Introduction
The Ministry of Health (MoH) identifies research as a key component for strengthening policy, planning,
monitoring and evaluation of systems in the health sector. In order to safeguard the dignity, rights, safety
and wellbeing of research participants; the Eswatini Health and Human Research Ethics Policy (2020/2030)
dictates the establishment of the autonomous EHHRRB as the final authority for approval of health
research. The Ministry has over the years progressively developed capacity to review ethics and scientific
soundness of research that involves human participants in the country. Ever since, research ethics review
and approval of research protocols was introduced in the country in 2006, there has been no capacity to
monitor if researchers were complying with approval conditions in conducting their research studies. Post
Approval Monitoring (PAM) was then introduced in 2020 to address the afore-mentioned concern.
Purpose
The purpose of the guidelines is to guide researchers on application, protocol review and PAM processes
with respect to health research ethics in the country. The guidelines are also designed with the intention of
assuring the research community, general public and research participants that appropriate steps are taken
to ensure protection of related rights and safety in the conduct of health research.
Scope
The EHHRRB receives, reviews and monitors implementation of all health research protocols that involve
human subjects in the country including traditional and alternative medicine for health research ethics
adherence. The research in question includes the four pillars of health research as described below:
a) Clinical research (focused towards improving diagnosis and treatment of disease and injury)
b) Biomedical research (focusing on understanding the normal and abnormal functioning at
molecular, cellular and organ systems of the body)
c) Health services and health systems research (focusing on improving efficiency and effectiveness
of the health systems)
d) Social, cultural, environmental, behavioral and population research (focusing on social and
cultural determinants of health)
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