The University of Pennsylvania is committed to developing and maintaining the highest standards of protection of human subjects in research. The University has taken major steps to enhance the support for both its Institutional Review Boards and to develop additional programs to provide for the training and oversight of human subject research. The overall objective of this grant request is to provide for additional support to two components of the University of Pennsylvania Human Research Protection Program (UPennHRPP). Funds are requested to strengenthen the Office of Regulatory Affairs in the University of Pennsylvania, the Office that supports the 8 IRBs under the University FWA. Specifically, funds are requested to: (1) provide techinical expertise to develop Phase 2 of the University electronic research administration initiative (PennERA), specifically to assist in the implementation of a web-based protocol development and submission interface to the new IRB protocol tracking system; (2) enhance the new adverse event tracking system for physician trial management designed to interface with the current web-based adverse event reporting system developed and implemented as part of an enhanced electronic IRB protocol tracking and development system. (3) To create an additional interface for the PennAE tracking system to facilitate use by the social behavioral sciences and to allow the software to be used by other IRBs without the need for Penn-specific security. Finally, (4) funds are requested for a joint project between the IRB and OHR to continue to develop a software system for consent form development and review. This new software will utilize the PennERA protocol development software, existing IRB templates, and word processing capacity designed to generate easy-to-read consent forms for human research participants. Funds are also requested to strengenthen the IRBs by providing an additional dedicated test server and additional replacement computers to implement a new intranet site for policies and procedures within the Office of Regulatory Affairs (ORA) the support office for the IRBs. Funds are also requested to enhance the interactive videoconferencing system to permit IRB to both display electronic IRB protocol submissions and to utilize external consultants in an interactive web-based conference environment. Finally funds are requested to expand the current web-based education modules to include specific IRB member training and make these available to local IRBs in the Delaware Valley as part of the local IRB Consortium.
