Strengthening Research Compliance and Integrity (RCI) Office capacity for rigorous oversight of HIV clinical trials at the Makerere University-Johns Hopkins University Research Collaboration.

PROJECT SUMMARY Uganda is one of the largest recipients of NIH funding in Africa, some of which provides opportunities for capacity building. However, the bulk of these opportunities are skewed towards scientists to the disadvantage of administrators in compliance and regulatory whose role in the conduct of clinical trials cannot be overstated. In recent years, the compliance landscape has moved at an unprecedented pace, challenging our research enterprise, its structure, and our ability to adjust to new requirements and regulations. In order to increase institutional capacity to review and monitor rigorously the conduct of clinical trials, it is imperative that the Research Compliance and Integrity (RCI) teams are equipped with the right knowledge and skills for effective and efficient compliance review of clinical trials, as well as established policies and procedures. It is against this background that this proposal has been developed. The overall goal of the proposed project is to further strengthen RCI team members’ capacity at the Makerere University- Johns Hopkins University (MU-JHU) Research Collaboration and other institutions in Uganda to manage research compliance and integrity-related activities. To this end, we propose to offer the RCI’s lead staff advanced training in research compliance and integrity management and exposure to US university research compliance practices. The RCI lead will receive training from (1) our partner institution, the Johns Hopkins University (JHU) Compliance office, (2) attending Research Integrity Officer (RIO) Boot Camps at the HHS Office of Research Integrity in Washington DC to obtain training on handling allegations of research misconduct, and (3) enrolling in an accredited compliance management degree program organized by the Africa Institute for Regulatory Affairs (AIFRA). The lessons learned by the RCI Lead will be cascaded to the co-Lead and others in Uganda. In addition, the RCI co-Lead and regulatory affairs coordinators at MU-JHU and sister institution, Baylor Foundation Uganda, will attend the post-diploma degree program on regulatory compliance at the AIFRA. We will also run seminars and create a forum through which consultation on research compliance and integrity policies, innovations, challenges, and opportunities in research compliance are shared. The capacity of other research compliance staff in Uganda will be strengthened by providing low-cost training and mentorship through a hybrid Compliance and Integrity support hub at MU-JHU, to be established as part of the project. The establishment of this hub will allow us to provide inexpensive support to other Ugandan research staff involved in regulatory and compliance thereby building their capacity for managing their clinical trials. This intervention will also create a pool of experts that funders can work with within the region to train other future staff. By the end of the three-year project period, we will have created an institutional compliance and integrity leader, trained and mentored compliance team members, regulatory administrators, research scientists, and improved clinical trial compliance practices through the implementation of rigorous systems at the institutional level.