Research Ethics Committee Members Research Articles

Perceptions of policymakers and ethicists on ethical considerations in the conduct of research during disease outbreaks in Nigeria

Background There is a dearth of literature on the perspectives of stakeholders from countries in Africa on the institution of a research culture as part of a holistic system of pandemic preparedness and response. This study aimed to explore the perspectives of policymakers, representatives from Research Ethics Committees (RECs), and international bioethics experts on the ethics of conducting research during infectious disease outbreaks in Nigeria. Methods We conducted structured interviews with six policymakers actively engaged in disease outbreak response. The interview themes included systems and structures for research, local researcher competency, regulatory oversight, study types, ethical review approaches, and integrating research into outbreak response. We further engaged 12 participants including REC members from Nigeria and Liberia, international bioethics experts, and study co-investigators in a structured discussion to appraise and expand on themes identified during the interviews at a 2-day meeting in December 2018. We also held two virtual consultations afterwards. The findings from these processes were synthesized to develop a comprehensive report. Results Participants stressed the significance of conducting research during disease outbreaks to understand causal factors, evaluate public health measures, and inform future prevention and treatment strategies, and identified the need for clear ethical guidelines for RECs during outbreaks. Participants proposed a sliding scale for prioritizing categorized studies, emphasizing immediate solutions over future-focused research. Discussants proposed a "systems approach" to ethics review, emphasizing interdependence, governance structures, communication infrastructure, effective communication with policymakers, and a funding structure. Conclusion Conducting ethical research during disease outbreaks requires a comprehensive, context-dependent approach, involving stakeholders, and ensuring robust ethical oversight through proficient RECs. The proposed "System Approach" offers a model for sustainable and effective ethics review during outbreaks, fostering locally relevant and socially valuable research while prioritizing the well-being of research participants and communities.

Exploring views of South African research ethics committees on pandemic preparedness and response during COVID-19

South African research ethics committees (RECs) faced significant challenges during the COVID-19 pandemic. Research ethics committees needed to find a balance between careful consideration of scientific validity and ethical merit of protocols, and review with the urgency normally associated with public health emergency research. We aimed to explore the views of South African RECs on their pandemic preparedness and response during COVID-19. We conducted in-depth interviews with 21 participants from RECs that were actively involved in the review of COVID-19 related research, at seven academic institutions across South Africa. Interviews were conducted remotely using an in-depth interview guide that included questions regarding REC preparedness and response to COVID-19. Interviews were conducted until data saturation, and audio-recordings were transcribed verbatim and coded. An inductive approach to thematic analysis was used to organise data into themes and sub-themes. This study focused on three main themes: coping during COVID-19, building REC capacity during pandemic times and a consistently cautious approach to mutual recognition of REC reviews. Despite an initial sense of unpreparedness, RECs were able to adapt and maintain careful ethical oversight of both COVID and non-COVID research, and the rigour of REC reviews. Several important lessons for preparedness and response to future pandemics were identified, including heightened awareness of publication, funding and political pressures, the importance of regular training for RECs and researchers, and strategies to enhance moral resilience of REC members. Incremental steps are needed to build trust and authentic partnerships among RECs in inter-pandemic times, to facilitate collaboration during future public health emergencies.

Research ethics and artificial intelligence for global health: perspectives from the global forum on bioethics in research

BackgroundThe ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022.MethodsThe GFBR is an annual meeting organized by the World Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was “Ethics of AI in Global Health Research”. The forum consisted of 6 case study presentations, 16 governance presentations, and a series of small group and large group discussions. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. In this paper, we highlight central insights arising from GFBR 2022.ResultsWe describe the significance of four thematic insights arising from the forum: (1) Appropriateness of building AI, (2) Transferability of AI systems, (3) Accountability for AI decision-making and outcomes, and (4) Individual consent. We then describe eight recommendations for governance leaders to enhance the ethical governance of AI in global health research, addressing issues such as AI impact assessments, environmental values, and fair partnerships.ConclusionsThe 2022 Global Forum on Bioethics in Research illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research.

Research Ethics Committee and Integrity Board Members’ Collaborative Decision Making in Cases in a Training Setting

AbstractThis research focuses on how research ethics committee and integrity board members discuss and decide on solutions to case scenarios that involve a dimension of research ethics or integrity in collaborative settings. The cases involved issues around authorship, conflict of interest, disregard of good scientific practice and ethics review, and research with vulnerable populations (children and neonates). The cases were set in a university, a hospital, or a research institute. In the research, we used a deductive qualitative approach with thematic analysis. Twenty-seven research ethics committee and research integrity board members from 16 European countries and one country outside Europe participated. Participants represented natural and life sciences, social sciences, and humanities. They worked on cases involving ethical/integrity issues in six different constellations. Results show that experts apply key elements of ethical decision making, namely identification of ethical issues, stakeholders, guidelines, solutions, and own positionality, in dealing collaboratively with ethics/ integrity problems, and the nature of the application depends on the complexity of the case. Understanding how individuals knowledgeable in research ethics and integrity, in this case, individuals serving on research ethics committees and integrity boards, approach ethical/ moral issues can help to identify strategies that may be useful in the development of research ethics and integrity training for junior researchers who may benefit from learning professional strategies.

One Health research ethics review processes in African countries: Challenges and opportunities

One Health research has gained attention over the past few decades due to its potential to improve health challenges across the globe. However, obtaining ethics approvals for timely implementation of One Health research is a challenge in some contexts. Our study was undertaken to describe various challenges faced by researchers, research ethics committees (RECs) and members of regulatory bodies in Africa. An online survey was conducted between March and June 2021. The effect of predictors, including respondents' role (e.g., REC member, regulator and/or One Health researcher), sex, education, age, and country, on the perception of challenges and opportunities when conducting and reviewing One Health research, was investigated using multivariable linear regression models. Participants with different roles did not perceive any of the examined challenges differently during review of One Health-related research; but female participants (p = 0.026) and those with ten or more years of experience (p = 0.0325) perceived insufficient One Health knowledge as less of a challenge. Professional role was an important predictor (p = 0.025) for the perception of the establishment of a mandatory One Health review system. Respondents with multiple roles perceived the creation of ad hoc committees for review of One Health research under emergency situations to be less important (p = 0.02); and REC members perceived the creation of such committees to be less feasible (p = 0.0697). Our study showed that perceptions of the importance and feasibility of opportunities for improvement of One Health research ethics review under emergency and non-emergency situations varied across professional roles. This emphasizes the need to consider such improvement strategies; and the need for continuous and timely evaluation for improvement of ethics review of One Health and emergency research in Africa.

Ethical challenges in global research on health system responses to violence against women: a qualitative study of policy and professional perspectives

BackgroundStudying global health problems requires international multidisciplinary teams. Such multidisciplinarity and multiculturalism create challenges in adhering to a set of ethical principles across different country contexts. Our group on health system responses to violence against women (VAW) included two universities in a European high-income country (HIC) and four universities in low-and middle-income countries (LMICs). This study aimed to investigate professional and policy perspectives on the types, causes of, and solutions to ethical challenges specific to the ethics approval stage of the global research projects on health system responses to VAW.MethodsWe used the Network of Ethical Relationships model, framework method, and READ approach to analyse qualitative semi-structured interviews (n = 18) and policy documents (n = 27). In March-July 2021, we recruited a purposive sample of researchers and members of Research Ethics Committees (RECs) from the five partner countries. Interviewees signposted policies and guidelines on research ethics, including VAW.ResultsWe developed three themes with eight subthemes summarising ethical challenges across three contextual factors. The global nature of the group contributed towards power and resource imbalance between HIC and LMICs and differing RECs’ rules. Location of the primary studies within health services highlighted differing rules between university RECs and health authorities. There were diverse conceptualisations of VAW and vulnerability of research participants between countries and limited methodological and topic expertise in some LMIC RECs. These factors threatened the timely delivery of studies and had a negative impact on researchers and their relationships with RECs and HIC funders. Most researchers felt frustrated and demotivated by the bureaucratised, uncoordinated, and lengthy approval process. Participants suggested redistributing power and resources between HICs and LMICs, involving LMIC representatives in developing funding agendas, better coordination between RECs and health authorities and capacity strengthening on ethics in VAW research.ConclusionsThe process of ethics approval for global research on health system responses to VAW should be more coordinated across partners, with equal power distribution between HICs and LMICs, researchers and RECs. While some of these objectives can be achieved through education for RECs and researchers, the power imbalance and differing rules should be addressed at the institutional, national, and international levels. Three of the authors were also research participants, which had potential to introduce bias into the findings. However, rigorous reflexivity practices mitigated against this. This insider perspective was also a strength, as it allowed us to access and contribute to more nuanced understandings to enhance the credibility of the findings. It also helped to mitigate against unequal power dynamics.

The readiness of the Asian research ethics committees in responding to the COVID-19 pandemic: A multi-country survey

Background COVID-19 is a highly challenging infectious disease. Research ethics committees (RECs) have challenges reviewing research on this new pandemic disease under a tight timeline and public pressure. This study aimed to assess RECs’ responses and review during the outbreak in seven Asian countries where the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) networks are active. Methods The online survey was conducted in seven Asian countries from April to August 2021. Two sets of online questionnaires were developed, one set for the chairs/secretaries and another set for the REC members. The REC profiles obtained from the REC members are descriptive in nature. Data from the chairs/secretaries were compared between the RECs with external quality assessment (SIDCER-Recognized RECs, SR-RECs) and non-external quality assessment (Non-SIDCER-Recognized RECs, NSR-RECs) and analyzed using a Chi-squared test. Results A total of 688 REC members and 197 REC chairs/secretaries participated in the survey. Most RECs have standard operating procedures (SOPs), and have experience in reviewing all types of protocols, but 18.1% had no experience reviewing COVID-19 protocols. Most REC members need specific training on reviewing COVID-19 protocols (93%). In response to the outbreak, RECs used online reviews, increased meeting frequency and single/central REC. All SR-RECs had a member composition as required by the World Health Organisation ethics guidelines, while some NSR-RECs lacked non-affiliated and/or layperson members. SR-RECs reviewed more COVID-related product development protocols and indicated challenges in reviewing risk/benefit and vulnerability (0.010), informed consent form (0.002), and privacy and confidentiality (P = 0.020) than NSR-RECs. Conclusions Surveyed RECs had a general knowledge of REC operation and played a significant role in reviewing COVID-19-related product development protocols. Having active networks of RECs across regions to share updated information and resources could be one of the strategies to promote readiness for future public health emergencies.

‘It is a complex process, but it’s very important to return these results to participants’. Stakeholders’ perspectives on the ethical considerations for returning individual pharmacogenomics research results to people living with HIV

This study aimed to explore stakeholders’ perspectives on the ethical considerations for returning individual pharmacogenomics research results to people living with HIV. A qualitative approach to investigation involved five focus group discussions with 30 Community representatives, 12 key informant interviews with researchers, and 12 in-depth interviews with research ethics committee members. In total, 54 stakeholders who were involved in pharmacogenomics research and HIV treatment and care contributed to the data collection between September 2021 and February 2022. The study explored five prominent themes: (i) defining the nature of research results to return to participants; (ii) preparing research participants to receive their results; (iii) obtaining informed consent for the return of results; (iv) opinions on health personnel to return the results to participants; and (v) opinions on how research results should be communicated to participants. Respondents identified various strategies for the return of individual results with minimal ethical risks including the setting up of a diverse and independent committee to undertake a risk-benefit assessment based on local context; ongoing discussions about the possible kinds of results and their implications throughout the study; and employing genetic counsellors to communicate results to participants. The strategies identified in this study should be further studied and independently verified.

Ranking Research Methodology by Risk — a cross-sectional study to determine the opinion of research ethics committee members

BackgroundWhen reviewing a protocol, research ethics committees (RECs, equivalent to institutional review boards — IRBs) have the responsibility to consider whether the proposed research is justified. If research is not justified, it can waste participants’ time, researchers’ time and resources. As RECs are not constituted to cover all areas of scientific or academic expertise, it can be difficult for RECs to decide whether research is scientifically or methodologically justified especially in the absence of authoritative (often in the form of systematic) reviews. Where such reviews are absent, some have argued that RECs should insist on a new review of existing evidence as a condition of the REC favourable opinion. However, as RECs review a wide range of research, such requests must be proportionate to the type, and extent, of proposed projects. Risk is one factor that may influence the extent of evidence need for a REC to determine that the new project is justified, but not the only factor. The aim of the work described here was to determine whether REC members and researchers specifically link risk to the type of research methodology, and if so, whether this link could be used to help guide the need for systematic, or other, types of reviews.MethodWe conducted a cross-sectional study, gathering data between November 2020 and January 2021, to examine whether proposed research methodologies impact how RECs perceive risk to participants. We presented 31 research methodologies to REC members and researchers in the form of an international survey.ResultsWe collected 283 responses that included both qualitative and quantitative data as to how research methodology impacts perceptions of risk to participants. We used the data to conclude that RECs did see a link between risk and type of research. We therefore constructed a hierarchy of risk with Phase 1 and 2 clinical trials, and clinical psychology/psychiatry intervention studies, at the top (i.e. viewed as most risky).ConclusionsWe discuss whether this hierarchy is useful for guiding RECs as to the level of scientific justification that they should seek when reviewing proposed research protocols, and present a one-page guidance sheet to help RECs during their reviews.

Co-production of guidance and resources to implement principled participant information leaflets (PrinciPILs)

Background: The way information about potential benefits and harms of trial is presented within participant information leaflets (PILs) varies widely and may cause unnecessary ‘nocebo’ effects. The Medical Research Council (MRC) funded a project that developed seven principles to reduce this variation. However, guidance has not been produced to facilitate the implementation of the principles. Stakeholder involvement is recommended to optimise the way these principles are disseminated and explained. To co-produce recommendations for developing: (1) user-friendly guidance for users of the principles; and (2) resources that support the implementation of the principles. Methods: We held a co-production workshop with representation from the following professional groups: the Health Research Authority (HRA), research ethics committee members, and trial managers. Two rounds of discussions focused on generating recommendations for guidance and resources that support the implementation of the seven principles. Extensive low inference style ethnographic notes were taken, and the data were analysed thematically using deductive codes. The data was collected on October 14, 2022. Results: 25 participants attended a hybrid workshop. Participants recommended that both researchers designing PILs and research ethics committee members should use the principles, and that that they should be simple, mention both benefits and harms explicitly, include examples of visual representations, and provide the evidence base for the principles. Conclusions: We were able to co-produce recommendations for developing and implementing the seven principles within PILs. These recommendations can now be implemented to reduce unexplained variation in the way potential benefits and harms are shared within PILs.

Evidence from UK Research Ethics Committee members on what makes a good research ethics review, and what can be improved.

The rapid development of vaccines and other innovative medical technologies in response to the COVID-19 pandemic required streamlined and efficient ethics and governance processes. In the UK the Health Research Authority (HRA) oversees and coordinates a number of the relevant research governance processes including the independent ethics review of research projects. The HRA was instrumental in facilitating the rapid review and approval of COVID-19 projects, and following the end of the pandemic, have been keen to integrate new ways of working into the UK Health Departments' Research Ethics Service. In January 2022 the HRA commissioned a public consultation that identified strong public support for alternative ethics review processes. Here we report feedback from 151 current research ethics committee members conducted at three annual training events, where we asked members to critically reflect on their ethics review activities, and to share new ideas or ways of working. The results showed a high regard for good quality discussion among members with diverse experience. Good chairing, organisation, feedback and the opportunity for reflection on ways of working were considered key. Areas for improvement included the consistency of information provided to committees by researchers, and better structuring of discussions by allowing signposting of the key issues that ethics committee members might need to consider.

Opinions and attitudes of research ethics committees in Arab countries in the Middle East and North African region toward ethical issues involving biobank research

Members of research ethics committees (RECs) face a number of ethical challenges when reviewing genomic research. These include issues regarding the content and type of consent, the return of individual research results, mechanisms of sharing specimens and health data, and appropriate community engagement efforts. This article presents the findings from a survey that sought to investigate the opinions and attitudes of REC members from four Arab countries in the Middle East and North Africa (Egypt, Morocco, Sudan, and Jordan) toward these ethical issues. Our findings suggest that efforts are required to better familiarize REC members with the requirements for ethical biobank research. Additionally, we recommend that further research is undertaken with REC members regarding the main items that should be present in the Material Transfer Agreements /Data Transfer Agreements in their corresponding countries and the type of consent that should be used in genomic research.

Research ethics committee members’ perspectives on paediatric research: a qualitative interview study

Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and participation. REC members supported a contextual and holistic approach to vulnerability and risk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatric research requires continuous ethical competence development within RECs.

Building Capacity for Research Ethics Committees in Uganda.

Timely communication from Research Ethics Committees (REC) to researchers is essential to meet deadlines. We conducted a capacity building program for REC members, REC and research administrators, and researchers from seven RECs in Uganda in order to improve the research regulatory approval cycle. The training was delivered from March 2020 to July 2021. Trainees were evaluated using pre and post-training tests. There was an increase in the average score from 38% to 53% in pre and post-training test respectively for the personal effectiveness and leadership programme for REC and research administrators. There was an increase in the average score of from 53.9% to 70.1% in pre and post-training test respectively for training on emerging and complex study designs. We achieved shift in knowledge and skills in use of the National Research Information Management System. We recommend regular training of REC members and administrators for efficient review of research protocols.

Exploring perspectives of research ethics committee members on the governance of big data in sub-Saharan Africa

Interest in the governance of big data is growing exponentially. However, finding the right balance between making large volumes of data accessible, and safeguarding privacy, preventing data misuse, determining authorship and protecting intellectual property remain challenging. In sub-Saharan Africa (SSA), research ethics committees (RECs) play an important role in reviewing data-intense research protocols. However, this regulatory role must be embedded in a context of robust governance. There is currently a paucity of published literature on how big data are regulated in SSA and if the capacity to review protocols is sufficient. The aim of this study was to provide a broad overview of REC members’ awareness and perceptions of big data governance in SSA. A descriptive cross-sectional survey was conducted from April to July 2022. We invited 300 REC members to participate in our online survey via Research Electronic Data Capture (REDCap). A total of 140 REC members, representing 34 SSA countries, completed the online survey. Awareness of data governance laws, policies and guidelines was variable across the subcontinent. A quarter of respondents (25%) indicated that national regulations on the transborder flow of research data are inadequate. Institutional policies on research data protection were also regarded as being inadequate. Most respondents (64%) believed that they lacked experience in reviewing data-intense protocols. Data governance and regulation in SSA need to be strengthened at both national and institutional levels. There is a strong need for capacity development in the review of data-intense research protocols on the subcontinent. Significance: This is the first empirical survey in SSA in which awareness and perspectives of REC members have been explored specifically relating to the review of data-intense research protocols. Big data have raised new ethics and legal challenges, and this survey provides a broad overview of these challenges in SSA. Our study confirms that knowledge and awareness of legislative frameworks and ethics guidance in SSA vary considerably where big data are concerned. The research results could be useful for a range of stakeholders, including RECs, data scientists, researchers, research and academic institutions, government decisionmakers and artificial intelligence (AI) coders.

Inclusion of adults with conditions that have the potential to affect capacity and or communication in research: triangulation from a mixed-methods study of current practice and values across multiple stakeholders

ObjectivesWe aimed to: (A) describe researcher decision-making when including or excluding adults with conditions that have the potential to affect capacity and/or communication in research and (B) explore the underlying...

The application of data altruism in clinical research through empirical and legal analysis lenses.

The legal framework for clinical research in the EU is complex and the lack of harmonization of the relevant legal and ethical rules remains one of the main challenges for stakeholders in the field. The recently adopted Data Governance Act (DGA) and the proposal for a European Health Data Space (EHDS) promise to solve the existing challenges with respect to access to and (re)use of personal data for research, but also risk to further complexify the field. The DGA introduced a novel mechanism - data altruism. Data altruism is understood as the voluntary sharing of personal and non-personal data, based on the consent of data subjects or the permission of natural and legal persons, without seeking a reward and for objectives of general interest. This study aimed to gain insights into the opinion of clinical research stakeholders on data altruism, and to critically discuss key issues pertaining to the application of data altruism from a legal point of view. Semi-structured interviews with (1) data protection officers (DPOs) and legal experts working with commercial and academic sponsors of clinical trials, (2) investigators, and (3) members of research ethics committees. Data underwent framework analysis. The legal discussion was comprised of legal doctrinal research with focus on the DGA, EHDS proposal, and the interplay with the EU General Data Protection Regulation (GDPR). Fourteen experts took part in the interviews, more than half of which were DPOs/legal experts. Interviewees were based in seven EU Member states and the United Kingdom. The majority of participants were critical towards the data altruism mechanism and pointed out challenges and risks associated with its application. Although data altruism holds the potential to facilitate data sharing, its application in clinical research at the moment is still riddled with uncertainties. The interplay of the DGA rules with the provisions of the GDPR and the EHDS proposal are insufficiently clear and further efforts from the legislator are required to build a working, patient-centered, and research fostering data altruism system.

URECA – the Research Ethics and Data Protection Online Review Platform used by the University of Malta Authors

Nowadays, research ethics and data protection are given very high importance, and research organizations, including universities, need to safeguard their level of professionalism and integrity by providing the necessary guidelines. Moreover, they need to ensure that these guidelines are being adhered to by their affiliated researchers, including students. This is needed for protection of the research subjects, researchers, and the organization (university) itself. However, care must be taken so that the research ethics review process is streamlined as much as possible to minimize bureaucracy, as such guidelines would then be viewed as a research barrier. This study describes URECA, the online review platform developed in-house by the University of Malta to streamline its research ethics review process, thus simplifying matters for the researchers/students, reviewers, and auditing committees. This platform is utilized by researchers and students to submit information regarding their research and related data collection, by supervisors to endorse their students’ research, by Faculty Research Ethics Committee members to review research proposals as required, and by the University Research Ethics Committee to manage and audit the overall process.

Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration.

Introduction: Controlled Human Infection Model (CHIM) studies provide a unique platform for studying the pathophysiology of infectious diseases and accelerated testing of vaccines and drugs in controlled settings. However, ethical issues shroud them as the disease-causing pathogen is intentionally inoculated into healthy consenting volunteers, and effective treatment may or may not be available. We explored the perceptions of the members of institutional ethics committees (IECs) in India about CHIM studies. Methods: This qualitative exploratory study, conducted across seven sites in India, included 11 focused group discussions (FGD) and 31 in-depth interviews (IDI). A flexible approach was used with the aid of a topic guide. The data were thematically analyzed using grounded theory and an inductive approach. Emerging themes and sub-themes were analyzed, and major emergent themes were elucidated. Results: Seventy-two IEC members participated in the study including 21 basic medical scientists, 29 clinicians, 9 lay people, 6 legal experts and 7 social scientists. Three major themes emerged from this analysis-apprehensions about conduct of CHIM studies in India, a perceived need for CHIM studies in India and risk mitigation measures needed to protect research participants and minimize the associated risks. Conclusion: Development of a specific regulatory and ethical framework, training of research staff and ethics committee members, and ensuring specialized research infrastructure along with adequate community sensitization were considered essential before initiation of CHIM studies in India.

Key ethical issues encountered during COVID-19 research: a thematic analysis of perspectives from South African research ethics committees

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.