This proposal describes a plan to utilize short-term interim support to support three goals. First, we propose to enhance the oversight of human subjects protections within the twenty-three campus California State University system by developing a web-based training that focuses on ethical issues unique to research conducted in the social and behavioral sciences. The training will target research investigators as well as IRB members. Once developed, this training will be available to each campus and will be updated as needed to respond to current ethical issues. In addition, SDSU plans to develop a standardized guidance and procedure manual for each institution to use in strengthening their human subjects protection program. This manual will provide the framework for each institution to implement a human subjects protection program that is compliant with federal regulations, yet can be modified as needed in response to specific institutional requirements. SDSU is the only CSU campus eligible for the interim support provided through the HSREP. Second, our proposal requests funding to purchase computer equipment to complement the software developed through our initial award. Specifically, equipment will be purchased to support IRB members in the review of web-based protocol applications. Document scanning equipment will also be purchased to support the transition from a manual submission system to a web-based system. Third, to reduce the burden to both investigators and human subjects that results when multiple institutions are involved in oversight of a research protocol, we will collaborate with UCSD to develop an electronic process to support IRB submission and review when multiple institutions have oversight. We will partner with institutions in the region that are not eligible for this interim support and who engage in collaborative research. It is expected the end product will 1- improve communications between regional IRB's; 2- allow for one protocol submission, by the investigator; and 3- allow for expansion to include other institutions that are involved in collaborative research.
