1,721,120 research outputs found
Setting the foundations: Individual rights, public interest, scientific research and biobanking
No full textThe EU lacks 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 EU aspirations, on the one hand, with limited competences in research regulation, on the other, as well as how to determine the extent to which data protection can 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, which it is hoped this book will answer. Key among these is, what are the implications of operationalisation of the Article 89 GDPR research regime in biobanking? This chapter introduces the tensions and also sets forth some conceptual foundations for the book. It provides insights into the EU’s interests in the area of biobanking and maps out the research regime that has been built around the GDPR. Thereafter, it analyses the key concepts used in the book: biobank, biorepository, 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
Introduction : The Significance of ELSPI Perspectives in Governing, Protecting, and Regulating the Future of Genome Editing
No full textAppropriate Safeguards and Article 89 of the GDPR:Considerations for Biobank, Databank and Genetic Research
Full text linkThe collection and use of biological samples and data for genetic research, or for storage in a biobank or databank for future research, impacts upon many fundamental rights, including the right to dignity, the right to private and family life, the right to protection of personal data, the right to freedom of arts and sciences, and the right to non-discrimination. The use of genetic data and other health-related data in this context must be used in a manner that is rooted in human rights. Owing in part to the General Data Protection Regulation (GDPR) coming into force, the right to the protection of personal data in the context of scientific research has been afforded increasing attention. The GDPR gives effect to the right to data protection, but states that this right must be balanced against other rights and interests. The GDPR applies to all personal data, with specific attention to special categories of data, that includes health and genetic data. The collection, access to, and sharing of such data must comply with the GDPR, and therefore directly impacts the use of such data in research. The GDPR does provide for several derogations and exemptions for research from many of the strict processing requirements. Such derogations are permitted only if there are appropriate safeguards in place. Article 89 states that to be appropriate, safeguards must be "in accordance" with the GDPR "for the rights and freedoms of the data subject". In particular, those safeguards must ensure "respect for the principle of data minimisation". Despite the importance of safeguards, the GDPR is silent as to the specific measures that may be adopted to meet these requirements. This paper considers Article 89 and explores safeguards that may be deemed appropriate in the context of biobanks, databanks, and genetic research.</p
You can't put the genie back in the bottle : On the legal and conceptual understanding of genetic privacy in the era of personal data protection in Europe
Full text linkThis article sheds a light on how the data protection requirements enshrined in the General Data Protection Regulation (GDPR) relate to shaping genetic privacy in the context of a complex and integrated genetic testing enterprise. It suggests that the informational dimension of genetic privacy in the era of data protection could be described as a sphere of controlled access. Given that the GDPR does not prescribe quantitative or contextual limitations relating to access once the applicable requirements are met, one could argue that there are good preconditions for the field to head in the direction of genetic transparency. This puts on the agenda the questions of what challenges this could bring and whether adequate mechanisms exist to deal with them
Biobanking and data transfer between the EU and Cape Verde, Mauritius, Morocco, Senegal and Tunisia. Adequacy considerations and Convention 108
No full textCase C-243/19, A v Veselibas ministrija, Judgement of the Court (Second Chamber) of 29 October 2020, EU:C:2020:872
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