An increasing proportion of clinical drug trials are conducted in developing countries where access to health care and government oversight of research are limited to nonexistent. Are vulnerable populations being exploited for benefits that accrue to people elsewhere? How do we protect against exploitation without unduly constraining much-needed health research that could, in fact, benefit vulnerable populations? What role should anthropologists play in the process of introducing and translating the purpose of clinical trials to local populations, insuring that they understand their rights, monitoring clinical trials in an environment subject to stakeholder and political economic interests, and serving as a watchdog?
Kathleen M. MacQueen, PhD, MPH
Family Health International, Durham, NC
Expenditures on clinical trials research have risen dramatically over the past decade, with an increasing proportion of trials being conducted in developing countries where access to health care and government oversight of research are limited to nonexistent.(1) Concerns have been voiced that vulnerable populations are being exploited for benefits that accrue to people elsewhere, initially spurred by controversies surrounding U.S. sponsored clinical trials in Africa and Asia to prevent the transmission of HIV from mothers to children.(2-4) A major ethical dilemma has emerged: how do we protect against exploitation without unduly constraining much-needed health research that could, in fact, benefit vulnerable populations?
Addressing this ethical dilemma has led to new conceptions of distributive and procedural justice in health research that emphasize the importance of ensuring that research is responsive to local needs, that populations targeted for study recruitment will ultimately benefit from the study results, and that consent to participate is truly voluntary and informed. There is also increasing pressure to ensure that research results can be, and are, effectively translated into health programs.(5;6) Awareness is emerging of the contribution of social, political, and economic factors to the pivotal relationship between health researchers and the people with whom they conduct their research.(7)
Anthropologists are ideally positioned to make important contributions to resolving the ethical dilemmas now confronting biomedical researchers. First, cultural anthropology provides an ideal base from which to contribute to the development and evaluation of culturally appropriate processes of informed consent. There is growing recognition of the fact that too much emphasis has been placed on written documentation that serves legalistic purposes, and not enough on assuring that the interaction between researchers and participants supports autonomous decision-making on the part of participants.(5;6) There is a need for both basic and applied research that goes beyond simplistic notions of cultural sensitivity and relativity(8) to substantive considerations of cultural heterogeneity, the moral and power dimensions of relationships, and the interplay between context and notions of coercion, inducement, and voluntariness.(9;10) Communities, not just research participants, need to be educated about key concepts in clinical trials research such as control arms, treatment arms, placebos, randomization, adverse events, and side effects, as well as related ethical concepts such as researcher obligations to participants and participant rights to redress should harm occur.(11;12) These are complex concepts with which even researchers at times struggle, and they warrant broader efforts at community education as part of the overall informed consent process.
Second, there is a strong base within anthropology for the development of participatory models for community involvement from which to develop approaches that are appropriate for the conduct of clinical trials. Currently, the most common model used by clinical researchers to engage local communities is community consultation, usually in the form of a community advisory board that may or may not include research participants. There is pressure for developing more meaningful partnerships with local communities that include decision-making authority as well as consultative input.(13) At the same time, global standards for the conduct of clinical research are increasingly rigorous. Reconciling the push for a participatory ethic with established roles, responsibilities, and accountability in high risk clinical research presents a daunting challenge that has received little formal attention. There is a critical need for systematic analyses of existing partnerships to identify strengths and weaknesses, as well as to provide data for developing improved models to support effective, participatory health research.
A third contribution is the potential role of anthropologists in monitoring local responses to clinical trials among individuals targeted for participation, within the communities where research takes place, and at political levels that cross-cut communities affected by the research process. For example, anthropologists can lead the way in assessments of individual-, family-, and community-level impacts of research on health care and quality of life. To adequately address the ethical issue of justice, techniques are needed for framing the risks and benefits of research more fully with reference to the social, political, and eocnomic contexts within which the research is embedded.(7;14)
In all these areas anthropologists can contribute to the development of models to assist stakeholders in their efforts to balance concerns at multiple levels from the local to the global. Researchers, sponsors, and host communities face practical challenges in each of the areas outlined above. Ethical guidance is evolving, often on the basis of anecdotal evidence and hearsay. As anthropologists we have an important opportunity to ensure that the ethical discourse in biomedical research is grounded in a substantive understanding of the full complexity and diversity of the human condition.
There is thus both an opportunity and an urgent need for anthropologists to get involved in these issues. In coming weeks the Society for Medical Anthropology will post a series of case studies on its web site to illustrate many of these challenges. A list of background readings has already been posted that outline the thorny nature of the complexly intertwined problems surrounding clinical trials research in developing countries. We invite the SMA membership to consider what we, as anthropologists, can contribute to their resolution, whether other issues need to be articulated, and how we can construct our role to have the greatest beneficial impact. As a starting point, SMA will establish a series of discussion groups, both virtual (web and email based) and real (in the context of the AAA and SfAA meetings). From these groups we hope to foster a coherent, viable, and effective partnership between anthropology and bioethics.
Freimuth et al., African Americans’ views on research and the Tuskegee Syphilis study.Social Science & Medicine 2(5) March 2001, 797-808.
Can transnational reseach be ethical in the developing world?
Paul Farmer (published in The Lancet, Oct. 26, 2002 – also available as pdf)
A new look at international research ethics (BMJ editorial) (pdf)
Solomon R Benatar & Peter A Singer, British Medical Journal 2000;321:824-6
Researchers Say They Have Little Input in Studies Sponsored by Drug Companies, Survey Indicates
re-posted from the Kaiser Daily Health Policy Report, Oct. 24, 2002
Globalizing Clinical Research by Sonia Shah, the Nation, July 1, 2002
The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects (OEi-01-00-00190; 09/01), Office of the Inspector General, U. S. Dept. of Health and Human Services
Comments on the Draft Health and Human Services Inspector General’s Report: The Globalization of Clinical Trials (OEI-01-00-00190)(HRG Publication #1591) by Peter Lurie, MD, Deputy Director and Sidney M. Wolfe, MD, Director
Public Citizen’s Health Research Group, July 5, 2001
A Cure for Clinical Trials by Janice Cruz Rowe, Martin E. Elling, Judith G. Hazlewood, and Randa Zakhary. The McKinsey Quarterly 2002:2.
Costs of Human Use Clinical Trials: Surprising Evidence from the US Orphan Drug Act
James Love & Michael Palmedo, Consumer Project on Technology
IRBs and Anthropological Reseach
Patricia A. Marshall, Case Western Reserve University, Anthropology News, April 2003
Responsible Research: A Systems Approach to Protecting Research Participants (pdf)
from the Institute of Medicine, October 2002
The Tuskegee Syphilis Study: A Hard Lesson Learned
from the CDC’s National Center for HIV, STD and TB Prevention, includes timeline
Madison Ave. Plays Growing Role in Drug Research
the New York Times, Nov. 22, 2002
The report highlights 22 cases of unethical clinical trials in developing but also developed countries. From the report:”Even though the overview below is necessarily incomplete and biased towards unethical trials that have caught some publicity, some general observations can still be made. Firstly, unethical trials have occurred around the world, in both developed and developing countries. In some cases, the trials had not been approved by an ethical review committee or institutional review board, or approval had be given for an unethical trial design. Hence there appear to be flaws, and sometimes rather serious ones, in the regulatory systems of various countries. Secondly, the research organizations involved range from relatively unknown local companies to leading multinational corporations. This might be surprising, given that large multinational corporations usually have clear public commitments to high ethical standards in clinical trials. Thirdly, some of the unethical trials are of a recent date, some were even being carried out in 2005 or 2006. Although it is sometimes argued that instances of unethical clinical trials are isolated and outdated, this is not always true. Note that some older cases have been included in the overview as well, mainly because the developments following these trials are still going on. And finally, the nature of ethical concerns appears to be rather diverse and relates to all paragraphs of the DoH summarized above. The lack of voluntary, informed participation and adequately informed consent are probably the most common problems. Trials with experimental drugs of which the safety for testing in humans had not yet been established may be among the most alarming examples.”
A working group has been formed in the Netherlands to discuss the issue. For more information, contact:
Annelies den Boer, project coordinator pharmaceuticals, Wemos, Tel
+31-20-4352050, mobile +31-6-30051233, e-mail: email@example.com;
Francis Weyzig, SOMO researcher, Tel +31-20-6391291, mobile +31-6-27511852,
About Clinical Trials and Complementary and Alternative Medicine from the National Center for Complementary and Alternative Medicine
Central resource for current information on federally and privately funded clinical trials for AIDS patients and others infected with the human immunodeficiency virus (HIV). This service is a Public Health Service (PHS) project provided collaboratively by the National Institute of Allergy and Infectious Diseases, the Food and Drug Administration, the National Library of Medicine, and the Centers for Disease Control and Prevention.
Links to Pharmaceutical Related Sites – from the Tufts Center for the Study of Drug Development
Margaret E. Bentley, Ph.D.
Department of Nutrition
Fellow, Carolina Population Center
123 W Franklin Street, Suite 308B
University of North Carolina
Chapel Hill, NC 27516
919 966 9575, 843 9962
Fax: 919 966 9159
Gene Bukhman, MD, PhD
Brigham and Women’s Hospital
75 Francis Street
Boston, MA 02115
Dept. of Anthropology
3rd Floor William James Hall
33 Kirkland St.
Cambridge, MA 02138
tel: 617-547-0469 (home)
Linda M. Hunt, Ph.D.
Department of Anthropology and
Julian Samora Research Institute
354 Baker Hall
Michigan State University
East Lansing, MI 48224
Patricia Marshall, PhD
Associate Professor of Bioethics
Department of Bioethics
School of Medicine
Case Western Reserve University
10900 Euclid Avenue
Cleveland, OH 44106-4976
Cynthia Woodsong, PhD
Family Health International
PO Box 13950
Research Triangle Park, NC 27709
Office: 919-544-7040 ext