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Ethical and research governance approval across Europe: Experiences from three European palliative care studies

BACKGROUND: Research requires high-quality ethical and governance scrutiny and approval. However, when research is conducted across different countries, this can cause challenges due to the differing ethico-legal framework requirements of ethical boards. There is no specific guidance for research wh...

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Autores principales: Preston, Nancy, van Delden, Johannes JM, Ingravallo, Francesca, Hughes, Sean, Hasselaar, Jeroen, van der Heide, Agnes, Van den Block, Lieve, Dunleavy, Lesley, Groot, Marieke, Csikos, Agnes, Payne, Sheila
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7521003/
https://www.ncbi.nlm.nih.gov/pubmed/32186242
http://dx.doi.org/10.1177/0269216320908774
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author Preston, Nancy
van Delden, Johannes JM
Ingravallo, Francesca
Hughes, Sean
Hasselaar, Jeroen
van der Heide, Agnes
Van den Block, Lieve
Dunleavy, Lesley
Groot, Marieke
Csikos, Agnes
Payne, Sheila
author_facet Preston, Nancy
van Delden, Johannes JM
Ingravallo, Francesca
Hughes, Sean
Hasselaar, Jeroen
van der Heide, Agnes
Van den Block, Lieve
Dunleavy, Lesley
Groot, Marieke
Csikos, Agnes
Payne, Sheila
author_sort Preston, Nancy
collection PubMed
description BACKGROUND: Research requires high-quality ethical and governance scrutiny and approval. However, when research is conducted across different countries, this can cause challenges due to the differing ethico-legal framework requirements of ethical boards. There is no specific guidance for research which does not involve non-medicinal products. AIM: To describe and address differences in ethical and research governance procedures applied by research ethics committees for non-pharmaceutical palliative care studies including adult participants in collaborative European studies. DESIGN: An online survey analysed using descriptive statistics. SETTING/PARTICIPANTS: Eighteen principal investigators in 11 countries conducting one of three European-funded studies. RESULTS: There was variation in practice including whether ethical approval was required. The time to gain full approvals differed with the United Kingdom having governance procedures that took the longest time. Written consent was not required in all countries nor were data safety monitoring committees for trials. There were additional differences in relation to other data management issues. CONCLUSION: Researchers need to take the differences in research approval procedures into account when planning studies. Future research is needed to establish European-wide recommendations for policy and practice that dovetail ethical procedures and enhance transnational research collaborations.
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spelling pubmed-75210032020-10-14 Ethical and research governance approval across Europe: Experiences from three European palliative care studies Preston, Nancy van Delden, Johannes JM Ingravallo, Francesca Hughes, Sean Hasselaar, Jeroen van der Heide, Agnes Van den Block, Lieve Dunleavy, Lesley Groot, Marieke Csikos, Agnes Payne, Sheila Palliat Med Short Report BACKGROUND: Research requires high-quality ethical and governance scrutiny and approval. However, when research is conducted across different countries, this can cause challenges due to the differing ethico-legal framework requirements of ethical boards. There is no specific guidance for research which does not involve non-medicinal products. AIM: To describe and address differences in ethical and research governance procedures applied by research ethics committees for non-pharmaceutical palliative care studies including adult participants in collaborative European studies. DESIGN: An online survey analysed using descriptive statistics. SETTING/PARTICIPANTS: Eighteen principal investigators in 11 countries conducting one of three European-funded studies. RESULTS: There was variation in practice including whether ethical approval was required. The time to gain full approvals differed with the United Kingdom having governance procedures that took the longest time. Written consent was not required in all countries nor were data safety monitoring committees for trials. There were additional differences in relation to other data management issues. CONCLUSION: Researchers need to take the differences in research approval procedures into account when planning studies. Future research is needed to establish European-wide recommendations for policy and practice that dovetail ethical procedures and enhance transnational research collaborations. SAGE Publications 2020-03-18 2020-06 /pmc/articles/PMC7521003/ /pubmed/32186242 http://dx.doi.org/10.1177/0269216320908774 Text en © The Author(s) 2020 https://creativecommons.org/licenses/by/4.0/ This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Short Report
Preston, Nancy
van Delden, Johannes JM
Ingravallo, Francesca
Hughes, Sean
Hasselaar, Jeroen
van der Heide, Agnes
Van den Block, Lieve
Dunleavy, Lesley
Groot, Marieke
Csikos, Agnes
Payne, Sheila
Ethical and research governance approval across Europe: Experiences from three European palliative care studies
title Ethical and research governance approval across Europe: Experiences from three European palliative care studies
title_full Ethical and research governance approval across Europe: Experiences from three European palliative care studies
title_fullStr Ethical and research governance approval across Europe: Experiences from three European palliative care studies
title_full_unstemmed Ethical and research governance approval across Europe: Experiences from three European palliative care studies
title_short Ethical and research governance approval across Europe: Experiences from three European palliative care studies
title_sort ethical and research governance approval across europe: experiences from three european palliative care studies
topic Short Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7521003/
https://www.ncbi.nlm.nih.gov/pubmed/32186242
http://dx.doi.org/10.1177/0269216320908774
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