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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

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 protectio...

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Autores principales: Scheibner, James, Ienca, Marcello, Kechagia, Sotiria, Troncoso-Pastoriza, Juan Ramon, Raisaro, Jean Louis, Hubaux, Jean-Pierre, Fellay, Jacques, Vayena, Effy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7381977/
https://www.ncbi.nlm.nih.gov/pubmed/32733683
http://dx.doi.org/10.1093/jlb/lsaa010
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author Scheibner, James
Ienca, Marcello
Kechagia, Sotiria
Troncoso-Pastoriza, Juan Ramon
Raisaro, Jean Louis
Hubaux, Jean-Pierre
Fellay, Jacques
Vayena, Effy
author_facet Scheibner, James
Ienca, Marcello
Kechagia, Sotiria
Troncoso-Pastoriza, Juan Ramon
Raisaro, Jean Louis
Hubaux, Jean-Pierre
Fellay, Jacques
Vayena, Effy
author_sort Scheibner, James
collection PubMed
description 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.
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spelling pubmed-73819772020-07-29 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 Scheibner, James Ienca, Marcello Kechagia, Sotiria Troncoso-Pastoriza, Juan Ramon Raisaro, Jean Louis Hubaux, Jean-Pierre Fellay, Jacques Vayena, Effy J Law Biosci Original Article 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. Oxford University Press 2020-05-06 /pmc/articles/PMC7381977/ /pubmed/32733683 http://dx.doi.org/10.1093/jlb/lsaa010 Text en © The Author(s) 2020. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) ), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original Article
Scheibner, James
Ienca, Marcello
Kechagia, Sotiria
Troncoso-Pastoriza, Juan Ramon
Raisaro, Jean Louis
Hubaux, Jean-Pierre
Fellay, Jacques
Vayena, Effy
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7381977/
https://www.ncbi.nlm.nih.gov/pubmed/32733683
http://dx.doi.org/10.1093/jlb/lsaa010
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