The Human Subjects Research Enhancements Program is intended to provide the means for sustainable improvements to the Univerity's program for the oversight of human subjects in research. The first goal of this project will significantly advance the system-wide education program for students, faculty and research personnel through additional training of current personnel and the acquisition of support resources. This first element of the project will also provide the basis for ensuring the long lasting ability to maintain program adherence to relevant federal requirements and guidelines through the development of comprehensive and current policies and procedures.
The second aim i s to acquire the computer-based ability to track research projects, maintain a log of active projects and associated approval periods, provide timely notice to investigators of pending expiration dates, and be able to monitor adverse events related to specific protocols. These two elements will also provide the basis for the expansion of the responsibility for protocol review and oversight into the entire research community of Hawaii by supporting the development of a cooperative IRB panel based at the University of Hawaii that includes the other major research institutions in our state: a single IRB for university-based, multi-site, NIH cooperative research protocols and clinical trials.
