OA-721 Leveraging digital platforms to support a sustainable national research information management system for research ethics and regulation in Uganda

Abstract

<h3>Background</h3> In Uganda, complex clinical research projects that require regulatory oversight are a growing phenomenon. Although there are functional national regulatory agencies (NRAs) to provide oversight, various constraints, including the lack of a robust digital platform to facilitate their work make them inefficient. This scenario has necessitated the establishment of a sustainable digital system to support the work of the NRAs and research ethics committees (RECs). Against this background, the EDTCP-II grants supported a project on Scaling up the Capacity of RECs in Uganda (SCRECU), 2019–2022, and facilitated further development of a National Research Information Management System (NRIMS) which had been developed with support from an earlier EDCTP grant. The overarching objective of SCRECU was to build sustainable capacity for the NRIMS with capabilities of facilitating multi-REC ethical reviews, national registration of research protocols, and their subsequent monitoring by NRAs and RECs. <h3>Methods</h3> We trained RECs personnel on the use of NRIMS for online protocol submissions and management; post-approval processes and enrolment of RECs. We provided the RECs with ICT equipment and followed them up to ensure utilization. We tested the effectiveness of the NRIMS, evaluated its adoption, and developed guidelines for its operationalization. <h3>Results</h3> We trained the chairperson, an administrator, and an IT officer from each of the 26 RECs in Uganda on the use of NRIMS and equipped them with Internet services and other relevant tools. Our study demonstrated the affordability of NRIMS and how digital tools can be leveraged to strengthen ethics and regulatory capacity in resource-constrained settings. The study also generated an inventory of equipment required for the operationalization of an NRIMS. The NRIMS has registered over 13,000 users, received over 6,000 applications, and granted 2,500 approvals online. The NRIMS has enhanced institutional workflows, reduced paperwork by over 95%, and turnaround time for protocol approvals by 50%. It has enhanced research ethics regulatory capacity in Uganda. <h3>Conclusion</h3> The NRIMs has revolutionized and strengthened research ethics and regulation in Uganda. It provides a secure, web-based solution for efficient submission, review, approval, and monitoring of research projects. Its success in Uganda provides a paradigm shift for other NRAs in sub-Saharan Africa.

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