The French Law on “Protection of Persons Undergoing Biomedical Research”: Implications for the U.S.

Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10 , vol. 2 (Washington, D.C.: U.S. Government Printing Office, 1949): At 181–82, available at <http://ohsr.od.nih.gov/nuremberg.php3>.

World Medical Association Declaration of Helsinki (June 1964), available at <http://ohsr.od.nih.gov/helsinki.php3>.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Washington, D.C.: U.S. Government Printing Office, 1979).

Protection of Human Subjects, 45 C.F.R. § 46.101(a) (2002).

Protection of Human Subjects, 21 C.F.R.§ 50 (2003); Institutional Review Boards, 21 C.F.R. § 56 (2003).

Emanuel E.J. Wendler D. Grady C. , “What Makes Clinical Research Ethical?,” JAMA, 283 (2000): 2701–11.

U.S. General Accounting Office, Scientific Research: Continued Vigilance Critical to Protecting Human Subjects (Washington, D.C.: U.S. General Accounting Office, 1996); Advisory Committee on Human Radiation Experiments, Research Ethics and the Medical Profession (1995), reprinted in JAMA , 276 (1996): 403–09; Moreno J. Caplan A.L. Wolpe P.R. , “Updating Protections for Human Subjects Involved in Research,” JAMA, 280 (1998): 1951–58; Woodward B. , “Challenges to Human Subject Protections in US Medical Research,” JAMA, 282 (1999): 1947–52; Shalala D. , “Protecting Research Subjects – What Must be Done?,” N. Engl. J. Med., 343 (2000): 808–10; National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants (Bethesda, MD, 2001).

National Bioethics Advisory Commission, supra note 7; U.S. Department of Health and Human Services, Office of Inspector General, Institutional Review Boards: A Time for Reform, (June 1998).

National Bioethics Advisory Commission, supra note 7; U.S. Department of Health and Human Services, supra note 8; Edgar H. Rothman D.J. , “The Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation,” Milbank Quarterly, 73 (1995): 489–506; Sugarman J. , “The Role of Institutional Support in Protecting Human Research Subjects,” Academic Medicine, 75 (2000): 687–92.

Burman W.J. , “Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards,” Annals of Internal Medicine, 134 (2001): 152–57.

National Bioethics Advisory Commission, supra note 7; U.S. Department of Health and Human Services, supra note 8; Agnew B. , “Financial Conflicts Get More Scrutiny in Clinical Trials,” Science, 289 (2000): 1266–67.

Dickert N. Grady C. , “What's the Price of a Research Subject? Approaches to Payment for Research Participation,” N Engl. J Med., 341 (1999) 198–203.

Advisory Committee on Human Radiation Experiments, supra note 7; Moreno J. , supra note 7; National Bioethics Advisory Commission, supra note 7; Marwick C. , “Compensation for Injured Research Subjects,” JAMA, 279 (1998): 1854.

See Advisory Committee on Human Radiation Experiments, supra note 7.

Law No. 88–1138 of December 20, 1988, J.O., December 22, 1988, pp. 16,032–16,035.

Law No. 98–535 of July 1, 1998, J;0., July 2, 1998, p. 10,056; Decree No. 99–146 of March 4, 1999, J.O., March 5, 1999, p. 3301.

Appendix to Order No. 2000–548 of June 15, 2000, J.O., June 22, 2000, pp. 37,505–37,509.

See Law No. 88–1138, supra note 15, at 16,032 (Art. L. 209–1). All translations from the French are by the author (IB).

45 C.F.R. 46.102(d) (2002).

Law No. 88–1138, supra note 15, at 16032 (Art. L. 209–2).

Id. at 16,032 (Art. L. 209–5).

Id. at 16,033 (Art. L. 209–7).

45 C.F.R.§ 46.116 (2002).

Law No. 88–1138, supra note 15, at 16,033 (Art. L. 209–11).

Baradat C. Verny A. , “Ethical Review of French Clinical Trials,” Applied Clinical Trials, 9 (2000): 54–56.

Appendix to order No. 2000–548 of June 15, 2000, J.O., June 22, 2000, p. 37,506, Art. L. 1123–3.

Appendix to Order No. 2000–548 of June 15, 2000, J.O., June 22, 2000, p. 37,506, Art. L. 1123–5.

Appendix to Order No. 2000–548 of June 15, 2000, J.O., June 22, 2000, pp. 37,506–37,507, Art. L. 1123–7.

Appendix to Order No. 2000–548 of June 15, 2000, J.O., June 22, 2000, p. 37,507, Art. L. 1123–8.

Appendix to Order No. 2000–548 of June 15, 2000, J.O.June 22, 2000, p. 37,507, Art. L. 1123–8.

Law No. 94–548 of July 1, 1994, J.O., July 2, 1994, p. 9,559.

Appendix to Order No. 2000–548 of June 15, 2000, J.O.June 22, 2000, p. 37,508, Art. L. 1126–1.

Personal communication from C. Grillot-Courvalin, Ministry of Health, France to author (IB) (February 26, 2001).

Personal communication from P. Vella and L. Fluckiger, FASHHP to author (IB) (February 26, 2001).

Huriet C. , The Protection of Persons Undergoing Biomedical Research: The Role of Ethics Committees: Balance and Suggestions, Reports of the Senate. No. 267 (2000–2001).

45 C.F.R. § 46 (2002).

See sources cited supra note 7.

See National Bioethics Advisory Commission, supra note 7 (Recommendation 2.1).

Id. (Recommendation 2.3)

See U.S. General Accounting Office, supra note 7.

See National Bioethics Advisory Commission, supra note 7 (Recommendation 3.10).

Id. (Recommendation 2.2).

Id. (Recommendation 6.6).

45 C.F.R. § 46.102(d) (2002).

45 C.F.R. § 46.107(a) (2002).

See U.S. General Accounting Office, supra note 7.

Ashcroft R. Pfeffer N. , “Ethics Behind Closed Doors: Do Research Ethics Committees Need Secrecy?,” British Medical Journal, 322 (2001): 1294–96.