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Ethics and legal requirements for data linkage in 14 European countries for children with congenital anomalies

Hugh Claridge Orcid Logo, Joachim Tan, Maria Loane Orcid Logo, Ester Garne Orcid Logo, Ingeborg Barisic, Clara Cavero-Carbonell Orcid Logo, Carlos Dias Orcid Logo, Miriam Gatt, Sue Jordan Orcid Logo, Babak Khoshnood Orcid Logo, Sonja Kiuru-Kuhlefelt, Kari Klungsoyr Orcid Logo, Olatz Mokoroa Carollo, Vera Nelen, Amanda J Neville, Anna Pierini, Hanitra Randrianaivo, Anke Rissmann Orcid Logo, David Tucker, Hermien de Walle, Wladimir Wertelecki, Joan K Morris Orcid Logo

BMJ Open, Volume: 13, Issue: 7, Start page: e071687

Swansea University Author: Sue Jordan Orcid Logo

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DOI (Published version): 10.1136/bmjopen-2023-071687

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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...

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Published in: BMJ Open
ISSN: 2044-6055 2044-6055
Published: BMJ 2023
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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. 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spelling v2 64005 2023-07-31 Ethics and legal requirements for data linkage in 14 European countries for children with congenital anomalies 24ce9db29b4bde1af4e83b388aae0ea1 0000-0002-5691-2987 Sue Jordan Sue Jordan true false 2023-07-31 HNU 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. Journal Article BMJ Open 13 7 e071687 BMJ 2044-6055 2044-6055 Data linkage, EUROlinkCAT, congenital anomalies, ethics, legal requirements 31 7 2023 2023-07-31 10.1136/bmjopen-2023-071687 http://dx.doi.org/10.1136/bmjopen-2023-071687 COLLEGE NANME Nursing COLLEGE CODE HNU Swansea University Another institution paid the OA fee Horizon 2020 2023-09-06T15:18:10.8942993 2023-07-31T19:52:37.2304514 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Hugh Claridge 0000-0001-5998-2860 1 Joachim Tan 2 Maria Loane 0000-0002-1206-3637 3 Ester Garne 0000-0003-0430-2594 4 Ingeborg Barisic 5 Clara Cavero-Carbonell 0000-0002-4858-6456 6 Carlos Dias 0000-0002-0206-5874 7 Miriam Gatt 8 Sue Jordan 0000-0002-5691-2987 9 Babak Khoshnood 0000-0002-4031-4915 10 Sonja Kiuru-Kuhlefelt 11 Kari Klungsoyr 0000-0003-2482-1690 12 Olatz Mokoroa Carollo 13 Vera Nelen 14 Amanda J Neville 15 Anna Pierini 16 Hanitra Randrianaivo 17 Anke Rissmann 0000-0002-9437-2790 18 David Tucker 19 Hermien de Walle 20 Wladimir Wertelecki 21 Joan K Morris 0000-0002-7164-612x 22 64005__28309__97331af386554823ae5046a560334f75.pdf 64005.VOR.pdf 2023-08-18T09:48:21.3038407 Output 528769 application/pdf Version of Record true 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. true eng https://creativecommons.org/licenses/by/4.0/
title Ethics and legal requirements for data linkage in 14 European countries for children with congenital anomalies
spellingShingle Ethics and legal requirements for data linkage in 14 European countries for children with congenital anomalies
Sue Jordan
title_short Ethics and legal requirements for data linkage in 14 European countries for children with congenital anomalies
title_full Ethics and legal requirements for data linkage in 14 European countries for children with congenital anomalies
title_fullStr Ethics and legal requirements for data linkage in 14 European countries for children with congenital anomalies
title_full_unstemmed Ethics and legal requirements for data linkage in 14 European countries for children with congenital anomalies
title_sort Ethics and legal requirements for data linkage in 14 European countries for children with congenital anomalies
author_id_str_mv 24ce9db29b4bde1af4e83b388aae0ea1
author_id_fullname_str_mv 24ce9db29b4bde1af4e83b388aae0ea1_***_Sue Jordan
author Sue Jordan
author2 Hugh Claridge
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
format Journal article
container_title BMJ Open
container_volume 13
container_issue 7
container_start_page e071687
publishDate 2023
institution Swansea University
issn 2044-6055
2044-6055
doi_str_mv 10.1136/bmjopen-2023-071687
publisher BMJ
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
url http://dx.doi.org/10.1136/bmjopen-2023-071687
document_store_str 1
active_str 0
description 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.
published_date 2023-07-31T15:18:12Z
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score 11.016235

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