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.
