GDPR and Biobanking
Individual Rights, Public Interest and Research Regulation across Europe
Samenvatting
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.
Specificaties
Inhoudsopgave
Pages 1-7
Slokenberga, Santa (et al.)
Setting the Foundations: Individual Rights, Public Interest, Scientific Research and Biobanking
Pages 11-30
Slokenberga, Santa
Striking a Balance Between Personalised Genetics and Privacy Protection from the Perspective of GDPR
Pages 31-42
Hansson, Mats G.
The Impact of the GDPR on the Governance of Biobank Research
Pages 45-60
Shabani, Mahsa (et al.)
Biobank and Biomedical Research: Responsibilities of Controllers and Processors Under the EU General Data Protection Regulation
Pages 61-89
Nordberg, Ana
Individual Rights in Biobank Research Under the GDPR
Pages 91-104
Staunton, Ciara
Safeguards and Derogations Relating to Processing for Scientific Purposes: Article 89 Analysis for Biobank Research
Pages 105-120
Duguet, Anne-Marie (et al.)
Biobank Oversight and Sanctions Under the General Data Protection Regulation
Pages 121-144
Hallinan, Dara
Brexit and Biobanking: GDPR Perspectives
Pages 145-183
Phillips, Andelka M. (et al.)
An Overview of Belgian Legislation Applicable to Biobank Research and Its Interplay with Data Protection Rules
Pages 187-213
Lalova, Teodora (et al.)
Balancing of Individual Rights and Research Interests in Danish Biobank Regulation
Pages 215-226
Hartlev, Mette
Regulatory Environment for Biobanking in Estonia
Pages 227-242
Pormeister, Kärt
Access to Biomedical Research Material and the Right to Data Protection in Finland
Pages 243-256
Southerington, Tom
Research Biobanking, Personal Data Protection and Implementation of the GDPR in France
Pages 257-276
Chassang, Gauthier (et al.)
The Regulation of Biobanking in Germany
Pages 277-290
Hoppe, Nils
Mapping the Biobank Landscape in Greece
Pages 291-307
Tzortzatou, Olga (et al.)
The Italian Way for Research Biobanks After GDPR: Hybrid Normative Solutions to Balance the Protection of Individuals and Freedom of Research
Pages 309-322
Penasa, Simone (et al.)
Norwegian Biobanks: Increased Complexity with GDPR and National Law
Pages 323-344
Befring, Anne Kjersti
Biobanks and GDPR: A Look at the Portuguese Panorama
Pages 345-362
Barbosa, Carla (et al.)
The New European Legal Framework on Personal Data Protection and the Legal Status of Biological Samples and Biobanks for Biomedical Research Purposes in Spanish Law
Pages 363-378
Romeo-Casabona, Carlos M.
Swedish Law on Personal Data in Biobank Research: Permissible But Complex
Pages 379-394
Stenbeck, Magnus (et al.)
Biobanking Across Europe Post-GDPR: A Deliberately Fragmented Landscape
Pages 397-419
Tzortzatou, Olga (et al.)
Allocation of Regulatory Responsibilities: Who Will Balance Individual Rights, the Public Interest and Biobank Research Under the GDPR?
Pages 421-434
Reichel, Jane
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