Setting the foundations: Individual rights, public interest, scientific research and biobanking

The EU lacks competence to regulate research in a comprehensive manner, yet furthering research is one of its aspirations. Data protection, however, is an area within which the EU has legislated extensively. During the development of the General Data Protection Regulation (GDPR), an important issue to tackle was how to balance the EU aspirations, on the one hand, with limited competences in research regulation, on the other, as well as how to determine the extent to which data protection can be used as a means to further scientific research in the EU legal order. The outcome is the GDPR multifaceted research regime that sets forth EU policy and opens up for further regulations from the Member States as well as the EU.
The research regime that the GDPR has created poses numerous questions, which it is hoped this book will answer. Key among these is, what are the implications of operationalisation of the Article 89 GDPR research regime in biobanking? This chapter introduces the tensions and also sets forth some conceptual foundations for the book. It provides insights into the EU’s interests in the area of biobanking and maps out the research regime that has been built around the GDPR. Thereafter, it analyses the key concepts used in the book: biobank, biorepository, biobanking, scientific research as undertaken under the GDPR, individual rights and public interest. Lastly, it shares some preliminary reflections as starting points for the analysis to come.