Data Sharing Under the General Data Protection Regulation
Hypertension, vol. 77, pp. 1029–1035
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.
Authors 39
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Academy of Athens · Biomedical Research Foundation of the Academy of Athens
Affiliation as printed
From the Systems Biology Center, Biomedical Research Foundation, Academy of Athens, Greece (A.V.)
BRFAA - Biomedical Research Foundation of the Academy of Athens (4 Soranou Ephessiou St., 115 27 Athens - Greece)
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FIZ Karlsruhe – Leibniz Institute for Information Infrastructure
Affiliation as printed
FIZ Karlsruhe – Leibniz-Institut für Informationsinfrastruktur, Eggenstein-Leopoldshafen, Germany (D.H., F.B.)
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European Bioinformatics Institute
Affiliation as printed
European Molecular Biology Laboratory, European Bioinformatics Institute (EMBL-EBI), Wellcome Genome Campus, Hinxton, Cambridge, United Kingdom (R.A.)
EMBL-EBI - European Bioinformatics Institute [Hinxton] (EMBL-EBI, Wellcome Trust Genome Campus, Hinxton, Cambridgeshire, CB10 1SD, UK - United Kingdom)
European Molecular Biology Laboratory [Hinxton] (United Kingdom)
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Université de Montpellier · Centre Hospitalier Universitaire de Montpellier
Affiliation as printed
SAS RD-Néphrologie and Bio-Communication Cardio-Métabolique (BC2M) EA7288 and University Hospital Lapeyronie, University of Montpellier, France (A.A.)
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Affiliation as printed
KfH-Nierenzentrum und Klinikum St. Georg, Nephrologie, Leipzig, Germany (J.B.)
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Mario Negri Institute for Pharmacological Research
Affiliation as printed
Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Bergamo, Italy (A.B., G.R.)
IRCCS - Istituto di Ricerche Farmacologiche 'Mario Negri' (Via Mario Negri, 2, 20156 Milano - Italy)
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Affiliation as printed
Department of Analytical Biochemistry, University of Groningen, The Netherlands (R.B.)
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University of British Columbia · Vancouver Prostate Centre
Affiliation as printed
Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Canada (P.C.B.)
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FIZ Karlsruhe – Leibniz Institute for Information Infrastructure
Affiliation as printed
FIZ Karlsruhe – Leibniz-Institut für Informationsinfrastruktur, Eggenstein-Leopoldshafen, Germany (D.H., F.B.)
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Institut de génétique et de biologie moléculaire et cellulaire · Institut de Cancérologie Strasbourg · Université de Strasbourg
Affiliation as printed
Institute of Genetics and Molecular and Cellular Biology, Institut de cancérologie Strasbourg Europe, Université de Strasbourg, France (J.C.)
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National and Kapodistrian University of Athens · Children's Hospital Agia Sophia
Affiliation as printed
University Research Institute of Maternal and Child Health & Precision Medicine, National and Kapodistrian University of Athens, ‘Aghia Sophia’ Children’s Hospital, Greece; (G.P.C.)
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Affiliation as printed
Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (C.D.)
Institute of Cardiovascular and Medical Sciences [Glasgow] ( Glasgow G12 8QQ - United Kingdom)
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Affiliation as printed
Laboratory of Nephrology, Department of Immunology and Microbiology, Leuven, Belgium (P.E.)
Department of Microbiology, Immunology and Transplantation [Leuven] ( Rega - Herestraat 49 - box 1030 3000 Leuven - Belgium)
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Tallinn University of Technology
Affiliation as printed
Department of Health Technologies, Tallinn University of Technology, Estonia (I.F.)
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Affiliation as printed
Nephrology Section, Department of Internal Medicine and Pediatrics, Ghent University Hospital, Belgium (G.G., R.V.)
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Radboud University Nijmegen · Radboud University Medical Center · Radboud Institute for Molecular Life Sciences
Affiliation as printed
Translational Metabolic Laboratory, Department of Laboratory Medicine, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands (A.J.v.G.)
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Affiliation as printed
Department of Urology, Medizinische Universität Innsbruck, Austria (I.H.)
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Affiliation as printed
Departments of Medicine and of Epidemiology and Population Health and Meta-Research Innovation Center at Stanford (METRICS), Stanford University (J.P.A.I.)
Departments of Medicine and of Epidemiology and Population Health and Meta-Research Innovation Center at Stanford (METRICS), Stanford University (United States)
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Affiliation as printed
Institute of Cardiovascular Research, RWTH Aachen University, Germany (J.J., V.J.)
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Affiliation as printed
Institute of Cardiovascular Research, RWTH Aachen University, Germany (J.J., V.J.)
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Affiliation as printed
Cancer Biology and Epigenetics Group, Portuguese Oncology Institute of Porto and Abel Salazar Institute of Biomedical Sciences, University of Porto, Portugal (C.J.)
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The University of Texas MD Anderson Cancer Center
Affiliation as printed
Division of Surgery, Department of Urology, The University of Texas MD Anderson Cancer Centre, Houston (A.K.)
Division of Surgery, Department of Urology, The University of Texas MD Anderson Cancer Centre (United States)
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Affiliation as printed
Div. Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, NL (R.M.)
Div. Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University (Netherlands)
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Affiliation as printed
Department of Internal Medicine IV (Nephrology and Hypertension), Medizinische Universität Innsbruck, Austria (G.M.)
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Mosaiques Diagnostics and Therapeutics (Germany)
Affiliation as printed
Mosaiques Diagnostics and Therapeutics AG, Hannover, Germany (H.M.)
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Affiliation as printed
Department of Nephrology and Hypertension, IIS – Fundación Jiménez Díaz-UAM, Madrid, Spain (A.O.)
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Mario Negri Institute for Pharmacological Research
Affiliation as printed
Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Bergamo, Italy (A.B., G.R.)
IRCCS - Istituto di Ricerche Farmacologiche 'Mario Negri' (Via Mario Negri, 2, 20156 Milano - Italy)
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University of Copenhagen · Steno Diabetes Center Copenhagen
Affiliation as printed
Steno Diabetes Center, University of Copenhagen, Denmark (P.R.)
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Université Toulouse III - Paul Sabatier · Inserm · Institut des Maladies Métaboliques et Cardiovasculaires · Université de Toulouse
Affiliation as printed
Institut National de la Santé et de la Recherche Médicale (INSERM), U1048, Institut of Cardiovascular and Metabolic Disease, Toulouse and Université Toulouse III Paul-Sabatier, France (J.P.S.)
Franco-czech Laboratory for clinical research on obesity (Prague - Czech Republic)
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Friedrich-Alexander-Universität Erlangen-Nürnberg
Affiliation as printed
Urologie 24, Nuremberg, and Department of Urology, Friedrich-Alexander University of Erlangen, Germany (B.J.S-D)
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Ss. Cyril and Methodius University in Skopje
Affiliation as printed
Department of Nephrology, University Clinical Center Skopje, North Macedonia (G.S.)
Department of Nephrology, University Clinical Center Skopje, North Macedonia (Macedonia)
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Affiliation as printed
Research Institute Alliance for the Promotion of Preventive Medicine, Mechelen, Belgium, Biomedical Science Group, University of Leuven (J.A.S.)
Research Institute Alliance for the Promotion of Preventive Medicine, Mechelen, Belgium, Biomedical Science Group, University of Leuven (Belgium)
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Affiliation as printed
Bioartificial organs, Department of Biomaterials Science and Technology, Technical Medical Centre, University of Twente, Enschede, The Netherlands (D.S.)
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Karolinska University Hospital
Affiliation as printed
Department of Renal Medicine M99, Karolinska University Hospital, Stockholm, Sweden (P.S.)
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Affiliation as printed
Department of Medicine, Division of Nephrology, University Hospital, Würzburg, Germany (C.W.)
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The University of Texas Medical Branch at Galveston
Affiliation as printed
Department of Surgery, Division of Urology, The University of Texas Medical Branch, Galveston (S.B.W.)
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Inserm · Centre Hospitalier Régional et Universitaire de Nancy · French Clinical Research Infrastructure Network · Université de Lorraine
Affiliation as printed
Centre d’Investigation Clinique Inserm and Université de Lorraine, CHU Nancy, France (F.Z.)
Cardiovascular & Renal Clinical Trialists - CRCT - French-Clinical Research Infrastructure Network - F-CRIN [Paris] (Paris. - France)
INI-CRCT - Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy] (4, rue du Morvan - 54500 VANDOEUVRE-LES-NANCY-France - France)
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Istituto di Fisiologia Clinica · National Research Council
Affiliation as printed
Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, National Council of Research, Institute of Clinical Physiology, Italy (C.Z.)
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Affiliation as printed
European Kidney Health Alliance (EKHA), Brussels, Belgium (R.V.)
Nephrology Section, Department of Internal Medicine and Pediatrics, Ghent University Hospital (Belgium)
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