Ethical and research governance approval across Europe: Experiences from three European palliative care studies.
Ethics
Europe
clinical trial as topic
palliative care
research governance
surveys and questionnaires
Journal
Palliative medicine
ISSN: 1477-030X
Titre abrégé: Palliat Med
Pays: England
ID NLM: 8704926
Informations de publication
Date de publication:
06 2020
06 2020
Historique:
pubmed:
19
3
2020
medline:
29
4
2021
entrez:
19
3
2020
Statut:
ppublish
Résumé
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. 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. An online survey analysed using descriptive statistics. Eighteen principal investigators in 11 countries conducting one of three European-funded studies. 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 32186242
doi: 10.1177/0269216320908774
pmc: PMC7521003
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
817-821Références
J Indian Med Assoc. 2009 Jun;107(6):403-5
pubmed: 19886379
Eur J Anaesthesiol. 2015 Feb;32(2):126-31
pubmed: 25503525
Palliat Med. 2000 Jan;14(1):69-74
pubmed: 10717728
Ger Med Sci. 2015 Nov 17;13:Doc21
pubmed: 26633964
Eur J Neurol. 2005 Mar;12(3):212-7
pubmed: 15693811
BMJ. 2004 Jan 17;328(7432):140-1
pubmed: 14726341
Eur J Public Health. 2014 Jun;24(3):514-20
pubmed: 23804079
BMC Med Ethics. 2019 May 7;20(1):30
pubmed: 31064358
Health Res Policy Syst. 2016 Jan 19;14:5
pubmed: 26865158
Clin Med (Lond). 2001 May-Jun;1(3):197-9
pubmed: 11446614
Reprod Toxicol. 2018 Sep;80:68-72
pubmed: 29913205
Palliat Med. 2013 Dec;27(10):908-17
pubmed: 23695828