Health research, consent and the GDPR exemption

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dc.check.date2020-04-24
dc.check.infoAccess to this article is restricted until 12 months after publication by request of the publisher.en
dc.contributor.authorDonnelly, Mary
dc.contributor.authorMcDonagh, Maeve
dc.date.accessioned2019-05-24T10:32:53Z
dc.date.available2019-05-24T10:32:53Z
dc.date.issued2019-04-24
dc.date.updated2019-05-24T10:16:18Z
dc.description.abstractThis article analyses the balance which the GDPR strikes between two important social values: protecting personal health data and facilitating health research through the lens of the consent requirement and the research exemption. The article shows that the normative weight of the consent requirement differs depending on the context for the health research in question. This more substantive approach to consent is reflected in the research exemption which allows for a more nuanced balancing of interests. However, because the GDPR articulates the exemption at an abstract and principled level, in practice the balance is struck at Member State level. Thus, the GDPR increases difficulties for EU cross-border health projects and impedes the policy goal of creating a harmonised regulatory framework for health research. The article argues that in order to address this problem, the European Data Protection Board should provide specific guidance on the operation of consent in health research.en
dc.description.statusPeer revieweden
dc.description.versionAccepted Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationDonnelly, M. and McDonagh, M. (2019) 'Health research, consent and the GDPR exemption', European Journal of Health Law, 26(2), pp. 97-119. doi: 10.1163/15718093-12262427en
dc.identifier.doi10.1163/15718093-12262427en
dc.identifier.eissn1571-8093
dc.identifier.endpage119en
dc.identifier.issn0929-0273
dc.identifier.issued2en
dc.identifier.journaltitleEuropean Journal of Health Lawen
dc.identifier.startpage97en
dc.identifier.urihttps://hdl.handle.net/10468/7975
dc.identifier.volume26en
dc.language.isoenen
dc.publisherBrill Academic Publishersen
dc.relation.urihttps://brill.com/view/journals/ejhl/26/2/article-p97_2.xml
dc.rights© 2019, Brill Koninklijke NV, Leiden. All rights reserved.en
dc.subjectData protectionen
dc.subjectHealth researchen
dc.subjectConsenten
dc.subjectCapacityen
dc.subjectResearch exemptionen
dc.subjectGeneral Data Protection Regulationen
dc.subjectGDPRen
dc.titleHealth research, consent and the GDPR exemptionen
dc.typeArticle (peer-reviewed)en
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