Moral Standards for Research in Developing Countries From "Reasonable Availability" to "Fair Benefits"
Commentators have argued that when research conducted in a developing country shows an intervention to be effective, the intervention must be made “reasonably available” to the host population after the trial. But this standard is sometimes too stringent, and sometimes too lenient. It offers a benef...
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| Published in | The Hastings Center report Vol. 34; no. 3; pp. 17 - 27 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Oxford, UK
Blackwell Publishing Ltd
01.05.2004
The Hastings Center Hastings Center |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0093-0334 1552-146X |
| DOI | 10.2307/3528416 |
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| Abstract | Commentators have argued that when research conducted in a developing country shows an intervention to be effective, the intervention must be made “reasonably available” to the host population after the trial. But this standard is sometimes too stringent, and sometimes too lenient. It offers a benefit, but not necessarily a fair benefit. |
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| AbstractList | One subject that has received less discussion in clinical research conducted and sponsored by developed countries in developing countries is the requirement that any drugs proven effective during research be made available to the host population after the trial. Commentators of the 2001 Conference on Ethical Aspects of Research in Developing Countries have argued that when research conducted in a developing country shows an intervention to be effective, the intervention must be made reasonably available to the host population after the trial. However, this standard is sometimes too stringent, and sometimes too lenient, offering benefit but not necessarily fair benefit. Here, the moral standards for research in developing countries are discussed. Argues the "fair benefits" framework offers a more reliable and justifiable way to avoid exploitation of the host population of medical research trials when research proves a treatment to be an effective intervention, as opposed to making interventions "reasonably available"; compares the two approaches in the hepatitis A vaccine trial in Thailand. Commentators have argued that when research conducted in a developing country shows an intervention to be effective, the intervention must be made “reasonably available” to the host population after the trial. But this standard is sometimes too stringent, and sometimes too lenient. It offers a benefit, but not necessarily a fair benefit. |
| Audience | Professional Academic |
| Author | English, Michael Diarra, Doumbia Aissata Clerk, Christine Alexandra Sugarman, Jeremy Mfutso-Bengu, Joseph Maiga, Saïbou Molyneux, Malcolm Agbenyega, Tsiri Higgs, Elizabeth Kumwenda, Newton Plowe, Christopher Lie, Reidar El Setouhy, Maged Anto, Francis Talisuna, Ambrose Youssouf, Dione Ecuru, Julius Wendler, David Sylla, Mamadou Taylor, Terrie Peshu, Norbert Ngassapa, David Falade, Catherine Olufunke Mugusi, Ferdinand Grady, Christine Juma, Rashid Molyneux, Catherine Koram, Kwadwo A. Gbadegesin, Segun Emanuel, Ezekiel |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/15281723$$D View this record in MEDLINE/PubMed |
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| References | T. Pogge, World Poverty and Human Rights (Cambridge, U.K.: Polity Press, 2002), chapters 1 and 4. L.H. Glantz et al., "Research in Developing Countries: Taking "Benefit" Seriously," Hastings Center Report 28, 6 (1998): 38-42; G.J. Annas and M.A. Grodin, "Human Rights and Maternal-Fetal HIV Transmission Prevention Trials in Africa," American Journal of Public Health 88 (1998): 560-63. Interview with Prof Natth," Good Clinical Practice Journal 6, 6 (1999): 11. H.T. Shapiro and E.M. Meslin, "Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries," NEJM 345 (2001): 139-42. See also National Bioethics Advisory Commission, Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries (Washington D.C.: U.S. Government Printing Office, 2001). J. Rawls, A Theory of Justice, 2nd edition (Cambridge, Mass.: Harvard University Press, DATE). A. Wertheimer, Exploitation (Princeton, N.J.: Princeton University Press, 1999), chapter 1; N.A. Christakis, "The Ethical Design of an AIDS Vaccine Trial in Africa," Hastings Center Report 28 (1998): 31-37. A. W. Wood, "Exploitation," Social Philosophy and Policy 12 (1995): 135-58. I. Chalmers, "What is the Prior Probability of a Proposed New Treatment being Superior to Established Treatments?" BMJ 314 (1997): 74-75; B. Djulbegovic et al., "The Uncertainty Principle and Industry-Sponsored Research," Lancet 356 (2000): 635-38. E.J. Emanuel, D. Wendler, and C. Grady, "What Makes Clinical Research Ethical?" JAMA 283 (2000): 2701-711; E.J. Emanuel et al., "What Makes Clinical Research in Developing Countries Ethicial? The Benchmarks of Ethical Research," Journal of Infectious Diseases 189 (2004): 930-37. C. Hoke et al., "Protection against Japanese Encephalitis by Inactivated Vaccines," NEJM 319 (1988): 608-614. Medical Research Council of the United Kingdom, Interim Guidelines 'Research Involving Human Participants in Developing Societies: Ethical Guidelines for MRC-sponsored Studies (London: MRC, 1999); Joint United National Programme on HIV/AIDS (UNAIDS), Ethical Considerations in HIV Preventive Vaccine Research (Geneva: UNAIDS, 2000); National Consensus Conference, Guidelines for the Conduct of Health Research Involving Human Subjects in Uganda (Kampala, Uganda: National Consensus Conference, 1997); Medical Research Council of South Africa, Guidelines on Ethics for Medical Research (South Africa: Medical Research Council, 1993). C.A. Kozik et al., "Causes of Death and Unintentional Injury among School Children in Thailand," Southeast Asian Journal of Tropical Medicine and Public Health 30 (1999): 129-35. Ibid.; R.J. Levine, Ethical and Regulatory Aspects of Clinical Research, 2nd Edition (New Haven, Conn.: Yale University Press, 1988). M. Barry, "Ethical Considerations of Human Investigation in Developing Countries: the AIDS Dilemma," NEJM 319 (1988) 1083-86; M. Angell, "Ethical Imperialism? Ethics in International Collaborative Clinical Research," NEJM 319 (1988): 1081-83; N.A. Christakas, "The Ethical Design of an AIDS Vaccine Trial in Africa," Hastings Center Report 18, no. 3 (1988): 31-37. CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2nd edition (Geneva: CIOMS, 2002). B.I. Innis et al. Protection against Hepatitis A by an Inactivated Vaccine," JAMA 271 (1994): 1328-34. A. Gutmann and D. Thompson, Democracy and Disagreement (Cambridge, Mass.: Harvard University Press, 1996). P. Lurie and S.M. Wolfe, "Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries," NEJM 337 (1997): 853-56; M. Angell, "The Ethics of Clinical Research in the Third World," NEJM 337 (1997): 847-49; H. Varmus and D. Satcher, "Ethical Complexities of Conducting Research in Developing Countries," NEJM 337 (1997): 1003-1005; R. Crouch and J. Arras, "AZT Trials and Tribulations," Hastings Center Report 28, no. 6 (1998): 26-34; C. Grady, "Science in the Service of Healing," Hastings Center Report 28, no. 6 (1998): 34-38; R.J. Levine, "The "Best Proven Therapeutic Method' Standard in Clinical Trials in Technologically Developing Countries," IRB 20 (1998): 5-9; B.R. Bloom, "The Highest Attainable Standard: Ethical Issues in AIDS Vaccines," Science 279 (1998): 186-88. N. Black, "Evidence based policy: proceed with care," BMJ 323 (2001): 275-79. 1998; 28 1997; 314 1997; 337 1995; 12 1994; 271 2000; 283 1996 1999; 30 2002 1988; 319 1999; 6 2001; 345 2001; 323 1999 1988 15281717 - Hastings Cent Rep. 2004 May-Jun;34(3):3 |
| References_xml | – reference: C.A. Kozik et al., "Causes of Death and Unintentional Injury among School Children in Thailand," Southeast Asian Journal of Tropical Medicine and Public Health 30 (1999): 129-35. – reference: J. Rawls, A Theory of Justice, 2nd edition (Cambridge, Mass.: Harvard University Press, DATE). – reference: H.T. Shapiro and E.M. Meslin, "Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries," NEJM 345 (2001): 139-42. See also National Bioethics Advisory Commission, Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries (Washington D.C.: U.S. Government Printing Office, 2001). – reference: N. Black, "Evidence based policy: proceed with care," BMJ 323 (2001): 275-79. – reference: CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2nd edition (Geneva: CIOMS, 2002). – reference: B.I. Innis et al. Protection against Hepatitis A by an Inactivated Vaccine," JAMA 271 (1994): 1328-34. – reference: T. Pogge, World Poverty and Human Rights (Cambridge, U.K.: Polity Press, 2002), chapters 1 and 4. – reference: L.H. Glantz et al., "Research in Developing Countries: Taking "Benefit" Seriously," Hastings Center Report 28, 6 (1998): 38-42; G.J. Annas and M.A. Grodin, "Human Rights and Maternal-Fetal HIV Transmission Prevention Trials in Africa," American Journal of Public Health 88 (1998): 560-63. – reference: Interview with Prof Natth," Good Clinical Practice Journal 6, 6 (1999): 11. – reference: Medical Research Council of the United Kingdom, Interim Guidelines 'Research Involving Human Participants in Developing Societies: Ethical Guidelines for MRC-sponsored Studies (London: MRC, 1999); Joint United National Programme on HIV/AIDS (UNAIDS), Ethical Considerations in HIV Preventive Vaccine Research (Geneva: UNAIDS, 2000); National Consensus Conference, Guidelines for the Conduct of Health Research Involving Human Subjects in Uganda (Kampala, Uganda: National Consensus Conference, 1997); Medical Research Council of South Africa, Guidelines on Ethics for Medical Research (South Africa: Medical Research Council, 1993). – reference: M. Barry, "Ethical Considerations of Human Investigation in Developing Countries: the AIDS Dilemma," NEJM 319 (1988) 1083-86; M. Angell, "Ethical Imperialism? Ethics in International Collaborative Clinical Research," NEJM 319 (1988): 1081-83; N.A. Christakas, "The Ethical Design of an AIDS Vaccine Trial in Africa," Hastings Center Report 18, no. 3 (1988): 31-37. – reference: E.J. Emanuel, D. Wendler, and C. Grady, "What Makes Clinical Research Ethical?" JAMA 283 (2000): 2701-711; E.J. Emanuel et al., "What Makes Clinical Research in Developing Countries Ethicial? The Benchmarks of Ethical Research," Journal of Infectious Diseases 189 (2004): 930-37. – reference: A. Gutmann and D. Thompson, Democracy and Disagreement (Cambridge, Mass.: Harvard University Press, 1996). – reference: I. Chalmers, "What is the Prior Probability of a Proposed New Treatment being Superior to Established Treatments?" BMJ 314 (1997): 74-75; B. Djulbegovic et al., "The Uncertainty Principle and Industry-Sponsored Research," Lancet 356 (2000): 635-38. – reference: A. Wertheimer, Exploitation (Princeton, N.J.: Princeton University Press, 1999), chapter 1; N.A. Christakis, "The Ethical Design of an AIDS Vaccine Trial in Africa," Hastings Center Report 28 (1998): 31-37. – reference: A. W. Wood, "Exploitation," Social Philosophy and Policy 12 (1995): 135-58. – reference: P. Lurie and S.M. Wolfe, "Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries," NEJM 337 (1997): 853-56; M. Angell, "The Ethics of Clinical Research in the Third World," NEJM 337 (1997): 847-49; H. Varmus and D. Satcher, "Ethical Complexities of Conducting Research in Developing Countries," NEJM 337 (1997): 1003-1005; R. Crouch and J. Arras, "AZT Trials and Tribulations," Hastings Center Report 28, no. 6 (1998): 26-34; C. Grady, "Science in the Service of Healing," Hastings Center Report 28, no. 6 (1998): 34-38; R.J. Levine, "The "Best Proven Therapeutic Method' Standard in Clinical Trials in Technologically Developing Countries," IRB 20 (1998): 5-9; B.R. Bloom, "The Highest Attainable Standard: Ethical Issues in AIDS Vaccines," Science 279 (1998): 186-88. – reference: Ibid.; R.J. Levine, Ethical and Regulatory Aspects of Clinical Research, 2nd Edition (New Haven, Conn.: Yale University Press, 1988). – reference: C. Hoke et al., "Protection against Japanese Encephalitis by Inactivated Vaccines," NEJM 319 (1988): 608-614. – volume: 6 start-page: 11 issue: 6 year: 1999 article-title: Interview with Prof Natth publication-title: Good Clinical Practice Journal – volume: 323 start-page: 275 year: 2001 end-page: 79 article-title: Evidence based policy: proceed with care publication-title: BMJ – volume: 337 start-page: 853 year: 1997 end-page: 56 article-title: Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries publication-title: NEJM – volume: 30 start-page: 129 year: 1999 end-page: 35 article-title: Causes of Death and Unintentional Injury among School Children in Thailand publication-title: Southeast Asian Journal of Tropical Medicine and Public Health – start-page: 87 – volume: 319 start-page: 608 year: 1988 end-page: 614 article-title: Protection against Japanese Encephalitis by Inactivated Vaccines publication-title: NEJM – volume: 314 start-page: 74 year: 1997 end-page: 75 article-title: What is the Prior Probability of a Proposed New Treatment being Superior to Established Treatments?” publication-title: BMJ – volume: 271 start-page: 1328 year: 1994 end-page: 34 article-title: Protection against Hepatitis A by an Inactivated Vaccine publication-title: JAMA – year: 2002 – volume: 345 start-page: 139 year: 2001 end-page: 42 article-title: Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries publication-title: NEJM – year: 1988 – start-page: 1993 – year: 1996 – volume: 28 start-page: 38 issue: 6 year: 1998 end-page: 42 article-title: Research in Developing Countries: Taking “Benefit” Seriously publication-title: Hastings Center Report – volume: 12 start-page: 135 year: 1995 end-page: 58 article-title: Exploitation publication-title: Social Philosophy and Policy – volume: 283 start-page: 2701 year: 2000 end-page: 711 article-title: What Makes Clinical Research Ethical?” publication-title: JAMA – volume: 319 start-page: 1083 year: 1988 end-page: 86 article-title: Ethical Considerations of Human Investigation in Developing Countries: the AIDS Dilemma publication-title: NEJM – year: 1999 – reference: 15281717 - Hastings Cent Rep. 2004 May-Jun;34(3):3 |
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| Snippet | Commentators have argued that when research conducted in a developing country shows an intervention to be effective, the intervention must be made “reasonably... One subject that has received less discussion in clinical research conducted and sponsored by developed countries in developing countries is the requirement... Argues the "fair benefits" framework offers a more reliable and justifiable way to avoid exploitation of the host population of medical research trials when... |
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| SubjectTerms | Bioethics Clinical Trials as Topic - ethics Developing Countries Economic benefits Ethical aspects Ethics, Research Fairness Health Services Accessibility Hepatitis Hepatitis A Vaccines Humans International aspects International Cooperation LDCs Medical research Medical service Medicine, Experimental Morality Morals Prevention Public health Research facilities Research studies Social Responsibility Socioeconomics Thailand Vaccination Vaccination and vaccines |
| Title | Moral Standards for Research in Developing Countries From "Reasonable Availability" to "Fair Benefits" |
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