Regulation of Biobanks in France.

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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.