The ultimate goal of this award is to improve the University of California, San Francisco's (UCSF) protections for human subjects. The challenges of expanding activity in human subjects research, an increasingly complex regulatory environment, and limited resources have hampered our ability to keep our educational programs, policies and infrastructure up to date. To address this, programs are proposed that will increase researchers' knowledge, reduce unnecessary correspondence and revision due to lack of knowledge, allow more efficient review and processing of applications, ensure that regulatory and ethical questions are addressed more clearly and completely, revise processes to incorporate recent changes in regulations and guidelines, and allow more detailed and accurate tracking. Specifically,(1) New educational modules will be developed which will improve the ability of the Committee on Human Research (CHR), UCSF's IRB, to deliver training; (2) all existing guidelines and policies will be updated, posted to the CHR web site, and made available as small brochures and booklets; and (3) a fully on-line application process will be developed that allows researchers to submit protocols electronically, correlates protocol types to training requirements, tracks adverse events, and tracks other compliance-related data. These activities will result in a reduction of time spent on routine submission, review, and tracking procedures and allow researchers and IRB members to focus on more substantive subject protection issues. IRB review letters will give less attention to correcting routine omissions and greater attention to larger issues. In order to assess the effectiveness of these activities, samples of letters will be evaluated before and after the grant period to see if the type of content has shifted. Process metrics will be tracked on IRB review cycles and other operational issues. Sample research records will be evaluated for the consistent use of IRB-approved consent forms. Feedback from knowledgeable faculty and staff who are aware of consent processes and subject satisfaction in multiple studies will be sought.
