This Human Subjects Protection Enhancement Program will support the operation of an Office of Human Subjects Protection, with expanded and integrated educational programs for internal and external clinical research training, and to enhance the functioning of the existing IRB systems. This is the logical next step in enhancing the infrastructure at the University of Rochester for the successful and safe conduct of research now and in the future. The expansion of human subjects protection education and expertise to regional institutions is consistent with the University's educational mission. To achieve these overall goals, the current proposal has the following specific aims: 1. To apply improved and upgraded computer software to additional IRB functions, including adverse event reporting, Data Safety and Monitoring Board activity tracking, and Phase 1 and 2 trial tracking systems. 2. To expand the use of the new computer software to interface with other University functions related to human subjects' protection, including compliance and grants administration. 3. To make available a comprehensive research ethics curriculum (with modules for IRB members, investigators, and IRB administrators) for institutions conducting human subjects research in the Upstate New York region. 4. To support regional institutions' IRB's with consultation and technical expertise related to accreditation, auditing and monitoring. The major aim of this project will be to continue integrate the review, education, and monitoring of clinical research at the University of Rochester and expand that capacity to external collaborative sites. This can be viewed as the first steps in the development of an interoperative clinical research network as envisioned within the NIH Strategic Plan.
