The goals of this continuation proposal are 1) to expand the computer based system that was proposed last year to encompass components beyond those previously included and 2) to collaborate with four institutions that conduct human subjects research, none of which were previously funded by the S 07 program. In addition to serving as an instrument for an investigator's development and submission of applications to the IRB, IRB office management and tracking of all appli cations, adverse events, and advert isements, a tool for monitoring the education of IRB members, staff and investigators and a means for preparing agendas and minutes, the expanded system will incorporate the following additional components that are highly relevant to the protection of hum an research subjects: a) conflicts of interest; b) the new requirements of the Health Insurance Portability and Accountability Act (HIPAA); c) biosafety considerations; and d) pharmacy information required for all drugs utilized in protocols that include human subjects. Furthermore, access to the computer based system will be expanded beyond the investigators, IRB members and staff to incorporate access to staff of the Grants and Contracts Offices and access to relevant components of the IRB application by designated individuals in the General Clinic al Research Center (GCRC) incl uding the Research Subject Advocate (RSA), the MSSM Conflicts of Interest in Research Committee, the Bios afety Officer and Biosafety Committee, the Research Pharmacy and the MSSM Compliance Officer. The collaboration with the external institutions will include integrating the needs of those institutions relative to human subjects research into the computer system and sharing the product that is devel oped with these institutions. The collaborating institutions will include Elmhurst Hospital Center, Queens Medical Center (both part of the Health and Hospital Corporation of New York City), the Jewish Home and Hospital of New York and the Bronx Veteran's Administration Medical Center. The expanded access to the computer system and the unique, rapidly available searchable system for adverse events that will be provided to the MSSM GCRC RSA and Biosafety Committee are considered particularly important elements of the proposed software that will greatly enhance the ability of the MSSM IRB and its collaborating instituti ons to protect human research subjects.
