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

Vlahou A, Hallinan D, Apweiler R, Argiles A, Beige J, Benigni A, Bischoff R, Black PC, Boehm F, Céraline J, Chrousos GP, Delles C, Evenepoel P, Fridolin I, Glorieux G, van Gool AJ, Heidegger I, Ioannidis JP, Jankowski J, Jankowski V, Jeronimo C, Kamat AM, Masereeuw R, Mayer G, Mischak H, Ortiz A, Remuzzi G, Rossing P, Schanstra JP, Schmitz-Dräger BJ, Spasovski G, Staessen JA, Stamatialis D, Stenvinkel P, Wanner C, Williams SB, Zannad F, Zoccali C, Vanholder R (2021)

Publication Type: Journal article

Publication year: 2021

Journal

Book Volume: 77

Pages Range: 1029-1035

Journal Issue: 4

DOI: 10.1161/HYPERTENSIONAHA.120.16340

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.

Involved external institutions

Université de Strasbourg (UDS) France (FR) Université de Lorraine France (FR) University of British Columbia Canada (CA) University of Copenhagen Denmark (DK) University of Glasgow United Kingdom (GB) University of Groningen / Rijksuniversiteit Groningen Netherlands (NL) University Hospital Ghent Belgium (BE) National Institute for Health and Medical Research / Institut national de la santé et de la recherche médicale (INSERM) France (FR) Karolinska University Hospital / Karolinska Universitetssjukhuset Sweden (SE) Medizinische Universität Innsbruck Austria (AT) Academy of Athens / Ακαδημία Αθηνών Greece (GR) Hôpital Lapeyronie France (FR) Klinikum St. Georg Germany (DE) European Kidney Health Alliance (EKHA) Belgium (BE) Saints Cyril and Methodius University of Skopje / Универзитет „Св. Кирил и Методиј“ во Скопје Republic of North Macedonia (MK) mosaiques diagnostics and therapeutics AG Germany (DE) Mario Negri Institute for Pharmacological Research (IRCCS) / Istituto di Ricerche Farmacologiche Mario Negri Italy (IT) Rheinisch-Westfälische Technische Hochschule (RWTH) Aachen Germany (DE) Consiglio Nazionale delle Ricerche (CNR) / National Research Council of Italy Italy (IT) Tallinn University of Technology Estonia (EE) University of Twente Netherlands (NL) Stanford University United States (USA) (US) University of Texas Medical Branch (UTMB) United States (USA) (US) Universidade do Porto Portugal (PT) Radboud University Nijmegen Medical Centre / Radboudumc of voluit Radboud Universitair Medisch Centrum (UMC) Netherlands (NL) National and Kapodistrian University of Athens Greece (GR) University of Texas MD Anderson Cancer Center United States (USA) (US) The European Bioinformatics Institute (EBI) United Kingdom (GB) Universiteit Utrecht (UU) / Utrecht University Netherlands (NL)

How to cite

APA:

Vlahou, A., Hallinan, D., Apweiler, R., Argiles, A., Beige, J., Benigni, A.,... Vanholder, R. (2021). Data Sharing Under the General Data Protection Regulation: Time to Harmonize Law and Research Ethics? Hypertension, 77(4), 1029-1035. https://dx.doi.org/10.1161/HYPERTENSIONAHA.120.16340

MLA:

Vlahou, Antonia, et al. "Data Sharing Under the General Data Protection Regulation: Time to Harmonize Law and Research Ethics?" Hypertension 77.4 (2021): 1029-1035.

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