Consent for Biobanking: The Legal Frameworks of Countries in the BioSHaRE-EU Project

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Kaye, J.; Briceño Moraia, L.; Curren, L.; Bell, J.; Mitchell, C. et al.: Consent for Biobanking: The Legal Frameworks of Countries in the BioSHaRE-EU Project. In: Biopreservation and Biobanking 14 (2016), Nr. 3, S. 195-200. DOI: https://doi.org/10.1089/bio.2015.0123

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To cite the version in the repository, please use this identifier: https://doi.org/10.15488/5339

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Sum total of downloads: 125




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Abstract: 
Currently, there is no single, Europe-wide regulation of biomedical research using human samples and data. Instead, the law that applies spans a number of areas of law, such as data protection, clinical trials, and tissue regulation. In the absence of harmonized regulation, there is considerable scope for national legal variation. This article analyzes the legislative frameworks that apply to biobanking activities to identify differences in legal requirements between the BioSHaRE-EU project countries: Finland, France, Germany, the Netherlands, Norway, and the United Kingdom. This article highlights the primary role of consent and accompanying governance mechanisms, such as research ethics committee oversight, which enable consent exemptions in the context of research. Our analysis identifies a complicated legal landscape, whereby broadly similar provisions are contained in varied sources of law in each jurisdiction. The challenge for researchers is locating the applicable legal provisions within each national legal framework.
License of this version: CC BY 4.0 Unported
Document Type: Article
Publishing status: publishedVersion
Issue Date: 2016
Appears in Collections:Forschungszentren

distribution of downloads over the selected time period:

downloads by country:

pos. country downloads
total perc.
1 image of flag of Germany Germany 56 44.80%
2 image of flag of United States United States 24 19.20%
3 image of flag of China China 7 5.60%
4 image of flag of Netherlands Netherlands 6 4.80%
5 image of flag of United Kingdom United Kingdom 5 4.00%
6 image of flag of New Zealand New Zealand 4 3.20%
7 image of flag of Canada Canada 4 3.20%
8 image of flag of Indonesia Indonesia 2 1.60%
9 image of flag of France France 2 1.60%
10 image of flag of Czech Republic Czech Republic 2 1.60%
    other countries 13 10.40%

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