PMID: identifier of
Pubmed reference: |
 |
 (15546685) |
|
| title: |
|
Improving protection for research subjects in France: analysis of regional ethics committees. |
|
| author(s): |
|
Isabelle Fauriel1, Grégoire Moutel1, Nathalie Duchange1, Ingrid Callies1, Irène François1, Claude Huriet2, Christian Hervé1 |
|
| laboratory: |
|
|
|
| abstract: |
|
OBJECTIVE: The aim of this study was to analyze the functioning of the French committees for the protection of people in biomedical research (CCPPRB). DESIGN: An independent evaluator visited all of the committees and analyzed their functioning by assessing the annual activity reports, filling data grids and observing the committees in session. RESULTS: We observed that the representation of a range of professions, which is required by law, was not always respected. This was partly because the administrative authority had accumulated delays in nominating members. Another explanation could be the absence of remuneration for the work and attendance of the members. There was considerable inter-committee variation concerning the way documents were distributed to the members during sessions and the extent of investigator and promoter involvement. Finally, large differences in the number of dossiers handled between committees led us to investigate the fairness of dossier distribution, as the number of dossiers dealt with has consequences, particularly for the finality of the opinions of the committees. CONCLUSIONS: This evaluation of the committees playing a crucial role in protecting participants in research trials provides new information that could be helpful for improving the way in which these committees function in the context of the European Directive. |
|
| subject: |
|
Life Sciences/Health Care Sciences and Epidemiology
|
|
| fulltext language: |
|
English |
|
| ISSN: |
|
0273-2300 |
|
|
| publication format: |
|
Article in peer-reviewed journal |
|
| DOI: |
|
10.1016/j.yrtph.2004.08.003 |
|
| journal: |
|
Regul Toxicol Pharmacol |
|
| publication date: |
|
2004 |
|
| volume: |
|
40 |
|
| page, identifiant, ...: |
|
312-8 |
|
|
| MeSH Descriptor(s): |
|
Clinical Protocols – Committee Membership – Data Collection – Documentation – Ethics Committees – Research – France – Research Subjects – Research Support – Non-U.S. Gov't – Clinical Protocols – Ethics |
|
| contract, financing: |
|
This study was supported by a grant from the Health Ministry of France in the framework of the PHRC (98– 115) and by the Institut International de Recherche enEthique Biomédicale (IIREB). |
|
