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 Human Research (OHR) in the University of Pennsylvania School of Medicine. Specifically, funds are requested to: (1) provide an enhanced computer tracking software, coupled to the Institutional Review Board (IRB) database for the purpose of tracking monitor visits and compliance of investigators with monitoring and compliance activities; (2) develop a new adverse event tracking system for physician trial management designed to interface with the current web-based adverse event reporting system under deployment as part of an enhanced electronic IRB protocol tracking and development system. This latter, new electronic research administration system known as PennERA will provide for total electronic human subject protocols submission by mid-2003. Finally, (3) funds are requested for a joint project between the IRB and OHR 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 a dedicated 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 for an interactive videoconferencing system to enhance the ability of the 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.
