Regulating international biobank networks. (360G-Wellcome-081407_Z_06_Z)

The purpose of this research is to identify, evaluate and recommend appropriate regulatory solutions to the current legal obstacles which inhibit the sharing of biological samples and digital information in biobanks used for genomic research within Europe and at a global level. It will generate recommendations for policy-makers about the best options for the future regulation of biobanks. This research will map the supranational organisations that are responsible for biomedical regulation and the key legal instruments that apply to biobanks and research networks. Drawing on specific case studies, regulatory theory and literature, this research will analyse the possible regulatory mechanisms that could be developed, or adapted, to facilitate the cross-border networking of biobanks. It will test some of the principles and theories of regulatory scholarship that have been developed in areas outside biomedicine, to determine how relevant they may be for biobank regulation. This research will address some of the current deficits in regulatory scholarship regarding biomedical regulation at European and international levels, as well as contributing to the wider debate about the regulation of innovative technologies.