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

Abstract

Background The 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. Methods We 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. Results Five 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. Conclusions Numerous, 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.

Challenges and solutions in clinical research during the COVID‐19 pandemic: A narrative review

“…The research hypotheses may not be investigated in time if they are not approved and started at the right time. Also, prioritizing critical issues related to health in the ethics committees should be considered due to the crisis conditions 6 . During the Ebola epidemic, for example, clinical trials proceeded non‐stop.…”

“…• Human ethics in study enrollment 5,11,41 • fear of infection among participants 7,41,50 • High risk participants (Elderly people, pregnant women) 41,45 • Obtaining informed consent form 7,24,49 • Expansion and diversity in communication networks 6,19 • Using online methods to collect information and interview 19,37 • Changing the type of execution 19 • Creating online classes, online exercises, using videos and virtual networks 11,56 • Creating online platforms for responding to participants, and completing questionnaires 49,56 • Considering financial incentive 56 Administrative issues…”

“…Research is a critical aspect of responding to public health emergencies. Research efforts from various groups were focused on the origin of the COVID‐19 disease and management strategies, including drugs and vaccines through numerous clinical trials 6 . Health scientists were confronting COVID‐19 and solving its complications with investigations, research, and clinical trials.…”

Research ethics review during the COVID-19 pandemic: An international study

“…Several of these contributions focus exclusively on one ERC, usually associated with an academic or health care institution. The literature includes descriptions of ERC operations during the pandemic in Central America and the Dominican Republic [17], China [18], Ecuador [19], Egypt [20], Germany [21], India [22–24], Iran [10], Ireland [25], Kenya [26], Kyrgyzstan [27], Latin America [28], the Netherlands [29], Pakistan [30], South Africa [31,32], Turkey [33], and the United States [34–36]. Most of these studies reported results from surveys, interviews, focus groups, and documentary analysis, including review of research protocols, ERC meeting minutes, and existing SOPs.…”

“…Kyrgyzstan [27], Latin America [28], the Netherlands [29], Pakistan [30], South Africa [31,32], Turkey [33], and the United States [34][35][36] Conversely, several ERCs availed themselves of international guidelines (Box 2), in particular those prepared by WHO [37][38][39][40] and PAHO [41][42][43][44].…”