Towards biobank privacy regimes in responsible innovation societies: ESBB conference in Granada 2012.

The creation of socially and technically robust biobank privacy regimes presupposes knowledge of and compliance with legal rules, professional standards of the biomedical community, and state-of-the-art data safety and security measures. The strategies in privacy management and data protection presented in this review show a trend that goes beyond searching for compromises or efforts of balancing scientific demands for efficiency and societal demands for effective privacy regimes. They focus on developing synergies that facilitate cooperative use of biomaterials and data and enhance sample search efficiency for researchers on the one hand, and protect rights and interests of donors and citizens on the other hand. Among the issues covered are: a) ethical sensitivities and public perceptions on privacy in biobanking b) tools and procedures that allow maintenance of the rights and dignity of donors, without jeopardizing legitimate information needs of researchers and autonomy of biobanks, and c) a privacy sensitive framework for sharing of data and biomaterials in the research context.

Biobank governance: heterogeneous modes of ordering and democratization.

The great interest in biobanks, the related, substantial investments, and the expectations connected with them raises the question of how to explain the relative successes and failures of contemporary biobank projects. In this article we will present and discuss areas that need ongoing attention by many stakeholders in order stabilize and utilize biobanks and biobank networks in the future. Our aim is to present and utilize an analytical model for comparing structures of biobank governance. The governance model we deduce from empirical case studies is not a well-ordered, almost bureaucratic type of government. The patchwork character and the interrelatedness of heterogeneous activities that constitute biobank governance in its multiple dimensions will be highlighted. Biobank governance should therefore be understood as strategy for patterning a network of interaction that unfolds within and across a number of different fields including a variety of activities that go beyond regulatory activities: the scientific/technological field, the medical/health field, the industrial-economic field, the legal-ethical, and the sociopolitical field. Our account emphasizes that biobanks are not technical visions that operate vis-à-vis an external society. The article discusses attempts to develop participatory governance structures. It concludes that facilitating and managing the integration of a network of more or less interrelated actors, in many nonhierarchic ways, should not be equated with democratization per se, but can nevertheless be regarded as an important step towards a more pluralistic and inclusive style of policy making.

Biobank governance in the post-genomic age.

Biobank governance is about the regulation of the relationship between individual citizens, society and biobanks. Its key agenda is to link society, citizens and biobanks with respect to issues of consent, privacy, ownership, access and benefit sharing. With the transformation of biobank research from local/national activities towards transnational projects and the emergence of post-genomic medical research, biobanks need to establish novel governance structures. We consider governance solutions that focus on 'bioethical-theoretical' arguments to be of only limited value in this context. By contrast, we think the key lies in developing participatory arrangements that are responsive to the views of patients and 'lay people', and also operate on a transnational level. The social-political and communicative competence of biobank infrastructures must be improved, thereby assuring the long-term legitimacy and commitment to these often highly expensive projects from a large variety of different stakeholders over the decades.