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探索南非研究伦理委员会对COVID-19大流行防范与应对的看法。

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

作者信息

Burgess Theresa, Rennie Stuart, Moodley Keymanthri

机构信息

Stellenbosch University, South Africa.

University of Cape Town, South Africa.

出版信息

Res Ethics. 2024 Oct;20(4):701-730. doi: 10.1177/17470161241250274. Epub 2024 May 4.

Abstract

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.

摘要

南非研究伦理委员会(RECs)在新冠疫情期间面临重大挑战。研究伦理委员会需要在审慎考虑研究方案的科学有效性和伦理价值与以通常与公共卫生应急研究相关的紧迫性进行审查之间找到平衡。我们旨在探讨南非研究伦理委员会对其在新冠疫情期间的大流行防范和应对措施的看法。我们对来自南非七所学术机构、积极参与新冠相关研究审查的21名研究伦理委员会参与者进行了深入访谈。访谈通过远程方式进行,使用了一份深入访谈指南,其中包括有关研究伦理委员会对新冠疫情的防范和应对措施的问题。访谈持续进行直至数据饱和,对录音进行逐字转录并编码。采用归纳式主题分析法将数据整理成主题和子主题。本研究聚焦于三个主要主题:新冠疫情期间的应对、大流行期间研究伦理委员会能力建设以及对研究伦理委员会审查相互认可的一贯谨慎态度。尽管最初有准备不足之感,但研究伦理委员会能够适应并对新冠和非新冠研究保持审慎的伦理监督以及研究伦理委员会审查的严谨性。确定了若干应对未来大流行的防范和应对的重要经验教训,包括提高对发表、资金和政治压力的认识、对研究伦理委员会和研究人员进行定期培训的重要性以及增强研究伦理委员会成员道德适应力的策略。在疫情间歇期,需要逐步建立研究伦理委员会之间的信任和真正伙伴关系,以便在未来公共卫生紧急情况期间促进合作。

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