Biobanking strategies and regulative approaches in the EU: recent perspectives

Abstract

Biobanks, ie, systematic collections of human biological materials and associated clinical and lifestyle data, provide an indispensable infrastructure for modern research. Although biobank research takes place on a global scale, there is no internationally binding framework for its ethical and legal regulation yet. A better understanding of existing regulative approaches is an important prerequisite for its ethical and legal harmonization and, thus, for improving the interoperability of biobank-based research in the future. This review focuses on biobanking strategies, regulative approaches, and recent developments in Europe. Specifically, we discuss selected ethical and legal issues in research biobanking in the European context by looking at population biobanks, new participation models, the cross-border sharing of samples, the participation of minors, the handling of incidental health findings, whole genome sequencing, and commercialization. We also provide an overview of regulations on biobank research in the EU and member states and highlight commonalities and differences. Although several common trends can be identified across Europe, we acknowledge the importance of national research traditions that cannot easily be set aside. Thus, harmonization, rather than a complete unification, of approach seems to be the most realistic vision for future biobank research in Europe.