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Genomic Databases and Biobanks in Denmark.

https://arctichealth.org/en/permalink/ahliterature280292
Source
J Law Med Ethics. 2015;43(4):743-53
Publication Type
Article
Date
2015
Author
Mette Hartlev
Source
J Law Med Ethics. 2015;43(4):743-53
Date
2015
Language
English
Publication Type
Article
Keywords
Access to Information - legislation & jurisprudence
Biological Specimen Banks - legislation & jurisprudence
Confidentiality - legislation & jurisprudence
Databases, Genetic - legislation & jurisprudence
Denmark
Genetic Research - legislation & jurisprudence
Humans
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.
PubMed ID
26711414 View in PubMed
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[Patient rights in training situations].

https://arctichealth.org/en/permalink/ahliterature145217
Source
Ugeskr Laeger. 2010 Feb 22;172(8):620-2
Publication Type
Article
Date
Feb-22-2010
Author
Nadia Lander Landex
Mette Hartlev
Author Affiliation
Københavns Universitet, Institut for Cellulaer og Molekylaer Medicin og Det Juridiske Fakultet, Denmark. nllandex@sund.ku.dk
Source
Ugeskr Laeger. 2010 Feb 22;172(8):620-2
Date
Feb-22-2010
Language
Danish
Publication Type
Article
Keywords
Clinical Clerkship
Denmark
Education, Medical
Humans
Informed Consent - legislation & jurisprudence
Internship and Residency
Patient Education as Topic
Patient Rights - legislation & jurisprudence
Practice Guidelines as Topic
Students, Medical
Abstract
Danish health law does not explicitly consider the participation of patients in clinical training of medical students. This causes uncertainty with regards to patients' rights and to the obligations of the hospital and the medical student. In this paper, we evaluate the legal aspects as regards information, consent and privacy in situations where patients are involved in the training of medical students. We conclude that it is necessary to elucidate the legal aspects and develop legal and practical guidelines for these situations.
PubMed ID
20184818 View in PubMed
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