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- Title
Regulation of Biobanks in France.
- Authors
Rial-Sebbag, Emmanuelle; Pigeon, Anna
- 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.
- Subjects
FRANCE; BIOBANKS -- Law &; legislation; RIGHT of privacy; GOVERNMENT regulation; HUMAN research subjects -- Legal status, laws, etc.; MEDICAL research laws; INFORMED consent (Medical law); MEDICAL ethics laws; TISSUE banks -- Law &; legislation; DATA security laws; HEALTH insurance; MEDICAL research; BIOETHICS; GENOMICS; HEALTH care industry
- Publication
Journal of Law, Medicine & Ethics, 2015, Vol 43, Issue 4, p754
- ISSN
1073-1105
- Publication type
Article
- DOI
10.1111/jlme.12317