Clinical Drug Trials

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?

Leading Questions:

  1. Is the point of informed consent conveying information as facts or enhancing the understanding of a potential participant in a research project or clinical trial?
  2. Is enhancing understanding by analogical reasoning an acceptable form of cultural translation?
  3. Is the point of informed consent to provide information to a potential participant in a clinical trial (or any research project) or to educate them?
  4. What kinds of translational research are necessary? What is the role of translation research in better understanding how participants understand informed consent forms and learning? What kinds of communication approaches might improve their comprehension?

Overview of the problem: Bioethics and Anthropology: A Call for Partnership

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.

Reference List

  1. Office of Inspector General, Department of Health and Human Services. The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects. 2001. Boston, MA, Office of Evaluation and Inspections.
  2. de Zulueta P. Randomised placebo-controlled trials and HIV-infected pregnant women in developing countries. Ethical imperialism or unethical exploitation? Bioethics 2001;15(4):289-311.
  3. Bayer R. The debate over maternal-fetal HIV transmission prevention trials in Africa, Asia, and Caribbean: racist exploitation or exploitation of racism? American Journal of Public Health 1998;88(4):567-70.
  4. Crouch RA, Arras JD. AZT trials and tribulations. Hastings Center Report 1998;28(6):26-34.
  5. National Bioethics Advisory Commission. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. 2001. Bethesda, MD, National Bioethics Advisory Commission.
  6. Council for International Organizations of Medical Sciences. The Draft CIOMS Guidelines. 2001. Geneva, Switzerland, CIOMS.
  7. Benatar SR. Distributive justice and clinical trials in the Third World. Theor Med Bioeth 2001;22(3):169-76.
  8. Ijsselmuiden CB, Faden RR. Research and informed consent in Africa—another look. New England Journal of Medicine 1992;326(12):830-4.
  9. Browner CH, Preloran M, Cox SJ. Ethnicity, bioethics, and prenatal diagnosis: the amniocentesis decisions of Mexican-origin women and their partners. American Journal of Public Health 1999;89:1658-66.
  10. Karim QA, Karim SSA. Informed consent for HIV testing in a South African hospital: is it truly informed and truly coluntary? American Journal of Public Health 1998;88(4):637-40.
  11. Coreil J, Losikoff P, Pincu R, Mayard G, Ruff AJ, Hausler HP et al. Cultural feasibility studies in preparation for clinical trials to reduce maternal-infant HIV transmission in Haiti. AIDS Education and Prevention 1998;10(1 ):46-62.
  12. Featherstone K, Donovan JL. “Why don’t they just tell me straight, why allocate it?” The struggle to make sense of participating in a randomised controlled trial. Social Science & Medicine 2002;55:709-19.
  13. Weijer C, Emanuel EJ. Protecting communities in biomedical research. Science 2000;289:1142-4.
  14. London AJ. The ambiguity and the exigency: clarifying ‘standard of care’ arguments in international research. Journal of Medicine and Philosophy 2000;25:379-97.


background readings

HIV Prevention Trials Network Ethical Guidance for Research (pdf)

  • In response to on-going questions and concerns raised by HPTN investigators and collaborators faced with shifting ethical guidance at national and international levels, the HPTN Executive Committee charged the Ethics Working Group with developing guidance for ethical decision-making and practice.

Freimuth et al., African Americans’ views on research and the Tuskegee Syphilis study.Social Science & Medicine 2(5) March 2001, 797-808.

  • The participation of African Americans in clinical and public health research is essential. However, for a multitude of reasons, participation is low in many research studies. This article reviews the literature that substantiates barriers to participation and the legacy of past abuses of human subjects through research.

Can transnational reseach be ethical in the developing world?
Paul Farmer (published in The Lancet, Oct. 26, 2002 – also available as pdf)

  • Are institutional review boards, irrespective of their constitution, capable of monitoring research across such steep grades of inequality? Is truly ethical research possible in poor communities?

A new look at international research ethics (BMJ editorial) (pdf)
Solomon R Benatar & Peter A Singer, British Medical Journal 2000;321:824-6

  • The normal “standard of care” against which new interventions are tested in medical research has not been formally defined. It is usually taken to mean the “best proved treatment” for any condition under investigation in a trial. We reject the arbitrariness of this notion of the standard of care and offer a more comprehensive alternative. Use of this new standard invokes a new approach to international research ethics that focuses on reducing inequalities in global health.

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

  • Most research contracts between academic institutions and pharmaceutical companies that fund clinical trials do not follow guidelines issued last year to prevent bias and conflict of interest in published research…

Globalizing Clinical Research by Sonia Shah, the Nation, July 1, 2002

  • By the end of July a US district court will decide whether drug giant Pfizer should stand trial in the United States for presiding over a coercive, botched 1996 experiment on Nigerian children with meningitis. In a class-action suit filed last August, thirty Nigerian families say the company violated the Nuremberg Code by forcing an unapproved, risky experiment on unwitting subjects who suffered brain damage, loss of hearing, paralysis and death as a result.

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

  • Summary: In conducting this inquiry, we analyzed two FDA databases: one of clinical investigators conducting drug research and one of clinical investigators conducting drug research who have been inspected by FDA.

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

  • While this report highlights the important issue of the increasing internationalization of medical research, it is lacking in three regards: 1. The report fails to draw adequately upon prior research in this area; 2. It fails to adequately emphasize the deficiencies of the data collected by the U.S. Food and Drug Administration (FDA); 3. The recommendations are too weak, even falling below those of the National Bioethics Advisory Commission (NBAC).

Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

  • Department of Health, Education, and Welfare, Office of the Secretary: Protection of Human Subjects: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.

A Cure for Clinical Trials by Janice Cruz Rowe, Martin E. Elling, Judith G. Hazlewood, and Randa Zakhary. The McKinsey Quarterly 2002:2.

  • Clinical trials are a vital step in bringing new drugs to market. But while pharmaceuticals companies pay close attention to the scientific side of designing their clinical trials, few consider how they will get enough patients to participate. As a result, most trials are plagued by delays that can cost pharma companies millions of dollars in missed sales. The take-away: To recruit enough patients, pharma companies must approach clinical trials as a marketing exercise. Bringing marketers into the process early will not only prevent costly delays but also enhance the trials’ efficiency.

Bad Blood: the troubling legacy of the Tuskegee Syphilis Study

  • An important starting point for the renewal of dialogue about the Tuskegee Syphilis Study was the symposium “Doing Bad in the Name of Good?: The Tuskegee Syphilis Study and its Legacy” convened on Wednesday, February 23, 1994 at The Claude Moore Health Sciences Library. The five-hour symposium undertook to apply historical perspective on the Tuskegee Study to the current problems of cultural difference in perceptions of health care workers and the appropriate nexus of scientific research and human rights.

Costs of Human Use Clinical Trials: Surprising Evidence from the US Orphan Drug Act
James Love & Michael Palmedo, Consumer Project on Technology

  • According to the US Internal Revenue Service (IRS), US taxpayers received Orphan Drug Tax Credits totaling $80.1 million in fy 1998, and $61.4 million in fy 1997, the most recent years for which data are available. The credit represents half the costs of qualified clinical testing on all drugs which are considered orphans under FDA and IRS rules, including both successful and unsuccessful products under development.

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

Lurie P, Wolfe SM, Klaus M. Letter to Tommy Thompson, Secretary of Health and Human Services, regarding planned placebo-controlled surfactant study in Latin America.

U.S. Department of Health and Human Services. Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance. March 2002.

U.S. Department of Health and Human Services. Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions. March 2002.

Office for Human Research Protections. Informed Consent Checklist – Basic and Additional Elements. January 2002.

Madison Ave. Plays Growing Role in Drug Research
the New York Times, Nov. 22, 2002

Related links

SOMO briefing paper on ethics in clinical trials

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:;

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

  • This fact sheet will provide you with an introduction to clinical trials and to trials of complementary and alternative medicine (CAM).

AIDS Clinical Trials Information Service (ACTIS)

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.

AIDS Education Global Information Serive (AEGIS): Clinical Trials

  • The following information is made available as a public service and does not constitute endorsement by ÆGIS or any other organization. It is the responsibility of the user to evaluate this information based on individual needs and community standards prior to use.

  • The U.S. National Institutes of Health, through its National Library of Medicine, has developed to provide patients, family members and members of the public current information about clinical research studies. Resources Information

  • An Introduction to Clinical Trials, Participation in Clinical Trials, Glossary, General Information on Clinical Trials

Pediatric AIDS Clinical Trials Group

  • The PACTG, a joint effort of the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute for Child Health and Human Development (NICHD), encompasses the mission for HIV-infected pregnant women and children that the Adult AIDS Clinical Trial Group (AACTG), the Community Programs for Clinical Research on AIDS (CPCRA), the AIDS Vaccine Evaluation Group (AVEG), the Division of AIDS Treatment Research Initiative (DATRI), and the pharmaceutical industry-sponsored studies represent for HIV-infected adults.

Veritas Medicine

  • Veritas Medicine is a free confidential resource providing access to clinical trials and information on treatment options.

Supercourse: Clinical Trial Concepts

  • Claudia Scala Moy, Ph. D.

The Society for Clinical Trials

  • The Society for Clinical Trials, created in 1978, is an international professional organization dedicated to the development and dissemination of knowledge about the design and conduct of clinical trials and related health care research methodologies.

National Reference Center for Bioethics Literature

Links to Pharmaceutical Related Sites — from the Tufts Center for the Study of Drug Development

The National Information Resource on Ethics & Human Genetics

BIOETHICS Information Retrieval Project

The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER)

  • The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) is an independent international cooperative project designed to facilitate the development of the ethical review of biomedical research. The project develops out of the capacity-building activities of TDR of the World Health Organization (WHO) in drafting, translating, distributing, and implementing the Operational Guidelines for Ethics Committees That Review Biomedical Research.


Task Force Members

Kate MacQueen, PhD, MPH (chair)
Senior Scientist
Family Health International
PO Box 13950
Research Triangle Park, NC 27709
Office: 919-544-7040 ext 587
Fax: 919-544-7261

Margaret E. Bentley, Ph.D.
Associate Professor
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

William W. Dressler, PhD
Department of Anthropology
PO Box 870210
The University of Alabama
Tuscaloosa, AL 35487-0210
205-348-1954 (voice)
205-348-7937 (fax)

Clara Han
MD/PhD Candidate
Dept. of Anthropology
Harvard University
3rd Floor William James Hall
33 Kirkland St.
Cambridge, MA 02138
tel: 617-547-0469 (home)
cell: 617-803-4089

Linda M. Hunt, Ph.D.
Associate Professor
Department of Anthropology and
Julian Samora Research Institute
354 Baker Hall
Michigan State University
East Lansing, MI 48224
Phone: 517/355-0114
Fax: 517/432-9952

Patricia Marshall, PhD
Associate Professor of Bioethics
Department of Bioethics
School of Medicine
Case Western Reserve University
10900 Euclid Avenue
Cleveland, OH 44106-4976
Office: 216-368-6196

Mark Nichter, Ph.D.
Department of Anthropology
University of Arizona
PO Box 210030
Tucson, AZ 85721-0030
(o) 520/621-2585
(f) 520/621-2088

Cynthia Woodsong, PhD
Senior Scientist
Family Health International
PO Box 13950
Research Triangle Park, NC 27709
Office: 919-544-7040 ext
Fax: 919-544-7261