Cargando…
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...
Autores principales: | , , , , , , , , , , |
---|---|
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 |
_version_ | 1783587890639405056 |
---|---|
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. |
format | Online Article Text |
id | pubmed-7521003 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT prestonnancy ethicalandresearchgovernanceapprovalacrosseuropeexperiencesfromthreeeuropeanpalliativecarestudies AT vandeldenjohannesjm ethicalandresearchgovernanceapprovalacrosseuropeexperiencesfromthreeeuropeanpalliativecarestudies AT ingravallofrancesca ethicalandresearchgovernanceapprovalacrosseuropeexperiencesfromthreeeuropeanpalliativecarestudies AT hughessean ethicalandresearchgovernanceapprovalacrosseuropeexperiencesfromthreeeuropeanpalliativecarestudies AT hasselaarjeroen ethicalandresearchgovernanceapprovalacrosseuropeexperiencesfromthreeeuropeanpalliativecarestudies AT vanderheideagnes ethicalandresearchgovernanceapprovalacrosseuropeexperiencesfromthreeeuropeanpalliativecarestudies AT vandenblocklieve ethicalandresearchgovernanceapprovalacrosseuropeexperiencesfromthreeeuropeanpalliativecarestudies AT dunleavylesley ethicalandresearchgovernanceapprovalacrosseuropeexperiencesfromthreeeuropeanpalliativecarestudies AT grootmarieke ethicalandresearchgovernanceapprovalacrosseuropeexperiencesfromthreeeuropeanpalliativecarestudies AT csikosagnes ethicalandresearchgovernanceapprovalacrosseuropeexperiencesfromthreeeuropeanpalliativecarestudies AT paynesheila ethicalandresearchgovernanceapprovalacrosseuropeexperiencesfromthreeeuropeanpalliativecarestudies |