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Has AIDS Changed the Ethics of Human Subjects Research?

Published online by Cambridge University Press:  28 April 2021

Extract

Jay Katz has been a pioneer in exploring the ethics of human subjects research. We are all the more grateful because he has given us a map of the landmarks along the path of what he has called his personal odyssey. That intellectual journey, from the horrors of Auschwitz to the callous disregard of human rights in the Tuskegee syphilis study, can serve as a guide to us today as we attempt to measure and direct the impact of AIDS on the ethics and regulation of research.

Professor Katz's account of his odyssey begins with the sources of his concern. At Yale Law School in 1966, with his colleague Richard Donnelly, he began teaching what was probably the first semester-long seminar on human experimentation. In preparation he read for the first time the trial transcripts of the Nuremberg proccedings against the Nazi physicians. I had lost most of my cousins, aunts, and uncles in the Holocaust, he writes. How many of them, I wondered, had been condemned to participation in these experiments?

Type
Autonomy and Risk-Taking
Copyright
Copyright © American Society of Law, Medicine and Ethics 1988

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References

Katz, Jay, “The Regulation of Human Experimentation in the United States—A Personal Odyssey”, IRB: A Review of Human Subjects Research Vol. 9, No. 1, January/February 1987, 16.Google Scholar
Beecher, Henry Knowles, “Ethics and Clinical Research”, New England Journal of Medicine, 274; 1966: 1354–60. For a recent review of Beecher's impact, see Rothman, David J., “Ethics and Human Experimentation: Henry Beecher Revisited”, New England Journal of Medicine, Vol. 317, No. 19, November 5, 1987, 1195–99.Google Scholar
Katz, , supra note 1, p. 1.Google Scholar
The most comprehensive discussion of both ethical norms and regulatory requirements is found in Robert, J. Levine, Ethics and Regulation of Clinical Research, 2nd ed. (Baltimore: Urban & Schwarzenberg, 1986).Google Scholar
Katz, , supra note 1, 3.Google Scholar
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report, Washington DC: Department of Health, Education and Welfare, 1978.Google Scholar
The Department of Health and Human Services regulations are contained in Tide 45; Code of Federal Regulations; Part 46; revised as of March 8, 1983. The most important sections of the Food and Drug Regulations are contained in Title 21; Code of Federal Regulations; Parts 50 and 56; issued January 27, 1981.Google Scholar
Jonas, Hans, “Philosophical Reflections on Experimenting with Human Subjects” in his Philosophical Essays: From Ancient Creed to Technological Man (Englewood Cliffs, NJ: Prentice-Hall, Inc., 1974), 124–25.Google Scholar
Bayer, Ronald Levine, Carol and Murray, Thomas H., “Guidelines for Confidentiality in Research with AIDS”, IRB: A Review of Human Subjects Research, 6: 6, November/December 1984, 17.Google Scholar
Bayer, Ronald Levine, Carol and Wolf, Susan M., “HIV Antibody Screening: An Ethical Framework for Evaluating Proposed Programs”, Journal of the American Medical Association 256: 13 (October 2, 1986), 1768–74.CrossRefGoogle Scholar
Hull, Harry F.et al, “Comparison of HIV-Antibody Prevalence in Patients Consenting to and Declining HIV-Antibody Testing in an STD Clinic”, Journal of the American Medical Association 260: 7 (1988), 935–38.Google Scholar
Novic, Alvin Dubler, Neveloff Nancy and Landesman, Sheldon M., “Do Research Subjects Have the Right Not to Know their HIV Antibody Status?” IRB: A Review of Human Subjects Research, 8: 5, September/October 1986, 69.Google Scholar
Windom, Robert E., Assistant Secretary for Health, “Policy on Informing Those Tested about HIV Serostatus,” letter to PHS agency heads, Washington DC, May 9, 1988.Google Scholar
Presidential Commission on the HIV Epidemic, Final Report, Washington DC: June 1988, 5053.Google Scholar
Food and Drug Administration: Investigational New Drug, Antibiotic, and Biological Drug Product Regulations; Treatment Use and Sale: Final Rule. Federal Register 52 (No. 99): 19466–19477, May 22, 1987.Google Scholar
Levine, Robert J., “FDA's New Rule on Treatment Use and Sale of Investigational New Drugs”, IRB: A Review of Human Subjects Research, 9: 4, July/August 1987, 14.Google Scholar
Mitchell, Sheila C. and Steingrub, Jay, “The Changing Clinical Trials Science: The Role of the IRB”, IRB: A Review of Human Subjects Research, 10: 4, July/August 1988, pp. 2, 4.Google Scholar
For an excellent analysis of these issues and questions of study design, see Macklin, Ruth and Friedland, Gerald, “AIDS Research: The Ethics of Clinical Trials,” Law, Medicine & Health Care, Volume 14: 56, December 1986, 273–80. Also see Grodin, Michael A. Kaminow, Paula V. and Sassower, Raphael, “Ethical Issues in AIDS Research”, New England Journal of Public Policy, 4 (1), Winter/Spring 1988, 215–225.Google Scholar
Appelbaum, Paul S.et al, “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception”, Hastings Center Report, April 1987, pp. 2024.Google Scholar
Caplan, Arthur L., “Is There a Duty to Serve as a Subject in Biomedical Research?” IRB: A Review of Human Subjects Research, 6: 5, September/October, 1984, pp. 15.Google Scholar
See Christakis, Nicholas A., “The Ethical Design of an AIDS Vaccine Trial in Africa,” Hastings Center Report, 18: 3, June/July, 1988, pp. 3137.Google Scholar
Ramsey, Paul, The Patient as Person (New Haven: Yale University Press, 1970), pp. 1011.Google Scholar
Katz, , supra note 1, 5.Google Scholar