Towards eliminating HIV in Uganda by 2030; Preparing Ethical Review Committees to support this agenda

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Project Abstract In order to reach the UNAIDS ambition of ending the HIV epidemic by 2030 we will need high quality research in high HIV burden countries such as Uganda. The overall goal of this program is to “future proof” Research Ethics Committees (RECs) at Makerere University and other institutions in Uganda for high priority HIV research. This will be achieved by building the capacity of REC experts as well as administrators by a multi-disciplinary team at the Infectious Diseases Institute (IDI), Makerere University, Uganda. The Objectives of this program are to 1) build local expertise of RECs in newer study designs and key populations to support innovative HIV research and 2) To build capacity of the administration and leadership teams of RECs. The program will be undertaken in 2 phases; Phase 1 (1-21 months) will address 4 REC at Makerere University and phase 2 (22- 36 months) at least 4 other REC, reaching 192 REC members and 32 administrative staff overall. The key elements of the training plan will be: 1.To harness expertise of the IDI PI and co-Is, as well as collaborative experts from IDI’s 80 collaborating organizations to design and deliver a curriculum around newer study designs and vulnerable populations to support high priority research. This will be a blended learning program. We will also develop interactive ethical review cases for our e-learning website. 2a.To develop RAIS4REC software. This will be based upon RAIS, a software developed by IDI to ensure regulatory compliance within for ongoing research. RAIS4REC will allow electronic REC submission, review, approval and notification of expiry in order to fast track these processes. It will also have capacity to monitor and track study compliance to local and national ethics guidelines. As with other software developed at IDI, it will have an in-built quality assurance component which trains users through use of mandatory fields and process flow. We will also provide face-to-face training on the system and mentoring at REC meetings whilst the REC become comfortable with the system. We will produce a RAIS4REC training video that will be made available on our e-learning website. 2b.Increase REC Administration Capacity. We will provide organizational planning, leadership, time management, mediation/ negotiation training to REC administrators through blended learning by an experienced management training team, Imprint Uganda. 3.The impact will be measured by both training outputs and qualitative and quantitative outcomes (e.g quality of reviews, response time of RECs).