Regulations and References Overview

The IRB/OHRPP office prepares and maintains records and documents associated with its oversight of research and the administration of the boards. These materials include, but are not limited to: • Individual protocol records- IRB/OHRPP applications and supporting documentation • Records of continuing review and amendment activities • Copies of all official correspondence between the IRB and the investigators and key personnel • Copies of the minutes of all IRB meetings. • Rosters of the current IRB members and their qualifications • Documentation of agreements to serve as IRB of record, or to rely upon external IRBs • OHRPP/IRB policies and procedures See the sections below for details. Documentation for projects reviewed and approved by the UCLA IRB using webIRB are stored within webIRB. Documentation for projects reviewed and approved by the UCLA IRB prior to implementation of webIRB are stored in a secure offsite storage facility (including copies of protocol documentation and IRB review communications) and in electronic records in the OHRPP office (including meeting minutes). webIRB Investigators and research staff submit research applications (initial, continuing, amendment, and post-approval reports) requiring UCLA IRB/OHRPP review via the online, web-based webIRB application. webIRB is used to complete exempt, expedited, and full committee reviews of research involving human participants