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BMC Medical Informatics and Decision Making
Published in: BMC Medical Informatics and Decision Making 1/2019

Open Access 01-12-2019 | Research article

Responsible data sharing in a big data-driven translational research platform: lessons learned

Authors: S. Kalkman, M. Mostert, N. Udo-Beauvisage, J. J. van Delden, G. J. van Thiel

Published in: BMC Medical Informatics and Decision Making | Issue 1/2019

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Abstract

Background

To foster responsible data sharing in health research, ethical governance complementary to the EU General Data Protection Regulation is necessary. A governance framework for Big Data-driven research platforms will at least need to consider the conditions as specified a priori for individual datasets. We aim to identify and analyze these conditions for the Innovative Medicines Initiative’s (IMI) BigData@Heart platform.

Methods

We performed a unique descriptive case study into the conditions for data sharing as specified for datasets participating in BigData@Heart. Principle investigators of 56 participating databases were contacted via e-mail with the request to send any kind of documentation that possibly specified the conditions for data sharing. Documents were qualitatively reviewed for conditions pertaining to data sharing and data access.

Results

Qualitative content analysis of 55 relevant documents revealed overlap on the conditions: (1) only to share health data for scientific research, (2) in anonymized/coded form, (3) after approval from a designated review committee, and while (4) observing all appropriate measures for data security and in compliance with the applicable laws and regulations.

Conclusions

Despite considerable overlap, prespecified conditions give rise to challenges for data sharing. At the same time, these challenges inform our thinking about the design of an ethical governance framework for data sharing platforms. We urge current data sharing initiatives to concentrate on: (1) the scope of the research questions that may be addressed, (2) how to deal with varying levels of de-identification, (3) determining when and how review committees should come into play, (4) align what policies and regulations mean by “data sharing” and (5) how to deal with datasets that have no system in place for data sharing.
Appendix
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Literature
1.
Kalkman S, Mostert M, Gerlinger C, van Delden JJM, van Thiel GJMW. Responsible data sharing in international health research: a systematic review of principles and norms. BMC Med Ethics. 2019 Mar 28;20(1):21.CrossRef
2.
Alfonso F. Data sharing: a new editorial initiative of the International Committee of Medical Journal Editors : implications for the Editors' network. Neth Hear J. 2017 May;25(5):297–303.CrossRef
3.
Taichman DB, Backus J, Baethge C, et al. Sharing clinical trial data—a proposal from the international committee of medical journal editors. N Engl J Med. 2016;374:384–6.CrossRef
4.
5.
Mittelstadt BD, Floridi L. The ethics of big data: current and foreseeable issues in biomedical contexts. Sci Eng Ethics. 2016 Apr;22(2):303–41.CrossRef
6.
Big Data for Better Outcomes: Improving Health Outcomes and Healthcare Systems in Europe by Maximising the Potential of Big Data. 2018; Available from: http://​bd4bo.​eu/​. Accessed 5 Oct 2019.
7.
Cole AM, Stephens KA, Keppel GA, Estiri H, Baldwin LM. Extracting Electronic Health Record Data in a Practice-Based Research Network: Processes to Support Translational Research across Diverse Practice Organizations. EGEMS (Wash DC). 2016;4(2):1206 Epub 2016/05/04.
8.
Hemingway H, Feder GS, Fitzpatrick NK, Denaxas S, Shah AD, Timmis AD. Using nationwide ‘big data’ from linked electronic health records to help improve outcomes in cardiovascular diseases: 33 studies using methods from epidemiology, informatics, economics and social science in the ClinicAl disease research using LInked bespoke studies and electronic health records (CALIBER) programme. Southampton (UK): NIHR Journals Library; 2017.CrossRef
9.
Shabani M, Dove ES, Murtagh M, Knoppers BM, Borry P. Oversight of genomic data sharing: what roles for ethics and data access committees? Biopreserv Biobank. 2017;15(5):469–74.CrossRef
10.
Eckstein L, Chalmers D, Critchley C, Jeanneret R, McWhirter R, Nielsen J, Otlowski M, Nicol D. Australia: regulating genomic data sharing to promote public trust. Hum Genet. 2018 Aug;137(8):583–91.CrossRef
11.
Phillips M. International data-sharing norms: from the OECD to the general data protection regulation (GDPR). Hum Genet. 2018;137(8):575–82.CrossRef
12.
Van Veen EB. Observational health research in Europe: understanding the general data protection regulation and underlying debate. Eur J Cancer. 2018 Nov;104:70–80.CrossRef
13.
Mostert M, Koomen BM, van Delden JJM, Bredenoord AL. Privacy in Big Data psychiatric and behavioural research: A multiple-case study. Int J Law Psychiatry. 2018;60:40–4.CrossRef
14.
15.
Hufty M. Governance: exploring four approaches and their relevance to research. In: Wiesmann U, Hurni H, editors. Research for Sustainable Development: Foundations, Experiences, and Perspectives. Bern: Geographica Bernensia; 2012. p. 165–83.
16.
17.
Boeije H. Analysis in qualitative research. Thousand Oaks: SAGE Publications Inc; 2012.
18.
Council for International Organizations of Medical Sciences. International Ethical Guidelines for Health-related Research Involving Humans. Geneva: World Medical Association; 2016.
19.
Mostert M, Bredenoord AL, Biesaart MC, van Delden JJ. Big data in medical research and EU data protection law: challenges to the consent or anonymise approach. Eur J Hum Genet. 2016;24(7):956–60.CrossRef
20.
Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks Adopted 2002, revised 2016.
Metadata
Title
Responsible data sharing in a big data-driven translational research platform: lessons learned
Authors
S. Kalkman
M. Mostert
N. Udo-Beauvisage
J. J. van Delden
G. J. van Thiel
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Medical Informatics and Decision Making / Issue 1/2019
Electronic ISSN: 1472-6947
DOI
https://doi.org/10.1186/s12911-019-1001-y

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