Consortium for Enhancing Human Subject Research Oversite

加州大学洛杉矶分校、兰德大学和查尔斯·R·德鲁医学与科学大学联盟于2002年9月由美国国立卫生研究院资助，以生产软件、数据库和教育增强系统，供所有三家机构使用，以加强人类主题研究、监督、教育和培训。我们的三个机构有着长期的历史合作，包括联合任命教员、研究合作和行政服务交换。我们建议的主要目标是创建一个智能机构审查委员会(IRB)电子提交和跟踪系统，用于审查、批准和监测人类受试者研究。此外，我们还建议扩大和加强我们现有的基于网络的人类学科研究认证计划。在这笔赠款获得资金的九个月里，我们花费了相当大的努力和机构资源来定义一个最佳的网上可访问的无纸化IRB提交和审查系统。我们现在正在编写一个基于Web的软件应用程序，以满足这些系统要求。与此同时，我们认识到，我们的灵活的内部评级委员会模式可以很容易地推广，并可能满足我们直属联盟以外的许多其他机构的需求。考虑到这一点，我们现在建议将我们的IRB系统转换为一个开源应用程序，可以免费分发给这些其他机构。我们将在新的合作机构实施这一应用程序，这些机构包括洛玛琳达大学、奥利弗·维尤医疗中心、退伍军人事务部大洛杉矶医疗系统、加州大学河滨分校和夏威夷大学。此外，我们将扩展我们现有的IRB系统，以加强东道国研究社区内其他监管审查委员会之间的沟通和数据管理。创建一个开源的可修改应用程序不仅可以满足我们联盟的大量和广泛的IRB需求，而且还可能为大量其他机构提供可行的解决方案。

The UCLA, RAND, and Charles R. Drew University of Medicine & Science consortium was funded by the NIH in the September of 2002 to produce software, databases and educational enhancement systems to be used by all three institutions to enhance human subject research, oversight, education and training. Our three institutions have a long-standing historical collaboration that includes joint faculty appointments, research collaborations and the exchange of administrative services. The primary goal of our proposal was to create an intelligent Institutional Review Board (IRB) electronic submission and tracking system for the review, approval, and monitoring of human subjects research. In addition we proposed to expand and enhance our current human subject research web based certification program. Over the nine months that this grant has been funded, we have expended considerable effort and institutional resources to define an optimum web accessible paperless IRB submission and review system. We are now are in the process of coding a web-based software application that will fulfill these system requirements. At the same time we recognize that our flexible IRB model can be readily generalized and likely to meet the needs of many other institutions outside of our immediate consortium. With this in mind, we now propose conversion of our IRB system to an open source application that can be freely distributed to these other institutions. We will implement this application at new collaborating institutions that include Loma Linda University, Olive View Medical Center, the VA Greater Los Angeles Healthcare System, University of California Riverside and the University of Hawaii. In addition, we will extend our current IRB system to enhance communication and data management among other regulatory review committees within the host's research community. Creating an open source modifiable application will not only meet the high volume and extensive IRB demands of our consortium, but will likely provide a viable solution to a large number of other institutions as well.