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GDPR and Biobanking

Individual Rights, Public Interest and Research Regulation across Europe

  • Presents the most up-to-date overview of European data protection frameworks for biobank research

  • Offers a comprehensive and in-depth analysis of genetic data governance at the EU level

  • Shares valuable insights into national biobank regulatory frameworks

  • This book is open access, which means that you have free and unlimited access

Part of the book series: Law, Governance and Technology Series (LGTS, volume 43)

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Table of contents (23 chapters)

  1. Front Matter

    Pages i-vii
  2. Introduction

    • Santa Slokenberga, Olga Tzortzatou, Jane Reichel
    Pages 1-7Open Access
  3. GDPR Insights

    1. Front Matter

      Pages 43-43
    2. The Impact of the GDPR on the Governance of Biobank Research

      • Mahsa Shabani, Gauthier Chassang, Luca Marelli
      Pages 45-60Open Access
    3. Individual Rights in Biobank Research Under the GDPR

      • Ciara Staunton
      Pages 91-104Open Access
    4. Brexit and Biobanking: GDPR Perspectives

      • Andelka M. Phillips, Tamara K. Hervey
      Pages 145-183Open Access
  4. National Implementation

    1. Front Matter

      Pages 185-185
    2. An Overview of Belgian Legislation Applicable to Biobank Research and Its Interplay with Data Protection Rules

      • Teodora Lalova, Anastassia Negrouk, Laurent Dollé, Sofie Bekaert, Annelies Debucquoy, Jean-Jacques Derèze et al.
      Pages 187-213Open Access
    3. Regulatory Environment for Biobanking in Estonia

      • Kärt Pormeister
      Pages 227-242Open Access
    4. Research Biobanking, Personal Data Protection and Implementation of the GDPR in France

      • Gauthier Chassang, Michael Hisbergues, Emmanuelle Rial-Sebbag
      Pages 257-276Open Access
    5. The Regulation of Biobanking in Germany

      • Nils Hoppe
      Pages 277-290Open Access
    6. Mapping the Biobank Landscape in Greece

      • Olga Tzortzatou, Anastasia Siapka
      Pages 291-307Open Access

About this book

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.


Editors and Affiliations

  • Faculty of Law, Uppsala University, Uppsala, Sweden

    Santa Slokenberga

  • Academy of Athens, Biomedical Research Foundation, Athens, Greece

    Olga Tzortzatou

  • Faculty of Law, Stockholm University, Stockholm, Sweden

    Jane Reichel

About the editors

Santa Slokenberga holds a LL.D. in Medical Law and is a researcher at Uppsala University in Sweden. Her research focuses on legal issues genetics, with a particular emphasis on the protection of personal data. Her other research interests include regulating the standards of medical care and scientific uncertainty. In 2016, she defended her doctoral thesis entitled “European Legal Perspectives on Health-Related Direct-to-Consumer Genetic Testing”. Since then, she has participated in two European research projects that relate to biobanking and data protection, B3Africa and SIENNA, carried out a postdoctoral research at Lund University in Sweden and has served as an ELSI expert at BBMRI-ERIC CS ELSI.

Olga Tzortzatou holds a LL.D. in Theory of Law on the protection of health data in the field of biomedical research from the National Kapodistrian University of Athens. As from 2008 she is an in house lawyer at the Biomedical Research Foundation of the Academy of Athens. She is also a member of the Bioethics Committee of BRFAA and an external ethics screener for the European Commission Research Executive Agency. Since 2015 she serves as an ELSI expert at BBMRI-ERIC CS ELSI.

Jane Reichel is a professor in Administrative Law at the Faculty of Law at Stockholm University and is since 2011 tied part-time to Center of Research Ethics & Bioethics at Uppsala University. She defended her thesis in European Administrative Law at Stockholm University in 2006. Between 2009 and 2018 she worked at the Faculty of Law in Uppsala University. She has participated in several European research projects on biobanking and data protection, for example BioBankCloud and B3Africa.


Bibliographic Information

  • Book Title: GDPR and Biobanking

  • Book Subtitle: Individual Rights, Public Interest and Research Regulation across Europe

  • Editors: Santa Slokenberga, Olga Tzortzatou, Jane Reichel

  • Series Title: Law, Governance and Technology Series

  • DOI: https://doi.org/10.1007/978-3-030-49388-2

  • Publisher: Springer Cham

  • eBook Packages: Law and Criminology, Law and Criminology (R0)

  • Copyright Information: The Editor(s) (if applicable) and The Author(s) 2021

  • License: CC BY

  • Hardcover ISBN: 978-3-030-49387-5Published: 06 January 2021

  • Softcover ISBN: 978-3-030-49390-5Published: 09 January 2022

  • eBook ISBN: 978-3-030-49388-2Published: 05 January 2021

  • Series ISSN: 2352-1902

  • Series E-ISSN: 2352-1910

  • Edition Number: 1

  • Number of Pages: VII, 434

  • Number of Illustrations: 6 b/w illustrations

  • Topics: European Law, Systems and Data Security, Human Genetics

Buy it now

Buying options

Hardcover Book USD 54.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Other ways to access