PMID: identifiant
de la référence Pubmed : |
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 (16530713) |
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| titre : |
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Evaluation of biobank constitution and use: multicentre analysis in France and propositions for formalising the activities of research ethics committees. |
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| auteur(s) : |
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Sandrine De Montgolfier1, Grégoire Moutel ( ) 1, Nathalie Duchange1, Ingrid Callies1, Lama Sharara1, Catherine Beaumont1, Josué Feingold1, Christian Hervé1 |
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| laboratoire : |
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| résumé : |
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Biobanks are collections of biological material and related files gathered and stored for clinical or research purposes. Here, we investigated the questions raised during the evaluation of biobanks by biomedical Research Ethics Committees (RECs), particularly in the context of genetic research. We sent a questionnaire to all RECs in France to survey their concerns and the ethical criteria used when evaluating research involving the storage of biological samples. Most of the RECs think that they should be consulted to evaluate the constitution of biobanks. The proportion of RECs of this opinion depended on whether the biobank is being constituted in the absence of an associated research project (initially created for clinical purposes or for undefined research) (14/28), whether the biobank is being constituted for research use (21/28) or whether an existing research biobank is being re-used (19/28). Views diverged concerning the way ethics principles are applied, showing that REC evaluations of biobanks might be formalised at each of the following steps: constitution, use and re-use. In this paper, we suggest concrete elements that could be integrated into the application of the new French law concerning the protection of the human beings participating in research as well as into international recommendations. |
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| domaine : |
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langue du texte
intégral : |
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Anglais |
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| ISSN : |
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1769-7212 |
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| type de publication : |
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Articles dans des revues avec comité de lecture |
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| DOI : |
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10.1016/j.ejmg.2004.12.002 |
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| journal : |
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| European Journal of Medical Genetics |
| Publisher |
Elsevier |
| ISSN |
1769-7212 |
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| Audience : |
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internationale |
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| date de publication : |
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2006 |
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| volume : |
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49 |
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| numéro : |
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2 |
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| page, identifiant, ... : |
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159-67 |
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| mots-clés auteur : |
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Biobank – Research Ethics Committee – Biomedical research – Informed consent – Human biological resources – Genetic databases |
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| Descripteur(s) MeSH : |
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Biomedical Research – Databases – Genetic – Ethics Committees – Research – France – Informed Consent – Questionnaires – Research Design |
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