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Erschienen in: Medicine, Health Care and Philosophy 1/2022

17.11.2021 | Scientific Contribution

Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road

verfasst von: Eugenijus Gefenas, J. Lekstutiene, V. Lukaseviciene, M. Hartlev, M. Mourby, K.Ó Cathaoir

Erschienen in: Medicine, Health Care and Philosophy | Ausgabe 1/2022

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Abstract

This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: (a) the data protection regime which follows the application of the European Union General Data Protection Regulation (GDPR), and (b) the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper.
Fußnoten
1
In this paper we also use the term “research ethics regulations”, which covers both the legally non-binding global research ethics guidelines as well as the Council of Europe Recommendation on research on biological materials of human origin (Council of Europe 2016) and the EU Regulation on clinical trials on medicinal products for human use (Regulation 2014) as far as these documents address the role and the meaning of consent in human participant research.
 
2
UK was an EU member state at the point the GDPR came into force and has retained the UK General Data Protection Regulation (UK GDPR) since its departure from the EU.
 
Literatur
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Metadaten
Titel
Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road
verfasst von
Eugenijus Gefenas
J. Lekstutiene
V. Lukaseviciene
M. Hartlev
M. Mourby
K.Ó Cathaoir
Publikationsdatum
17.11.2021
Verlag
Springer Netherlands
Erschienen in
Medicine, Health Care and Philosophy / Ausgabe 1/2022
Print ISSN: 1386-7423
Elektronische ISSN: 1572-8633
DOI
https://doi.org/10.1007/s11019-021-10060-1