Journal article 229 views 49 downloads
Ethics and legal requirements for data linkage in 14 European countries for children with congenital anomalies
,
Joachim Tan,
Maria Loane ,
Ester Garne ,
Ingeborg Barisic,
Clara Cavero-Carbonell ,
Carlos Dias ,
Miriam Gatt,
Sue Jordan ,
Babak Khoshnood ,
Sonja Kiuru-Kuhlefelt,
Kari Klungsoyr ,
Olatz Mokoroa Carollo,
Vera Nelen,
Amanda J Neville,
Anna Pierini,
Hanitra Randrianaivo,
Anke Rissmann ,
David Tucker,
Hermien de Walle,
Wladimir Wertelecki,
Joan K Morris
BMJ Open, Volume: 13, Issue: 7, Start page: e071687
Swansea University Author:
Sue Jordan
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This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made.
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DOI (Published version): 10.1136/bmjopen-2023-071687
Abstract
Introduction: Linking healthcare data sets can create valuable resources for research, particularly when investigating rare exposures or outcomes. However, across Europe, the permissions processes required to access data can be complex. This paper documents the processes required by the EUROlinkCAT...
| Published in: | BMJ Open |
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| ISSN: | 2044-6055 2044-6055 |
| Published: |
BMJ
2023
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| Online Access: |
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| URI: | https://cronfa.swan.ac.uk/Record/cronfa64005 |
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| Abstract: |
Introduction: Linking healthcare data sets can create valuable resources for research, particularly when investigating rare exposures or outcomes. However, across Europe, the permissions processes required to access data can be complex. This paper documents the processes required by the EUROlinkCAT study investigators to research the health and survival of children with congenitalanomalies in Europe. Methods: Eighteen congenital anomaly registries in 14 countries provided information on all the permissions required to perform surveillance of congenital anomalies and to link their data on live births with available vital statistics and healthcare databases for research. Smallnumber restrictions imposed by data providers were also documented. Results: The permissions requirements varied substantially, with certain registries able to conduct congenital anomaly surveillance as part of national or regional healthcare provision, while others were required to obtain ethics approvals or informed consent. Data linkage and analysis for research purposes addedadditional layers of complexity for registries, with some required to obtain several permissions, including ethics approvals to link the data. Restrictions relating to small numbers often resulted in a registry’s data on specific congenital anomalies being unusable. Conclusion: The permissions required to obtain and link data on children with congenital anomalies varied greatly across Europe. The variation and complexity present a significant obstacle to the use of such data, especially in large data linkage projects. Furthermore, small number restrictions severely limited the research that could be performed for children with specific rare congenital anomalies. |
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| Keywords: |
Data linkage, EUROlinkCAT, congenital anomalies, ethics, legal requirements |
| College: |
Faculty of Medicine, Health and Life Sciences |
| Funders: |
Horizon 2020 |
| Issue: |
7 |
| Start Page: |
e071687 |