This decade is witnessing the proliferation of large-scale population-based biobanks. Many biobanks have reached the stage of offering access to their collection of data and samples to the scientific community. This, however, requires that access arrangements be established to govern the relationship between biobanks and users. Access arrangements capture the convergence of all normative elements in the life cycle of a biobank: policies, laws, common practices, commitments made by the biobank to participants, the expectations of funders, and the needs of the scientific community. Furthermore, access arrangements shape new legal agreements between 'biobankers' and researchers to ensure appropriate, regulated and efficient use of biobank materials. This paper begins by examining the particularities of access arrangements, identifying the key elements of these new regulatory instruments. Second, the paper looks at various strategies used by biobanks to regulate access and surveys the underlying motivations of these strategies and the impact they can have on potential international collaboration. Third, an example of the challenges encountered in creating access policy is illustrated using the case of CARTaGENE, a biobank based in Montreal, Canada. Last, the paper presents how Public Population Project in Genomics (P(3)G) facilitates the work of biobankers and improves collaboration throughout the international human genomics research community.

Copyright © 2010 S. Karger AG, Basel.