Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Preston N

PROVIDER: S-EPMC7521003 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Preston Nancy N van Delden Johannes Jm JJ Ingravallo Francesca F Hughes Sean S Hasselaar Jeroen J van der Heide Agnes A Van den Block Lieve L Dunleavy Lesley L Groot Marieke M Csikos Agnes A Payne Sheila S

Palliative medicine 20200318 6

<h4>Background</h4>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.<h4>Aim</h4>To describe and address differences in ethical and research governance procedures applied by research ethics committees for non-pharmaceu ...[more]

PMID: 32186242

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Project description:IntroductionStakeholder engagement remains scarce in basic brain research. However, it can greatly improve the relevance of investigations and accelerate the translation of study findings to policy. The Lifebrain consortium investigated risk and protective factors influencing brain health using cognition, lifestyle and imaging data from European cohorts. Stakeholder activities of Lifebrain-organized in a separate work package-included organizing stakeholder events, investigating public perceptions of brain health and dissemination. Here, we describe the experiences of researchers and stakeholders regarding stakeholder engagement in the Lifebrain project.MethodsStakeholder engagement in Lifebrain was evaluated through surveys among researchers and stakeholders and stakeholders' feedback at stakeholder events through evaluation forms. Survey data were analysed using a simple content analysis approach, and results from evaluation forms were summarized after reviewing the frequency of responses.ResultsConsortium researchers and stakeholders experienced the engagement activities as meaningful and relevant. Researchers highlighted that it made the research and research processes more visible and contributed to new networks, optimized data collection on brain health perceptions and the production of papers and provided insights into stakeholder views. Stakeholders found research activities conducted in the stakeholder engagement work package to be within their field of interest and research results relevant to their work. Researchers identified barriers to stakeholder engagement, including lack of time, difficulties in identifying relevant stakeholders, and challenges in communicating complex scientific issues in lay language and maintaining relationships with stakeholders over time. Stakeholders identified barriers such as lack of budget, limited resources in their organization, time constraints and insufficient communication between researchers and stakeholders.ConclusionStakeholder engagement in basic brain research can greatly benefit researchers and stakeholders alike. Its success is conditional on dedicated human and financial resources, clear communication, transparent mutual expectations and clear roles and responsibilities.Public contributionPatient organizations, research networks, policymakers and members of the general public were involved in engagement and research activities throughout the project duration.

Dataset Information

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

Background

Aim

Design

Setting/participants

Results

Conclusion

Publications

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

Similar Datasets

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