"Losing the tombola": a case study describing the use of community consultation in designing the study protocol for a randomised controlled trial of a mental health intervention in two conflict-affected regions

Community consultation is increasingly recommended, and in some cases, required by ethical review boards for research that involves higher levels of ethical risk such as international research and research with vulnerable populations. In designing a randomised control trial of a mental health intervention using a wait list control, we consulted the community where the research would be undertaken prior to finalising the study protocol. The study sites were two conflict-affected locations: Grozny in the Chechen Republic and Kitchanga in eastern Democratic Republic of Congo.