Setting up of a Clinical Research Centers Ethics Committee in Rhône-Alpes-Auvergne district;Création d'un Comité d'Éthique des Centres d'Investigation Clinique en région Rhône-Alpes-Auvergne

Therapie

Volumn 63, Issue 4, 2008, Pages 321-325

  Varagnes, Séverine Chomel De ^a   Duale, Christian ^b   Dubray, Claude ^b   Cracowski, Jean Luc ^a,c  

^a GRENOBLE UNIVERSITY HOSPITAL   (France)

^b SERVICE DE RHUMATOLOGIE   (France)

^c HÔPITAL MICHALLON   (France)

Author keywords

Ethics committee; IRB acknowledgment; Non interventional research

Indexed keywords

ARTICLE; CLINICAL RESEARCH; ETHICS; FRANCE; HUMAN; INSTITUTIONAL REVIEW; LAW ENFORCEMENT; MEDICAL RESEARCH; PRIORITY JOURNAL; RESEARCH ETHICS;

EID: 55049112208     PISSN: 00405957     EISSN: None     Source Type: Journal    
DOI: 10.2515/therapie:2008050     Document Type: Article

References (12)

1. Loi Française sur la recherche biomédicale (chapitre Ier du titre II du livre Ier de la première partie du Code de la Santé Publique). Journal officiel de la République Française, Loi no 2004-806 du 9 août 2004 modifiant la loi no88-1138. http://www.legifrance. gouv.fr/
2. Lemaire F. Do all types of human research need Ethics Committee approval? Am J Respir Crit Care Med 2006; 141: 363-4
3. Institutional Review Board guidebook. http://www.hhs.gov/ohrp/irb/ irb_guidebook.htm
4. Code of federal regulations, title 45-public welfare-department of health and human services, part 46-protection of human subjects, Subpart A- Basic HHS Policy for Protection of Human Research Subjects, §46.101 To what does this policy apply? http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101
5. Déclaration d'Helsinki de l'Association Médicale Mondiale. Principes éthiques applicables aux recherches médicales sur des sujets humains. http://www.wma.net/f/policy/b3.htm
6. The office of human research ethics. A guide to IRB process. What kinds of IRB review are there? http://ohre.unc.edu/guide_to_irb.php#whatirbrev
7. Code of federal regulations, title 45-public welfare-department of health and human services, part 46-protection of human subjects, subpart A- Basic HHS Policy for Protection of Human Research Subjects, §46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. http://www.hhs.gov/ohrp/ humansubjects/guidance/45cfr46.htm#46.110
8. http://www.hhs.gov/ohrp/assurances/index.html
9. Office for Human Research Protections (OHRP). Registration of an Institutional Review Board (IRB) or Independent Ethics Committee (IEC). http://www.hhs.gov/ohrp/assurances/#registernew
10. Lemaire F, Ravoire S, Golinelli D. Non-interventional research and usual care: definition, regulatory aspects, difficulties and recommendations. Therapie 2008; 63 (2): 103-6
11. Decullier E, Lhéritier V, Chapuis F. The activity of French research ethics committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study. BMC Medical Ethics 2005; 6: 9
12. Office for Human Research Protections (OHRP). List of registered IRBs. http://ohrp.cit.nih.gov/search/irctrypck.asp