This Human Subjects Protection Enhancement Program will support the creation of an Office of Human Subjects Protection, to expand and integrate educational programs into ongoing clinical research training, to place the audit and monitoring functions within the OHSP, and to enhance the functioning of the existing IRB's. The OHSP would serve as the integrated and integrating unit within the University for the review, education, and monitoring of research. To achieve this overall goal, the current proposal has the following specific aims: 1. To coordinate and expand the educational functions of the OHSP with other clinical research units within the University, to include community outreach programs and continuing education programs. 2. To expand the capacity for auditing and monitoring of studies involving human subjects within the OHSP. 3. To improve the Institutional Review Board (IRB) function using upgraded computer software which manages the IRB review process, expanded file storage capacity, and improved electronic access by nonaffiliated members of the four RSRBs. The major aim of the OHSP will be to integrate the review, education, and monitoring of research at the University. Such a coordinated effort should be better able to respond to institutional needs as they are identified in any one of these three areas. OHSP will seek to build the infrastructure that will be required to successfully and safely conduct research now and in the future.
