This is a request for funding via the Human Subjects Research Enhancements Program to provide interim support for the development of a web-based core IRB application which will strengthen oversight of human subjects research at the University of Nebraska Medical Center (UNMC) and Creighton University (CU). The grant wilt finance the design, development, and implementation of an electronic IRB application which addresses the criteria for IRB approval of research specified under HHS and FDA regulations. The technology-based system will utilize a combination of computers, servers, and the internet to collect the information necessary for a thorough IRB review. The program will be designed to lead investigators through a thought and decision-making process which addresses the core elements as identified by the regulations, via a series of web-based core modules, while facilitating investigator responses in an efficient manner. In order to improve investigators' decision-making regarding study design and conduct, the addition of linked educational components of the IRB application should be valuable in explaining the ethical and regulatory-based rationale behind the IRB review and approval criteria. Additionally, by guiding the investigators through the necessary elements for a protocol review, the efficiency of IRB review should be enhanced as investigators will provide applications that are more complete and, therefore, require less modification and/or clarification as a consequence of IRB review. UNMC and CU, the only two medical schools in Nebraska, will develop a collaborative relationship in order to conduct this project.
