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

摘要 拟议的项目将通过以下方式加强中低收入国家的研究基础设施 与埃塞俄比亚亚的斯亚贝巴大学(AAU)合作，加强其机构审查委员会(IRB)。 具体来说，我们将提高AAU学院的道德审查质量和行政效率 健康科学IRB(AAU-CHS-IRB)。这项工作是与AAU公共卫生学院密切合作的， 在AAU和约翰霍普金斯大学(JHU)之间现有伙伴关系的基础上，包括多个 JHU和AAU教员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， 所有这些国家都渴望支持增加非盟-CHS-IRB的能力。这个项目的具体目标是 为了：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系统和业务的效率和问责制，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使用 伦理知识工具和一个新的研究伦理委员会评估工具。在进行伦理审查的同时 人类主题研究总是重要的，艾滋病毒研究往往提出特别复杂或具有挑战性的问题 涉及尊重和保护弱势和边缘化人口的道德问题，公平惠及 参与者，以及适当的护理标准。因此，拟议的计划将支持 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，包括研究减少 减少艾滋病毒/艾滋病的发病率，开发下一代疗法，减少健康差距。高性能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。我们三年的训练 该计划将包括让选定的个人参加为期一个月的集中研究道德 JHU的培训方案，JHU IRB的一名专家和两名非洲生物伦理专家的现场技术咨询 专家(均为Fogarty校友)，由当地伦理专家主持的伦理研讨会，每月与 JHU和非洲IRB顾问，以及应对IRB业务的实际挑战的网络研讨会系列。 这些活动将提供严谨、持续的战略，以加强非盟道德审查的质量-- CHS-IRB及其行政效率，建立在JHU在研究伦理和伦理方面的专业知识 审查和利用两位精通高质量内部评级机构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成员在计划前后的伦理知识， 我们将记录各种行政效率措施，如审查完成情况的时间。我们也 将实施原创的需求评估工具，以更广泛地衡量委员会的优势和 根据需要量身定制培训的需求/差距。我们期望AAU-CHS-IRB最终成为一个典范 为非洲的其他国际研究机构以及在其艾滋病毒和其他研究中面临道德挑战的研究人员提供资源。

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.