title: Evaluation of biobank constitution and use: multicentre analysis in France and propositions for formalising the activities of research ethics committees.
abstract: 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.
authors.affiliation: Laboratoire d'éthique médicale et médecine légale et institut international de recherche en éthique biomédicale (IIREB), faculté de médecine de Paris-5, 45, rue des Saints-Pères, 75006 Paris, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: de Montgolfier
authors.forename: Grégoire
authors.initials: G
authors.lastname: Moutel
authors.forename: Nathalie
authors.initials: N
authors.lastname: Duchange
authors.forename: Ingrid
authors.initials: I
authors.lastname: Callies
authors.forename: Lama
authors.initials: L
authors.lastname: Sharara
authors.forename: Catherine
authors.initials: C
authors.lastname: Beaumont
authors.forename: Josué
authors.initials: J
authors.lastname: Feingold
authors.forename: Christian
authors.initials: C
authors.lastname: Hervé
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000458:organization & administration* / Q000592:standards; D030541:Databases, Genetic / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards; D028744:Ethics Committees, Research / Q000592:standards* / Q000706:statistics & numerical data; D005602:France; D007258:Informed Consent; D012107:Research Design / Q000331:legislation & jurisprudence / Q000592:standards / Q000639:trends; D011795:Surveys and Questionnaires