Guidance for undertaking research in the Republic of South Sudan.
The overall responsibility for health research in South Sudan falls under the Division of Research, Monitoring and Evaluation and has been the remit of the Directorate of Planning and Coordination in the Ministry of Health, Republic of South Sudan. The existing structure of the research department includes the research data hub, the ethical committee and the research secretariats.
The Republic of South Sudan (ROSS) established a Research Ethics Committee (REC) in June 2006. Its purpose is to ensure that research in South Sudan is conducted according to internationally accepted norms in order to protect healthy volunteers and patients from exploitation and harm by researchers and commercial organizations.
Compliance with these guidelines helps to ensure that the dignity, rights, safety, and well-being of research participants are promoted and that the results of the investigations are credible. Over the years it has been noted that pharmaceutical companies and research organizations based in the developed countries have carried out research in less developed countries, such as ROSS, without regard to patient autonomy. On rare occasions the practice of research has even involved the deliberate and appalling violation of human beings.
All international guidelines require the ethical and scientific review of biomedical research alongside informed consent, and the appropriate protection of those unable to consent, as essential measures to protect the individual person and the communities who participate in research. For example, it is no longer possible in the United Kingdom to publish a paper on original research in any reputable medical journal without prior Research Ethical approval. ROSS will be no different in this regard.
The South Sudan Research Ethics Committee (SSREC) will publish full guidance on undertaking original research in ROSS on the South Sudan Medical Journal website (www.southsudanmedicaljournal.com). This will enable prospective researchers from any part of the world to read it and download application forms for Research Ethics approval well ahead of their arrival in the South Sudan. Applications for Research Ethics approval must be accompanied by the following documentation:
- Completed application form signed by the lead researchers.
- Covering letter from the researcher or researcher institution.
- Copy of REC approval if this proposal was reviewed by another institution.
- Curriculum vitae of all those involved in the research.
- Soft copy and seven hard copies of the research proposal.