Rhetoric and Research Ethics: An Answer to Annas

42 U.S.C. §289–3(a), (b).

45 C.F.R. §46.101 et seq.

45 C.F.R. §46. 106–46.

P.L. 93–348, Title II §§201–205, July 12, 1974.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research [hereinafter cited as National Commission), the Belmont Report (DHEW Pub. No. (OS) 78–0012, Washington, D.C.) (1978).

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

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

President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Meeting IV Minutes, pp. 2–3 (September 15–16, 1980).

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

National Commission, supra note 5, Report and Recommendations on Institutional Review Boards (DHEW Pub. No. (OS) 78–008, Washington, D.C.) (1978).

Appendix (bound separately) to Report and Recommendations on Institutional Review Boards, supra note 10; 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).

Annas G.J. Glantz L.H. Katz B.F. , Informed Consent to Human Experimentation: The Subject's Dilemma (Ballinger, Cambridge, Mass.,) (1977) [hereinafter cited as Annas, Informed Consent].

National Commission, supra note 5, Report and Recommendations: Psychosurgery (DHEW, Washington, D.C.) (1977) at 68.

National Commission, supra note 5, Report and Recommendations: Research Involving Children (DHEW, Washington, D.C.) (1977) at 7–17.

Annas, Informed Consent, supra note 12, at 182–83.

National Commission, supra note 5, Report and Recommendations: Research Involving Prisoners (DHEW, Washington, D.C.) (1976) at 14–21; Annas, Informed Consent, supra note 12, at 133–34.

43 Fed. Reg. 53652–56 (November 16, 1978).

National Commission, supra note 5, Report and Recommendations: Research Involving Those Institutionalized as Mentally Infirm (DHEW, Washington, D.C.) (1978) at 1–22; Annas, Informed Consent, supra note 12, at 182–83.

40 Fed. Reg. 33526 (August 8, 1975).

Annas, Informed Consent, supra note 12, at 211.