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)

Background Since the beginning of the COVID-19 pandemic, different countries sought to manufacture and supply effective vaccines to control the disease and prevent and protect public health in society. The implementation of vaccination has created many ethical dilemmas for humans, which must be recognized and resolved. Therefore, the present study was conducted to analyze the ethical considerations in vaccination against COVID-19 from the perspective of service providers. Methods The present qualitative research was conducted in 2022 in the north of Iran. (...) The participants included 23 health workers with at least five years of work experience and members of the COVID-19 vaccination team. The data were initially collected through systematic semi-structured interviews, then snowball sampling and finally continued until data saturation. The next steps were transcription of interviews, identification of meaning units, coding, categorization based on similarity and symmetry, extraction of themes and the analysis of themes through content analysis. Results The analysis of participants’ experiences led to the extraction of five main categories of themes and fifteen sub-categories of the ethical considerations of COVID-19 vaccination. Safe and standard vaccine production, vaccine supply, fairness, respect for autonomy, and accountability were the main categories. The subcategories included compliance with scientific and ethical procedures, effectiveness and profitability of vaccine, absence of severe adverse effects, allocation of resources for vaccine supply, vaccine availability, diversity and comprehensiveness of alternative vaccines, vaccination prioritization, prioritization of the vulnerable populations of society, autonomy of patient (equal rights), autonomy of community, autonomy of service providers, reporting correct information, reporting vaccine side effects, public trust and acceptance. Conclusion The health system managers should be adequately prepared to solve the ethical problems posed by COVID-19 vaccination. Therefore, it is recommended to avoid haste in vaccination and pay more attention to vaccination safety standards, provide sufficient resources for a comprehensive vaccine supply, pay close attention to collective interests versus individual interests, and meet community needs. (shrink)

The recent review by Monrad1 presents several issues about secondary vaccine trials. It lays out the case in which a vaccine has been tested through phases I–III and is being deployed. Subsequently, consideration is being given to conducting ‘trials for another vaccine for the pathogen’. Monrad states: ‘In summary, we may say that researchers have strong prima facie reasons not to conduct a secondary vaccine trial.’ Monrad discusses several factors meriting careful consideration about the need for developing and testing more (...) than one vaccine: relative efficacy, length of immunity, adverse reactions, ease of storage and administration, economic and logistical factors. What is not addressed are the ethical duties that exist when there are competing phase III vaccine candidates for COVID-19. We have serious concerns about potential ethical inadequacies about these ongoing trials and …. (shrink)