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.