A comparative analysis of the requirements for the use of data in biobanks based in Finland, Germany, the Netherlands, Norway and the United Kingdom

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Moraia, L.B.; Kaye, J.; Tasse, A.M.; Knoppers, B.M.; Mitchell, C. et al.: A comparative analysis of the requirements for the use of data in biobanks based in Finland, Germany, the Netherlands, Norway and the United Kingdom. In: Medical Law International 14 (2014), Nr. 4, S. 187-212. DOI: https://doi.org/10.1177/0968533215571956

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To cite the version in the repository, please use this identifier: https://doi.org/10.15488/2284

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Sum total of downloads: 277




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Abstract: 
To understand the causes of disease and improve diagnosis and treatment regimes, biomedical researchers need access to large numbers of well-characterized data and samples. Over the past decade, biobanks have been established across Europe to collect and manage access to data and samples. The challenge that we face is how to develop the tools and collaborations to enable researchers to access samples and data from a network of biobanks, rather than applying to individual biobanks. One of the perceived stumbling blocks to achieving this is represented by the different legal requirements in each country. The aim of the BioSHaRE-European Union (EU) project is to address these challenges by developing tools and methods for researchers to access and use pooled data from different cohort and biobank studies. The purpose of this article is to identify and compare the key legal requirements regarding research use of data across biobanks based in Finland Germany, the Netherlands, Norway and the UK. Our investigation starts with the analysis of the key differences for the use of data between these countries. As a result, we identified three key areas where legal requirements differ across the five BioSHaRE-EU jurisdictions, namely, in the definition of personal data, the requirements regarding pseudonymization and processing for medical research purposes. This article provides an overview of these differences and describes them in the light of the proposed EU regulation on data protection. © The Author(s) 2014.
License of this version: Es gilt deutsches Urheberrecht. Das Dokument darf zum eigenen Gebrauch kostenfrei genutzt, aber nicht im Internet bereitgestellt oder an Außenstehende weitergegeben werden. Dieser Beitrag ist aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.
Document Type: Article
Publishing status: publishedVersion
Issue Date: 2014
Appears in Collections:Philosophische Fakultät

distribution of downloads over the selected time period:

downloads by country:

pos. country downloads
total perc.
1 image of flag of Germany Germany 100 36.10%
2 image of flag of United States United States 58 20.94%
3 image of flag of No geo information available No geo information available 12 4.33%
4 image of flag of Netherlands Netherlands 9 3.25%
5 image of flag of France France 7 2.53%
6 image of flag of China China 7 2.53%
7 image of flag of Ukraine Ukraine 5 1.81%
8 image of flag of Sweden Sweden 5 1.81%
9 image of flag of Russian Federation Russian Federation 5 1.81%
10 image of flag of Belgium Belgium 5 1.81%
    other countries 64 23.10%

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