Ethics review of multicenter neuro-psychiatric & neurodevelopmental genetics research protocols: a case study of the NeuroDev & NeuroGap-Psychosis studies

Complex research such as neuropsychiatric genetics presents unique challenges for research ethics committees (REC), particularly in Africa where genetics research on mental & neurological disorders is still in its infancy. To reflect on these experiences of reviewing Neuropsychiatric Genetic studies we use two multicenter studies, the NeuroDev and NeuroGap-Psychosis studies. We explored the content of the national guidelines and regulatory frameworks and the processes for ethics review in the participating African countries, to identify regulatory challenges, and to recommend areas for improvement. We also held reflective discussions with REC members involved in the review of the two studies were interviewed discussing their experiences of reviewing the two studies from the point of view of an African REC/REC member who reviewed the studies. Across all sites, a distinct theme was that the RECs did not have adequate knowledge and expertise for reviewing genetics and genomics studies in general. The review of guidelines showed the need to proactively update guidelines to meet the increasing complexity of research, ensure awareness creation, and continual capacity building of REC members.