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. (shrink)

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. (shrink)