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Ethics of clinical research in the developing world

Nature Reviews Immunology volume 2, pages 210–215 (2002)Cite this article

Abstract

Many commentators believe that all clinical-trial participants must receive a level of care equivalent to the world's best. Using HIV/AIDS research as an example, we show how this 'Uniform Care Requirement' can undermine biomedical research aimed at improving global health, and then we point towards a more rational and balanced approach to ethical assessment.

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Figure 1: The global burden of HIV/AIDS.
Figure 2: March for treatment access.
Figure 3: Early versus delayed initiation of antiretroviral therapy.

References

  1. Piot, P., Bartos, M., Ghys, P. D., Walker, N. & Schwartlander, B. The global impact of HIV/AIDS. Nature 410, 968–973 (2001).

    Article  CAS  Google Scholar 

  2. Joint United Nations Programme on HIV/AIDS and World Health Organization. AIDS Epidemic Update: December 2001 [online], (cited 19 Feb 02), (2001).

  3. National Intelligence Council. The global infectious disease threat and its implications for the United States [online], (cited 15 Jan 02), (2000).

  4. Centers for Disease Control and Prevention. HIV and AIDS cases reported through December 2000. HIV/AIDS Surveillance Report 12, 1–44 (2001).

  5. Binswanger, H. P. Public health: HIV/AIDS treatment for millions. Science 292, 221–223 (2001).

    Article  CAS  Google Scholar 

  6. Individual members of the faculty of Harvard University. The consensus statement on antiretroviral treatment for AIDS in poor countries [online], (cited 15 Jan 02), (2001).

  7. Cohen, J. AIDS meeting. Companies, donors pledge to close gap in AIDS treatment. Science 289, 368–369 (2000).

    Article  CAS  Google Scholar 

  8. Opinion. Grounds for hope on AIDS in Africa. Nature 406, 219 (2000).

  9. Cameron, E. C. Life, health and justice in the AIDS epidemic. GMHC Treatment Issues 15, 1–7 (2001).

    CAS  PubMed  Google Scholar 

  10. Farmer, P. The major infectious diseases in the world — to treat or not to treat? N. Engl. J. Med. 345, 208–210 (2001).

    Article  CAS  Google Scholar 

  11. Banta, D. Worldwide interest in global access to drugs. JAMA 285, 2844–2846 (2001).

    Article  CAS  Google Scholar 

  12. United Nations General Assembly Special Session on AIDS. Declaration of commitment on HIV AIDS: global crisis – global action. June 27, 2001 [online], (cited 15 Jan 02), (2001).

  13. Department of Health and Human Services and Henry J. Kaiser Family Foundation. Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents [online], (cited 15 Feb 02), (2002).

  14. Bartlett, J. G. & Gallant, J. E. Medical Management of HIV Infection (Johns Hopkins University, Baltimore, 2001).

    Google Scholar 

  15. Stephens, J. et al. The Body Hunters. Washington Post (December 17–22, 2001).

  16. Macklin, R. After Helsinki: unresolved issues in international research. Kennedy Inst. Ethics J. 11, 17–36 (2001).

    Article  CAS  Google Scholar 

  17. Koski, G. & Nightingale, S. L. Research involving human subjects in developing countries. N. Engl. J. Med. 345, 136–138 (2001).

    Article  CAS  Google Scholar 

  18. Shapiro, H. T. & Meslin, E. M. Ethical issues in the design and conduct of clinical trials in developing countries. N. Engl. J. Med. 345, 139–142 (2001).

    Article  CAS  Google Scholar 

  19. Lurie P., & Wolfe, S. M. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N. Engl. J. Med. 337, 853–856 (1997).

    Article  CAS  Google Scholar 

  20. Angell, M. The ethics of clinical research in the third world. N. Engl. J. Med. 337, 847–849 (1997).

    Article  CAS  Google Scholar 

  21. Angell, M. Ethical imperialism? Ethics in international collaborative clinical research. N. Engl. J. Med. 319, 1081–1083 (1988).

    Article  CAS  Google Scholar 

  22. Angell, M. Investigators' responsibilities for human subjects in developing countries. N. Engl. J. Med. 342, 967–969 (2000).

    Article  CAS  Google Scholar 

  23. Rothman, D. The shame of medical research. The New York Review of Books [online], (cited 30 Nov 00).

  24. Annas, G. Prominent opinion: the ethics of international research trials in the developing world. J. Med. Ethics II, 7–10 (2001).

    Google Scholar 

  25. Emanuel, E. J., Wendler, D. & Grady C. What makes clinical research ethical? JAMA 283, 2701–2711 (2000).

    Article  CAS  Google Scholar 

  26. Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS, Geneva, 1993).

  27. National Bioethics Advisory Commission. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries [online], (cited 20 Feb 02), (2001).

  28. RED BOOK™ Database Service (MICROMEDEX, Greenwood Village, Colorado, 2002).

  29. World Health Organization. World Health Report 2001 (WHO, Geneva, 2001).

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Author information

Authors and Affiliations

  1. the National Institutes of Health, 9000 Rockville Pike, Bethesda, 20892, Maryland, USA

    Jack Killen, Christine Grady, Gregory K. Folkers & Anthony S. Fauci

Authors
  1. Jack Killen
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  2. Christine Grady
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  3. Gregory K. Folkers
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  4. Anthony S. Fauci
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Corresponding author

Correspondence to Jack Killen.

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DATABASES

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FURTHER INFORMATION

General information about HIV/AIDS Centers for Disease Control and Prevention

Joint United Nations Programme on HIV/AIDS (UNAIDS)

National Institute of Allergy and Infectious Diseases

HIV/AIDS treatment Department of Health and Human Services and Henry J. Kaiser Family Foundation. Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents

Harvard Consensus Statement on Antiretroviral Treatment for AIDS in Poor Countries

Medical Management of HIV Infection by John G. Bartlett, M.D. and Joel E. Gallant, M.D., M.P.H.

Bioethics resources Council for International Organizations of Medical Sciences

National Institutes of Health: Bioethics Resources on the Web

National Reference Center for Bioethics Literature

World Medical Association

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Killen, J., Grady, C., Folkers, G. et al. Ethics of clinical research in the developing world. Nat Rev Immunol 2, 210–215 (2002). https://doi.org/10.1038/nri745

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