Rush-Presbyterian-St. Luke's Medical Center (RPSLMC) is currently in the midst of a series of orchestrated research infrastructure enhancements. One pivotal enhancement currently underway (and funded by the original Grant#OD-02-003) is the development of a web-based Project Tracking System that includes electronic submissions of research proposals to the IRB; management of proposals and related documents; communication among Investigators, IRB administrators, and IRB members; tracking of IRB assignment and review; and tracking of IRB approvals and continuing review. The scale of efficiencies introduced by this software system will allow IRB members and support staff alike to devote a significantly greater portion of their time to their core responsibilities - i.e., evaluating proposals for safety, risk, and safeguards; improving the quality of the informed consent process; and educating investigators and research staff about the responsible conduct of research. I will provide a crucial step for improving record-keeping, facilitating IRB member access to critical information, safeguarding against temporary and permanent loss of IRB records, and facilitating the completeness of initial and continuing reviews. The project is currently in the final functionality testing phase and will be successfully completed by 9/1/03. This proposal outlines our plan for further strengthening the protection of human subjects at Rush by adding additional functions to the Project Tracking System, including enhanced adverse event reporting and tracking, and integrating Office of Sponsored Projects administration and related institutional committee approvals such as the Radiation Safety Committee and Biosafety Committee. Concurrently, a comprehensive training program for investigators, research administrators and IRB members will be developed and implemented by IRB administration to ensure a smooth transition of the system, and the Office of Research Affairs will work closely with a network of Chicago area institutions to 1) share information about the new technology, processes, and training programs, and 2) to coordinate and streamline IRB submission, approval and site monitoring when common protocols are involved. All of the key personnel involved on the project have extensive research administration experience at Rush and have been actively involved in the successful development of the initial Project Tracking System project funded by Grant#OD-02-003. The scale of efficiencies introduced by Project Tracking System, and additional enhancements outlined in this proposal will allow IRB members, investigators and support staff alike to be more effective at their core responsibilities, and will provide the appropriate level of infrastructure to handle the continued growth in the volume of human subjects research for years to come.
