In this application, the Medical University of South Carolina (MUSC) focuses on performance enhancements of its system for protecting human subjects in research, including three IRBs that carry a caseload of more than 1,300 active protocols. Funds are requested for technical services, hardware and software to construct, test and implement an array of databases for use as a decision support system by the IRB and related MUSC activities (biosafety, academic compliance [education, audits], conflict of interest).
Our specific aims are to: 1. Develop and implement a secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant, Web-based IRB database system that increases the quality and efficiency of all interactions with human research teams and the review of research protocols (new, continuing, amendments), adverse events, recruitment practices and progress, protocol deviations and violations, and outcomes of corrective action plans resulting from protocol audits. 2. Develop and implement a set of secure, HIPAA-compliant parallel databases for other university activities contributing to human subjects protection. Parallel databases for university biosafety, academic compliance [education, audits], and conflict of interest activities will be linked to the new IRB database, creating an array of relational databases that can be queried to answer specific questions about oversight system activity. 3. Evaluate the effectiveness of the relational database array as an IRB decision support system in: (a) identifying areas of protection of human subjects that need improvement, and (b) facilitating the development, implementation and evaluation of action plans designed to make those improvements. The objective is to increase the quality and efficiency of procedures to protect human subjects in research protocols.The database array will enable identification of areas that need improvement, facilitate evaluation of action plans designed to effect those improvements, and provide data that can be used locally (with distribution to PIs, IRB members, university administration) and nationally in conjunction with other institutions to enhance the protection of human subjects.
