Structural and functional characteristics of two institutional research ethics committees in Eswatini

Abstract

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.