Consortium for Enhancing Human Subject Research Oversite

加强人类受试者现场研究联盟

• 批准号: 6777828
• 负责人: LEONARD H ROME
• 金额: $ 50万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6777828
• 关键词: Internet; behavioral /social science research tag; clinical research; computer program /software; data management; education evaluation /planning; educational resource design /development; health science research support; human rights; information dissemination; information systems; training

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.

UCLA，RAND和CHARLE R. DREW医学与科学联盟由NIH于2002年9月资助，以生产所有三个机构使用的软件，数据库和教育增强系统，以增强人类学科研究，监督，教育和培训。我们的三个机构进行了长期的历史合作，包括联合教师任命，研究合作和行政服务交流。我们提案的主要目标是建立一个智能的机构审查委员会（IRB）电子提交和跟踪系统，以审查，批准和监测人类受试者研究。此外，我们建议扩展和增强我们当前的人类主题研究网络认证计划。在资助这笔赠款的九个月中，我们花费了大量的努力和机构资源来定义最佳的无纸无纸IRB提交和审核系统。我们现在正在编码基于Web的软件应用程序，该应用程序将满足这些系统要求。同时，我们认识到我们的灵活的IRB模型可以很容易被概括，并且很可能满足直接财团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IRB系统转换为可以自由分发给这些其他机构的开源应用程序。我们将在新的合作机构中实施此申请，包括洛马·琳达大学，橄榄景医学中心，弗吉尼亚州大洛杉矶医疗保健系统，加利福尼亚大学河滨大学和夏威夷大学。此外，我们将扩展当前的IRB系统，以在主机研究社区内的其他监管审查委员会中增强通信和数据管理。创建开源可修改应用程序不仅可以满足我们财团的大量和广泛的IRB需求，而且还可能为许多其他机构提供可行的解决方案。