Web-Based Human Subjects Protocol and Training Program

加州大学伯克利分校和河滨分校提出了一项独特的合作，以利用这两个地点正在进行的人类受试者合规努力。伯克利校区一直在开发一个全面的基于网络的合规系统，称为研究电子协议系统(REPS)。去年，伯克利获得了HSREP资金(赠款编号：S07 RR18201-01)进行其电子动物协议模块的基本设计，该模块 已经处于开发的早期阶段，并创建一个人类主体代表模块。河滨校区目前有一个正在使用的电子动物主题系统，并即将推出一个生物危害系统和人类主题系统，但不是HSREP的接受者。 我们建议： 共享教育资源。河滨校区已经适应并实施了人类和动物科目的合规培训/教程系统，该系统最初是由加州大学欧文分校开发的。伯克利希望采用加州大学欧文/河滨分校的系统，河滨分校将与伯克利分校分享其适应项目的计划、时间表、方法和结果。 共享计算机技术。这两个机构在许多方面非常相似。两家公司都进行了大量的社会和行为人类主题研究；两家公司都没有将医学院作为校园的一部分；两家公司都使用动物学科协议的“主协议”模型；两家公司都在致力于整合合同和拨款、合规和财务系统的项目；两家公司都使用麻省理工学院的Coeus合同和拨款系统来跟踪研究提案和 奖项；两者都需要满足加州大学校长办公室关于报告的要求。由于这些相似之处，在一个园区部署的许多技术将直接适用于另一个园区。 分享最佳实践。简化业务流程、加强对人类和动物研究对象的保护、减轻研究人员和工作人员的行政负担、报告不良事件、系统和网络安全、培训和教育推广、基于网络的方案提交、跟踪、流程和委员会审查等领域的合作将使两家机构受益匪浅。 我们坚信，从长远来看，拟议的合作将加强这两个机构的能力。该项目将改进业务流程和实践，减轻行政负担，极大地改善对研究合规管理信息的获取，并最终增强每个机构保护其人类和动物研究对象的能力。

The University of California campuses at Berkeley and Riverside propose a unique collaboration to leverage human subjects compliance efforts underway at both locations. The Berkeley campus has been developing a comprehensive web-based compliance system called the Research e-Protocol System (RePS). Last year Berkeley received HSREP funding (grant no. S07 RR18201-01 ) to take the basic design of its electronic animal protocol module, which was already in the early stages of development, and create a human subjects RePS module. The Riverside campus currently has an electronic animal subjects system in use and is about to unveil a biohazards system and human subjects system but was not a HSREP recipient. We propose to: Share educational resources. The Riverside campus has adapted and implemented a compliance training/tutorial system for human and animal subjects, which was originally developed at UC Irvine. Berkeley wishes to adopt the UC Irvine/Riverside system and Riverside will share its adaptation project plan, schedule, methods, and results with Berkeley. Share computer technologies. The two institutions are very similar in many regards. Both conduct significant amounts of social & behavioral human subjects research; neither have a medical schools as part of the campus; both use a "master protocol" model for animal subjects protocols; both are working on projects to integrate contract & grant, compliance, and financial systems; both use MIT's Coeus contract & grant system to track research proposals and awards; both need to satisfy the University of California's Office of the President on reporting requirements. Because of these similarities, many technologies deployed at one campus will have direct applicability to the other. Share best practices. Streamlining of business processes, strengthening of protections for human and animal subjects in research, reduction of administrative burdens on researchers and staff, reporting of adverse events, system and network security, training and educational outreach, web-based protocol submission, tracking, flow and committee review are among the areas where the collaboration will benefit both institutions enormously. We strongly believe that the proposed collaboration will strengthen the capabilities of both institutions in the long term. This project will improve business processes and practices, reduce administrative burdens, dramatically improve access to management information about research compliance, and ultimately enhance the ability of each institution to protect its human and animal research subjects.