Project: Enhancing Ethics in Sudan

Acronym	Enhancing Ethics in Sudan (Reference Number: EDCTP-Ethics2015-873)
Duration	01/02/2017 - 31/01/2019
Project Topic	This grant aims at improving the ethical review process in Sudan through enhancing the roles of the national regulatory authorities as well as the institutional and state Research Ethics Committees (RECs). We believe that building and strengthening the capacity of the National Health Research Health Committee and National Medicine Board as the two main regulatory authorities will enhance their performance in the regulation of research ethical review in the whole country. This enhanced ethics review system will positively impact the protection of many vulnerable populations that are involved in biomedical research in Sudan. Accordingly, we started by reviewing the guidelines that govern human subjects research issued by the Federal Ministry of Health in 2007. The review was conducted though the hard work of 13 experts in research ethics. As a result we have produced through this grant an updated version of the guidelines that govern human subject’s research in Sudan. These guidelines were endorsed by the Federal Ministry of Health in a workshop conducted by the Health Research Council chaired by the undersecretary in the Federal Ministry of Health and were distributed to all RECs in Sudan. We also worked through a series of meetings and workshops to develop a consensus document that clarifies the roles of the National Regulatory Authorities - a step that facilitates the review of clinical trials. The grant in its first year has also supported the training of research ethics committee members of 16 institutes and 5 states, a total of 116 trainees. In addition and through this fund, we have actively assisted the Federal Ministry of Health in reviewing and strengthening the NHREC, the dissemination of the updated guidelines and the recognition of the accreditation system that was recently established through workshops that included representatives of RECs in all states of Sudan. Through this grant we were able to develop a strong network between the national regulatory authorities and other RECs. A website was launched to facilitate the networking of RECs (www. snrec.sd). We believe that the establishment of the Sudanese Network of Research Ethics Committees will highly impact the overall ethical review process through standardization and harmonization of the ethical review process and creating a platform where all RECs can discuss ethical issues and challenges. We believe that the first year of this project has been an important milestone for enhancing the ethical review system in Sudan and for reaching our goal of a robust regulatory system in Sudan. It has contributed to the recognition and understanding of institutes and their RECs of the strength of the ethical review system in Sudan. The grant also contributed (indirectly) to the formulation of new RECs in Sudan especially at the state level, as the Federal Ministry of Health used the opportunity of the availability of funded training to remind the Ministries of health at state level to establish RECs to review research in their relative states, a step that was delayed for several years now, as the ministry issued an executive order back in 2007 urging ministries of health in the states and institutions to create RECs, but due to lack of awareness and proper training many of them were not able to create those committees. Therefore this grant enabled coverage of those different areas with different vulnerable groups and we are optimistic that this will eventually enhance the development of many clinical trials and development of medicinal products through research all through Sudan.
Network	EDCTP2
Call	Ethics and Regulatory capacities 2015

Project partner

Number	Name	Role	Country
1	University of Khartoum	Coordinator	South Sudan
3	Al-Neelain University	Partner	South Sudan
5	Federal Ministry of Health - Sudan	Partner	South Sudan