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

到 2030 年在乌干达消除艾滋病毒；

• 批准号: 9914147
• 负责人: Pauline BYAKIKA-KIBWIKA
• 金额: $ 9.92万
• 依托单位: INFECTIOUS DISEASES INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-12 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9914147
• 关键词: Accreditation; Acquired Immunodeficiency Syndrome; Address; Administrator; Africa South of the Sahara; Area; Automobile Driving; Clinical; Committee Members; Communicable Diseases; Complex; Computer software; Country; Discipline; E-learning; Educational Curriculum; Elements; Ensure; Epidemic; Ethical Issues; Ethical Review; Ethics; Feedback; Future; Goals; Guidelines; HIV; HIV therapy; Human; Individual; Institutes; Institution; International; Intervention; Interview; Leadership; Learning; Manuals; Measures; Mediation; Mentors; Monitor; Notification; Outcome; Output; Participant; Phase; Pilot Projects; Population; Population Heterogeneity; Procedures; Process; Protocols documentation; Reaction Time; Research; Research Activity; Research Design; Research Ethics Committees; Research Personnel; Research Priority; Research Proposals; Research Support; Research Training; Review Committee; Surveys; System; Therapeutic Studies; Time; Time Management; Training; Training Programs; Uganda; United States National Institutes of Health; Universities; Visit; Vulnerable Populations; Workload; base; comorbidity; design; experience; human subject protection; imprint; innovation; meetings; multidisciplinary; next generation; novel; programs; protocol violation; quality assurance; response; satisfaction; skills; software development; study population; success; systems research; tool; web site

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).

项目摘要 为了达到联合国艾滋病规则的野心，到2030年结束艾滋病毒流行病，我们将需要高 乌干达等高艾滋病毒伯宁国家的质量研究。总体目标 计划是Makerere大学的“未来证明”研究伦理委员会（REC）和 乌干达的其他机构进行高优先型艾滋病毒研究。这将通过构建来实现 REC专家和管理人员的能力由一个多学科团队 乌干达Makerere University的传染病研究所（IDI）。 该计划的目标是1）在较新的研究中建立REC的本地专业知识 设计和关键人群支持创新的艾滋病毒研究，2）建造 REC的行政和领导团队的能力。该程序将是 分为两个阶段；第1阶段（1-21个月）将在Makerere大学讲话4 Rec 第2阶段（22-36个月）至少有4个其他REC，达到了192个REC成员和32个 总体行政人员。培训计划的关键要素将是： 1。利用IDI PI和CO-IS的专业知识，以及IDI 80的合作专家 协作组织设计和提供围绕新的研究设计的课程 和弱势群体以支持高优先研究。这将是一个混合学习 程序。我们还将为我们的电子学习网站开发交互式道德审查案例。 2A.开发RAIS4REC软件。这将基于Rais，该软件由 IDI以确保内部进行监管的合规性。 RAIS4REC将允许 电子恢复提交，审查，批准和通知到期，以便快速轨道 这些过程。它还将有能力监视和跟踪研究对本地的依从性和 国家道德准则。与在IDI开发的其他软件一样，它将具有内置 质量保证组件，通过使用强制性字段和流程来培训用户 流动。我们还将在REC会议上对系统进行面对面的培训 虽然REC对系统感到满意。我们将进行RAIS4REC培训 将在我们的电子学习网站上提供的视频。 2B。促进管理能力。我们将提供组织计划， 通过 由经验丰富的管理培训团队融合了乌干达的学习。 3.影响将通过训练输出以及定性和定量来衡量 结果（例如评论质量，REC的响应时间）。