Research in Sudan dates back to 1903 when the Welcome Tropical Laboratory was established. At that time, the Welcome Tropical Research laboratories pioneered various research in environmental health, control of endemic diseases such as Leishmaniasis, Malaria and Schistimoisis. The 1970s has witnessed an increase in research activities resulting from the return of many health scholars from international training although guidelines that regulate ethics of medical practice were issued in 1968 there were no mention of research ethics. With increased collaboration with international bodies in various research areas, the director of the National Health laboratory was entitled to give ethical clearance. The first ethical review committee was established in 1979 by a group of doctors and scientists from the National Health Research and was named the Committee of Ethics in Research Involving Humans. This committee was formed to respond to ethical dilemmas in health research; protect human subjects involved in research especially involving international collaboration. It was not until 2008 that the National Health Ethics Research Committee (NHREC) issued a document entitled “National Guidelines for Human Subject Protection” as a guideline to be followed for research involving human subjects. Amongst its guidelines, the NHREC advised that all medical schools and states to establish their own research ethical committees to review human subject research.
In December 2015, the Federal Ministry of Health (FMOH) where the NHREC is housed conducted a quick survey that could be regarded as a situation analysis of the registered Research Ethics Committees (RECs). Only 15 out of the 37 health institutions have RECs that are registered with the FMOH. We know that to date there are still some RECs that are not registered with the FMOH. Regarding the registered ones many admitted that they do not have a functioning REC, while others which have heard about the survey were surprised that they were in the FMOH list. Therefore even the list of the FMOH cannot be considered reliable. There is a need to identify the number of RECs in health institutions in Sudan, the RECs that are functioning, and the health institutes that need to establish an REC in order to carry out improvement plans for the future.
Our overall strategy is to strengthen and enhance the coordination of the national ethics and medicines regulatory frameworks that exist in Sudan by providing training, promotion of good practices, and networking between these regulatory bodies. We also propose to enhance the oversight and coordination of the research ethics committees that exist at the State and Institutional levels.
The national regulatory authorities for the review of human research involving human subjects in Sudan are the National Health Research Ethical Committee (NHREC) at the Federal Ministry of Health and the National Medicine and Poisons Board (NMPB). Both committees have the legal authority and thus the responsibility and accountability to develop guidelines, regulate and oversee the ethical review process. There are many challenges that these regulatory authorities face that hinder their role in regulating the ethical review process in Sudan. The main challenge is the lack of coordination and collaboration between these two national regulatory committees and the other state and institutional research ethics committees. In addition, both authorities are deficient in their constitution and functionality.
We have developed several work plan packages that will 1) develop the capacities of the NHREC to perform their national ethical oversight function over the Research Ethics Committees (RECs) at the State and Institutional levels; efficiently review clinical trial applications; and to provide ethical oversight for clinical trials and health research in general; and 2) support the NMPB’s development of institutional and personnel capacities to enable improved regulatory pathway activities directly related to clinical trials, registration of new medicinal products and strengthening of their pharmacovigilance systems.
Our hypothesis is that strengthening the performance of the two national regulatory bodies will enable them to perform their national ethical oversight function over the States and Institutional Research Ethical Committees.