Human Subjects Research Enhancements Program at MUSC

在此应用程序中，南卡罗来纳医科大学（MUSC）专注于其系统的性能增强，以保护研究中的人类受试者，包括三个irb，这些irb承载了超过1300个活跃协议的病例负载。要求为技术服务、硬件和软件提供资金，以建立、测试和执行一系列数据库，供内部审查委员会和有关的科学技术委员会活动(生物安全；

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.