KatzJay, “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, 1–6.
2.
BeecherHenry Knowles, “Ethics and Clinical Research”, New England Journal of Medicine, 274; 1966: 1354–60. For a recent review of Beecher's impact, see RothmanDavid J., “Ethics and Human Experimentation: Henry Beecher Revisited”, New England Journal of Medicine, Vol. 317, No. 19, November 5, 1987, 1195–99.
3.
Katz, supra note 1, p. 1.
4.
Ibid.
5.
The most comprehensive discussion of both ethical norms and regulatory requirements is found in RobertJ. Levine, Ethics and Regulation of Clinical Research, 2nd ed. (Baltimore: Urban & Schwarzenberg, 1986).
6.
Katz, supra note 1, 3.
7.
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.
8.
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.
9.
JonasHans, “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.
10.
BayerRonaldLevineCarol and MurrayThomas H., “Guidelines for Confidentiality in Research with AIDS”, IRB: A Review of Human Subjects Research, 6: 6, November/December 1984, 1–7.
11.
BayerRonaldLevineCarol and WolfSusan M., “HIV Antibody Screening: An Ethical Framework for Evaluating Proposed Programs”, Journal of the American Medical Association 256: 13 (October 2, 1986), 1768–74.
12.
HullHarry F., “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.
13.
NovicAlvinDublerNeveloff Nancy and LandesmanSheldon 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, 6–9.
14.
WindomRobert E., Assistant Secretary for Health, “Policy on Informing Those Tested about HIV Serostatus,” letter to PHS agency heads, Washington DC, May 9, 1988.
15.
Presidential Commission on the HIV Epidemic, Final Report, Washington DC: June 1988, 50–53.
16.
Food and Drug Administration: Investigational New Drug, Antibiotic, and Biological Drug Product Regulations; Treatment Use and Sale: Final Rule. Federal Register52 (No. 99): 19466–19477, May 22, 1987.
17.
LevineRobert 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, 1–4.
18.
MitchellSheila C. and SteingrubJay, “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.
19.
For an excellent analysis of these issues and questions of study design, see MacklinRuth and FriedlandGerald, “AIDS Research: The Ethics of Clinical Trials,”Law, Medicine & Health Care, Volume 14: 5–6, December 1986, 273–80. Also see GrodinMichael A.KaminowPaula V. and SassowerRaphael, “Ethical Issues in AIDS Research”, New England Journal of Public Policy, 4 (1), Winter/Spring 1988, 215–225.
20.
AppelbaumPaul S., “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception”, Hastings Center Report, April 1987, pp. 20–24.
21.
CaplanArthur 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. 1–5.
22.
See Nicholas A. Christakis, “The Ethical Design of an AIDS Vaccine Trial in Africa,”Hastings Center Report, 18: 3, June/July, 1988, pp. 31–37.
23.
RamseyPaul, The Patient as Person (New Haven: Yale University Press, 1970), pp. 10–11.
