title: Genomic Databases and Biobanks in Denmark.
abstract: Biobanking in Denmark is regulated via patients' rights laws, data protection laws, and research ethics reviews. Danish law recognizes tissue samples as personal data for purposes of the data protection laws, meaning research with tissue samples may be subject to research ethics review, data protection laws, and patients' rights requirements depending on the circumstances of collection. However, research on information gained through whole genome sequencing is subject only to data protection laws, despite the similarity in the nature of the information. The regulatory framework treats biobank samples collected from patients differently than samples collected from research participants, particularly with respect to autonomy. Importantly, biobanks established for future unspecified research are not subject to research ethics review. Biobank-based research has gained more prominence on the national level recently, and the potential for a less fragmented and more consistent regulatory approach may emerge from this attention.
authors.affiliation: Professor of Health Law at the Faculty of Law at the University of Copenhagen, where she is heading the Centre for Legal Studies in Welfare and Market. She has a Ph.D. in Law from the University of Copenhagen in Denmark (1993) and an LL.D. in Law from the University of Copenhagen in Denmark (2006).
authors.forename: Mette
authors.initials: M
authors.lastname: Hartlev
mesh_terms: D022126:Access to Information / Q000331:legislation & jurisprudence; D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence*; D003219:Confidentiality / Q000331:legislation & jurisprudence*; D030541:Databases, Genetic / Q000331:legislation & jurisprudence*; D003718:Denmark; D036281:Genetic Research / Q000331:legislation & jurisprudence; D006801:Humans