Claridge, Hugh;
Tan, Joachim;
Loane, Maria;
Garne, Ester;
Barisic, Ingeborg;
Cavero-Carbonell, Clara;
Dias, Carlos;
... Morris, Joan K; + view all
(2023)
Ethics and legal requirements for data linkage in 14 European countries for children with congenital anomalies.
BMJ Open
, 13
(7)
, Article e071687. 10.1136/bmjopen-2023-071687.
Preview |
Text
Ethics_and_legal_requirements_for_data_linkage_in_.pdf - Published Version Download (528kB) | Preview |
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 congenital anomalies 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. Small number 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 added additional 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.
| Type: | Article |
|---|---|
| Title: | Ethics and legal requirements for data linkage in 14 European countries for children with congenital anomalies |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1136/bmjopen-2023-071687 |
| Publisher version: | http://dx.doi.org/10.1136/bmjopen-2023-071687 |
| Language: | English |
| Additional information: | © 2023 BMJ Publishing Group Ltd. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license (https://creativecommons.org/licenses/by/4.0/). |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Population, Policy and Practice Dept |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10174847 |
Archive Staff Only
 |
View Item |
