Improving the quality and efficiency of the Univ Zambia Research Ethics Committee with HIV Research Training

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 DESCRIPTION (provided by applicant): The proposed project will strengthen research infrastructure in low and middle income countries by working with the University of Zambia to strengthen its research ethics committee (or "IRB"). Specifically, we will enhance the ethical review quality and administrative efficiency of the University of Zambia Biomedical Research Ethics Committee (UNZABREC). This work is closely collaborative with the University of Zambia School of Medicine (UNZA SOM), building upon our existing partnership with UNZA through the Johns Hopkins-Fogarty African Bioethics Training Program and the African Bioethics Consortium; this proposed work also supports and is supported by multiple existing HIV and other biomedical research collaborations between Johns Hopkins and numerous different researchers in Zambia, all of whom are eager to see increased quality and efficiency of the UNZABREC. The specific aims of this project are to: 1) strengthen ethics knowledge and applied ethical reasoning for members of University of Zambia School of Medicine Biomedical Research Ethics Committee (UNZABREC), 2) strengthen ethics knowledge and applied ethical reasoning for UNZABREC office staff, 3) improve the administrative efficiency and accountability of UNZABREC operations, and 4) evaluate changes in UNZABREC knowledge, skills, and efficiency using an ethics knowledge tool and an original and novel REC Capacity Assessment Tool. 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 REC operations. These activities will provide rigorous, on-going strategies to strengthen the quality o ethics review by UNZABREC 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 UNZABREC members' ethics knowledge before and after the program using an original tool, and we will measure 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 then training to what is needed. We expect UNZABREC ultimately to be a model and resource for other RECs in Africa and for researchers facing ethics challenges in their HIV and other studies.