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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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North-South benefit sharing arrangements in bioprospecting and genetic research: a critical ethical and legal analysis.

https://arctichealth.org/en/permalink/ahliterature167048
Source
Dev World Bioeth. 2006 Dec;6(3):122-34
Publication Type
Article
Date
Dec-2006
Author
Udo Schüklenk
Anita Kleinsmidt
Author Affiliation
Centre for Ethics in Public Policy and Corporate Governance, Glasgow Caledonian University, Glasgow, UK.
Source
Dev World Bioeth. 2006 Dec;6(3):122-34
Date
Dec-2006
Language
English
Publication Type
Article
Keywords
Biodiversity
Databases, Factual
Developed Countries
Developing Countries
Drug Industry - economics
Genetic Research - legislation & jurisprudence
Humans
International Cooperation
Organizations
Patents as Topic
Plants, Medicinal
Population Groups - genetics
Poverty
Public Policy
Social Justice
Tissue Donors
United Nations
Abstract
Most pharmaceutical research carried out today is focused on the treatment and management of the lifestyle diseases of the developed world. Diseases that affect mainly poor people are neglected in research advancements in treatment because they cannot generate large financial returns on research and development costs. Benefit sharing arrangements for the use of indigenous resources and genetic research could only marginally address this gap in research and development in diseases that affect the poor. Benefit sharing as a strategy is conceptually problematic, even if one, as we do, agrees that impoverished indigenous communities should not be exploited and that they should be assisted in improving their living conditions. The accepted concept of intellectual property protection envisages clearly defined originators and owners of knowledge, whereas the concept of community membership is fluid and indigenous knowledge is, by its very nature, open, with the originator(s) lost in the mists of time. The delineation of 'community' presents serious conceptual and practical difficulties as few communities form discrete, easily discernable groups, and most have problematic leadership structures. Benefit sharing is no substitute for governments' responsibility to uplift impoverished communities. Benefit sharing arrangements may be fraught with difficulties but considerations of respect and equity demand that prior informed consent and consultation around commercialisation of knowledge take place with the source community and their government.
PubMed ID
17038004 View in PubMed
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