DOI: 10.12688/openreseurope.24264.1 ISSN: 2732-5121

A Qualitative Exploration of Stakeholder Experiences and Perceptions of Uganda’s Clinical Research Policies and Guidelines During the COVID-19 Pandemic

Christopher Ddamulira, Hellen Opolot, Beth Mutumba, Dorcas Lamunu, Steven Ssebale, Irene Semakula, Jacob Komakech, Bernard Kikaire, Helen Byomire Ndagijje, Vivian Nchanchou Mbanya, Rosemarie De La Cruz Bernabe
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Background The COVID-19 pandemic disrupted research globally, placing unprecedented pressure on regulatory systems. In Uganda, research ethics committees (RECs) and regulatory bodies faced challenges in maintaining oversight, ethical compliance, and continuity of research. Specifically, the study explored stakeholder experiences and perceptions of how Uganda’s clinical research policies and guidelines were implemented and how they influenced the conduct of ethical and safe research during the COVID-19 pandemic. Methods A qualitative descriptive study was conducted across seven districts, involving all UNCST-accredited RECs. Data were collected through in-depth interviews, focus group discussions, and key informant interviews with 56 participants, including REC Chairpersons, administrators, researchers, and representatives from research regulatory authorities in Uganda. Purposive sampling ensured recruitment of participants with relevant expertise. Virtual interviews were audio-recorded, transcribed verbatim, and analyzed using thematic analysis. Ethical approval and informed consent were obtained. Results Uganda’s research policies and guidelines were reported by participants to support continuity of research through strengthened collaboration, including joint protocol reviews and coordinated regulatory processes. Standardization and adaptive measures, such as digital submissions, virtual meetings, remote monitoring, and hybrid consent models, were perceived to enhance efficiency and facilitate study adjustments. However, constraints including increased workload, limited oversight due to movement restrictions, and financial challenges persisted, highlighting the need for more adaptable and resilient regulatory systems. Conclusions Uganda’s research policies and guidelines were perceived to supported continuity of ethical research during the pandemic through strengthened collaboration and standardized yet adaptable regulatory processes. However, operational and resource constraints highlighted gaps in system resilience. Strengthening digital infrastructure, institutionalizing collaborative review mechanisms, embedding adaptable procedures, and securing emergency research funding will be critical to enhance the responsiveness and resilience of Uganda’s research regulatory system in future public health emergencies.

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