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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 Ceraline, et al.
(2021) HYPERTENSION. 77(4). p.1029-1035
Author
Organization
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.
Keywords
biomedical research, data management, Ethics, Research, Government Regulation, informed consent

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MLA
Vlahou, Antonia, et al. “Data Sharing under the General Data Protection Regulation : Time to Harmonize Law and Research Ethics?” HYPERTENSION, vol. 77, no. 4, 2021, pp. 1029–35, doi:10.1161/HYPERTENSIONAHA.120.16340.
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://doi.org/10.1161/HYPERTENSIONAHA.120.16340
Chicago author-date
Vlahou, Antonia, Dara Hallinan, Rolf Apweiler, Angel Argiles, Joachim Beige, Ariela Benigni, Rainer Bischoff, et al. 2021. “Data Sharing under the General Data Protection Regulation : Time to Harmonize Law and Research Ethics?” HYPERTENSION 77 (4): 1029–35. https://doi.org/10.1161/HYPERTENSIONAHA.120.16340.
Chicago author-date (all authors)
Vlahou, Antonia, Dara Hallinan, Rolf Apweiler, Angel Argiles, Joachim Beige, Ariela Benigni, Rainer Bischoff, Peter C. Black, Franziska Boehm, Jocelyn Ceraline, George P. Chrousos, Christian Delles, Pieter Evenepoel, Ivo Fridolin, Griet Glorieux, Alain J. van Gool, Isabel Heidegger, John P. A. Ioannidis, Joachim Jankowski, Vera Jankowski, Carmen Jeronimo, Ashish M. Kamat, Rosalinde Masereeuw, Gert Mayer, Harald Mischak, Alberto Ortiz, Giuseppe Remuzzi, Peter Rossing, Joost P. Schanstra, Bernd J. Schmitz-Draeger, Goce Spasovski, Jan A. Staessen, Dimitrios Stamatialis, Peter Stenvinkel, Christoph Wanner, Stephen B. Williams, Faiez Zannad, Carmine Zoccali, and Raymond Vanholder. 2021. “Data Sharing under the General Data Protection Regulation : Time to Harmonize Law and Research Ethics?” HYPERTENSION 77 (4): 1029–1035. doi:10.1161/HYPERTENSIONAHA.120.16340.
Vancouver
1.
Vlahou A, Hallinan D, Apweiler R, Argiles A, Beige J, Benigni A, et al. Data sharing under the General Data Protection Regulation : time to harmonize law and research ethics? HYPERTENSION. 2021;77(4):1029–35.
IEEE
[1]
A. Vlahou et al., “Data sharing under the General Data Protection Regulation : time to harmonize law and research ethics?,” HYPERTENSION, vol. 77, no. 4, pp. 1029–1035, 2021.
@article{8716446,
  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.}},
  author       = {{Vlahou, Antonia and Hallinan, Dara and Apweiler, Rolf and Argiles, Angel and Beige, Joachim and Benigni, Ariela and Bischoff, Rainer and Black, Peter C. and Boehm, Franziska and Ceraline, Jocelyn and Chrousos, George P. and Delles, Christian and Evenepoel, Pieter and Fridolin, Ivo and Glorieux, Griet and van Gool, Alain J. and Heidegger, Isabel and Ioannidis, John P. A. and Jankowski, Joachim and Jankowski, Vera and Jeronimo, Carmen and Kamat, Ashish M. and Masereeuw, Rosalinde and Mayer, Gert and Mischak, Harald and Ortiz, Alberto and Remuzzi, Giuseppe and Rossing, Peter and Schanstra, Joost P. and Schmitz-Draeger, Bernd J. and Spasovski, Goce and Staessen, Jan A. and Stamatialis, Dimitrios and Stenvinkel, Peter and Wanner, Christoph and Williams, Stephen B. and Zannad, Faiez and Zoccali, Carmine and Vanholder, Raymond}},
  issn         = {{0194-911X}},
  journal      = {{HYPERTENSION}},
  keywords     = {{biomedical research,data management,Ethics,Research,Government Regulation,informed consent}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{1029--1035}},
  title        = {{Data sharing under the General Data Protection Regulation : time to harmonize law and research ethics?}},
  url          = {{http://doi.org/10.1161/HYPERTENSIONAHA.120.16340}},
  volume       = {{77}},
  year         = {{2021}},
}
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