Challenges of Ethical Clearance in International Health Policy and Social Sciences Research: Experiences and Recommendations from a Multi-Country Research Programme

Background: Research ethics review practices vary considerably across countries and this variability poses a challenge for international research programmes. Although published guidelines exist, which describe underlying principles that should be considered and pragmatic approaches that could be followed in seeking ethics approval, most have roots in biomedical and clinical research. The result is that there is generally less clarity around institutional and/or country-level structures for ethics review of health policy and social sciences research. This is an important gap that needs to be addressed in order to ensure ethical practices in multi-country research programmes. Context and purpose: This paper explores research ethics requirements for a multicountry health policy research programme and provides recommendations based on experiences in seeking ethics approval. The context for this paper is a five-year, cross-country, European Commission-funded international programme: Research into Policy to enhance Physical Activity (REPOPA). Results: Ethics requirements and review processes for health policy and social sciences research varied considerably across the seven REPOPA countries. Specifically, requirements and infrastructure for ethics approval have been influenced by how the purpose and domain of health research are defined in legislation, what types of research have been most prominently funded, and international requirements for ethics approval by external funders and journal editors. Significance: Multi-country research programmes provide an opportunity to enhance and build transparent ethics review practices and to strengthen ethics review structures at all levels. Such programmes also enable reciprocal learning about relevant practices and processes for the ethical conduct of research.