Background: The universal principles of biomedical ethics provide overall guidance which are applicable to all settings. However, the range of ethical issues present in different communities differs subject to variations in ethno-cultural contexts. Rapid Ethical Assessment (REA) is an approach developed to improve context-tailored application of the informed consent process in low-income settings. The tool employs ethnographic and action research techniques to explore and address context specific ethical issues. However, information is lacking on its feasibility and applicability for wide-scale use. This study aimed to explore the need for REA and establish its usefulness for research in Ethiopia and similar settings. The study also aimed to assess feasibility of REA so as to provide further guidance on strategies for its future application.
Methods: Pilot REA studies were conducted in three different research projects, 'parent studies', in Ethiopia between 2012 and 2013. The studies employed a range of study designs with multi-disciplinary approach and were conducted in multi-ethnic and multi-cultural settings in Ethiopia. The study disciplines employed ranged from ethics, social science and anthropology to public health. The study designs employed ranged from qualitative, ethnographic and mixed methods to quantitative interventional studies.
Results: Qualitative and quantitative studies of research stakeholders indicated presence of gaps in the research consent process in Ethiopia. The need for the REA approach in understanding and addressing these gaps was highlighted. Based on the pilot studies, REA was found to be useful to identify important context-specific ethical issues and contextualizing consent processes for community-based medical research. The ethical issues ranged from general issues such as the cultural setting of the study, perception about research, health and health care practices to perceptions about the research subject matters, and communication dynamics and norms and their hierarchies. REA was associated with improved levels of information comprehension and quality of the informed consent process. REA also appeared to be a feasible intervention in terms of cost, time and skill. REA skills were easily transferrable to local experts and the approach was flexible and adaptable to circumstances, settings and needs.
Conclusion: Given clear strategic guidelines, REA is a highly useful approach to identify important ethical issues in research conducted in the Ethiopian context. It is feasible that the approach could be applied at wider scale in such settings. The approach is recommended for further dissemination coupled with continued documentation and validation.
|Date of Award||Mar 2015|