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E-book GDPR and Biobanking : Individual Rights, Public Interest and Research Regulation across Europe

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Penilaian

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Discrepancies in biobank research regulations have commonly been regarded as one of the most significant hurdles for effective research collaboration. One of the more central aspects of biobank research regulation concerns the use of personal data—health and genetic data and other information related to individuals, either as indi-vidual research subjects or participants in a particular scientific study or as one of many in a registry. Accordingly, the adoption of the EU General Data Protection Regulation (GDPR) in 2016 and its applicability from May 2018 had been long awaited by the biobank community. Although the GDPR is not a research regulatory instrument, in the attempt to regulate personal data processing activities it creates a rather complex ‘research regime’, also known as ‘scientific research regime’ or ‘research exemption’, through which it shapes how scientific research in so far as personal data are concerned is regulated by the EU and could further be shaped either by the EU itself or the Member States. The GDPR sets forth stringent require-ments for the processing of health and genetic data and a set of data subject rights and imposes considerable obligations on biobanks and researchers, while simulta-neously allowing for considerable derogations, directly applicable or enabled through the Member State or the EU law, for the purposes of scientific research. Occasionally, further derogations from individual rights could be possible and other requirements apply if research can be regarded as in the public interest. Article 89 is the central provision that regulates scientific research under the GDPR. It is also a key provision in enabling derogations from individual rights for the purposes of scientific research. Following operationalisation of Article 89, these derogations can be made by directly invoking the provisions of the GDPR on a case-by-case basis, as well as through the national laws of the Member States of the EU, as well as laws of the EU. Consequently, although the GDPR harmonises data protec-tion requirements for resarch, and in that way contributes to the governance of bio-banking, considerable divergences between requirements in different EU Member States could occur. Additionally, the Member States of the EU as well as the EU may address questions of public interest that could open up for further fragmentation. This room for divergence, while it offers flexibility for accommodating various standards and values, also creates uncertainty and poses questions about scientific collaboration and data sharing when different standards apply. One can therefore question whether the EU has built a platform upon which biobanking can accelerate or it has created a platform that allows for fragmentation of the regulatory landscape, and thereby cre-ates risks of slowing down research collaborations and scientific advances.

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Ketersediaan

Informasi Detail

Judul Seri

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No. Panggil

341 SLO g

Penerbit

Switzerland : Springer Nature., 2021

Deskripsi Fisik

432 hlm

Bahasa

English

ISBN/ISSN

9783030493882

Klasifikasi

341

Tipe Isi

text

Tipe Media

computer

Tipe Pembawa

online resource

Edisi

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Subjek

International Law

Info Detail Spesifik

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Pernyataan Tanggungjawab

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Versi lain/terkait

Lampiran Berkas

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