South Florida Human Subjects Benchmarking Coalition

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The University of Miami seeks funding through the Human Subjects Research Enhancement Program to support and expand its activities through the development of the South Florida Human Subjects Research Benchmarking Coalition. The coalition will assess the function and effectiveness of their institutional review boards and human subject offices in order to identify and develop new opportunities for enhanced human subject research and the protection of human subjects enrolled in experimental protocols. The University of Miami has designed and will soon implement the Integrated Clinical Research and Protection System. This system provides a network structure for human subject research protocols, tracking and auditing mechanisms for communications, adverse event reporting, and educational initiatives. The deployment of this system will advance the monitoring and reporting of human subject research activities. Critical information from the implementation of this system will be shared with coalition partners and forms the basis of this application. The specific aims are to develop and apply benchmarks for IRB structure; conduct interviews and surveys to assess individual practices; compare the safety and welfare of human subjects across a sample of institutions; provide a real-time communication mechanism for collaborating institutions; provide educational knowledge workshops; provide Collaborative IRB Training Initiative (CITI) certification to collaborating institutions; and provide an educational system that employs a on-line bilingual version. Collaborating institutions will receive access to individual and collective benchmark results via a web-based )ortal allowing institutions to make informed decisions regarding institutional and procedural change.