title: Regulation of Biobanks in France.
abstract: The privacy of biobank research participants in France is protected by a combination of bioethics laws, research laws, and data protection laws. Although the law has attempted to facilitate research by creating an opt-out regime for research with pre-existing samples, other aspects of the law hinder research. The requirement for multiple consents throughout the process of biobank sample collection and use, the lack of acceptance of a broad consent for biobanking, and genetic exceptionalism in the law all complicate biobank research. With IRB approval, opt-out consent may be used for genetic research using human tissue collected for other purposes, but express consent is still required for research with the associated genetic data. Among the important issues remaining to be addressed are harmonizing and simplifying the various informed consent processes.
authors.affiliation: Permanent researcher in biolaw and bioethics at Inserm (French National Institute for research and health). Graduated from Toulouse and Bordeaux Universities, she has defended her thesis on the issues raised by the governance of biobanks at Paul Sabatier University in Toulouse. She is leading the ELSI common service of the French infrastructure "Biobanques."
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Rial-Sebbag
authors.affiliation: Ph.D. student in law at the University of law and political sciences Toulouse 1 Capitole. The title of her thesis is "Legal Issues Related to Access and Circulation of Genetic Information." She is also working at Inserm (French National Institute for research and health) as a jurist on legal and ethical issues raised by biomedical innovations. She graduated from University Toulouse 1 Capitole.
authors.forename: Anna
authors.initials: A
authors.lastname: Pigeon
mesh_terms: D022126:Access to Information / Q000331:legislation & jurisprudence; D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D003219:Confidentiality / Q000331:legislation & jurisprudence*; D005602:France; D036281:Genetic Research / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence