Human Subjects Online Submission System

加州大学戴维斯分校致力于将有效的程序和教育作为保护人类主体的关键。通过教育，研究人员和IRB成员意识到对研究对象的责任以及知情同意程序、IRB程序、知情同意和有关研究过程的规定。通过我们之前从NIH获得的拨款，加州大学戴维斯分校已经能够通过确定需要发展的领域并促进扩大教育项目来实现我们的目标，从而进一步推动这一进程。 本提案所述下一阶段发展的重点将是加强2002年开始的议定书跟踪系统，并开发电子提交、无纸化审查程序和无缝报告系统。目标是开发一个基于网络的跟踪系统的前端，研究人员可以在线输入协议，将它们发送到系主任、院长办公室，然后发送到OHRP，在那里将对其完整性进行行政检查。将在会议前向IRB成员提供协议。审查员将获得CD上的议定书副本，或者他们可以在线检索。他们还可以直接或通过加州大学戴维斯分校将他们的评论输入系统 OHRP工作人员。通过以电子方式编写和发送协议，消除重复的数据输入并减少复印成本和运输时间，这一过程将更加有效。 该在线系统还将帮助加州大学戴维斯分校与目前无法获得此类创新的其他附属于加州大学戴维斯分校的本地系统共享我们的知识和教育系统。我们正在扩大一个人类学科项目联盟，以共同改善流程和教育。第一个行动将是完成认证的准备过程。 提交这项拨款提案是为了帮助加州大学戴维斯分校努力创建一个卓越的IRB教育项目，并将其延伸到其他社区人类主体保护项目。

The University of California, Davis is committed to efficient processes and education as keys to human subjects protection. Through education, researchers and IRB members become aware of the responsibility to research subjects and of the informed consent process, IRB processes, informed consent, and regulations regarding the research process. Through our previous grant from NIH, UC Davis has been able to further this process by pinpointing areas that need development and promoting expanded education programs to achieve our goals. The focus of this next phase of development as described in this proposal will be to enhance the protocol tracking system begun in 2002 and develop electronic submission, paperless review processes and a seamless reporting system. The objective is to develop a Web-based front-end to the tracking system where researchers can enter protocols online, route them to department chairs, deans offices, and then to the OHRP where they will be administratively checked for completeness. Protocols will be made available to IRB members in advance of a meeting. Reviewers will be provided copies of protocols on CDs or they can retrieve them online. They will also be able to enter their comments directly into the system or by UC Davis OHRP staff. By electronically preparing and routing protocols the process will be more efficient by removing duplicate data entry and reducing photocopy costs and transportation time. This online system will also aid UC Davis in sharing our knowledge and education system with other local systems affiliated with UC Davis that do not presently have access to such innovations. We are expanding a consortium of human subjects programs to jointly improve processes and education. The first action will be to work through the process of preparation for accreditation. This grant proposal is being submitted to help UC Davis in its endeavor to create a superior program of IRB education that reaches out to other community human subjects protection programs.