This proposal establishes the Southern California Human Research Enhancement Collaboration (SCHREC), consisting of the University of California, Irvine; University of California, Riverside; Veterans Administration Medical Center Long Beach; Children's Hospital of Orange County; and California State University at Fullerton. Each participating institution brings varied expertise to this collaboration based upon its organizational structure, project types, and volume of research, all of which will serve to strengthen the SCHREC activities. The first goal of SCHREC is to develop an informed consent document writing tool that will be used at each collaborating institution. The University of California, Irvine (UCI) will be assisted by its collaborators in the design of the tool (writer) that will aid investigators in the drafting of clear and concise informed consent documents. The informed consent form writer will provide necessary text for fulfillment of the eight basic elements of informed consent while tailoring the additional required elements as appropriate to the research procedures to be performed. It will also ensure the language used is understandable to research subjects and is free of exculpatory language. The informed consent form writer will also facilitate IRB review of informed consent documents. UCI programmers will develop the informed consent writer tool and the collaborating institutions will mount the program on their website. A second, but equally important, goal is the development of training materials related to human subjects research, which will be available to all collaborators. Beginning with the UCI Research Administration Management Program as a template, SCHREC will develop training activities to improve understanding of human subjects requirements, thereby raising the level of compliance. The involvement of each member of SCHREC will be especially important in determining and prioritizing the training topics, key concepts to be learned by trainees, and the presentation outline and style. """"""""Train the trainer"""""""" concepts will be used to expand the training capabilities at each institution. SCHREC members believe these project-oriented goals will serve to establish permanent lines of communication and collaboration long after the grant expires.
