Big Biobanks: Three Major Governance Challenges and Some Mini-constitutional Responses

Volume: 4

Pages: 175-196

DOI: 10.1007/978-3-319-28731-7_14

Abstract:

The development of “Big Biobanks” (population-wide biobanks that are established as a resource to be curated for access and use by the research community) is relatively new, and it is taking place at a time when the possibility of undertaking quite detailed genotyping and sequencing is assuming much greater prominence. Although there is much to debate concerning such biobanks, there is broad agreement that their good governance and legitimacy hinges on two fundamental conditions: first, that the interests of the participants are respected; and, secondly, that the activities are compatible with the public interest. Given this context, three of the many governance challenges faced by Big Biobanks will be discussed. First, there is question of whether individual “informed consent” can continue to function where hundreds of thousands of participants are involved and where the particular research purposes and projects to be pursued are not specified in advance. Secondly, there is the hot topic of the moment, namely whether biobanks have any responsibility to return individual clinically-significant findings to participants who, because of the longitudinal nature of such research, remain identifiable. Thirdly, there is the question of how the public interest is to be understood and applied: in which circumstances will access be denied as contrary to the public interest (even if the application is otherwise consistent with the consent given by participants) and, conversely, in which circumstances will access be granted for reasons of the public interest notwithstanding that the application is inconsistent with the consent given by participants?.

Source: Scopus