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

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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.