provided by the
Government of Norway to promote collaborative ethics training between the
University of Bergen and Thammasat and Mahidol Universities in Thailand, as well
as the International Bioethics Education and Career Development Award funded by
the Fogarty International Center and National Institutes of Health in the United
States.
There appeared to be some general agreement that
while the value of a template for conceptualising and negotiating community
benefits in advance of trials would be useful, this cannot be a 'one size fits
all' arrangement. Extensive developing country input is required in the drafting
of such a prototype.
Finally, the participants at the Forum hoped that
the agenda for the next forum in the Gambia in 2001 and those that follow would
continue to provide a platform where ongoing and unresolved issues can be openly
discussed.
References:
1. Bagla P. New guidelines promise stronger bioethics. Science 2000; 290: 919.
2. Stephens J et al. The body hunters series. Washington Post December 17-23, 2000.
3. Vastag B. Helsinki discord? A controversial declaration. JAMA 2000; 284: 2983.
4. Loff B. Violence in research. Lancet 2000; 355: 1806.
5. Hofman K. The Global Forum Meeting for Bioethics in Research: report of a meeting, November 1999. Journal of Law, Medicine and Ethics 2000; 28: 174-175.
6. WHO. Operational guidelines for ethics committees that review biomedical research. Geneva, Switzerland: World Health Organization, 2000.
7. UNAIDS, Ethical considerations in HIV preventive vaccine research. Geneva, Switzerland: Joint United Nations Program, 2000.
1. Bagla P. New guidelines promise stronger bioethics. Science 2000; 290: 919.
2. Stephens J et al. The body hunters series. Washington Post December 17-23, 2000.
3. Vastag B. Helsinki discord? A controversial declaration. JAMA 2000; 284: 2983.
4. Loff B. Violence in research. Lancet 2000; 355: 1806.
5. Hofman K. The Global Forum Meeting for Bioethics in Research: report of a meeting, November 1999. Journal of Law, Medicine and Ethics 2000; 28: 174-175.
6. WHO. Operational guidelines for ethics committees that review biomedical research. Geneva, Switzerland: World Health Organization, 2000.
7. UNAIDS, Ethical considerations in HIV preventive vaccine research. Geneva, Switzerland: Joint United Nations Program, 2000.
Bebe Loff, Department of
Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria,
Australia;
Dr Karen Hofman, The
John E. Fogarty International Center, National Institutes of Health, Bethesda,
Maryland, USA;
Corresponding author: Dr
Vasantha Muthuswamy,Division of Basic Medical Sciences, Indian
Council of Medical Research, Ansari Nagar, New Delhi, Email:. vmuthuswamy@hotmail.com.
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