The broad objectives of this application are to facilitate the conduct of quality research by University of California, Irvine faculty while increasing and improving protection of the human research subjects who participate in our studies. To accomplish these objectives, we intend to focus on the following three specific aims: 1) Streamlining of Review Processes for Human Subjects Research; 2) Increased Training on Human Subject Protections; and 3) Improved Post-Approval Monitoring Activities. Successful implementation of this project will result in reduced administrative and clerical burdens for investigators, streamlining of protocol review processes; increased time and resources spent on training and consultation with investigators and post-approval monitoring activities; increased expertise of IRB staff, IRB membership, research staff, and research investigators; and reduction of noncompliance. The project will yield multiple health-related outcomes, such as improved well-being of study subjects, facilitation of groundbreaking medical research, and advancement of ethical and rigorous scientific inquiry. The methods to be used include the following: 1. Streamlining of IRB reviews by development of a web-based """"""""paperless"""""""" IRB submission and protocol distribution system. 2. Training of research staff through certification of IRB personnel, formal instruction of IRB members, and additional of one full-time trainer who will provide education to researchers and their staff. 3. Post-approval monitoring activities, such as routine evaluation of investigator performance in key areas and information sharing with other research monitoring entities on the campus.
