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

项目摘要 为了实现联合国艾滋病规划署到2030年结束艾滋病毒流行的雄心壮志，我们将需要 在乌干达等艾滋病毒负担高的国家进行高质量的研究。这个项目的总体目标是 Makerere大学的研究伦理委员会(REC)和 乌干达的其他机构为高度优先的艾滋病毒研究提供资金。这将通过构建 REC专家以及管理人员的能力由一个多学科团队在 乌干达马克雷雷大学传染病研究所(IDI)。 该计划的目标是1)在较新的研究中建立区域经济合作组织的本地专业知识 设计和关键人群以支持创新的艾滋病毒研究和2)建立 区域经济共同体的管理和领导团队的能力。该计划将是 分两个阶段进行；第一阶段(1-21个月)将针对Makerere大学的4个REC 和第二阶段(22-36个月)至少4个其他REC，覆盖192个REC成员和32个REC成员 总体而言，行政人员。培训计划的主要内容包括： 1.利用国际开发协会的专门知识和合作伙伴，以及国际开发协会80的协作专家 合作组织围绕较新的学习设计设计和交付课程 和弱势群体，以支持高优先级研究。这将是一种混合学习 程序。我们还将为我们的电子学习网站开发互动伦理审查案例。 2.开发RAIS4REC软件。这将基于RAIS，这是由 IDI确保正在进行的研究的内部法规遵从性。RAIS4REC将允许 电子REC提交、审查、批准和到期通知，以便快速跟踪 这些过程。它还将有能力监测和跟踪研究对当地和 国家道德准则。与IDI开发的其他软件一样，它将具有内置的 通过使用必填字段和流程培训用户的质量保证组件 流。我们还将在REC会议上提供关于该系统的面对面培训和指导 同时让REC对这个系统感到满意。我们将制作RAIS4REC培训 将在我们的电子学习网站上提供的视频。 2b.增加REC管理能力。我们将提供组织规划， 通过以下方式对REC管理员进行领导力、时间管理、调解/谈判培训 由经验丰富的管理培训团队进行混合学习，印记乌干达。 3.将通过培训产出以及定性和定量来衡量影响 结果(如评审质量、区域经济合作委员会的反应时间)。

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).