Report on the National Commission: Good as Gold

Heller J. , Good as Gold (Simon and Schuster, New York) (1979) at 195.

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).

Established 42 U.S.C. §300v (subchapter xvi) (Nov. 9, 1978) [hereinafter cited as President's Commission].

National Research Service Award Act of 1974, P.L. 93–348, Title II, §201(b)(1), July 12, 1974.

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).

See generally, Limits of Scientific Inquiry, Daedalus 107 (Spring 1978).

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).

Id.

43 Fed. Reg. 53242 (November 15, 1978).

Veatch R.M. , The National Commission Recommendations on IRBs: An Evolutionary Approach, Hastings Center Report 9(1): 22–28 (February 1979).

Beecher H.K. , Ethics and Clinical Research, New England Journal of Medicine 274(24): 1354–60 (June 16, 1966).

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. , Injuries to Research Subjects, New England Journal of Medicine 295(12): 650–54 (September 16, 1976).

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.

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).

Holden C. , FDA Tells Senators of Doctors Who Fake Data in Clinical Drug Trials, Science 206(4417): 432–33 (October 26, 1979).

Rosenberg K. , Human Experimentation: Adding Insult to Injury, Health/PAC Bulletin, p. 2 (1979).

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).

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).

Appendix (bound separately) to Report and Recommendations on Institutional Review Boards, supra note 12.

Gray B.H. , Human Subjects in Medical Experimentation: A Sociological Study of the Conduct and Regulation of Clinical Research (Wiley, New York) (1975).

Supra note 10, at 26.

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.

Id.

Robertson J. , Ten Ways to Improve IRBs, Hastings Center Report 9(1): 29–33 (February 1979).

Supra note 1, at 198.