Conducting non-pandemic research during the COVID-19 pandemic: A case study and documentary review.

The COVID-19 pandemic presented unprecedented challenges to the conduct of non-pandemic research. The pandemic disrupted regulatory processes, strained health systems, and necessitated ethical recalibrations. This paper is a case study retrospectively examining the experience of conducting one non-pandemic clinical study of infant nutritional supplements in western Kenya between October 2020 and January 2024. The original study documents were reviewed to identify lessons learned, particularly those relevant to ethical and regulatory aspects of conducting non-pandemic research during a pandemic. A retrospective documentary case analysis was conducted using the archived ethics and regulatory submissions, feedback received during those submissions, study progress reports, meeting minutes, and relevant peer-reviewed literature. A framework analysis approach guided thematic coding, supported by independent dual review to ensure reliability (Cohen's Kappa ≥0.6). Public health restrictions during the third pandemic wave, particularly at the main recruitment site, compounded delays. Adaptive measures included reduced physical contact, use of satellite recruitment centers, community engagement with Traditional Birth Attendants, and remote monitoring via digital platforms. Parallel submission to both the Ethics Review Committee and the Regulatory Authority notably expedited the overall turnaround time for approval of protocol amendments. Despite these challenges, the study achieved an impressive 91% follow-up completion rate, with 96% of scheduled home visits successfully carried out. This case study highlights how flexible, community-informed, and ethically responsive research practices can sustain clinical trials under adverse conditions. Strong stakeholder collaboration, open communication, and proactive risk mitigation were essential to maintaining study integrity and protecting participant welfare. These findings underscore the need for future research designs to embed contingency planning, community partnerships, and regulatory adaptability to ensure continuity and resilience for research conducted during public health emergencies.