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 C Black
(11)
,
Franziska Boehm
(2)
,
Jocelyn Céraline
(12, 13, 14)
,
George P Chrousos
(15)
,
Christian Delles
(16)
,
Pieter Evenepoel
(17)
,
Ivo Fridolin
(18)
,
Griet Glorieux
(19)
,
Alain J van Gool
(20)
,
Isabel Heidegger
(21)
,
John P A Ioannidis
(22)
,
Joachim Jankowski
(23)
,
Vera Jankowski
(23)
,
Carmen Jeronimo
(24)
,
Ashish M Kamat
(25)
,
Rosalinde Masereeuw
(26)
,
Gert Mayer
(21)
,
Harald Mischak
(27)
,
Alberto Ortiz
(28)
,
Giuseppe Remuzzi
(9)
,
Peter Rossing
(29)
,
Joost P Schanstra
(30, 31, 32)
,
Bernd J Schmitz-Dräger
(33)
,
Goce Spasovski
(34)
,
Jan A Staessen
(35)
,
Dimitrios Stamatialis
(36)
,
Peter Stenvinkel
(37)
,
Christoph Wanner
(38)
,
Stephen B Williams
(39)
,
Faiez Zannad
(40, 41, 42, 43)
,
Carmine Zoccali
(44)
,
Raymond Vanholder
(19, 45)
1
BRFAA -
Biomedical Research Foundation of the Academy of Athens
2 FIZ Karlsruhe - Leibniz-Institut für Informationsinfrastruktur
3 EMBL-EBI - European Bioinformatics Institute [Hinxton]
4 European Molecular Biology Laboratory [Hinxton]
5 BC2M - Biocommunication en Cardio-Métabolique
6 Hôpital Lapeyronie [CHU Montpellier]
7 UM - Université de Montpellier
8 KfH-Nierenzentrum und Klinikum St. Georg, Nephrologie, Leipzig
9 IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri" = Mario Negri Institute for Pharmacological Research
10 University of Groningen [Groningen]
11 Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia
12 ICANS - Institut de Cancérologie de Strasbourg Europe
13 UNISTRA - Université de Strasbourg
14 IGBMC - Institut de Génétique et de Biologie Moléculaire et Cellulaire
15 NKUA - National and Kapodistrian University of Athens
16 Institute of Cardiovascular and Medical Sciences [Glasgow]
17 Department of Microbiology, Immunology and Transplantation [Leuven]
18 Department of Health Technologies, Tallinn University of Technology
19 Nephrology Section, Department of Internal Medicine and Pediatrics, Ghent University Hospital
20 Translational Metabolic Laboratory, Department of Laboratory Medicine, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center
21 IMU - Innsbruck Medical University = Medizinische Universität Innsbruck
22 Stanford University
23 RWTH - Rheinisch-Westfälische Technische Hochschule Aachen University
24 Universidade do Porto = University of Porto
25 Division of Surgery, Department of Urology, The University of Texas MD Anderson Cancer Centre
26 Div. Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
27 Mosaiques Diagnostics GmbH - Mosaiques Diagnostics and Therapeutics AG
28 Department of Nephrology and Hypertension, IIS - Fundación Jiménez Díaz-UAM
29 UCPH - University of Copenhagen = Københavns Universitet
30 Franco-czech Laboratory for clinical research on obesity
31 I2MC - Institut des Maladies Métaboliques et Cardiovasculaires
32 UT3 - Université Toulouse III - Paul Sabatier
33 Urologie 24, Nuremberg, and Department of Urology, Friedrich-Alexander University of Erlangen
34 Department of Nephrology, University Clinical Center Skopje, North Macedonia
35 Research Institute Alliance for the Promotion of Preventive Medicine, Mechelen, Belgium, Biomedical Science Group, University of Leuven
36 University of Twente
37 Karolinska University Hospital [Stockholm]
38 Department of Medicine, Division of Nephrology, University Hospital, Würzburg
39 Department of Surgery, Division of Urology, The University of Texas Medical Branch
40 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
41 CIC-P - Centre d'investigation clinique plurithématique Pierre Drouin [Nancy]
42 INI-CRCT - Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy]
43 Cardiovascular & Renal Clinical Trialists - CRCT - French-Clinical Research Infrastructure Network - F-CRIN [Paris]
44 Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, National Council of Research, Institute of Clinical Physiology
45 European Kidney Health Alliance (EKHA)
2 FIZ Karlsruhe - Leibniz-Institut für Informationsinfrastruktur
3 EMBL-EBI - European Bioinformatics Institute [Hinxton]
4 European Molecular Biology Laboratory [Hinxton]
5 BC2M - Biocommunication en Cardio-Métabolique
6 Hôpital Lapeyronie [CHU Montpellier]
7 UM - Université de Montpellier
8 KfH-Nierenzentrum und Klinikum St. Georg, Nephrologie, Leipzig
9 IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri" = Mario Negri Institute for Pharmacological Research
10 University of Groningen [Groningen]
11 Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia
12 ICANS - Institut de Cancérologie de Strasbourg Europe
13 UNISTRA - Université de Strasbourg
14 IGBMC - Institut de Génétique et de Biologie Moléculaire et Cellulaire
15 NKUA - National and Kapodistrian University of Athens
16 Institute of Cardiovascular and Medical Sciences [Glasgow]
17 Department of Microbiology, Immunology and Transplantation [Leuven]
18 Department of Health Technologies, Tallinn University of Technology
19 Nephrology Section, Department of Internal Medicine and Pediatrics, Ghent University Hospital
20 Translational Metabolic Laboratory, Department of Laboratory Medicine, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center
21 IMU - Innsbruck Medical University = Medizinische Universität Innsbruck
22 Stanford University
23 RWTH - Rheinisch-Westfälische Technische Hochschule Aachen University
24 Universidade do Porto = University of Porto
25 Division of Surgery, Department of Urology, The University of Texas MD Anderson Cancer Centre
26 Div. Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
27 Mosaiques Diagnostics GmbH - Mosaiques Diagnostics and Therapeutics AG
28 Department of Nephrology and Hypertension, IIS - Fundación Jiménez Díaz-UAM
29 UCPH - University of Copenhagen = Københavns Universitet
30 Franco-czech Laboratory for clinical research on obesity
31 I2MC - Institut des Maladies Métaboliques et Cardiovasculaires
32 UT3 - Université Toulouse III - Paul Sabatier
33 Urologie 24, Nuremberg, and Department of Urology, Friedrich-Alexander University of Erlangen
34 Department of Nephrology, University Clinical Center Skopje, North Macedonia
35 Research Institute Alliance for the Promotion of Preventive Medicine, Mechelen, Belgium, Biomedical Science Group, University of Leuven
36 University of Twente
37 Karolinska University Hospital [Stockholm]
38 Department of Medicine, Division of Nephrology, University Hospital, Würzburg
39 Department of Surgery, Division of Urology, The University of Texas Medical Branch
40 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
41 CIC-P - Centre d'investigation clinique plurithématique Pierre Drouin [Nancy]
42 INI-CRCT - Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy]
43 Cardiovascular & Renal Clinical Trialists - CRCT - French-Clinical Research Infrastructure Network - F-CRIN [Paris]
44 Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, National Council of Research, Institute of Clinical Physiology
45 European Kidney Health Alliance (EKHA)
Antonia Vlahou
- Fonction : Auteur
- PersonId : 910491
Dara Hallinan
- Fonction : Auteur
- PersonId : 805839
- ORCID : 0000-0002-1160-821X
Jocelyn Céraline
- Fonction : Auteur
- PersonId : 1145871
- IdHAL : jocelyn-ceraline
- ORCID : 0000-0001-6476-8797
- IdRef : 125095775
Christian Delles
- Fonction : Auteur
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- ORCID : 0000-0003-2238-2612
Griet Glorieux
- Fonction : Auteur
- PersonId : 1224163
- ORCID : 0000-0002-7641-4707
Alberto Ortiz
- Fonction : Auteur
- PersonId : 776609
- ORCID : 0000-0002-9805-9523
Joost P Schanstra
- Fonction : Auteur
- PersonId : 837350
- ORCID : 0000-0002-7471-372X
- IdRef : 076749304
Peter Stenvinkel
- Fonction : Auteur
- PersonId : 763473
- ORCID : 0000-0002-8785-4820
Christoph Wanner
- Fonction : Auteur
- PersonId : 765154
- ORCID : 0000-0001-9507-5301
Faiez Zannad
- Fonction : Auteur
- PersonId : 756877
- ORCID : 0000-0001-7456-1570
Carmine Zoccali
- Fonction : Auteur
- PersonId : 776724
- ORCID : 0000-0002-6616-1996
- IdRef : 033425809
Raymond Vanholder
- Fonction : Auteur
- PersonId : 768115
- ORCID : 0000-0003-2633-1636
Résumé
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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