Data protection and ethics requirements for multisite research with health data: a comparative examination of legislative governance frameworks and the role of data protection technologies.

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State: Public
Version: Final published version
License: CC BY-NC-ND 4.0
Serval ID
serval:BIB_E81CB33F863F
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Data protection and ethics requirements for multisite research with health data: a comparative examination of legislative governance frameworks and the role of data protection technologies.
Journal
Journal of law and the biosciences
Author(s)
Scheibner J., Ienca M., Kechagia S., Troncoso-Pastoriza J.R., Raisaro J.L., Hubaux J.P., Fellay J., Vayena E.
ISSN
2053-9711 (Print)
ISSN-L
2053-9711
Publication state
Published
Issued date
2020
Peer-reviewed
Oui
Volume
7
Number
1
Pages
lsaa010
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
Personalised medicine can improve both public and individual health by providing targeted preventative and therapeutic healthcare. However, patient health data must be shared between institutions and across jurisdictions for the benefits of personalised medicine to be realised. Whilst data protection, privacy, and research ethics laws protect patient confidentiality and safety they also may impede multisite research, particularly across jurisdictions. Accordingly, we compare the concept of data accessibility in data protection and research ethics laws across seven jurisdictions. These jurisdictions include Switzerland, Italy, Spain, the United Kingdom (which have implemented the General Data Protection Regulation), the United States, Canada, and Australia. Our paper identifies the requirements for consent, the standards for anonymisation or pseudonymisation, and adequacy of protection between jurisdictions as barriers for sharing. We also identify differences between the European Union and other jurisdictions as a significant barrier for data accessibility in cross jurisdictional multisite research. Our paper concludes by considering solutions to overcome these legislative differences. These solutions include data transfer agreements and organisational collaborations designed to `front load' the process of ethics approval, so that subsequent research protocols are standardised. We also allude to technical solutions, such as distributed computing, secure multiparty computation and homomorphic encryption.
Keywords
Advanced cryptography, Biomedical data, Data protection, Data sharing, Multisite research, Personalised healthcare
Pubmed
Web of science
Open Access
Yes
Create date
13/08/2020 8:03
Last modification date
21/11/2022 8:17
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