The Medical University of South Carolina (MUSC) continues to focus on enhancing performance of its institutional review boards (IRBs), which carry a caseload of over 1300 active protocols. During the first year of support, we initiated development of a series of data-driven decision support tools to equip the IRBs and associated compliance activities. During the second year, we propose to: a) continue this development, b) initiate development of tools for web-based meetings, and c) partner with another institution as a first step toward a statewide virtual IRB system.
Our specific aims are to: 1. Continue the development and implementation of a secure, HIPAA-compliant, web-based 1RB database system that increases the quality and efficiency of interactions with investigator teams in addition to enhancing the review of protocols involving human subjects, adverse events, recruitment practices and progress, protocol deviations and violations, and outcomes of corrective action plans resulting from protocol audits. 2. Develop and implement parallel databases for issues contributing to human subject protection, e.g., biosafety, academic compliance (education, audits), and conflict of interest. These databases will be linked to the new IRB database, creating an array of relational databases that can be queried about oversight system activity and effectiveness. 3. Evaluate the effectiveness of the database array as an IRB decision tool in: a) identifying areas of protection of human subjects that need improvement, and b) facilitating implementation of action plans designed to make those improvements. 4. Establish a partnership with South Carolina State University (SCSU) for enhancement of the protection of human research subjects at both institutions. SCSU, a comprehensive, state-supported, minority-serving institution and land-grant university, is located 80 miles from MUSC in Orangeburg, SC. In addition to providing direct benefits to the partnering institutions, experience gained from formation of the partnership will facilitate linkage with other institutions in the state. As indicated above, the longer-range goal of this proposal is to create a statewide virtual IRB based on a network of institutions. Such a system will link local expertise into a statewide system to enhance protection of human subjects and other research compliance issues while retaining the flexibility of each institution to deal with its local issues.
