Human Subjects Online Submission System

加州大学戴维斯分校致力于将高效的流程和教育作为人类受试者保护的关键。通过教育，研究人员和IRB成员了解对研究受试者的责任以及知情同意过程、IRB过程、知情同意和研究过程相关法规。通过我们以前从美国国立卫生研究院的赠款，加州大学戴维斯分校已经能够通过精确定位需要发展的领域和促进扩大教育计划，以实现我们的目标，进一步这一进程。 本提案所述下一阶段发展工作的重点将是加强2002年开始的方案跟踪系统，并开发电子提交、无纸审查程序和无缝报告系统。目标是开发一个基于Web的跟踪系统前端，研究人员可以在线输入协议，将其发送到系主任，院长办公室，然后到OHRP，在那里他们将被行政检查的完整性。在会议之前，将向IRB成员提供方案。将向评审员提供CD上的方案副本，或者他们可以在线检索。他们也将能够进入他们的意见直接进入系统或加州大学戴维斯分校 人权高专办工作人员。通过以电子方式编写和发送协议，这一过程将更加有效，因为它消除了重复的数据输入，减少了影印成本和运输时间。 这个在线系统还将帮助加州大学戴维斯分校与加州大学戴维斯分校附属的其他当地系统分享我们的知识和教育系统，这些系统目前无法访问这些创新。我们正在扩大一个人类受试者项目联盟，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。 这项拨款建议正在提交，以帮助加州大学戴维斯分校在其奋进创造一个上级计划的IRB教育，达到了其他社区人类受试者的保护计划。

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.