Sustained and Discontinued Operational Changes to Ethics Committees in the Post- Pandemic Era: A Qualitative Study in Kenya

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Abstract

Background Ethics Committees (ECs) play a vital role in protecting the rights, safety, and welfare of human participants enrolled in research. In special circumstances such as pandemics, ECs conduct rapid review of research protocols to respond to a Public Health Emergency (PHE). Globally, many ECs made operational changes to their processes during the COVID-19 era in a bid to continue providing research oversight amidst strict measures to combat the spread of the disease. Little is known about any sustained and/or discontinued EC operational adjustments made during the COVID-19 pandemic. This study explored the EC operational changes that were retained and those that were dropped after COVID-19 pandemic and any preparedness plans for potential future PHEs. Methods This explorative qualitative study used in-depth interviews to gather data from target population of EC members, chairpersons, secretaries, and research administrators from selected Kenya ECs that were operational during the pandemic. Data was collected between July and October 2025. We used purposive and snowballing methods until saturation was reached. We developed codes using both inductive and deductive approaches while adopting the five-stage framework analysis method of data familiarization, thematic framework development, codes generation, thematic map generation, and examination of data patterns. We used NVIVO version 12 software to analyze the data. Results A total of 16 participants from the 7 selected ECs in Kenya took part in the study. We generated three (3) broad themes and various sub-themes from the analysis of in-depth interviews: (1) EC operational adjustments retained post-pandemic including technological adoption in protocol submissions and virtual meetings, frameworks for decentralized research, and discussants for protocol review meetings (2) EC operational adjustments dropped in the post-pandemic era including special COVID-19 scientific committees, parallel reviews, quick turnaround reviews, and COVID-19 sensitization sessions during EC meetings (3) EC future directions in preparation for other PHEs including reciprocal approvals, community engagement plans, verbal presentation of protocols, continuous ethics education, and additional EC secretariat support. Conclusions In Kenya, ECs have retained selective operations that enhance efficiency and have discontinued practices that were directly related to the emergency situations and could affect the ethical review rigor when applied continuously.

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