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AIDS Research: The Ethics of Clinical Trials

Published online by Cambridge University Press:  28 April 2021

Ruth Macklin  and
Gerald Friedland
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Extract

Research on AIDS involving human subjects poses in stark form a familiar dilemma: Can the demands of a rigorous scientific research design be met without violating the rights or harming the interests of research subjects? The dilemma is especially troubling in the early phases of drug research, when promising medications showing some signs of success in combatting this fatal disease must be tested for safety and efficacy. The research design using randomized controlled trials, in which an experimental drug is tested against a placebo, highlights the dilemma. Although the use of this research design does not pose the only ethical problem for AIDS research, it is perhaps the most dramatic. Related ethical issues include the question of when an experimental drug that holds out the only present hope may be released for general use; who should be selected to receive experimental drugs that are in short supply; how much information should be released about safety and efficacy while a clinical trial is still in progress; and what factors determine the appropriateness of early termination of a study.

Type
Article
Information
Law, Medicine and Healthcare , Volume 14 , Issue 5-6 , December 1986 , pp. 273 - 280
Copyright
Copyright © American Society of Law, Medicine and Ethics 1986

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References

Chase, M, AIDS research stirs bitter fight over use of experimental drugs, Wall Street Journal, June 18, 1986.Google Scholar
Schwartz, H, For society's sake, don't end test now, USA Today, September 18, 1986.Google Scholar
Chase, , supra note 1.Google Scholar
Id.Google Scholar
Id.Google Scholar
Yarchoan, R et al., Administration of 3-Azido-3-deoxythymidine, an inhibitor of HTLV-III/LAV replication to patients with AIDS or ARC, Lancet 1986, i (March 15): 575–80.Google Scholar
Burroughs, Wellcome, Uncontrolled clinical trial of the long term safety of AZT® (protocol for use of AZT supplied by the company).Google Scholar
Unpublished data presented at plenary session of the 26th Annual International Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September 1986.Google Scholar
National Commission for the Protection of Human Subjects, Belmont report, Washington, D.C.: Department of Health and Human Services, April 1979.Google Scholar
Id. at 4.Google Scholar
45 CFR 46.116.Google Scholar
National Commission, supra note 9, at 4.Google Scholar
Id.Google Scholar
Id. at 3.Google Scholar
Id. at 5.Google Scholar
Id.Google Scholar
Basile, H, on bill to add $47 million to AIDS research funding, quoted in USA Today, September 18, 1986.Google Scholar
Krim, M, Grant the gravely ill peace of hope, dignity, USA Today, September 18, 1986.Google Scholar
Schwartz, , supra note 2 (making an argument for continued evaluation using double-blind randomized trials with placebo control).Google Scholar
For patients' sake, release AZT now, USA Today, September 18, 1986.Google Scholar
Friedman, LM, Furberg, CD, DeMets, DL, Fundamentals of clinical trials, 2d ed., Littleton, Mass.: PSG Publishing Company, 1985 at 2.Google Scholar
Id. at 23.Google Scholar
Id. at 34.Google Scholar
Id. at 148.Google Scholar
Levine, RJ, The use of placebos in randomized clinical trials, IRB: A Review of Human Subjects Research 1985, 7:1.Google ScholarPubMed
Id.Google Scholar
Id. at 3.Google Scholar
Peto, R et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient, British Journal of Cancer 1976, 34: 594.Google ScholarPubMed
Chase, supra note 1.Google Scholar
Eckholm, E, AIDS drug is raising host of thorny issues, New York Times, September 28, 1986.Google Scholar
Gutmann, A, For and against equal access to health care, in President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Securing access to health care, vol. 2, Washington, D.C.: U.S. Government Printing Office, 1983: 51–66.Google Scholar