The main objectives of this proposal are to maximize institutional capacity for educating and training individuals who are involved in the conduct and oversight of human subject research and to strengthen monitoring, management and efficiency of our oversight program by upgrading the IRB database program. Our established program for educating faculty, IRB members, IRB staff and the lay community will be expanded by creating computer-based training modules available through the Health System website, adding more inservice programs by IRB staff for institutional workshops and increasing access to national and regional meetings to junior staff of the IRB office. The online modules will cover a complete range of topics pertinent to various audiences within the research and lay community. Eventually, a complete learning center will be available with courses assigned to individuals as appropriate. A system will be developed to track completion of the online training modules in order to ensure compliance with Institutional training mandates. Regularly scheduled educational sessions will be held in the Office of the IRB conference room. In addition, the equipment and software requested in the proposal will enable IRB staff to go to individual department/institutions within the NS-LIJHS to deliver customized training sessions as part of Grand Rounds, Department meetings, etc. in order to address individual needs as they are identified. In addition, the Office of the IRB will purchase a commercially available database developed specifically for use by IRBs that will integrate the two separate databases of the North Shore and LIJ IRBs. This will streamline processes across both IRBs for greater efficiency as well as provide more progressive methods for information sharing. In addition to enhancing preparation of pre- and post-meeting materials, the new database will improve compliance by decreasing the possibility for error in scheduling continuing review and adverse event reporting, and providing a consistent and automated method by which to monitor research activities. This unified database will also enable read-only access to data by the General Clinical Research Center and the Office of Grants and Contracts and will serve as a tool to link IRB compliance and GCRC processes to strengthen overall human subjects protections. The new database will also keep track of education and training information and permit cross-referencing of serious adverse events.
