| 1. |
- Nordberg, Ana, et al.
(författare)
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Biobank and Biomedical Research: Responsibilities of Controllers and Processors under the EU General Data Protection Regulation
- 2021
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Ingår i: GDPR and biobanking : Individual rights, public interest and research regulation across Europe - Individual rights, public interest and research regulation across Europe. - Cham : Springer International Publishing. - 9783030493875 - 9783030493882 ; , s. 61-89
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Bokkapitel (refereegranskat)abstract
- Biobanks are essential infrastructures in current health and biomedical research. Advanced scientific research increasingly relies on processing and correlating large amounts of genetic, clinical and behavioural data. These data are particularly sensitive in nature and the risk for privacy invasion and misuse is high. The EU General Data Protection Regulation (GDPR) developed and increased harmonization, resulting in a framework defining specific duties and obligations of entities processing personal data – controllers and processors. Biobanks, in the exercise of their functions assume the role of controllers and/or processors and as such need to comply with a number of complex rules. This chapter analyses these rules, in light of Article 89 GDPR, which creates safeguards and derrogations relating to processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. It identifies key compliance challenges faced by biobanks as data controllers and processors, such as determining whether the GDPR is applicable and its intersection with other regulations; when should a biobank be considered controller and processor; what are the main duties of biobanks as data controllers and processors and options for compliance.
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| 2. |
- Reichel, Jane, 1971-
(författare)
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Allocation of Regulatory Responsibilities : Who Will Balance Individual Rights, the Public Interest and Biobank Research Under the GDPR?
- 2021
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Ingår i: GDPR and Biobanking. - Cham : Springer. - 9783030493882 - 9783030493875 ; , s. 421-434, s. 421-434
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Bokkapitel (refereegranskat)abstract
- In this chapter, an analysis is undertaken of the division of legislative power in the space created by the GDPR, regarding the balancing of individual rights, the public interest and biobank research. The legislative competences of the EU, international obligations within bioethics, and the regulatory space left for Member States are all examined. The conclusion of the chapter is that in spite of the aim of the GDPR to further legal harmonisation, it is more likely that unity will be brought about through administrative cooperation and soft law tools.
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| 3. |
- Slokenberga, Santa, et al.
(författare)
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Introduction
- 2021
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Ingår i: GDPR and Biobanking. - Cham : Springer. - 9783030493882 - 9783030493875 ; , s. 1-7
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Bokkapitel (övrigt vetenskapligt/konstnärligt)abstract
- 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.
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| 4. |
- Stenbeck, Magnus, et al.
(författare)
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Swedish Law on Personal Data in Biobank Research : Permissible But Complex
- 2021
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Ingår i: GDPR and Biobanking. - Cham : Springer. - 9783030493882 - 9783030493875 ; , s. 379-394-, s. 379-394
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Bokkapitel (refereegranskat)abstract
- This chapter describes the regulatory and organisational infrastructure of biobank research in Sweden, and how the introduction of the GDPR affects the possibilities to use biobank material in future research. The Swedish legislator has chosen a rather minimalistic approach in relation to the research exception in Article 89 GDPR and has only enacted limited general exceptions to the data protection rules. This may be partly explained by the comprehensive right to public access to official documents which gives researchers vast access to information held in registries, albeit conditioned on abiding by secrecy and confidentiality rules. The Swedish legislation implementing the GDPR includes a general exception from the data protection rules in relation to the right to access to official documents, which researchers also benefit from. However, confidentiality rules for different categories of information differ between sectors, which hinders an effective use of the registries in research. The regulatory regime for using biobank and registry data in Sweden thus involves both data protection and secrecy rules, which makes the legal landscape permissible but complex. The operationalisation of the research exception in Article 89 GDPR is analysed against this background. Special attention is given to the possibility to link personal information derived from biobanks with personal information from other data sources, including large national population based statistical registries as well as information from national clinical registers.
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| 5. |
- Slokenberga, Santa
(författare)
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Setting the Foundations : Individual Rights, Public Interest, Scientific Research and Biobanking
- 2021
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Ingår i: GDPR and Biobanking. - Cham : Springer. - 9783030493875 ; , s. 11-30
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Bokkapitel (övrigt vetenskapligt/konstnärligt)abstract
- The principle of conferral tames the EU 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 ambitious EU aspirations and differing stakeholder interests, on the one hand, with limited competences in research regulation, on the other, and how to determine the extent to which data protection could 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. Key among these is, what are the implications of the operationalisation of Article 89 GDPR in biobanking? This chapter sets out some of the underlying tensions in the area and pins down key conceptual foundations for the book. It provides insights into the EU’s interests in the area of biobanking and maps out central elements of the research regime that has been built within the GDPR. Thereafter, it analyses the key concepts used in the book, including biobank and 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.
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