Supporting Performance of the Ethics Committee for Research (SUPER) in Ethiopia

支持埃塞俄比亚研究伦理委员会 (SUPER) 的表现

• 批准号: 9904789
• 负责人: Wakgari Deressa
• 金额: $ 9.91万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-24 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9904789
• 关键词: AIDS/HIV problem; Accountability; Administrative Efficiency; Africa; Africa South of the Sahara; African; Area; Assessment tool; Attention; Awareness; Bioethics; Biomedical Research; Caring; Collaborations; Communities; Complex; Consultations; Country; Development; Ensure; Ethical Issues; Ethical Review; Ethics; Ethiopia; Ethiopian; Faculty; Fostering; Guidelines; HIV; Health; Health Sciences; Human; Human Subject Research; Incidence; Individual; Infrastructure; Institution; Institutional Review Boards; International; Knowledge; Leadership; Life; Measures; Medicine; Mentors; Methods; Modeling; Needs Assessment; Office for Human Research Protections; Participant; Performance; Population; Prevention strategy; Process; Protocols documentation; Public Health Schools; Research; Research Ethics; Research Ethics Committees; Research Infrastructure; Research Personnel; Research Training; Resources; Science; Series; Site; System; Telephone; Time; Training; Training Programs; United States National Institutes of Health; Universities; Work; Zambia; college; design; effective therapy; experience; health disparity; human subject protection; improved; innovation; institutional capacity; international center; low and middle-income countries; meetings; member; next generation; novel; operation; programs; response; service delivery; skills; sound; tool; webinar

Abstract The proposed project will strengthen research infrastructure in low and middle income countries by working with the Addis Ababa University (AAU) in Ethiopia to strengthen its Institutional Review Board (IRB). Specifically, we will enhance the ethical review quality and administrative efficiency of the AAU College of Health Sciences IRB (AAU-CHS-IRB). This work is closely collaborative with the AAU School of Public Health, building upon existing partnerships between AAU and Johns Hopkins University (JHU), including multiple existing HIV/AIDS and other biomedical research and training collaborations amongst faculty at JHU and AAU, all of whom are eager to support increased capacity of the AAU-CHS-IRB. The specific aims of this project are to: 1) strengthen ethics knowledge and applied ethical reasoning for members of AAU-CHS-IRB, 2) strengthen ethics knowledge and applied ethical reasoning for AAU-CHS-IRB office staff, 3) improve the administrative efficiency and accountability of AAU-CHS-IRB systems and operations, and 4) evaluate needs and changes in knowledge, skills, and efficiency of AAU-CHS-IRB members, staff and the committee as a whole using an ethics knowledge tool and a novel Research Ethics Committee Assessment Tool. While ethics review of human subject research is always important, HIV research often raises particularly complex or challenging ethical issues involving respect for and protection of vulnerable and marginalized populations, fair benefits to participants, and appropriate standards of care. The proposed program will therefore support the ethical conduct of HIV/AIDS research in all areas of high national and global priority, including research to reduce the incidence of HIV/AIDS, develop next generation therapies, and reduce health disparities. High functioning IRB members and staff are critical components of the HIV/AIDS research workforce. Our three year training program will include having selected individuals participate in an intensive, one-month focused research ethics training program at JHU, on-site technical consultations from a JHU IRB expert and two African bioethics experts (both Fogarty alumni), ethics seminars led by local ethics experts, monthly support telephone calls with JHU and African IRB consultants, and a webinar series on meeting practical challenges of IRB operations. These activities will provide rigorous, on-going strategies to strengthen the quality of ethics review by AAU- CHS-IRB and its administrative efficiency, building both on JHU's expertise in research ethics and ethics review and leveraging the expertise of two African colleagues well versed in high quality IRB operations. We will measure AAU-CHS-IRB members' ethics knowledge before and after the program using an original tool, and we will document various administrative efficiency measures such as time to review completion. We also will implement an original needs assessment tool that more broadly measures committee strengths and needs/gaps to tailor training to what is needed. We expect AAU-CHS-IRB ultimately to be a model and resource for other IRBs in Africa and for researchers facing ethics challenges in their HIV and other studies.

摘要 拟议的项目将加强低收入和中等收入国家的研究基础设施， 与埃塞俄比亚的阿迪斯大学合作，加强其机构审查委员会。 具体而言，我们会提升澳大书院的伦理审查质量和行政效率， 健康科学IRB（AAU-CHS-IRB）。这项工作是与公共卫生的AAU学校密切合作， 在AAU和约翰霍普金斯大学（JHU）之间现有伙伴关系的基础上， JHU和AAU教师之间现有的艾滋病毒/艾滋病和其他生物医学研究和培训合作， 他们都渴望支持AAU-CHS-IRB的能力增加。该项目的具体目标是 1）加强AAU-CHS-IRB成员的伦理知识和应用伦理推理，2）加强 AAU-CHS-IRB办公室工作人员的伦理知识和应用伦理推理，3）改善行政管理 AAU-CHS-IRB系统和操作的效率和问责制，以及4）评估以下方面的需求和变化： AAU-CHS-IRB成员、工作人员和整个委员会的知识、技能和效率 伦理知识工具和一个新的研究伦理委员会评估工具。虽然道德审查 人类受试者的研究始终是重要的，艾滋病毒的研究往往提出特别复杂或具有挑战性 涉及尊重和保护弱势和边缘化群体的伦理问题， 参与者和适当的护理标准。因此，拟议的方案将支持道德 * 在国家和全球高度优先的所有领域开展艾滋病毒/艾滋病研究，包括研究如何减少艾滋病毒/艾滋病感染， 艾滋病毒/艾滋病发病率，开发下一代疗法，减少健康差距。高功能IRB 成员和工作人员是艾滋病毒/艾滋病研究队伍的重要组成部分。三年的训练 该计划将包括有选定的个人参加一个密集的，为期一个月的重点研究伦理 JHU的培训计划，JHU IRB专家和两名非洲生物伦理学专家的现场技术咨询 专家（均为Fogarty校友），由当地道德专家领导的道德研讨会，每月与 JHU和非洲IRB顾问，以及关于应对IRB运营实际挑战的网络研讨会系列。 这些活动将提供严格的持续战略，以加强AAU的伦理审查质量， CHS-IRB及其行政效率，建立在JHU在研究伦理和道德方面的专业知识基础上 审查和利用两名精通高质量IRB业务的非洲同事的专业知识。我们 将使用原始工具测量AAU-CHS-IRB成员在项目前后的伦理知识， 并会记录各项提高行政效率的措施，例如检讨完成进度所需的时间。我们也 将实施一个原始的需求评估工具，更广泛地衡量委员会的优势， 需要/差距，使培训适合所需。我们希望AAU-CHS-IRB最终成为一个模型， 为非洲其他IRB和在艾滋病毒和其他研究中面临伦理挑战的研究人员提供资源。