IRB Training Through a Web-Based Protocol Review Form

这是一项通过人类受试者研究增强计划提供资金的申请，旨在为开发基于网络的核心IRB应用程序提供临时支持，该应用程序将加强对内布拉斯加大学医学中心（UNMC）和克雷顿大学（CU）人类受试者研究的监督。 该补助金将资助电子IRB申请的设计、开发和实施，该申请涉及HHS和FDA法规规定的IRB批准研究的标准。基于技术的系统将利用计算机、服务器和互联网的组合来收集彻底IRB审查所需的信息。该方案旨在通过一系列基于网络的核心模块，引导调查人员进行思考和决策过程，解决条例确定的核心要素，同时促进调查人员以有效的方式作出反应。为了改善研究者关于研究设计和实施的决策，在IRB申请中增加相关的教育部分，对于解释IRB审查和批准标准背后的伦理和法规依据是有价值的。此外，通过引导 研究者通过方案审查的必要要素，IRB审查的效率应得到提高，因为研究者将提供更完整的申请，因此，IRB审查所需的修改和/或澄清较少。内布拉斯加州仅有的两所医学院UNMC和CU将建立合作关系，以开展这一项目。

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.