Approximately two years ago OHRP suspended VCU's MPA due to systemic problems in its system for protecting the rights and safety of human subjects in research. Since that time VCU has completely re-built its IRB system, which included an administrative reorganization, expansion of IRB staff and facilities, acquisition of a new and improved database system, and implementation of investigator and IRB training programs. In addition, a separate Office of Compliance Oversight was established to provide investigational and reporting functions. One important lesson learned from this experience was the importance of having a strong and effective human subjects educational program. In the proposed project, a four-tiered educational program will be developed to educate graduate and postdoctoral students, general faculty, investigators and coordinators, IRB members and staff, and senior university administrators in the areas of scientific ethics and regulatory compliance. Educational materials will be developed for each group in relation to their roles and responsibilities in protecting the rights and safety of subjects in research. The objectives are for general faculty and staff to understand when their activities require IRB review; investigators and research personnel to understand their shared responsibilities under federal regulations for the protection of human subjects; IRB members to understand how federal regulations are applied in protocol review and operationalized within the VCU IRB system; and institutional officials to understand their responsibilities and roles in providing oversight of IRB operations to ensure a properly functioning IRB system. The educational program will utilize the latest web-based technology to allow each group to be individually targeted with appropriate educational material. The web-based technology will be developed by the VCU Instructional Development Center (IDC), an award-winning producer of web-based educational materials. Specific criteria must be met for individuals to successfully complete each module (e.g., investigators must pass an examination with a score of 85% or higher to submit protocol for IRB review). The educational program will be shared with the University of Virginia and Eastern Virginia Medical School IRBs without cost. UVA has agreed to share its application developed under this announcement with VCU.
