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

Date: 
18-03-2020

Authors: Nancy Preston, Johannes Jm van Delden, Francesca Ingravallo, Sean Hughes, Jeroen Hasselaar, Agnes van der Heide, Lieve Van den Block, Lesley Dunleavy, Marieke Groot, Agnes Csikos, Sheila Payne

Source: 
Palliative medicine (2020)
Links: 
PubMed

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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