Hostname: page-component-586b7cd67f-dlnhk Total loading time: 0 Render date: 2024-11-20T06:57:20.241Z Has data issue: false hasContentIssue false
  • English
  • Français

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

Published online by Cambridge University Press:  01 January 2021

Ivan Berlin  and
David A. Gorelick
Get access Rights & Permissions [Opens in a new window]

Extract

Because research involving human subjects exposes people to risk not always for their own potential benefit, the question arises as to how best ensure that: (1) research participants are protected and benefited according to the highest ethical standards, while, on the other hand, (2) researchers are protected and free to do research that will produce clinical advances for both research participants and society as a whole.

The balancing of the risk to research participants versus the benefits derived from the research is performed in many counrries by a system for the protection of human research participants that is laid out in national laws and regulations. In the United States, this system is based on principles emanating from the Nuremberg Code, the World Medical Association Declaration of Helsinki,and the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the Belmont Rept).

Type
Article
Information
Journal of Law, Medicine & Ethics , Volume 31 , Issue 3 , Fall 2003 , pp. 434 - 441
Copyright
Copyright © American Society of Law, Medicine and Ethics 2003

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

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>..>Google Scholar
World Medical Association Declaration of Helsinki (June 1964), available at <http://ohsr.od.nih.gov/helsinki.php3>..>Google Scholar
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).Google Scholar
Protection of Human Subjects, 45 C.F.R. § 46.101(a) (2002).Google Scholar
Protection of Human Subjects, 21 C.F.R.§ 50 (2003); Institutional Review Boards, 21 C.F.R. § 56 (2003).Google Scholar
Emanuel, E.J. Wendler, D. Grady, C., “What Makes Clinical Research Ethical?,” JAMA, 283 (2000): 2701–11.Google Scholar
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).Google ScholarPubMed
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).Google Scholar
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.CrossRefGoogle Scholar
Burman, W.J. et al., “Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards,” Annals of Internal Medicine, 134 (2001): 152–57.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
Advisory Committee on Human Radiation Experiments, supra note 7; Moreno, J. et al., supra note 7; National Bioethics Advisory Commission, supra note 7; Marwick, C., “Compensation for Injured Research Subjects,” JAMA, 279 (1998): 1854.Google Scholar
See Advisory Committee on Human Radiation Experiments, supra note 7.Google Scholar
Law No. 88–1138 of December 20, 1988, J.O., December 22, 1988, pp. 16,032–16,035.Google Scholar
Law No. 98–535 of July 1, 1998, J;O., July 2, 1998, p. 10,056; Decree No. 99–146 of March 4, 1999, J.O., March 5, 1999, p. 3301.Google Scholar
Appendix to Order No. 2000–548 of June 15, 2000, J.O., June 22, 2000, pp. 37,505–37,509.Google Scholar
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).Google Scholar
45 C.F.R. 46.102(d) (2002).Google Scholar
Law No. 88–1138, supra note 15, at 16032 (Art. L. 209–2).Google Scholar
Id. at 16,032 (Art. L. 209–5).Google Scholar
Id. at 16,033 (Art. L. 209–7).Google Scholar
Id.Google Scholar
Id.Google Scholar
45 C.F.R.§ 46.116 (2002).CrossRefGoogle Scholar
Law No. 88–1138, supra note 15, at 16,033 (Art. L. 209–11).Google Scholar
Baradat, C. Verny, A., “Ethical Review of French Clinical Trials,” Applied Clinical Trials, 9 (2000): 54–56.Google Scholar
Appendix to order No. 2000–548 of June 15, 2000, J.O., June 22, 2000, p. 37,506, Art. L. 1123–3.Google Scholar
Appendix to Order No. 2000–548 of June 15, 2000, J.O., June 22, 2000, p. 37,506, Art. L. 1123–5.Google Scholar
Appendix to Order No. 2000–548 of June 15, 2000, J.O., June 22, 2000, pp. 37,506–37,507, Art. L. 1123–7.Google Scholar
Appendix to Order No. 2000–548 of June 15, 2000, J.O., June 22, 2000, p. 37,507, Art. L. 1123–8.Google Scholar
Appendix to Order No. 2000–548 of June 15, 2000, J.O.June 22, 2000, p. 37,507, Art. L. 1123–8.Google Scholar
Law No. 94–548 of July 1, 1994, J.O., July 2, 1994, p. 9,559.Google Scholar
Appendix to Order No. 2000–548 of June 15, 2000, J.O.June 22, 2000, p. 37,508, Art. L. 1126–1.Google Scholar
Personal communication from C. Grillot-Courvalin, Ministry of Health, France to author (IB) (February 26, 2001).Google Scholar
Personal communication from P. Vella and L. Fluckiger, FASHHP to author (IB) (February 26, 2001).Google Scholar
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).Google Scholar
45 C.F.R. § 46 (2002).Google Scholar
See sources cited supra note 7.Google Scholar
See National Bioethics Advisory Commission, supra note 7 (Recommendation 2.1).Google Scholar
Id. (Recommendation 2.3)Google Scholar
See U.S. General Accounting Office, supra note 7.Google Scholar
See National Bioethics Advisory Commission, supra note 7 (Recommendation 3.10).Google Scholar
Id. (Recommendation 2.2).Google Scholar
Id. (Recommendation 6.6).Google Scholar
45 C.F.R. § 46.102(d) (2002).Google Scholar
45 C.F.R. § 46.107(a) (2002).CrossRefGoogle Scholar
See U.S. General Accounting Office, supra note 7.Google Scholar
Ashcroft, R. Pfeffer, N., “Ethics Behind Closed Doors: Do Research Ethics Committees Need Secrecy?,” British Medical Journal, 322 (2001): 1294–96.CrossRefGoogle Scholar