探讨南非研究伦理委员会对 COVID-19 期间大流行病防备和应对工作的看法

Theresa Burgess, Stuart Rennie, K. Moodley
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摘要

在 COVID-19 大流行期间,南非的研究伦理委员会 (REC) 面临着重大挑战。研究伦理委员会需要在仔细考虑方案的科学有效性和伦理价值以及通常与公共卫生紧急研究相关的审查紧迫性之间找到平衡。我们旨在探讨南非区域经济委员会对 COVID-19 期间大流行病准备和应对工作的看法。我们对南非七个学术机构中积极参与 COVID-19 相关研究审查的区域经济委员会的 21 名参与者进行了深入访谈。访谈使用深度访谈指南进行,其中包括有关区域经济委员会准备和应对 COVID-19 的问题。访谈一直进行到数据饱和为止,并对录音进行逐字转录和编码。采用归纳法进行主题分析,将数据整理成主题和次主题。本研究主要关注三个主题:COVID-19 期间的应对、大流行病期间的区域执行委员会能力建设以及对区域执行委员会审查互认的一贯谨慎态度。尽管最初感觉毫无准备,但区域执行委员会还是能够适应并保持对 COVID 和非 COVID 研究的审慎伦理监督,以及区域执行委员会审查的严谨性。会议确定了未来大流行病防备和应对的几条重要经验,包括提高对出版、资金和政治压力的认识,对区域执行委员会和研究人员进行定期培训的重要性,以及提高区域执行委员会成员道德承受力的战略。需要采取循序渐进的步骤,在大流行病间歇期建立区域经济共同体之间的信任和真正的伙伴关系,以促进在未来公共卫生紧急情况下的合作。
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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.
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