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；

基本信息

批准号：
9769188
负责人：
Pauline BYAKIKA-KIBWIKA
金额：
$ 9.93万
依托单位：
INFECTIOUS DISEASES INSTITUTE
依托单位国家：
美国
项目类别：
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/9769188
关键词：
Accreditation Acquired Immunodeficiency Syndrome Address Administrator Africa South of the Sahara Area Automobile Driving Clinical Committee Members Communicable Diseases Comorbidity 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 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

项目摘要

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).

项目摘要为了实现联合国艾滋病规划署到 2030 年结束艾滋病毒流行的目标，我们需要高度重视乌干达等艾滋病毒高负担国家的高质量研究总体目标。该计划旨在“面向未来”麦克雷雷大学的研究伦理委员会（REC）和乌干达其他高度优先的艾滋病毒研究机构将通过建设来实现。 REC 专家以及多学科团队管理人员的能力乌干达麦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 REC 的本地专业知识支持创新型艾滋病毒研究的设计和关键人群，以及 2) 建立 REC 的行政和领导团队的能力。分 2 个阶段进行；第 1 阶段（1-21 个月）将在麦克雷雷大学解决 4 个 REC 第 2 阶段（22-36 个月）至少 4 个其他 REC，达到 192 个 REC 成员和 32 个总体而言，行政人员培训计划的关键要素是： 1. 利用 IDI PI 和 co-Is 的专业知识，以及来自 IDI 80 个组织的协作专家合作组织围绕新的研究设计设计和提供课程和弱势群体来支持高度优先的研究这将是一种混合学习。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，这是由 RAIS 开发的软件。 IDI 确保正在进行的研究符合法规。电子 REC 提交、审查、批准和到期通知，以便快速跟踪它还将有能力监控和跟踪研究对当地和地区的遵守情况。与 IDI 开发的其他软件一样，它将有一个内置的道德准则。质量保证组件，通过使用强制字段和流程来培训用户我们还将在 REC 会议上提供有关系统的面对面培训和指导。当 REC 熟悉该系统时，我们将进行 RAIS4REC 培训。视频将在我们的电子学习网站上提供。 2b. 提高 REC 管理能力。我们将提供组织规划、通过以下方式向 REC 管理员提供领导力、时间管理、调解/谈判培训由经验丰富的管理培训团队 Imprint Uganda 进行混合式学习。 3.影响将通过培训产出以及定性和定量来衡量结果（例如评审质量、REC 的响应时间）。