By 2023, the country’s health sector will be sufficiently capacitated to generate and utilize evidence for effective delivery of health services.
To guide and promote scientifically sound and ethical health research practice through a well-regulated resourced coordinated national research system.
Policy and Legal environment
Implementation of this policy shall be supported by dictates of public health and national research legislation and shall formalize existence of the National Health Research Department and the National Health Research Review Board. The National Health Research Department shall assume a status of an Institute of Health Research upon establishment of the National Research Council.
Governance and Leadership
Overall leadership and coordination of research on human subjects in the country shall be the responsibility of the Ministry of Health through actions of the National Health Research Department. The National Health Research Review Board shall be accorded a semi-autonomous status in order to ensure independence of its operations.
The health sector through actions of National Health Research Department shall be responsible for facilitating capacity development in all spheres of health research across its four pillars based on a sector wide approach. Additional to national efforts to develop health research capacity, international agencies and individual researchers who seek to conduct research in the country shall contribute to capacity development of local researchers as a condition for protocol approval.
National Health Research Agenda
The National Health Research Department shall facilitate development of a national health research agenda, a guiding document which shall articulate priority health research issues based on burden of disease; bio-medical; clinical; health services and health systems; socio-cultural, environmental heath and special populations. All health research carried out in the country shall address National Research Agenda issues, except in cases of emerging and re-emerging issues.
Conduct of Health Research
Conduct of health research in the country shall adhere to high scientific and ethical standards as defined by international research guidelines. By consequence of this policy, all research on human subjects conducted in the country shall require prior approval of the National Health Research Review Board. Review of research protocols to be implemented in the country shall be carried out as the final review subsequent to reviews by institutional review boards whether national or international. Similarly, transfer of research databases and specimens shall require prior approval of the MOH, under facilitation of the health research department (NHRD). The National Health Research Department shall facilitate development and implementation of operational guidelines and tools to guide the practice of health research in the country. In approving research protocols, the National Health Research Review Board shall give consideration to the best interest of research participants (subjects) based on a risk/benefit analysis. Approval of clinical trials shall comply with Good Clinical Practice Guidelines as defined by the International conference on Harmonization (ICH) and Standard of Care requirements.
Health Research Financing
Efforts to mobilize resources for health research shall be facilitated by the National Health Research Department with the support of ministry of health leadership. A proportion of financing for health research shall be provided by the national budget as part of health sector expenditure. Funding for health research shall prioritize dictates of the national research agenda in an effort to promote evidence-based planning and policy making.
Information and Knowledge Management
The National Health Research Department shall facilitate management and periodic dissemination of health research products.
1 . The Minister of Health , in consultation with the Principal Secretary together with Directorate, shall provide guidelines for the conduct of clinical trials in Swaziland.
2. The Principal Secretary may constitute a special expert review panel on matters of public interest, public policy or national security concerning the conduct of clinical trials.
3. The medicine to be used in a clinical trial shall be approved by the Swaziland Scientific and Ethics Committee and Swaziland Medicines and Regulatory Authority.
4. A clinical trial on human beings shall only be conducted:
(a) In the prescribed manner according to guidelines of good clinical practice;
(b) If the researcher is in possession of a letter of approval issued by the relevant research ethics committee;
(c) If the researcher has a clinical trial certificate issued by the relevant Regulatory Authority;
(d) Has ethical approval granted by the Board;
(e) With proven evidence of being in possession of a no fault
(f) Insurance for all research participants.
Implementation of this policy shall be the responsibility of the National Health Research Department. The NHRD shall constitute operational technical committees as required and shall collaborate with the national research council once established and all research stakeholders based on sector wide principles.
This policy shall be translated into related legislation, a national health research strategic plan, and costed annual action plans as well as operational protocols and guidelines. The policy and related documents shall be communicated and disseminated to policy makers and stakeholders for purposes of sensitization and implementation.
Monitoring and Evaluation
Progress assessment in implementation of this policy and related instruments shall be based on a monitoring and evaluation framework which will be developed by the health research unit with assistance of the Monitoring and Evaluation unit of the Ministry of Health. The policy shall be subjected to mid and end of term reviews. Review findings shall be disseminated to all stakeholders.
The Health Research Unit shall develop budget estimates based on annual action plans as part of the national health sector budget and in line with sector wide principles.
The Health Research Unit shall facilitate revision of this policy in consultation with the Public Policy Coordination Unit (PPCU) and stakeholders based on findings of policy reviews and emerging health research issues.