The standard of care debate: Can research in developing countries be both ethical and responsive to those countries' health needs?

American Journal of Public Health

Volumn 94, Issue 6, 2004, Pages 923-928

  Wendler, David ^a   Emanuel, Ezekiel J ^a   Lie, Reidar K ^a,b  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b UNIVERSITY OF BERGEN   (Norway)

Author keywords

[No Author keywords available]

Indexed keywords

ADVISORY COMMITTEE; CLINICAL RESEARCH; COMMUNITY; DEVELOPING COUNTRY; HEALTH CARE NEED; HUMAN; MEDICAL CARE; MEDICAL ETHICS; METHODOLOGY; REVIEW;

EID: 2542431297     PISSN: 00900036     EISSN: None     Source Type: Journal    
DOI: 10.2105/AJPH.94.6.923     Document Type: Review

References (44)

1. Macklin R. After Helsinki: unresolved issues in international research. Kennedy Inst Ethics J. 2001;11:17-36.
2. Levine RJ. The "best proven therapeutic method" standard in clinical trials in technologically developing countries. IRB: Rev Human Subjects Res. 1998;20:5-9.
3. Lie RK. Ethics of placebo-controlled trials in developing countries. Bioethics. 1998;12:307-311.
4. Varmus H, Satcher D. Ethical complexities of conducting research in developing countries. N Engl J Med 1997; 337:1003-1005.
5. Resnik DB. The ethics of HIV research in developing nations. Bioethics. 1998;12:286-306.
6. Killen J, Grady C, Folkers GK, Fauci AS. Ethics of clinical research in the developing world. Nature Rev. 2002;2:210-215.
7. Declaration of Helsinki, paragraph 29, revised October 2000. Available at: http://www.wma.net/e/home/html. Accessed January 10, 2004.
8. Lurie P, Wolf SM. Unethical trials of methods to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med. 1997;337:853-856.
9. Angell M. The ethics of clinical research in the third world. N Engl J Med 1997;337:847-849.
10. Angell M. Ethical imperialism? Ethics in international collaborative clinical research. N Engl J Med. 1988;319: 1081-1083.
11. Angell M. Investigators' responsibilities for human subjects in developing countries. N Engl J Med. 2000;342: 967-969.
12. Rothman KJ, Michels KB. The continuing unethical use of placebos. N Engl J Med. 1994;331:394.
13. Rothman D. The shame of medical research. The New York Review of Books. Available at: http://www.nybooks.com/articles/13907. Accessed January 10, 2004.
14. Annas G. Prominent opinion: the ethics of international research trials in the developing world. J Med Ethics. 2001;2:7010.
15. Brennan TA. Proposed revisions to the Declaration of Helsinki-will they weaken the ethical principles underlying human research? N Engl J Med. 1999; 341:527-531.
16. Shapiro HT, Meslin EM. Ethical issues in the design and conduct of clinical trials in developing countries. N Engl J Med. 2001;345:139-142.
17. Dabis F, Msellati P, Meda N, et al. 6-month efficacy, tolerance, and acceptability of a short regimen of oral zidovudine to reduce vertical transmission of HIV in breastfed children in Cote d'Ivoire and Burkina Faso: a double-blind placebo-controlled multicentre trial. Lancet. 1999;353:786-792.
18. Karim SSA. Placebo controls in HIV perinatal transmission trials: a South African's viewpoint. Am J Public Health. 1998;88:564-566.
19. Conner EM, Sperling RJ, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med. 1994;331: 1173-1180.
20. Shaffer N, Chuachoowong R, Mock PA, et al. Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomized controlled trial. Lancet. 1999;353: 773-780.
21. Wiktor SZ, Ekpini E, Karon JM, et al. Short-course oral zidovudine for prevention of mother-to-child transmission of HIV-1 in Abidjan, Cote d'Ivoire: a randomized trial. Lancet. 1999; 353: 781-785.
22. Lallemont M, Jourdain G, Le Coeur S, et al. A trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1. N Engl J Med 2000;343:982-991.
23. Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared to zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet. 1999;354:795-802.
24. Rouzioux C, Costagliola D, Burgard M, et al. Estimated timing of mother-to-child human immunodeficiency virus type 1 transmission by use of a Markov model: the HIV infection in newborns French collaborative study group. Am J Epidemiol 1995;142:1330-1337.
25. Consensus statement. Science, ethics, and the future of research into maternal infant transmission of HIV-1. Lancet. 1999;353:832-835.
26. Mirochnick M, Fenton T, Gagnier P, et al. Pharmacokinetics of nevirapine in human immunodeficiency virus type 1-infected pregnant women and their neonates. J Infect Dis. 1998;178: 368-374.
27. Marseille E, Kahn JG, Mmiro F, et al. Cost effectiveness of a single-dose nevirapine regimen for mothers and babies to decrease vertical HIV-1 transmission in sub-Saharan Africa. Lancet. 1999;354:803-809.
28. Jha P, Mills A, Hanson K, et al. Improving the health of the global poor. Science. 2002;295:2036-2039.
29. Attaran A, Sachs J. Defining and refining international donor support for combating the AIDS pandemic. Lancet. 2002;357:57-61.
30. Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries. Fair benefits for research in developing countries. Science. 2002;298:2133-2134.
31. National Bioethics Advisory Commission. Ethical and policy issues in international research: clinical trials in developing countries. Available at: http://www.georgetown.edu/research/nrcbl/nbac/pubs.html. Accessed January 10, 2004.
32. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317:141-145.
33. Lurie P, Wolfe SM. HIVNET nevirapine trials [letter]. Lancet. 1999;354: 1816.
34. Lurie P, Wolfe SM. Science, ethics, and the future of research into maternal infant transmission of HIV-1 [letter]. Lancet. 1999;353:1878-1879.
35. Omene JA. Science, ethics, and the future of research into maternal infant transmission of HIV-1 [letter]. Lancet. 1999;353:1878.
36. Bloom BR. The highest attainable standard: ethical issues in AIDS vaccines. Science. 1998;279:186-188.
37. Kass N, Faden R. HIV research, ethics, and the developing world. Am J Public Health, 1998;88:548-550.
38. Kagan S. The Limits of Morality. Oxford, England: Oxford University Press; 1989:64-70.
39. Raz J. Practical Reason and Norms. Oxford, England: Oxford University Press; 1975:15-32.
40. Beauchamp T, Childress J. The Principle of Biomedical Ethics. 5th ed. Oxford, England: Oxford University Press; 2001:14-21.
41. Brown D, Faler B. US to give AIDS foundation $100 Million Grant. Washington Post. August 1, 2002:A8.
42. Orentlicher D. Universality and its limits: when research ethics can reflect local circumstances. J Law Med Ethics. 2002;30:403-410.
43. Freedman B. Placebo-controlled trials and the logic of clinical purpose. IRB. 1990;12:1-6.
44. Msamanga G. Letter to the editor. N Engl J Med. 1998;338:842.