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This open access book focuses on the discrepancies in biobank
research regulations that are among the most significant hurdles to
effective research collaboration. The General Data Protection
Regulation (GDPR) has established stringent requirements for the
processing of health and genetic data, while simultaneously
allowing considerable multi-level exceptions for the purposes of
scientific research. In addition to directly applicable exceptions,
the GDPR places the regulatory responsibility for further defining
how the Member States strike a balance between the individuals'
rights and the public interest in research within their national
legal orders. Since Member States' approaches to the trade-off
between data subjects' rights on the one hand, and appropriate
safeguards on the other, differ according to their ethical and
legal traditions, their data protection requirements for research
also differ considerably. This study takes a comprehensive approach
to determine how the GDPR affects regulatory regimes on the use of
personal data in biobanking research, with a particular focus on
the balance between individuals' rights, public interest and
scientific research. In this regard, it has two main goals: first,
to scrutinize the GDPR research regime, its objective and
constitutive elements, the impact it has on biobanking, and its
role in a changing EU landscape post-Brexit; and second, to examine
how various exceptions have been operationalized nationally, and
what challenges and opportunities this diversification entails. The
book not only captures the complexity GDPR creates for biobanking,
but also sheds light on various approaches to tackling the
corresponding challenges. It offers the first comprehensive
analysis of GDPR for biobanking, and the most up-to-date overview
of the national biobank regulatory frameworks in Europe.
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