Strengthening Ethical Review Capacity in Democratic Republic of Congo (SERC-DRC)

加强刚果民主共和国的道德审查能力 (SERC-DRC)

• 批准号: 10321965
• 负责人: ADNAN A HYDER
• 金额: $ 10.05万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-19 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10321965
• 关键词: Acquired Immunodeficiency Syndrome; Administrative Efficiency; Administrator; Africa; Africa South of the Sahara; African; Applied Skills; Assessment tool; Attention; Awareness; Bioethics; Biomedical Research; Caring; Childhood; Collaborations; Communication; Complex; Country; Democratic Republic of the Congo; Educational process of instructing; Ensure; Equipment; Ethical Issues; Ethical Review; Ethics; Foundations; Goals; HIV; HIV prevention trials network; Human; Infrastructure; Institution; Institutional Policy; Institutional Review Boards; Joints; Knowledge; Leadership; Mentors; Mission; Modeling; Needs Assessment; Participant; Performance; Persons; Policies; Positioning Attribute; Procedures; Process; Protocols documentation; Public Health Schools; Research; Research Ethics; Research Infrastructure; Resources; Schools; Site; Structure; System; Telephone; Time; Training; Training and Infrastructure; United States National Institutes of Health; Universities; Visit; Vulnerable Populations; Washington; Work; experience; global health; human subject protection; improved; infrastructure development; low and middle-income countries; marginalized population; member; operation; professor; programs; response; skills; sound; tool; webinar

Project Summary/Abstract The growing research enterprise in low and middle-income countries (LMICs) has brought attention to the need for high quality research infrastructure, especially institutional review boards (IRBs) for the protection of human subjects. Sub-Saharan Africa is increasingly the site of HIV research which raises particularly complex and challenging ethical issues involving vulnerable and marginalized populations, fair benefits to participants, and appropriate standards of care. Under such circumstances, sound ethical review requires both experience and sophistication, along with understanding of the local context, to adequately protect participants. At the same time, given that much HIV research is multi-site, it also is essential that reviews occur with some degree of efficiency. In addition, building capacity for local ethics review and ensuring adequate protection of human subjects in HIV research advances not only the global HIV response but biomedical research more broadly. The specific aims of the George Washington University (GWU)-Kinshasa University (KU) Strengthening Ethical Review Capacity in Democratic Republic of Congo (SERC-DRC) proposed project are: Aim 1: To strengthen ethics knowledge and reasoning skills of the KU School of Public Health (KH-SPH) Institutional Review Board: through KUSPH-IRB leadership and key members attending a GWU one-month intensive program, ethics seminars at KUSPH, and a joint webinar program. Aim 2: To enhance knowledge of IRB administration and standard operating procedures at KUSPH-IRB: through intensive technical assistance, brief attachments at GWU IRB, local support by African consultants, and transfer of best practices from GWU. Aim 3: To improve efficiency and performance of KUSPH-IRB: by intensive mentoring including in-person visits from African experts; biweekly support phone calls; in-person visit from GWU-IRB experts; implementation of a tracking and quality system; support for staff and key equipment. Aim 4: To evaluate performance of the KUSPH-IRB over a 3-year period: through administration of an existing knowledge and skills assessment tool for members/staff; and administration of an existing IRB needs assessment and efficiency tool for KUSPH-IRB. By the end of this project, we expect to have strengthened the administrative infrastructure of KUSPH-IRB operations and in turn improved its administrative efficiency, reduced review times, and improved the quality of the review process. We also expect to increase the knowledge and skills of all current IRB members such that changes in quality of ethical review can be sustained. The proposed collaboration will build upon a strong GWU-KUSPH partnership, our 20 years of experience in developing ethics capacity in Africa, our experience with NIH-Fogarty programs, and our expertise in global health in Africa, to elevate KUSPH-IRB as a regional leader in research ethics review.

项目概要/摘要 低收入和中等收入国家 (LMIC) 不断增长的研究事业引起了人们对这一需求的关注 高质量的研究基础设施，特别是保护人类的机构审查委员会 (IRB) 科目。撒哈拉以南非洲日益成为艾滋病毒研究的场所，这引起了特别复杂和 挑战涉及弱势和边缘群体的道德问题，为参与者提供公平的利益，以及 适当的护理标准。在这种情况下，健全的伦理审查需要经验和 复杂性以及对当地情况的了解，以充分保护参与者。同时 鉴于许多艾滋病毒研究是多地点的，因此审查时一定程度上的审查也很重要 效率。此外，建设当地道德审查能力并确保充分保护人类 艾滋病毒研究课题不仅推动了全球艾滋病毒应对工作，而且推动了更广泛的生物医学研究。 乔治华盛顿大学（GWU）-金沙萨大学（KU）强化的具体目标 刚果民主共和国道德审查能力 (SERC-DRC) 拟议项目是： 目标 1： 加强 KU 公共卫生学院 (KH-SPH) 的伦理知识和推理能力 机构审查委员会：通过 KUSPH-IRB 领导层和主要成员参加为期一个月的 GWU 强化课程、KUSPH 道德研讨会以及联合网络研讨会计划。目标2：增进知识 KUSPH-IRB 的 IRB 管理和标准操作程序：通过密集的技术 援助、GWU IRB 的简短附件、非洲顾问的本地支持以及最佳实践的转让 来自 GWU。目标 3：通过强化指导提高 KUSPH-IRB 的效率和绩效 包括非洲专家的亲自访问；每两周一次支持电话； GWU-IRB 亲自来访 专家；实施跟踪和质量体系；对员工和关键设备的支持。目标 4： 评估 KUSPH-IRB 在 3 年期间的绩效：通过管理现有的 会员/工作人员的知识和技能评估工具；和现有 IRB 需求的管理 KUSPH-IRB 的评估和效率工具。到本项目结束时，我们预计将加强 KUSPH-IRB 运营的行政基础设施，进而提高了其行政效率， 减少了审核时间，提高了审核过程的质量。我们还期望增加 所有现有 IRB 成员的知识和技能，以便可以改变伦理审查的质量 持续。拟议的合作将建立在 GWU-KUSPH 强大的合作伙伴关系之上，这是我们 20 年来的合作伙伴关系 我们在非洲发展伦理能力方面的经验、我们在 NIH-Fogarty 项目方面的经验以及我们的经验 非洲全球健康领域的专业知识，将 KUSPH-IRB 提升为研究伦理审查的区域领导者。