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
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
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
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
4. A clinical trial on human beings shall only be conducted:
- (a) In the prescribed manner according to guidelines of good clinical
- (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
- (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.