TY - JOUR

T1 - Ethical and research governance approval across Europe

T2 - Experiences from three European palliative care studies

AU - Preston, N.

AU - van Delden, J.J.M.

AU - Ingravallo, F.

AU - Hughes, S.

AU - Hasselaar, J.

AU - van der Heide, A.

AU - Van den Block, L.

AU - Dunleavy, L.

AU - Groot, M.

AU - Csikos, A.

AU - Payne, S.

N1 - The final, definitive version of this article has been published in the Journal, Palliative Medicine, 34 (6), 2020, © SAGE Publications Ltd, 2020 by SAGE Publications Ltd at the Palliative Medicine page: https://journals.sagepub.com/home/pmj on SAGE Journals Online: http://journals.sagepub.com/

PY - 2020/6/1

Y1 - 2020/6/1

N2 - 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.

AB - 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.

KW - clinical trial as topic

KW - Ethics

KW - Europe

KW - palliative care

KW - research governance

KW - surveys and questionnaires

U2 - 10.1177/0269216320908774

DO - 10.1177/0269216320908774

M3 - Journal article

VL - 34

SP - 817

EP - 821

JO - Palliative Medicine

JF - Palliative Medicine

SN - 0269-2163

IS - 6

ER -