STRUCTURAL AND FUNCTIONAL CHARACTERISTICS OF TWO INSTITUTIONAL RESEARCH ETHICS COMMITTEES IN ESWATINI BY BABAZILE HAZEL SHONGWE A THESIS SUBMITTED TO THE SCHOOL OF MEDICINE IN PARTIAL FULFILMENT OF THE REQUIREMENTS FOR THE AWARD OF MASTER’S DEGREE IN INTERNATIONAL HEALTH RESEARCH ETHICS MOI UNIVERSITY 2021 ii DECLARATION Declaration by the candidate I hereby declare that the work for this thesis is my original work and has not been presented for a degree in any other University. No part of this thesis may be produced without the permission of the author or university. Babazile Shongwe Signature………………………… Date…………………… SMPGIHRE/01/16 Declaration by supervisors: This thesis has been submitted to the School of Medicine for examination with our approval as University supervisors Prof. Ann Mwangi Signature………………………… Date…………………… Department of Behavioural Science MOI University Prof. David Ayuku Signature………………………… Date…………………… Department of Behavioural Science MOI University iii DEDICATION This work is dedicated to the following: my beloved parents Mr M.M. Dlamini and my ever loving and caring mother Mrs Siphelile Nothando Dlamini for being an inspiration, to my supportive, encouraging and loving husband Nsimbi Sibusiso Shongwe and children (Sinakekelwe Tandzile Shongwe, my angel and Mncobi Mnakekeli Shongwe, my shining armour). iv 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. Recommendation There is need for capacity building, resource mobilization and enactment of policies within the two IRECs in order to strengthen their structural and functional characteristics. The findings call for the Government of Eswatini, the University authorities and the national board to assist the IRECs with resource mobilization, protocol review mentorship to improve their capacity. v TABLE OF CONTENTS DECLARATION .......................................................................................................... ii DEDICATION ............................................................................................................. iii ABSTRACT ................................................................................................................. iv TABLE OF CONTENTS ...............................................................................................v LIST OF TABLES ...................................................................................................... vii LIST OF FIGURE...................................................................................................... viii ABBREVIATIONS AND ACRONYMS .................................................................... ix ACKNOWLEDGEMENTS ......................................................................................... xi CHAPTER ONE ..........................................................................................................1 1.1 Introduction ..............................................................................................................1 1.2. Study Background ...................................................................................................3 1.3. Problem Statement ................................................................................................12 1.4. Study Justification .................................................................................................13 1.5. Significance...........................................................................................................14 1.6. General Objective .................................................................................................14 1.7 Specific Objectives ................................................................................................14 1.8 Research Questions ................................................................................................14 CHAPTER TWO .......................................................................................................15 2.0. Literature Review..................................................................................................15 CHAPTER THREE ...................................................................................................24 RESEARCH METHODOLOGY .............................................................................24 3.1. Study Design .........................................................................................................24 3.2. Study Site ..............................................................................................................24 3.3. Target Population ..................................................................................................25 3.4. Eligibility Criteria .................................................................................................25 3.4.1 Inclusion criteria .............................................................................................. 25 3.4.2 Exclusion criteria............................................................................................. 25 3.5 Sampling Procedure ...............................................................................................25 3.6. Data Collection Instrument ...................................................................................26 3.7. Data Collection .....................................................................................................27 3.8. Data Management .................................................................................................28 3.9. Data Analysis ........................................................................................................28 vi 3.10. Study Validity .....................................................................................................29 3.11. Ethical Considerations ........................................................................................29 3.12. Dissemination of Results and Publication Policy ...............................................29 CHAPTER FOUR ......................................................................................................30 4.1 IRECs Scores on Individual Domains of MERETI Tool.......................................30 4.2. Profile and Distribution.........................................................................................31 4.3 Structural Characteristics .......................................................................................32 4.4 Functional Characteristics ......................................................................................32 CHAPTER FIVE .......................................................................................................34 DISCUSSION .............................................................................................................34