Hostname: page-component-6bf8c574d5-xtvcr Total loading time: 0 Render date: 2025-02-21T13:17:29.187Z Has data issue: false hasContentIssue false
  • English
  • Français

Report on the National Commission: Good as Gold

Published online by Cambridge University Press:  01 January 2021

George J. Annas
Get access Rights & Permissions [Opens in a new window]

Abstract:

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research ended its work by substantially endorsing the status quo which places primary reliance on local Institutional Review Boards for subject protection. This was predictable because of the Commission's researcher-dominated composition which permitted it to assume that (1) research is good; (2) experimentation is almost never harmful to subjects, and (3) researcher-dominated IRBs can adequately protect the interests of human subjects. The successor Presidential Commission can learn much by re-examining these premises.

Type
Article
Information
Medicolegal News , Volume 8 , Issue 6 , December 1980 , pp. 4 - 7
Copyright
Copyright © American Society of Law, Medicine and Ethics 1980

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Heller, J., Good as Gold (Simon and Schuster, New York) (1979) at 195.Google Scholar
See, e.g., Levine, R.J., Clarifying the Concepts of Research Ethics, Hastings Center Report 9(3): 21–26 (June 1979); and Neville, R., On the National Commission: A Puritan Critique of Consensus Ethics, Hastings Center Report 9(2): 22–27 (April 1979).CrossRefGoogle ScholarPubMed
Established 42 U.S.C. §300v (subchapter xvi) (Nov. 9, 1978) [hereinafter cited as President's Commission].Google Scholar
National Research Service Award Act of 1974, P.L. 93–348, Title II, §201(b)(1), July 12, 1974.Google Scholar
42 U.S.C., §§(a)(1)(B), (C). Also see Annas, G.J., All the President's Bioethicists, Hastings Center Report 9(1): 14–15 (February 1979).Google ScholarPubMed
See generally, Limits of Scientific Inquiry, Daedalus 107 (Spring 1978).Google Scholar
Annas, G.J. Glantz, L.H. Katz, B.F., Informed Consent to Human Experimentation: The Subject's Dilemma (Ballinger, Cambridge, Mass.) (1977) at 234–42[hereinafter cited as Annas, Informed Consent).Google Scholar
Id.Google Scholar
43 Fed. Reg. 53242 (November 15, 1978).Google Scholar
Veatch, R.M., The National Commission Recommendations on IRBs: An Evolutionary Approach, Hastings Center Report 9(1): 22–28 (February 1979).CrossRefGoogle Scholar
Beecher, H.K., Ethics and Clinical Research, New England Journal of Medicine 274(24): 1354–60 (June 16, 1966).CrossRefGoogle ScholarPubMed
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Report and Recommendations on Institutional Review Boards (DHEW Pub. No. (OS) 78-008, Washington, D.C.) (1978) at 61–62; and Cardon, P. et al., Injuries to Research Subjects, New England Journal of Medicine 295(12): 650–54 (September 16, 1976).CrossRefGoogle ScholarPubMed
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Report and Recommendations: Psychosurgery (DHEW, Washington, D.C.) (1977); and Annas, , Informed Consent, supra note 7.Google ScholarPubMed
Comptroller General of the United States, Federal Control of New Drug Testing is Not Adequately Protecting Human Test Subjects and the Public, H.R. Doc. 76–96 (July 15, 1976).Google Scholar
Holden, C., FDA Tells Senators of Doctors Who Fake Data in Clinical Drug Trials, Science 206(4417): 432–33 (October 26, 1979).CrossRefGoogle ScholarPubMed
Rosenberg, K., Human Experimentation: Adding Insult to Injury, Health/PAC Bulletin, p. 2 (1979).Google Scholar
Letter Report of Comptroller General, H.R. Doc. 79–49 (February 6, 1979). One could also discuss bone marrow transplant cases involving death from graft vs. host disease in unsuccessful cases. See also, McCartney, J.M., Encephalitis and Ara–A: An Ethical Case Study, Hastings Center Report 8(6): 5–7 (December 1978).CrossRefGoogle Scholar
Barber, B. Lally, J.J. Makarushka, J.L. Sullivan, D., Research on Human Subjects: Problems of Social Control in Medical Experimentation (Russell Sage Foundation, New York) (1973).Google Scholar
Appendix (bound separately) to Report and Recommendations on Institutional Review Boards, supra note 12.Google Scholar
Gray, B.H., Human Subjects in Medical Experimentation: A Sociological Study of the Conduct and Regulation of Clinical Research (Wiley, New York) (1975).Google Scholar
Supra note 10, at 26.Google Scholar
Nuestadt, R.E. Fineberg, H.V., The Swine Flu Affair: Decision–making on a Slippery Disease (U.S. Gov. Printing Office, Stock No. 017–000–00210–4. Washington, D.C.) (1978) at 63.Google Scholar
Id.Google Scholar
Robertson, J., Ten Ways to Improve IRBs, Hastings Center Report 9(1): 29–33 (February 1979).CrossRefGoogle ScholarPubMed
Supra note 1, at 198.Google Scholar