Introduction: Why exploitation?

Exploitation and Developing Countries: The Ethics of Clinical Research

Volumn , Issue , 2008, Pages 1-20

  Hawkins, Jennifer S ^b   Emanuel, Ezekiel J ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

EID: 79960546947     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1515/9781400837328.1     Document Type: Editorial

References (38)

1. Edward M. Connor et al. "Reduction of Maternal-Infant Transmission of Human Immunodeficiency Virus Type 1 with Zidovudine Treatment," New England Journal of Medicine 331 (1994): 1173-80.
2. Christine Grady, "Science in the Service of Healing,"Hastings Center Report 28, no. 6 (1998): 34-38, at 35.
3. Connor et al., supra note 1, at 1173.
4. Peter Lurie and Sidney M.Wolfe, "Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries," New England Journal of Medicine 337 (1997): 1853-55, at 853.
5. Indeed, 90 percent of all HIV-infected individuals reside in developing countries. These statistics are based on November 2004 figures from the UNAIDS Web site, http://www.unaids.org/en/resources/questions_answers.asp#II (accessed July 24, 2005).
6. Grady, supra note 3, at 35.
7. Robert A. Crouch and John D. Arras, "AZT Trials and Tribulations," Hastings Center Report 28, no. 6 (1998): 26-34, at 33.
8. Crouch and Arras, supra note 8, at 26.
9. Grady, supra note 3, at 35.
10. World Health Organization, Recommendations from the Meeting on Mother-to-Infant Transmission of HIV by Use of Antiretrovirals (Geneva:WHO, 1994).
11. Lurie and Wolfe, supra note 5, at 853.
12. Id 15. Marcia Angell, "The Ethics of Clinical Research in the Third World," New England Journal of Medicine 337 (1997): 847- 49.
13. Richard Saltus, "Journal Departures Reflect AIDS Dispute," Boston Globe, October 16, 1997, A11.
14. Harold Varmus and David Satcher, "Ethical Complexities of Conducting Research in Developing Countries," New England Journal of Medicine 337 (1997): 1003-5.
15. Lurie and Wolfe, supra note 15; Angell, supra note 15. The language of "double standards" originates with Lurie and Wolfe.
16. The Declaration of Helsinki, September 1989, par. II.3.
17. Grady, supra note 3, at 35.
18. Robert J. Levine, "The 'Best Proven Therapeutic Method' Standard in Clinical Trials in Technologically Developing Countries," IRB: A Review of Human Subjects Research 20 (1999): 5-9; Reidar K. Lie, Ezekiel J. Emanuel, Christine Grady, and David Wendler, "The Standard of Care Debate: The Declaration of Helsinki versus the International Consensus Opinion," Journal of Medical Ethics 30 (2004): 190-93.
19. For discussion of this, see chapter 1 in this volume.
20. See, e.g., Howard W. French, "AIDS Research in Africa: Juggling Risks and Hopes," New York Times, October 9, 1997; Sharon LaFraniere, Mary Pat Flaherty, and Joe Stephens, "The Dilemma: Submit or Suffer: The Body Hunters, Article III,"Washington Post, December 19, 2000.
21. George Annas quoted in LaFraniere, Flaherty, and Stephens, supra note 28.
22. Nicholas A. Christakis, "The Ethical Design of an AIDS Vaccine Trial in Africa," Hastings Center Report 18, no. 3 (1988): 31-37, at 31.
23. LaFraniere, Flaherty, and Stephens, supra note 28.
24. Christine Pace, Christine Grady, and Ezekiel J. Emanuel, "What We Don't Know about Informed Consent," SciDevNet,August 28, 2003,www.scidev.net/en/opinions/what-we-dont-know-about-informed-consent.html.
25. See, e.g., Glantz, Annas, Grodin, and Mariner, supra note 18; Crouch and Arras, supra note 8.
26. The Council for International Organizations of Medical Sciences (CIOMS) is an international nongovernmental organization closely tied to the World Health Organization (WHO) and founded by WHO and the United Nations Educational Scientific and Cultural Organization (UNESCO).
27. The Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 1993), Commentary on Guideline 15, at 45.
28. The Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 2002), Guideline 10, at 32.
29. eorge J. Annas and Michael A. Grodin, "Human Rights and Maternal-Fetal HIV Transmission Prevention Trials in Africa," American Journal of Public Health 88 (1998): 560-63, at 561.
30. Glantz, Annas, Grodin, and Mariner, supra note 18, at 39.
31. Harold T. Shapiro and Eric M. Meslin, "Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries," New England Journal of Medicine 345 (2001): 139-42, at 139. Also see National Bioethics Advisory Commission, Ethical and Policy Issues in International Research, chap. 4.
32. Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries, "Fair Benefits for Research in Developing Countries," Science 298 (2002): 2133-34; and "Moral Standards for Research in Developing Countries: From 'Reasonable Availability' to 'Fair Benefits,'"Hastings Center Report 34, no. 3 (2004): 17-27, reprinted as chapter 9 of this volume.
33. Christine Grady, "The Challenge of Assuring Continued Post-trial Access to Beneficial Treatment," Yale Journal of Health Policy, Law, and Ethics 5, no. 1 (2005): 425-35.
34. See, e.g., NIH Guidance for Addressing the Provision of Antiretroviral Treatment for Trial Participants Following Their Completion of NIH-Funded Antiretroviral Treatment Trials in Developing Countries (Bethesda, MD: National Institutes of Health, Office of Extramural Research, 2005), available at http://grants.nih.gov/grants/policy/antiretroviral/QandA.htm#Purpose.44. Lurie and Wolfe, supra note 5, at 855.
35. Angell, supra note 15, at 848.
36. Annas and Grodin, supra note 37.
37. Karim, supra note 43, at 565.
38. Ezekiel J. Emanuel, David Wendler, and Christine Grady, "What Makes Clinical Research Ethical?" Journal of the American Medical Association 283 (2000): 2701-11.