Introduction

Health research in low-income and middle-income countries (LMICs), which face the greatest burden of disease, is a vital component of efforts to combat global health inequity.1 The benefit of increased research is accompanied by major challenges for research governance.2 3 International collaboration and external funding can skew priorities; external investigators may lack knowledge of the local context and local researchers may have had limited exposure to research methodology and ethics training.4 Gross ethical misconduct has occurred in sub-Saharan Africa (SSA), such as not obtaining informed consent from meningitis vaccine participants or giving placebos to HIV-infected pregnant women despite evidence of the beneficial effect of antiretroviral therapy on mother-to-child transmission.5 6 Many less blatant challenges to ethical research exist. These can be because participants in SSA are more likely to be vulnerable and questions have been raised on the nature of ‘informed consent’ for such participants.7 Further, new and complex challenges are also emerging. These are observed when urgent measures such as during the Ebola outbreak were implemented or resulting from research involving genetic and genomic analyses, and the use of artificial intelligence in healthcare.8–10

A key component of health research governance involving human participants includes ethical review by a Research Ethics Committee (REC). RECs may also be called an Institutional Review Board or an Ethics Review Committee. RECs set out to protect human participants by conducting ethical reviews of health-related research. The Declaration of Helsinki11 highlights the need for ethical review by an independent and appropriately constituted REC. The committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence, and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards. The committee must have the right to monitor ongoing studies including information about any serious adverse events. At the end of the study, a final report should be submitted to the committee including the study’s findings and conclusions.

While ethical and regulatory bodies in LMICs and SSA are best placed to understand their local context and advise on challenges to informed consent, vulnerable populations, cultural beliefs and the way care is delivered, their capacity to do so may be limited by a range of factors. These include a lack of infrastructure (eg, Information Technology (IT) resources, meeting and storage space, transport to trial sites); limited financial and administrative support; a small pool of REC members and regulators; lack of theoretical training in ethics and regulatory affairs; and a lack of comprehensive governance structures.12

There has been ongoing concern about ethical and regulatory issues and the state of RECs in SSA, with various attempts to strengthen them. In 2007, a mapping of ethical review committee activity in western and central Africa reported little available information on existing committee structures.13 Subsequent workshops followed that led to the creation of national structures in many countries. As health research initiatives in SSA grew in scope and complexity, increased research activity resulted in the need for sound ethical review structures and functions in the form of REC. A large-scale survey of research ethics policies and practices in SSA concluded that there are extensive gaps in the capacity of health research institutions in Africa to undertake ethical reviews of studies.14 The Mapping African Research Ethics Capacity (MARC) project started in 2009. It has created an interactive wiki-type platform and tools, which can be found on the Council on Health Research for Development’s Health Research website.15 The platform was to understand the capacity of the research institutions that were part of the network, to help to facilitate the flow of information between the centres and provide a public space where researchers could provide each other with technical and strategic support for health research. Tools were designed for strengthening ethical review and regulation of health research in Africa16 17 There was a need to identify existing capacity and funding and demonstrate the areas where this needed to be developed. In 2012, this was seen to be lagging in requirements, often because of poor resource availability and lack of capacity.16 MARC went on to develop an interactive map of health research ethics review capacity and drug regulatory capacity in Africa.15 Since then, studies focussing on different aspects of national research systems of different countries have identified weaknesses and in some counties, have recommended extensive work to strengthen the ethical and regulatory systems.10 18 19 A 2015 systematic review, focusing on the structure, functioning and outcomes of biomedical RECs in SSA, found several factors that hinder the work of RECs including lack of membership diversity, scarcity of resources, insufficient training of members, inadequate capacity to review and monitor studies, and lack of national ethics guidelines and accreditation.19 Further, studies have conducted assessments of needs in different countries,20 sometimes as part of developmental programmes21 22 while other studies have conducted only partial evaluations looking at certain aspects of research development.23 The overall evidence on health-related RECs in SSA is growing but is largely fragmented. This review will provide a more comprehensive understanding of the health-related RECs in SSA.

A scoping review is considered to be the most suitable approach to establish the current situation, rather than a systematic review and meta-analysis.24 A scoping review provides an overview of a broad field.25 This review will identify and examine current literature to understand how ethics committees for health-related research operate and ways of developing them in SSA. The evidence about RECs is likely to be from disparate or heterogeneous sources which a scoping review can bring together. Scoping reviews provide a map of the existing literature. These reviews do not normally assess the quality of evidence as the main purpose is to identify and map the evidence itself. While scoping reviews may inform future systematic reviews, they are also useful for policy-makers and practitioners.26

The objectives of the review were formulated from the issues outlined above and the preliminary literature search. They are to identify and analyse literature on leadership and governance, strategies to develop the technical ability of ethical committees, and the administrative and financial capacity of health-related RECs in SSA.