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dc.contributor.authorKaye, J
dc.contributor.authorMoraia, LB
dc.contributor.authorCurren, L
dc.contributor.authorBell, J
dc.contributor.authorMitchell, C
dc.contributor.authorSoini, S
dc.contributor.authorHoppe, N
dc.contributor.authorOien, M
dc.contributor.authorRial-Sebbag, E
dc.date.accessioned2020-12-21T02:37:24Z
dc.date.available2020-12-21T02:37:24Z
dc.date.issued2016-06-01
dc.identifier.citationKaye, J., Moraia, L. B., Curren, L., Bell, J., Mitchell, C., Soini, S., Hoppe, N., Oien, M. & Rial-Sebbag, E. (2016). Consent for Biobanking: The Legal Frameworks of Countries in the BioSHaRE-EU Project. BIOPRESERVATION AND BIOBANKING, 14 (3), pp.195-200. https://doi.org/10.1089/bio.2015.0123.
dc.identifier.issn1947-5535
dc.identifier.urihttp://hdl.handle.net/11343/257001
dc.description.abstractCurrently, 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.
dc.languageEnglish
dc.publisherMARY ANN LIEBERT, INC
dc.titleConsent for Biobanking: The Legal Frameworks of Countries in the BioSHaRE-EU Project
dc.typeJournal Article
dc.identifier.doi10.1089/bio.2015.0123
melbourne.affiliation.departmentMelbourne Law School
melbourne.source.titleBiopreservation and Biobanking
melbourne.source.volume14
melbourne.source.issue3
melbourne.source.pages195-200
dc.rights.licenseCC BY
melbourne.elementsid1236763
melbourne.contributor.authorKaye, Jane
melbourne.contributor.authorBell, Jessica
dc.identifier.eissn1947-5543
melbourne.accessrightsOpen Access


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