We propose to strengthen our Human Subjects Protections Program in the following ways: 1. We will develop quarterly educational sessions for investigators and study coordinators to improve communication with the Institutional Review Board staff and members on standard operating procedures and regulations. 2. We will develop mandated educational sessions for Institutional Review Board (IRB) members on regulatory issues for reviewing and approving protocols and consent forms to improve consistency and increase an individual voting members knowledge base for making decisions on new submissions. 3. We will continue to improve IRB efficiency by revising standardized forms and procedures and maintaining the data entry for tracking and monitoring ongoing studies and adverse events into the database management system. 4. We will continue to link the communication between the National Jewish IRB, the Data and Safety Monitoring Committee (DSMC) and the clinical research units to improve standardization and to develop and implement an efficient and resourceful institutional-wide research network. To accomplish these goals we will develop and implement this major initiative: 1. Develop a IRB Assessment and Education Program, in conjuction with the clinical research units, to assess IRB and investigator compliance with federal regulations, to increase clinical study personnel knowledge to improve the protocol review and approval process flow and to increase the overall efficiency and functions of the Institutional Review Board.
