Ideas and Opinions
12 February 2019

Are Requirements to Deposit Data in Research Repositories Compatible With the European Union's General Data Protection Regulation?

Publication: Annals of Internal Medicine
Volume 170, Number 5
To reproduce study findings and facilitate new discoveries, many funding bodies, publishers, and professional communities are encouraging—and increasingly requiring—investigators to deposit their data, including individual-level health information, in research repositories. For example, in some cases the National Institutes of Health (NIH) and editors of some Springer Nature journals require investigators to deposit individual-level health data via a publicly accessible repository (1, 2). However, this requirement may conflict with the core privacy principles of European Union (EU) General Data Protection Regulation 2016/679 (GDPR), which focuses on the rights of individuals as well as researchers' obligations regarding transparency and accountability.

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Information & Authors

Information

Published In

cover image Annals of Internal Medicine
Annals of Internal Medicine
Volume 170Number 55 March 2019
Pages: 332 - 334

History

Published online: 12 February 2019
Published in issue: 5 March 2019

Keywords

Authors

Affiliations

Deborah Mascalzoni, PhD
Institute for Biomedicine, Eurac Research, Bolzano, Italy, and Uppsala University, Uppsala, Sweden (D.M.)
Heidi Beate Bentzen, LLM
Norwegian Research Center for Computers and Law and Centre for Medical Ethics, University of Oslo, Oslo, Norway (H.B.B.)
Isabelle Budin-Ljøsne, PhD
Norwegian Institute of Public Health, Oslo, Norway (I.B.)
Lee Andrew Bygrave, LLD
Norwegian Research Center for Computers and Law, University of Oslo, Oslo, Norway (L.A.B.)
Jessica Bell, PhD
University of Oxford, Oxford, United Kingdom, and University of Melbourne, Melbourne, Victoria, Australia (J.B., J.K.)
Edward S. Dove, PhD
University of Edinburgh, Edinburgh, United Kingdom (E.S.D.)
Christian Fuchsberger, PhD
Institute for Biomedicine, Eurac Research, Bolzano, Italy (C.F., V.M., C.P., P.P.P., A.R.)
Kristian Hveem, MD, PhD
Institute for Biomedicine, Eurac Research, Bolzano, Italy; HUNT Research Center and K.G. Jebsen Center for Genetic Epidemiology, Norwegian University of Science and Technology, Levanger, Norway (K.H.)
Michaela Th. Mayrhofer, PhD
BBMRI-ERIC, Graz, Austria (M.T.M.)
Viviana Meraviglia, PhD
Institute for Biomedicine, Eurac Research, Bolzano, Italy (C.F., V.M., C.P., P.P.P., A.R.)
David R. O'Brien, JD
Harvard University, Boston, Massachusetts (D.R.O.)
Cristian Pattaro, PhD
Institute for Biomedicine, Eurac Research, Bolzano, Italy (C.F., V.M., C.P., P.P.P., A.R.)
Peter P. Pramstaller, MD
Institute for Biomedicine, Eurac Research, Bolzano, Italy (C.F., V.M., C.P., P.P.P., A.R.)
Vojin Rakić, PhD
Center for the Study of Bioethics, University of Belgrade, Belgrade, Serbia (V.R.)
Alessandra Rossini, PhD
Institute for Biomedicine, Eurac Research, Bolzano, Italy (C.F., V.M., C.P., P.P.P., A.R.)
Mahsa Shabani, PhD
KU Leuven and Leuven Institute for Human Genomics and Society, Leuven, Belgium (M.S.)
Dan Jerker B. Svantesson, PhD
Bond University, Gold Coast, Queensland, Australia (D.J.S.)
Marta Tomasi, PhD
University of Trento, Trento, Italy, and Free University of Bozen-Bolzano, Bolzano, Italy (M.T.)
Lars Ursin, PhD
Norwegian University of Science and Technology, Trondheim, Norway (L.U.)
Matthias Wjst, MD
Helmholtz Zentrum München and Technical University Munich, Munich, Germany (M.W.)
Jane Kaye, DPhil
University of Oxford, Oxford, United Kingdom, and University of Melbourne, Melbourne, Victoria, Australia (J.B., J.K.)
Note: This article is based on work from European Cooperation in Science and Technology (COST) Action IS1303—Citizen's Health Through Public–Private Initiatives: Public Health, Market and Ethical Perspectives—supported by COST (https://www.cost.eu).
Grant Support: Ms. Bentzen receives funding from the Research Council of Norway under the project Legal Regulation of Information Processing Relating to Personalized Cancer Medicine (grant 238999). Drs. Mascalzoni, Bygrave, and Kaye and Ms. Bentzen are supported by NordForsk (grant 81105) and the Economic and Social Research Council (part of United Kingdom Research and Innovation) under the project Governance of Health Data in Cyberspace. Dr. Budin-Ljøsne receives funding from Biobank Norway, which is funded by the Research Council of Norway (grant 245464). Dr. Mayrhofer receives funding from ADOPT BBMRI-ERIC (GA 676550). Mr. O'Brien receives funding from the U.S. National Science Foundation (grant CNS-1237235). Dr. Rakić receives funding from the Serbian Ministry of Education, Science and Technological Development (grant 41004). Dr. Shabani is supported by an FWO postdoctoral fellowship.
Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-2854.
Corresponding Author: Jane Kaye, DPhil, HeLEX Centre for Health, Law and Emerging Technologies, Nuffield Department of Population Health, University of Oxford, Ewert House, Ewert Place, Summertown, Oxford OX2 7DD, United Kingdom; e-mail, [email protected].
Current Author Addresses: Drs. Mascalzoni, Fuchsberger, Meraviglia, Pattaro, Pramstaller, and Rossini: Institute for Biomedicine, Eurac Research, Via Galvani 31, 39100 Bolzano, Italy.
Ms. Bentzen and Dr. Bygrave: Norwegian Research Center for Computers and Law, Department of Private Law, Faculty of Law, University of Oslo, P.O. Box 6706, St. Olavs plass, 0130 Oslo, Norway.
Dr. Budin-Ljøsne, Norwegian Institute of Public Health, P.O. Box 222, Skøyen, 0213 Oslo, Norway.
Dr. Bell: Melbourne Law School, 185 Pelham Street, The University of Melbourne, Victoria, 3010, Australia.
Dr. Dove: School of Law, University of Edinburgh, LG.12, Old College, South Bridge, Edinburgh EH8 9YL, United Kingdom.
Drs. Fuchsberger, Meraviglia, Pattaro, Pramstaller, and Rossini: Institute for Biomedicine, Eurac Research, Via Galvani 31, 39100 Bolzano, Italy.
Dr. Hveem: HUNT Research Center, Forskningsvegen 2, 7600 Levanger, Norway.
Dr. Mayrhofer: BBMRI-ERIC, Neue Stiftingtalstrasse 2/B/6, 8010 Graz, Austria.
Mr. O'Brien: Berkman Klein Center for Internet and Society, Harvard University, 23 Everett Street, 2nd Floor, Cambridge, MA 02138.
Dr. Rakić: Center for the Study of Bioethics, Institute for Social Sciences, University of Belgrade, Kraljice Natalije 45, P.O. Box 605, 11000 Beograd, Serbia.
Dr. Shabani: Center for Biomedical Ethics and Law, University of Leuven, Kapucijnenvoer 35, 3000 Leuven, Belgium.
Dr. Svantesson: Faculty of Law, Bond University, Gold Coast, Queensland, 4229, Australia.
Dr. Tomasi: Faculty of Law, University of Trento, Via Verdi 53, 38100, Trento, Italy.
Dr. Ursin: K. G. Jebsen Center for Genetic Epidemiology, Department of Public Health and Nursing, Norwegian University of Science and Technology, Håkon Jarls gate 11, 7030 Trondheim, Norway.
Dr. Wjst: Helmholtz Zentrum München, National Research Centre for Environmental Health, Institute of Lung Biology and Disease, D-85764 Neuherberg, Germany.
Dr. Kaye: HeLEX Centre for Health, Law and Emerging Technologies, Nuffield Department of Population Health, University of Oxford, Ewert House, Ewert Place, Summertown, Oxford OX2 7DD, United Kingdom.
Author Contributions: Conception and design: D. Mascalzoni, H.B. Bentzen, I. Budin-Ljøsne.
Analysis and interpretation of the data: D. Mascalzoni, H.B. Bentzen, I. Budin-Ljøsne, L.A. Bygrave, J. Bell, E.S. Dove, K. Hveem, M.T. Mayrhofer, D.R. O'Brien, C. Pattaro, V. Rakić, M. Shabani, D.J.B. Svantesson, M. Tomasi, L. Ursin, M. Wjst, J. Kaye.
Drafting of the article: D. Mascalzoni, H.B. Bentzen, I. Budin-Ljøsne, L.A. Bygrave, J. Bell, E.S. Dove, K. Hveem.
Critical revision for important intellectual content: D. Mascalzoni, H.B. Bentzen, I. Budin-Ljøsne, L.A. Bygrave, J. Bell, C. Fuchsberger, K. Hveem, M.T. Mayrhofer, V. Meraviglia, C. Pattaro, P.P. Pramstaller, V. Rakić, A. Rossini, M. Shabani, M. Tomasi, M. Wjst, J. Kaye.
Final approval of the article: D. Mascalzoni, H.B. Bentzen, I. Budin-Ljøsne, L.A. Bygrave, J. Bell, E.S. Dove, C. Fuchsberger, K. Hveem, M.T. Mayrhofer, V. Meraviglia, D.R. O'Brien, C. Pattaro, P.P. Pramstaller, V. Rakić, A. Rossini, M. Shabani, D.J.B. Svantesson, M. Tomasi, L. Ursin, M. Wjst, J. Kaye.
Obtaining of funding: D. Mascalzoni, H.B. Bentzen, I. Budin-Ljøsne.
Administrative, technical, or logistic support: D. Mascalzoni, H.B. Bentzen, I. Budin-Ljøsne.
Collection and assembly of data: D. Mascalzoni, H.B. Bentzen, I. Budin-Ljøsne, L.A. Bygrave, J. Bell, E.S. Dove, K. Hveem, M.T. Mayrhofer, D.R. O'Brien, C. Pattaro, V. Rakić, M. Shabani, D.J.B. Svantesson, M. Tomasi, L. Ursin, M. Wjst, J. Kaye.
This article was published at Annals.org on 19 February 2019.
* Dr. Mascalzoni and Ms. Bentzen share first authorship.

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Deborah Mascalzoni, Heidi Beate Bentzen, Isabelle Budin-Ljøsne, et al. Are Requirements to Deposit Data in Research Repositories Compatible With the European Union's General Data Protection Regulation?. Ann Intern Med.2019;170:332-334. [Epub 12 February 2019]. doi:10.7326/M18-2854

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