AI Article Synopsis
- Biobanking in Denmark is governed by laws regarding patients' rights, data protection, and research ethics reviews, emphasizing the legal status of tissue samples as personal data.
- Research involving tissue samples may require ethics review and comply with data protection laws, while whole genome sequencing data only falls under data protection regulations.
- There is a distinction in regulations for biobank samples based on their source, with biobanks for unspecified future research exempt from ethics review, potentially leading to a more unified regulatory framework as biobanking gains national attention.
Article 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.
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| http://dx.doi.org/10.1111/jlme.12316 | DOI Listing |
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