The Regulation of Biobanking in Germany

Biobanking in Germany is currently not subject to sui generis regulation. Instead, a plethora of norms from differing areas of law form the bundle of regulation that applies to biobanking. The exact shape and extent of the bundle depends on the exact configuration of the biobank. In the context of data protection, the rather fragmented nature of the regulation is to a certain extent alleviated by the direct impact of the EU General Data Protection Regulation (GDPR). In particular, the federalized system of data protection in Germany is simplified by an overarching set of norms that apply equally across the board. Whilst this is a welcome systematization of this part of the regulation of biobanking in Germany, the exact nature of the implementation of the Regulation raises novel issues in its own right. In this paper, I will outline the fragmented nature of biobank regulation in Germany, illustrate the issues on the basis of Germany’s population biobank NaKo and then discuss some of the more significant issues raised by the GDPR in the context of biobanking

Introduction

The General Data Protection Regulation (GDPR) is already four years old legal instrument, with over two years of practical experience, yet, several central questions on its application, its importance in scientific research, rights of the data subjects, and obligations on the controllers and processors remain uncharted. In this edited volume, questions ranging from the meaning of the GDPR provisions for a particular research project to impact of the GDPR on long term collaborations, when the UK is leaving the EU are is discussed. This chapter sets out the aim of this book and provides an overview of how various contributions interplay to shed light on how the GDPR shapes the research regimes on the use of personal data in biobanking by EU Member States

Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity

Biobanks’ activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first–hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four‐step checklist aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU

Biobanking across Europe post-GDPR : a deliberately fragmented landscape

This chapter seeks to provide insight into the ways in which Member States leveraged the regulatory discretion afforded to them by the GDPR. Specifically, it reviews the biobank regulatory environment; whether and how derogations under Article 89(2) GDPR are enabled; the legal basis for scientific research and the role of consent in biobanking post-GDPR; the balance between individual rights and public interest in national law; and finally, the GDPR’s impact and future possibilities for biobanking. In exercising self-determination, Member States can, to a certain extent, align data protection requirements with their values and aspirations. Such alignment, though, could jeopardize collaborative research. In light of the need to bridge divergent legal and ethical requirements at a national and supranational level, the role of Research Ethics Committees (RECs) might prove to be essential