The participation of human subjects in research is essential to the advancement of scientific and medical knowledge and integral to Yale University's research mission. In recent years, the rapid growth in the volume and complexity of human subjects research, coupled with a disturbing number of adverse research events, has heightened the concern of the public, funding and oversight agencies, and the research community regarding the adequacy of protections for humans who participate as subjects in research. Numerous reports have cited the growing workload of institutional review boards (IRBs), the bodies charged with approving and overseeing human research protocols, as an important factor impacting the quality of human subjects protections. The objective of this proposal is to enhance Yale University's human subjects protections program by implementing a Comprehensive IRB Management System (CIMS) that will automate routine IRB and IRB office functions; permit on-line research protocol submission and tracking; enhance the communication among IRBs, investigators, and other participants in the human subjects protections program; and create a robust, accessible data base of protocol related information. The CIMS will be designed in two phases (Phase I is the IRB Administrative Module, Phase II is the Principal Investigator Module) through a collaborative process that engages peer academic institution in the identification of best practices and the design of system requirements. The final product, an integrated protocol and IRB management system, will be interfaced with key partners of the Yale human subjects protections program, e.g., grants and contracts offices, the Conflict of Interest Committee, clinical trials centers. The efficiencies and information generated by the CIMS will promote regulatory compliance; enhance the education of IRB members, investigators and key research personnel; facilitate compliance auditing and quality improvement activities; and permit IRBs and members of the research community to enrich their deliberations regarding human research design and expand their efforts to implement robust and effective human subjects protections.
