The University of Utah began in 1999 with a plan of reforms for our Institutional Review Board (IRB) in order to improve the protection of human subject research and to provide better service to our research community. A central component of the plan was the development of an information technology driven system (ITS). Therefore, the goal of this proposal is development of an IRB ITS through completion of the following four objectives: 1) development of an IRB ITS database; 2) creation of an electronic process for Board review of all applicable required materials; 3) creation of an electronic based safety and monitoring system for improved protection and reporting to required agencies; and 4) creation of a University-wide tracking number for research studies in order to facilitate tracking of protocols across compliance offices at the University of Utah. An IRB ITS will allow more efficient research material submission, and facilitate easier access and movement of research through the system. This will improve the review, safety, and monitoring of human subject research. Furthermore, the IRB ITS will combine existing institutional guidelines and procedures and also those of the FDA, NIH OHRP and other regulatory agencies as the design bases for collecting, storing and tracking of all reported adverse events. The University of Utah understands that core funding from this RFA will not completely meet the needs for project completion but will act as a sufficient base to leverage further funding within the University to complete the IRB ITS.
