This proposal submission is in response to the NIH RFA OD-03-007, Human Subjects Research Enhancements Program (HSREP). The purpose is to obtain short-term interim support for institutional activities to strengthen the oversight of human subjects research at the University of Georgia (listed in Appendix 3 of the RFA OD-02-003 and awarded grant # RR018176 in 2002) and the Medical College of Georgia (not funded under RFA OD-02-003). If granted, the proposal request for $100,000 (to be shared equally by the two institutions via a subcontract) will be applied to continuing human subjects protection initiatives in the most critical areas of research compliance. The Medical College of Georgia (MCG) and the University of Georgia (UGA) are increasingly collaborating on an institutional level to promote biomedical and health research funded through state funded initiatives like the Georgia Cancer Coalition (GCC) and the Georgia Research Alliance (GRA). This collaboration extends to the Institutional Review Board's at the two institutions. The cooperative agreement between the two institutions dates back to 2000. In addition to deferring to MCG on protocols, UGA has relied on them for medical/clinical expertise. This grant will further cement the relationship through the development of a human research protections program (HRPP) that is mutually beneficial. Justification for initiatives like continuing office, programmatic and educational enhancements at UGA and MCG is based upon increasing scrutiny of the human research protections process and the need to ensure protections for research participants.
The specific aims of this project are to expand the existing educational program and to implement infrastructural enhancements that synthesize data to minimize redundancy and maximize productivity. The challenge is to find innovative and sustainable ways to reduce the burden on the administrators and make the process user friendly for researchers.
