Improving protection for research subjects in France: Analysis of regional ethics committees

Regulatory Toxicology and Pharmacology

Volumn 40, Issue 3, 2004, Pages 312-318

  Fauriel, I ^a   Moutel, G ^a   Duchange, N ^a   Callies, I ^a   Francois I ^a   Huriet, C ^b   Herve C ^a  

^a UNIVERSITÉ PARIS DESCARTES   (France)

^b INSTITUT CURIE   (France)

Author keywords

Biomedical research; Ethics; Evaluation; Research Ethics Committees

Indexed keywords

ADULT; AGED; ANALYSIS; ARTICLE; AUTHORITY; CONTROLLED STUDY; FEMALE; FRANCE; HUMAN; LAW; MALE; MEDICAL ETHICS; MEDICAL RESEARCH; OCCUPATION; ORGANIZATION; PRIORITY JOURNAL; PROTECTION; WORK;

BIOMEDICAL AND BEHAVIORAL RESEARCH; EMPIRICAL APPROACH;

CLINICAL PROTOCOLS; COMMITTEE MEMBERSHIP; DATA COLLECTION; DOCUMENTATION; ETHICS COMMITTEES, RESEARCH; FRANCE; RESEARCH; RESEARCH SUBJECTS;

EID: 8844281637     PISSN: 02732300     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.yrtph.2004.08.003     Document Type: Article

References (22)

1. M.R. Anderlik, and N. Elster Currents in contemporary ethics J. Law Med. Ethics 29 2 2001 220 228
2. R. Dal-Re, J. Espada, and R. Ortega Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines J. Med. Ethics 25 1999 168 173
3. Decree No. 90-872 of 27th September 1990 concerning the application of law no. 88-1138 of 20th December 1988, modified concerning the protection of people participating in biomedical research and modifying the Public Health Code (second part: Conseil d'Etat decrees). JO République française, 20th September 1990, pp. 11862-11868
4. Decree no. 97-888 of 1st October 1997 relating to the protection of people participating in biomedical research and modifying the Public Health Code (second part: Conseil d'Etat decrees): permanent and deputy members
5. Decree no. 97-889 of 1st October 1997 relating to the nomination of members to consultative committees for the protection of people participating in biomedical research and modifying the Public Health Code (third part: Decrees)
6. DHHS Inspector General, 1998. Institutional Review Boards: a time for reform. Bulletin of Medical Ethics August 7-11
7. Directive 2001/20/EC of the European Parliament and of the Council of 4th April 2001 on the harmonisation of laws, regulations and administrative provisions of the Member States relating to the implantation of good clinical practice in the conduct of clinical trials on medicinal products for human use, 1 May 2001. Official Journal L121 pp. 34-44
8. F.A. Goldner Dealing with conflicts of interest in biomedical research: IRB oversight as the next best solution to the abolitionist approach J. Law Med. Ethics 28 2000 379 404
9. M.A. Hayes, A.C. Timmins, E.H. Yau, M. Palazzo, C.J. Hinds, and D. Watson Elevation of systemix oxygen delivery in the treatment of critically ill patients New England Journal of Medicine 330 24 1994 1717 1722
10. Hervé, C., 1999. Il ne peut être d'Ethique en santé publique que dans la multidisciplinarité. In: Une responsabilité de santé publique ? Interfaces européennes, Industriels/ utilisateurs. L'Harmattan eds, Condé-sur-Noireau, pp. 11-17
11. Huriet, C., 2001. Rapport d'information N°267 du Sénat fait au nom des Affaires Sociales sur le fonctionnement des Comités consultatifs de protection des Personnes dans la Recherche Biomédicale
12. Huriet Law No. 88-1138 of 20th December 1988 concerning the protection of persons participating in biomedical research. JO République française, 22nd December 1988, pp. 5-8
13. Lemaire, F., 2002. Les pratiques de recherche biomédicale visitées par la bioéthique. Dalloz eds, Malesherbes, pp. 44-49
14. G. McGee, A.L. Caplan, J.P. Spanogme, and D.A. Asch A national study of ethics committees Am. J. Bioethics 4 1 2001 60 64
15. G. McGee, J. Spanogle, A.L. Caplan, D. Penny, and D.A. Asch Successes and failures of hospital ethics committees: a national survey of ethics committee chairs Camb. Q. Healthc. Ethics II 2002 87 93
16. G. Moutel, N. Leroux, and C. Hervé Analysis of a survey of 36 French research committees on intracystoplasmic sperm injection Lancet 351 1998 1121 1123
17. Nuremberg Code, No. 5, 1947
18. R.G. Rawbone Observations from six years' experience of a health and safety research ethics committee Bull. Med. Ethics 2000 13 19
19. R. Steinbrook Improving protection for research subjects N. Engl. J. Med. 346 18 2002 1425 1429
20. J. Takala, E. Ruokonen, N.R. Webster, and M.S. Nielsen Increased mortality associated with growth hormone treatment in critical adults N. Engl. J. Med. 341 11 1999 785 792
21. World Medical Association Declaration of Heath, Helsinki, 1989. Declaration of Helsinki: Ethical Principles for Research Involving Human Subjects. Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964. Amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975; the 35th World Medical Assembly, Venice, Italy, October 1983; the 41st World Medical Assembly, Hong Kong, September 1989; the 48th General Assembly, Somerset West, republic of South Africa, October 1996; and the 52nd General Assembly, Edinburgh, Scotland, October 2000
22. P. Wolkenstein, J. Latarjet, J.C. Roujeau, and C. Duguet Randomised comparison of thalidomide versus placebo in toxic epiderm necrolysis Lancet 352 9140 1998 1586 1589