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Data Sharing Under the General Data Protection Regulation: Time to Harmonize Law and Research Ethics?

Antonia Vlahou 1 Dara Hallinan 2 Rolf Apweiler 3, 4 Angel Argilés 5, 6, 7 Joachim Beige 8 Ariela Benigni 9 Rainer Bischoff 10 Peter Black 11 Franziska Boehm 2 Jocelyn Céraline 12, 13, 14 George Chrousos 15 Christian Delles 16 Pieter Evenepoel 17 Ivo Fridolin 18 Griet Glorieux 19 Alain van Gool 20 Isabel Heidegger 21 John Ioannidis 22 Joachim Jankowski 23 Vera Jankowski 23 Carmen Jeronimo 24 Ashish Kamat 25 Rosalinde Masereeuw 26 Gert Mayer 27 Harald Mischak 28 Alberto Ortiz 29 Giuseppe Remuzzi 9 Peter Rossing 30 Joost Schanstra 31, 32, 33 Bernd Schmitz-Dräger 34 Goce Spasovski 35 Jan Staessen 36 Dimitrios Stamatialis 37 Peter Stenvinkel 38 Christoph Wanner 39 Stephen Williams 40 Faiez Zannad 41, 42, 43, 44 Carmine Zoccali 45 Raymond Vanholder 19, 46
Abstract : The General Data Protection Regulation (GDPR) became binding law in the European Union Member States in 2018, as a step toward harmonizing personal data protection legislation in the European Union. The Regulation governs almost all types of personal data processing, hence, also, those pertaining to biomedical research. The purpose of this article is to highlight the main practical issues related to data and biological sample sharing that biomedical researchers face regularly, and to specify how these are addressed in the context of GDPR, after consulting with ethics/legal experts. We identify areas in which clarifications of the GDPR are needed, particularly those related to consent requirements by study participants. Amendments should target the following: (1) restricting exceptions based on national laws and increasing harmonization, (2) confirming the concept of broad consent, and (3) defining a roadmap for secondary use of data. These changes will be achieved by acknowledged learned societies in the field taking the lead in preparing a document giving guidance for the optimal interpretation of the GDPR, which will be finalized following a period of commenting by a broad multistakeholder audience. In parallel, promoting engagement and education of the public in the relevant issues (such as different consent types or residual risk for re-identification), on both local/national and international levels, is considered critical for advancement. We hope that this article will open this broad discussion involving all major stakeholders, toward optimizing the GDPR and allowing a harmonized transnational research approach.
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Submitted on : Friday, February 19, 2021 - 3:10:15 PM
Last modification on : Wednesday, November 10, 2021 - 5:38:05 PM
Long-term archiving on: : Thursday, May 20, 2021 - 7:42:12 PM


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Antonia Vlahou, Dara Hallinan, Rolf Apweiler, Angel Argilés, Joachim Beige, et al.. Data Sharing Under the General Data Protection Regulation: Time to Harmonize Law and Research Ethics?. Hypertension, American Heart Association, 2021, 74 (4), pp.1029-1035. ⟨10.1161/HYPERTENSIONAHA.120.16340⟩. ⟨hal-03147039⟩



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