The ultimate goal of this award is to enhance the Human Subjects Protection Programs at the University of California, San Francisco's (UCSF), the San Francisco Department of Public Health and Children's Hospital. Our collaborative efforts will focus on the development and implementation of enhanced educational materials for those who conduct research as well as the creation of educational materials for those who participate in or consider participating in research. The following are the specific aims: 1. Modify and expand UCSF's on-line training modules and educational materials to include issues of collaborative research and research on public health. 2: Collaboratively develop self-assessment tools and guidelines for a postapproval monitoring program. 3. Collaboratively develop education materials about human research for the patient and subject community. These activities are a logical and timely extension of the activities that were funded by the previous NIH grant awarded to UCSF to enhance its Human Subjects Protection Program (HSPP). As a result of UCSF's extensive collaboration with other sites in the San Francisco Bay Area, this grant will improve not only UCSF's program of protection but add to other programs as well. The tools that will be created for self-audits by the researchers can be shared with other sites, in particular our collaborators. This will enable us to together to achieve a full circle human subjects protection program that will include education and training, review and approval of protocols, and post-approval monitoring. In order to assess the effectiveness of these activities, samples of applications will be evaluated before and after the educational materials have been disseminated to see if the issues of collaboration and working at multiple institutions have been addressed appropriately. The Quality Improvement Unit of the HSPP will conduct sample audits on the effectiveness of the self-assessment tools. We will seek feedback from subjects and researchers, both formally and informally, about the usefulness of the patient and subject educational materials and make adjustments as needed.
