Consortium for Enhancing Human Subject Research Oversite

点击翻译按钮获取中文摘要

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.