A fundamental challenge facing research institutions is how best to address an increasingly complex human subjects research environment. The University of Cincinnati is addressing the issues raised in this environment in many ways, including previously awarded HSREP grant #S07 R25 RR18258. The proper conduct of research involving human subjects requires that institutional officials, research investigators and their staff, as well as human subjects review board members be properly trained and educated in the ethical and scientific aspects of such research. However, the addition of procedures, safeguards, and regulations to the conduct of scientific research and the review of such protocols produce significant workload challenges for all parties involved. Further, the increased amount of research activity in many biomedical research centers, the greater need for training and education of researchers in the ethics of research, and the expanded reporting and monitoring activities pose major challenges to Institutional Review Boards (IRBs) and researchers. This project will provide the electronic resources to address two urgent needs: 1) collecting and maintaining information related to IRB protocols; and 2) cost effective training for human subjects researchers. In a continued effort to address these needs, this proposal' specific aims are to: ? Develop electronic resources that will track, monitor, and coordinate human subjects protocols and related documents, and ? Develop web-based training for investigators, administrators, and IRB members in the safe and ethical conduct of research. This proposed development will be built on our existing training and monitoring programs and will provide flexibility to meet increased human subjects research activities.
