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    Access Governance for Biobanks: The Case of the BioSHaRE-EU Cohorts

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    Author
    Kaye, J; Moraia, LB; Mitchell, C; Bell, J; Bovenberg, JA; Tasse, A-M; Knoppers, BM
    Date
    2016-06-01
    Source Title
    Biopreservation and Biobanking
    Publisher
    MARY ANN LIEBERT, INC
    University of Melbourne Author/s
    Kaye, Jane; Bell, Jessica
    Affiliation
    Melbourne Law School
    Metadata
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    Document Type
    Journal Article
    Citations
    Kaye, J., Moraia, L. B., Mitchell, C., Bell, J., Bovenberg, J. A., Tasse, A. -M. & Knoppers, B. M. (2016). Access Governance for Biobanks: The Case of the BioSHaRE-EU Cohorts. BIOPRESERVATION AND BIOBANKING, 14 (3), pp.201-206. https://doi.org/10.1089/bio.2015.0124.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/257017
    DOI
    10.1089/bio.2015.0124
    Abstract
    Currently, researchers have to apply separately to individual biobanks if they want to carry out studies that use samples and data from multiple biobanks. This article analyzes the access governance arrangements of the original five biobank members of the Biobank Standardisation and Harmonisation for Research Excellence in the European Union (BioSHaRE-EU) project in Finland, Germany, the Netherlands, Norway, and the United Kingdom to identify similarities and differences in policies and procedures, and consider the potential for internal policy "harmonization." Our analysis found differences in the range of researchers and organizations eligible to access biobanks; application processes; requirements for Research Ethics Committee approval; and terms of Material Transfer Agreements relating to ownership and commercialization. However, the main elements of access are the same across biobanks; access will be granted to bona fide researchers conducting research in the public interest, and all biobanks will consider the scientific merit of the proposed use and it's compatibility with the biobank's objectives. These findings suggest potential areas for harmonization across biobanks. This could be achieved through a single centralized application to a number of biobanks or a system of mutual recognition that places a presumption in favor of access to one biobank if already approved by another member of the same consortium. Biobanking and Biomolecular Resources Research Infrastructure-European Research Infrastructure Consortia (BBMRI-ERIC), a European consortium of biobanks and bioresources with its own ethical, legal, and social implications (ELSI) common service, could provide a platform by developing guidelines for harmonized internal processes.

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