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Background
Institutional Research Ethics Committees (lRECs) are in their infancy in Eswatini (formerly
Swaziland). Currently, there are delays in submission of ethics review minutes for approval of
institutional research protocols from local IRECs to the Eswatini Health and Human Research
Review Board (EHHRRB) formerly the National Health Research Review Board (NHRRB).
This puts into question the resource and functional capacity of these IRECs in performing
their oversight role of protecting human participants in biomedical research within their
institutions. Understanding how these IRECs function is critical in improving the ethical and
scientific quality of biomedical research in the country.
Objectives
This study sought to describe the resource needs and operational challenges of the University
of Eswatini-Faculty of Health Sciences Research Ethics Committee (UNESWA-FHSREC)
and the Southern Africa Nazarene University-Faculty of Health Sciences Research Ethics
Committee (SANU-FHSREC) in Eswatini.
Methods
A cross-sectional, descriptive survey was conducted in October-December 2017 with the only
two university IRECs in Eswatini at the time. A purposive sampling strategy was employed
and data were collected among all the committee members of the two institutions (N=15 from
UNESWA-FHSREC and N=5 from SANU-SHSREC) using the Research Ethics Committee
(REC) Quality Assurance Self-Assessment Tool. Descriptive statistics were used to describe
the characteristics of each IREC in each of the following domains of the tool: organizational
aspects (54 possible points), membership and education training (30 possible points),
communication of decisions (5 possible points), review of specific items in protocols (43
possible points) and committee resources (16 possible points), among other domains.
Results
Both IRECs did not attain the maximum achievable points of 200 in the assessment. The
UNESWA-FHSREC’s overall score was 104 (52%) and 86 (43%), for the SANU-FHSREC.
For the profile and distribution of the IRECs, the results showed that a majority of the IREC
members were males (n = 13, 65%) with master’s degrees (75% n = 15). In terms of the
structural aspects, both IRECs had a number of gaps; they scored less than 50% in almost all
the domains. The functional characteristics have a possible overall score of 100, UNESWA-
FHSREC scored 72 (72%) whilst the SANU-FHSREC scored 48 (48%); generally, both
IRECs did better in this part of the assessment.
Conclusion
Notwithstanding that the two institutions had IRECs in place, the study showed a number of
gaps in their profile & distribution, structural and functional characteristics. The study
showed that both IRECs have limited resource and functional capacity which may
compromise their ability to perform their oversight role in protecting human participants in
biomedical research within their institutions. |
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