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.

Project Narrative The overall goal of the George Washington University-Kinshasa University (GWU-KU) Strengthening Ethical Review Capacity in Democratic Republic of Congo (SERC-DRC) is to strengthen operational efficiency, quality of ethical reviews and general research oversight practices of the KU School of Public Health Institutional Review Board. This will be achieved through various ways including implementation of a tracking and quality system that will begin with a formal needs assessment of bioethics related programs, teaching, institutional policies, and structures of the KUSPH-IRB, intensive mentoring of the REC administrators and members from GWU-IRB experts, participation of key members of the IRB in intensive training with GWU, participation of KU IRB members in seminars and webinars, enhancing IRB administration along with standard operating procedures through intensive technical support from African consultants, and implementation of best practices from GWU. 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 all consistent with the mission of KUSPH and DRC to improve the KUSPH-IRB into a highly functional and well respected IRB.