title: Consent for Biobanking: The Legal Frameworks of Countries in the BioSHaRE-EU Project.
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.
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: Liam
authors.initials: L
authors.lastname: Curren
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: 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: 2 Academic Medical Centre of Helsinki (AMCH) Biobank , Helsinki, Finland .
authors.forename: Sirpa
authors.initials: S
authors.lastname: Soini
authors.affiliation: 3 CELLS-Centre for Ethics and Law in the Life Sciences , Leibniz, Universitaet Hannover, Hannover, Germany .
authors.forename: Nils
authors.initials: N
authors.lastname: Hoppe
authors.affiliation: 4 NTNU Norwegian University of Science and Technology , Trondheim, Norway .
authors.forename: Morten
authors.initials: M
authors.lastname: Øien
authors.affiliation: 5 INSERM UMR 1027 Département d'épidémiologie et de santé publique, Faculté de Médecine, Université Paul Sabatier-Toulouse III , Toulouse, France .
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Rial-Sebbag
mesh_terms: D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence*; D035843:Biomedical Research / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D032962:Consent Forms / Q000458:organization & administration; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence*; D005062:European Union / Q000458:organization & administration; D005387:Finland; D005602:France; D005858:Germany; D006801:Humans; D009426:Netherlands; D009664:Norway; D006113:United Kingdom