Evidence map›Paper›PMID 33583200›Full record

ReviewHypertension (Dallas, Tex. : 1979)2021

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

Antonia Vlahou, Dara Hallinan, Rolf Apweiler, Angel Argiles, Joachim Beige, Ariela Benigni, Rainer Bischoff, Peter C Black, Franziska Boehm, Jocelyn Céraline and 29 more

Open access · hybridAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Hypertension (Dallas, Tex. : 1979), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 2 pooled it
14.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 2 syntheses or guidelines pooled it, 123 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors at 20 institutions in 16 countries.

Antonia VlahouFrom the Systems Biology Center, Biomedical Research Foundation, Academy of Athens, Greece (A.V.).
Dara HallinanFIZ Karlsruhe - Leibniz-Institut für Informationsinfrastruktur, Eggenstein-Leopoldshafen, Germany (D.H., F.B.).
Rolf ApweilerEuropean Molecular Biology Laboratory, European Bioinformatics Institute (EMBL-EBI), Wellcome Genome Campus, Hinxton, Cambridge, United Kingdom (R.A.).
Angel ArgilesSAS RD-Néphrologie and Bio-Communication Cardio-Métabolique (BC2M) EA7288 and University Hospital Lapeyronie, University of Montpellier, France (A.A.).
Joachim BeigeKfH-Nierenzentrum und Klinikum St. Georg, Nephrologie, Leipzig, Germany (J.B.).
Ariela BenigniIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Bergamo, Italy (A.B., G.R.).
Rainer BischoffDepartment of Analytical Biochemistry, University of Groningen, The Netherlands (R.B.).
Peter C BlackVancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Canada (P.C.B.).
Franziska BoehmFIZ Karlsruhe - Leibniz-Institut für Informationsinfrastruktur, Eggenstein-Leopoldshafen, Germany (D.H., F.B.).
Jocelyn CéralineInstitute of Genetics and Molecular and Cellular Biology, Institut de cancérologie Strasbourg Europe, Université de Strasbourg, France (J.C.).
George P ChrousosUniversity Research Institute of Maternal and Child Health & Precision Medicine, National and Kapodistrian University of Athens, 'Aghia Sophia' Children's Hospital, Greece; (G.P.C.).
Christian DellesInstitute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (C.D.).
Pieter EvenepoelLaboratory of Nephrology, Department of Immunology and Microbiology, Leuven, Belgium (P.E.).
Ivo FridolinDepartment of Health Technologies, Tallinn University of Technology, Estonia (I.F.).
Griet GlorieuxNephrology Section, Department of Internal Medicine and Pediatrics, Ghent University Hospital, Belgium (G.G., R.V.).
Alain J van GoolTranslational Metabolic Laboratory, Department of Laboratory Medicine, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands (A.J.v.G.).
Isabel HeideggerDepartment of Urology, Medizinische Universität Innsbruck, Austria (I.H.).
John P A IoannidisDepartments of Medicine and of Epidemiology and Population Health and Meta-Research Innovation Center at Stanford (METRICS), Stanford University (J.P.A.I.).
Joachim JankowskiInstitute of Cardiovascular Research, RWTH Aachen University, Germany (J.J., V.J.).
Vera JankowskiInstitute of Cardiovascular Research, RWTH Aachen University, Germany (J.J., V.J.).
Carmen JeronimoCancer Biology and Epigenetics Group, Portuguese Oncology Institute of Porto and Abel Salazar Institute of Biomedical Sciences, University of Porto, Portugal (C.J.).
Ashish M KamatDivision of Surgery, Department of Urology, The University of Texas MD Anderson Cancer Centre, Houston (A.K.).
Rosalinde MasereeuwDiv. Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, NL (R.M.).
Gert MayerDepartment of Internal Medicine IV (Nephrology and Hypertension), Medizinische Universität Innsbruck, Austria (G.M.).
Harald MischakMosaiques Diagnostics and Therapeutics AG, Hannover, Germany (H.M.).
Alberto OrtizDepartment of Nephrology and Hypertension, IIS - Fundación Jiménez Díaz-UAM, Madrid, Spain (A.O.).
Giuseppe RemuzziIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Bergamo, Italy (A.B., G.R.).
Peter RossingSteno Diabetes Center, University of Copenhagen, Denmark (P.R.).
Joost P SchanstraInstitut 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.).
Bernd J Schmitz-DrägerUrologie 24, Nuremberg, and Department of Urology, Friedrich-Alexander University of Erlangen, Germany (B.J.S-D).
Goce SpasovskiDepartment of Nephrology, University Clinical Center Skopje, North Macedonia (G.S.).
Jan A StaessenResearch Institute Alliance for the Promotion of Preventive Medicine, Mechelen, Belgium, Biomedical Science Group, University of Leuven (J.A.S.).
Dimitrios StamatialisBioartificial organs, Department of Biomaterials Science and Technology, Technical Medical Centre, University of Twente, Enschede, The Netherlands (D.S.).
Peter StenvinkelDepartment of Renal Medicine M99, Karolinska University Hospital, Stockholm, Sweden (P.S.).
Christoph WannerDepartment of Medicine, Division of Nephrology, University Hospital, Würzburg, Germany (C.W.).
Stephen B WilliamsDepartment of Surgery, Division of Urology, The University of Texas Medical Branch, Galveston (S.B.W.).
Faiez ZannadCentre d'Investigation Clinique Inserm and Université de Lorraine, CHU Nancy, France (F.Z.).
Carmine ZoccaliClinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, National Council of Research, Institute of Clinical Physiology, Italy (C.Z.).
Raymond VanholderEuropean Kidney Health Alliance (EKHA), Brussels, Belgium (R.V.).
FIZ Karlsruhe – Leibniz Institute for Information Infrastructure · DEGhent University Hospital · BEInnsbruck Medical University · ATMario Negri Institute for Pharmacological Research · ITRWTH Aachen University · DEAcademy of Athens · GREuropean Bioinformatics Institute · GBFriedrich-Alexander-Universität Erlangen-Nürnberg · DEHospital Universitario Fundación Jiménez Díaz · ESInserm · FRInstitut de génétique et de biologie moléculaire et cellulaire · FRIstituto di Fisiologia Clinica · ITKarolinska University Hospital · SEKlinikum St. Georg · DEKU Leuven · BEMosaiques Diagnostics and Therapeutics (Germany) · DENational and Kapodistrian University of Athens · GRPHI University Psychiatric Clinic - Skopje · MKProtein Metrics (United States) · USRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Biomedical ResearchComputer SecurityInformation DisseminationEuropeHealth Records, PersonalHumansbiomedical researchdata managementEthics, ResearchGovernment Regulationinformed consent

Identifiers

PMID33583200
PMCPMC7968961
OpenAlexW3130854907

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.