Research Ethics Committees in Africa: Building Capacity

BackgroundThe COVID-19 pandemic presents significant challenges to research ethics committees (RECs) in balancing urgency of review of COVID-19 research with careful consideration of risks and benefits. In the African context, RECs are further challenged by historical mistrust of research and potential impacts on COVID-19 related research participation, as well as the need to facilitate equitable access to effective treatments or vaccines for COVID-19. In South Africa, an absent National Health Research Ethics Council (NHREC) also left RECs without national guidance for a significant duration of the COVID-19 pandemic. We conducted a qualitative descriptive study that explored the perspectives and experiences of RECs regarding the ethical challenges of COVID-19 research in South Africa.MethodsWe conducted in-depth interviews with 21 REC chairpersons or members from seven RECs at large academic health institutions across South Africa that were actively involved in the review of COVID-19 related research from January to April 2021. In-depth interviews were conducted remotely via Zoom. Interviews (60–125 min) were conducted in English using an in-depth interview guide, until data saturation was achieved. Audio-recordings were transcribed verbatim and field notes were converted into data documents. Line-by-line coding of transcripts was performed, and data were organised into themes and sub-themes. An inductive approach to thematic analysis was used to analyse data.ResultsFive main themes were identified, namely: rapidly evolving research ethics landscape, extreme vulnerability of research participants, unique challenges to informed consent, challenges to community engagement during COVID-19, and overlapping research ethics and public health equity issues. Sub-themes were identified for each main theme.ConclusionsNumerous, significant ethical complexities and challenges were identified by South African REC members in the review of COVID-19 related research. While RECs are resilient and adaptable, reviewer and REC member fatigue were major concerns. The numerous ethical issues identified also highlight the need for research ethics teaching and training, especially in informed consent, as well as the urgent requirement for the development of national guidelines for research ethics during public health emergencies. Further, comparative analysis between different countries is needed to develop the discourse around African RECs and COVID-19 research ethics issues.

Debates about cross-cultural research have sparked growing interest in international research ethics and have initiated collaborative efforts addressing international ethical concerns. This is a case study describing the attempt of the Johns Hopkins Fogarty African Research Ethics Training Program (JHF), recipient of a National Institutes of Health Fogarty International Center (FIC) award, to strengthen research ethics capacity in Africa. The aim of this article is to identify critical elements of an effective research ethics capacity development process through a case study of this particular training program. More specifically, this article describes the JHF program in detail, assesses its outputs during four years, and analyzes its implications of the current model for further growth of this and similar FIC programs. This article assesses the JHF program using materials produced in the first four years of its existence (2001-2004): curriculum materials; application records; informal progress notes and evaluations; transcripts from the trainees' coursework; resumes; and formal progress reports submitted by trainees. The framework used to assess the program is a systems approach, which explores inputs, processes, outputs, and outcomes of the program. The nature and types of inputs changed over time as experience was gained in the program and a continuous improvement in specific processes was implemented. The JHF program has been successful in providing research ethics education and motivating trainees to contribute in the field of research ethics in their countries. How this translates to changes in research ethics in Africa remains to be seen.

Situated at the southern-most tip of the African continent, South Africa is geographically stable with few acute natural disasters. However spurts of political violence create acute man-made disasters from time to time. While disasters typically have a sudden monumental onset they can also have an insidious onset and then escalate to reach catastrophic proportions. Over the past three decades South Africa has had the latter experience of a public health disaster in the form of HIV/AIDS and drug resistant tuberculosis. Irrespective of the mode of onset of the disaster the sequelae are similar: significant physical, psychological, social and environmental harm. Consequently this public health disaster in South Africa created unparalleled opportunities for research. Research ethics regulatory infrastructure and guidelines evolved in response to the public health disaster. When disasters occur in resource depleted settings a situation of escalated vulnerability ensues. South African Research Ethics Committees (RECs) immediately developed guidelines to address this vulnerability. However, acute disaster research ethics is not currently included in national research ethics guidelines or standard operating procedures of RECs in the country. This chapter will revisit the ethical dilemmas that arose in the context of HIV/AIDS research and how these issues were encapsulated in guidelines. It will also examine the approaches to research ethics review that can be implemented in the setting of an acute disaster. These approaches are to be incorporated into South African research ethics guidelines that are currently under revision.KeywordsData Safety Monitoring BoardDisaster ResearchResearch Ethic GuidelineSouth African CommunityCapita Health Care ExpenditureThese keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Technical Issues Encountered During Ethics Review: Quality Assurance in the Research Process

We describe the research ethics capacity needs of the countries from the Middle East region. Against this background, we relate the experience of an international training program focused on providing long-term training in research ethics to individuals from low and middle-income countries in the Middle East area. We describe our pedagogical approach to training, program changes to address challenges faced, and accomplishments of trainees. Many former trainees developed research ethics curricula in their home institutions, established or enhanced their institutions' research ethics committees, provided leadership to national research ethics systems, and conducted research in research ethics. Based on our analysis, we make recommendations for how trainees can further address current regional research ethics needs in the Middle East and conduct future research. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program.

BackgroundDespite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines.MethodsThe 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees.ResultsHealth RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely.ConclusionMost major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity.

Research Ethics is a new area even though the questions that are being addressed are as ancient as humanity since they are about doing right and avoiding moral wrong. Research ethics is a subdiscipline of applied ethics, supposing the existence of ethical theory upon which ethical solutions are based for solving the problems that arise. As a new area, scholars have been addressing its definition. Most of research ethics literature is based on the medical sciences. This chapter will identify ethical issues arising from research and give examples of how African indigenous thinking is left out when research ethics is discussed. A good understanding of African thought systems will suggest a distinct approach to African Research Ethics. This is important because African research ethics will make demands from researchers from an African perspective, not an imposition of understanding ethical decision-making from a Western perspective. The chapter therefore identifies strands in African research ethics that demand attention. It will go on to show how more needs to be done to ensure ethical considerations are made in research in a way that acknowledges the African world view. This exercise will ensure that African societies are the authorities of their ethical perspectives on research among their people taking the question of positionality and decoloniality seriously in research. For example, when we assess risk in research, we are not going to be using Western type of analysis. If we do, we are likely to miss the people we are trying to address when we examine the ethical issues of research in Africa.KeywordsAfrican research ethicsAfrican epistemological liberationApplied ethicsBioethicsPhilosophyResponsible conduct of research

Background. Current research ethics guidelines and legislation provide research ethics committees (RECs) with the prerogative to review and approve the ethical acceptability of human research before commencement. However, individual REC members’ views on the ethical issues identified behind closed doors remain largely empirically unexplored. Objective. To investigate the views and perceptions of South African biomedical REC members on their own aggregated ethics review outcomes. Methods. Semi-structured interviews were conducted with nine REC members from two different institutions in South Africa. Results. All respondents concurred with the prioritisation of informed consent in the review outcomes, emphasising the importance of the use of simple and understandable language for participants. Respondents also discussed lack of scientific validity as a common problem when reviewing proposals. Interestingly, while the majority of respondents reiterated the common view that scientifically invalid research is unethical, some REC members believed that there was an overemphasis on evaluation of scientific validity, and that it was not within the remit of RECs to review the scientific quality of proposed studies. The REC members felt that HIV and tuberculosis research had high social value, because it addresses national and regional public health priorities. For this reason, there was no concern expressed that a high proportion of research proposals involved HIV and TB. Conclusion. Although most respondents found the aggregated results unsurprising, there was some disagreement with the ranked review outcomes, with a minority of respondents arguing that scientific validity was overemphasised. These findings have potential training and practice implications for RECs and researchers. The study findings call for further studies to validate such findings in other RECs.

<h3>Background</h3> Findings from several studies (Kirigia <i>et al</i>., 2005; Milford <i>et al</i>., 2006) indicate a need for increased and ongoing research ethics training for African REC members. Research Ethics Capacity Building (RESCAP)-Medical Education Partnership Initiative (MEPI) is a minor component of a training grant awarded to UKZN by the National Institute of Health (NIH) and Fogarty International Centre (FIC). The aim of RESCAP is to build and strengthen research ethics capacity at UKZN and improve our national capacity. <h3>Objectives</h3> The aim of MEPI is to e nhance UKZN medical training and research capacity at UKZN and the province while the aim of RESCAP is to develop and improve institutional research ethics capacity at UKZN, provincially and nationally. <h3>Methods</h3> The MEPI- RESCAP portfolio has been in operation from 2011. RESCAP consists of 5 elements and each element aims to provide research ethics training in various ways. There is advanced modular training in health research ethics through the South African Research Ethics Training (SARETI) programme, specialised South African online ethics module for research teams and RECs/IRBs, Research Ethics Fellowships, NIH grant writing and management workshops and lastly, RESCAP Internships. <h3>Result</h3> From 2011 we have sponsored and subquently trained 138 students. This presentation will highlight the usefulness of the training initiatives. <h3>Conclusion</h3> The specialised South African online ethics module is live on the training and resources in research ethics evaluation (TRREE http://elearning.trree.org/), we have trained sixteen UKZN staff &amp; students through the SARETI programme, forty-five research administrators have received training on NIH Grant Management and five fellows have received research ethics fellowships. One post-graduate student is serving her internship as RESCAP project manager/administrator.

The COVID-2019 pandemic caused disruption of health services globally due to increased need for critical care facilities and collateral damage to routine healthcare services. Global and local research into disease pathogenesis and management strategies is central to a public health emergency response. South African legislation mandates that no health research may be conducted without approval from a registered Research Ethics Committee. For results to have maximum impact and relevance in a pandemic situation, ethics review and approval must be rapid and timeous, without compromising rigour and quality of review. This chapter argues that South African Research Ethics Committees were under-prepared for this task, largely due to gaps in national ethics guidance and the critical absence of the National Health Research Ethics Council. Although ethics guidance documents contain enabling clauses, no specified procedures for rapid review in emergencies exist. Consequently, and in an unprecedented initiative, several Research Ethics Committee chairpersons and members formed a spontaneous informal, ad hoc group, ‘Research Ethics Support in COVID-19 Pandemic’ (RESCOP), to share resources and support for managing the review of research related to COVID-19. The chapter outlines the processes put in place and mechanisms introduced by RESCOP in the interest of responsible and accountable, but rapid, ethics review. We describe good practices for rapid full ethics review of COVID-19 health research, including clinical trials. RESCOP’s innovative collaboration enabled rapid but thorough ethics review of research protocols during the epidemic. The processes established can serve as a good-practice model that could be adopted and adapted by other committees and future versions of national research ethics guidelines.

The research ethics committee (REC) is a key element of university administration and has gained increasing importance as a review mechanism for those institutions that wish to conduct responsible research, along with safeguarding research ethics standards, scientific merit and human rights of participants. Given the critical role of the university REC, it is argued that there is a need to assesses and understand the work of RECs to identify areas for improvement and thus focus on capacity building to respond to the escalating volume, type and complexity of research. This paper reports on the research ethics outcomes of a social science REC in a Business Faculty at a South African university during its seminal period of operation (2010–2015). Content methodology and a standardised questionnaire were used to assess the REC. The results show the increasing workload of the REC with favourable scores for submission/review processes and minute-taking. However, lower scores were seen for ethics education/training and tracking previously approved research. These shortcomings appear to be related to inadequate funding and resource support for research ethics education/training and administrative structures. Factors contributing to proposal rejections included weak research questions or hypotheses, poor questionnaires/interview schedule design and inadequate research ethics consideration in the proposal. It is argued that the complexity and escalation of research submissions to South African RECs necessitates that they are appropriately developed and capacitated to enhance their utility and thereby support the research mandate of universities.

The Middle East Research Ethics Training Initiative (MERETI), established in 2004 with funding from the Fogarty International Center at the NIH, aimed to enhance research ethics capacity in the Middle East North Africa (MENA) region. Initially focused on Egypt, MERETI expanded to other Arab countries, providing advanced training in international research ethics to over 100 individuals. The program emphasized additional skills in research methodology, pedagogy, scientific writing, and leadership. MERETI's training evolved from a one-year program to a two-year model incorporating sequential hybrid/blended and asynchronous online components and, eventually, included a fully online 12-credit graduate certificate in research ethics. The program's impact is demonstrated through the professional achievements of its trainees, which included publishing in peer-reviewed journals, assuming key roles in national research ethics committees and ministries of health and contributing to the development of ethics research practices in their respective countries. MERETI also fostered a sustainable Egyptian network of research ethics committees.

"Mission creep”, “closed doors”, “bureaucracy”, “time delays”, “incompetence” are terms used in some of the arguments advanced by researchers who are not in favour of or are critical of the system of independent ethics review of research by Research Ethics Committees (RECs). “Human subjects’ projection”, “public accountability”, “good research governance” are some of the terms used by researchers who embrace the system of independent ethics review of research. Also known and referred to as institutional review boards (IRBs), ethics review boards (ERBs), ethical review committees (ERCs), human research ethics committees (HRECs) evaluate all human research to ensure that proposed studies comply with international and national ethics principles and guidelines for conducting human research. These committees may either approve, reject, or require modifications to submitted protocols and their decision is binding. A key feature of such committees and their members is their independence. Despite being for or against ethics review, there is a growing body of work attempting to describe and understand the functioning and outcomes of RECs in protecting research participants and promoting ethical research. In this area, there is relatively little work describing the actual issues that RECs look for and subsequently raise when reviewing research protocols. The current study therefore assessed minutes of a South African biomedical REC and identified ethical concerns raised during review of protocols submitted between 2015 - 2016. Ten sets of minutes were retrospectively analysed using Emanuel et al.’s (2004, 2008) framework to code, rank and classify the issues raised by the REC. There were 813 queries raised in the two-year period; 86% (697) of the queries were consistent with the framework. Top four most frequently queries were identified with scientific validity (38%) being the most frequently raised concern, followed by informed consent (33%), ongoing respect for participants (11%) and independent ethics review (9%). Of the 813 queries raised, 14% (116) of queries could not be accommodated by the framework and these pertained to administrative issues. The results of this study support the findings of the primary study by Tsoka-Gwegweni and Wassenaar who were the first to propose and establish that the Emanuel et al. framework is a useful tool to categorize concerns raised by one South African REC. In this study, it was found that 99,7% of 1,043 queries raised for the years 2008 to 2012 were compatible with the Emanuel et al. framework with informed consent emerging as the most frequently raised concern. Equally comparable are the results of a subsequent study by Silaigwana and Wassenaar who also reported that 97,7% of the 1,272 queries raised for the years 2009 to 2014 could be categorised using the Emanuel et al. framework. The Emanuel et al. framework of eight principles and benchmarks proves to be a useful and important tool in evaluating ethical queries raised during EC protocol review meetings. Both the current study and these previous studies support use of this framework.

Following promulgation of the Nuremberg code in 1947, the ethics of research on human subjects has been a challenging and often contentious topic of debate. Escalation in the use of...

This study aims to assess the effect of the Protection of Personal Information Act No. 4 of 2013 on research data ethics in South Africa. The Protection of Personal information Act No 4 of 2013 includes a clause on protection of confidentiality and privacy during the collection of data. This research recommends universities to develop privacy data policy and records management policy to improve compliance with the legislation. Furthermore, training and awareness of staff on data ethics is necessary in universities. The research ethics committees are to be established to provide advice on conducting of research in South African universities.