Background In Sudan, there is an increase in health research in a situation of scarce resources and limited counteractive quality assurance in research ethics. The aim of this project was to enhance the ethical review system in Sudan.

Methods Our framework for enhancing the ethical review capacity was based on the context of Sudan with emphasis on governance, coordination, feasibility, efficiency and sustainability. Activities conducted to achieve our goals included reviewing the guidelines that govern human subjects research, enhancing the governance of national authorities (National Health Research Ethics Committee and National Medicine and Poisons Board), improving coordination between the national authorities by developing a consensus clarifying their roles and functions, capacity building for the oversight bodies and institutional ethical review committees (RECs) as well as establishing a network of research ethics committees.

Results The guidelines that govern human subjects research in Sudan were reviewed and updated. In addition, a consensus document was endorsed to clarify the roles of the national regulatory authorities creating channels of coordination and cooperation between them and institutional RECs. Thirty-nine RECs from different parts of Sudan have been trained and the results of the pre/post test have shown an increase in the knowledge score among trainees (p<0.05). The project has also provided a platform for sharing experiences and maintaining partnerships with regional and international institutes in addition to provision of technical support for newly established RECs.

Conclusion We believe that the array of activities conducted through this project had enhanced the governance, coordination, feasibility and, efficiency of the ethical review system in Sudan.