title: Access Governance for Biobanks: The Case of the BioSHaRE-EU Cohorts.
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.
authors.affiliation: 1 HeLEX Centre for Health, Law and Emerging Technologies, Nuffield Department of Population Health, University of Oxford , Oxford, United Kingdom .
authors.forename: Jane
authors.initials: J
authors.lastname: Kaye
authors.affiliation: 1 HeLEX Centre for Health, Law and Emerging Technologies, Nuffield Department of Population Health, University of Oxford , Oxford, United Kingdom .
authors.forename: Linda
authors.initials: L
authors.lastname: Briceño Moraia
authors.affiliation: 1 HeLEX Centre for Health, Law and Emerging Technologies, Nuffield Department of Population Health, University of Oxford , Oxford, United Kingdom .
authors.forename: Colin
authors.initials: C
authors.lastname: Mitchell
authors.affiliation: 1 HeLEX Centre for Health, Law and Emerging Technologies, Nuffield Department of Population Health, University of Oxford , Oxford, United Kingdom .
authors.forename: Jessica
authors.initials: J
authors.lastname: Bell
authors.affiliation: 2 Legal Pathways Institute for Health and Bio-Law , Aerdenhout, the Netherlands .
authors.forename: Jasper Adriaan
authors.initials: JA
authors.lastname: Bovenberg
authors.affiliation: 3 Public Population Project in Genomics and Society (P3G) , Montreal, Canada .
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Tassé
authors.affiliation: 3 Public Population Project in Genomics and Society (P3G) , Montreal, Canada .|4 Centre of Genomics and Policy, McGill University , Montreal, Canada .
authors.forename: Bartha Maria
authors.initials: BM
authors.lastname: Knoppers
mesh_terms: D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence* / Q000458:organization & administration*; D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D003299:Cooperative Behavior; D016208:Databases, Factual; D005062:European Union; D005387:Finland; D005858:Germany; D006801:Humans; D033181:Information Dissemination / Q000331:legislation & jurisprudence*; D007400:Interprofessional Relations; D009426:Netherlands; D009664:Norway; D006113:United Kingdom