Human Subjects Research Protections at UT Austin

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The purpose of this application is to request an additional, final year of funding to extend current efforts at UT Austin to increase support for research with human subjects. Over the past year with NIH funding, we have implemented an electronic IRB application, refined the human subjects database used to track actions for each protocol, enhanced training modules and verification system, and disseminated information about UT Austin's new electronic tools. The specific aims of the current proposal are to: 1. Extend the electronic submission of the IRB application by adding electronic systems for submission, review, approval, and management of: a) continuing review applications; b) project termination forms; c) non-compliance and adverse event reporting and tracking; d) amendment forms; and e) student research forms. 2. Develop and implement a system of electronic review of protocols by IRB members and ORSC staff using the above electronic submission system. 3. Develop and implement an electronic system that will provide more detailed, real-time documentation in the IRB meeting minutes of protocol revisions and regulatory requirements. 4. Conduct a national summit in May 2004 on human subjects research, focusing on the social and behavioral sciences and jointly sponsored by UT Austin, NIH, and OHRP. 5. Hold a technical seminar for the purpose of sharing electronic tools, thus enabling other institutions to incorporate UT Austin's systems into their human research protection programs. Our intent is to prepare the University for accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Funding received from NIH during this past fiscal year has enabled us to increase our oversight of human research and enhance research compliance mechanisms. Activities outlined in this proposal will prepare us further for accreditation, as well as for the significant growth in health research that is anticipated at UT Austin over the next few years.