IACUC Protocol Application and Review Process

  1. Establish the need for an application for an IACUC protocol. Review the IACUC CSUF handbook, which can be downloaded from the Policies and Guidelines page. Obtain any necessary federal or state permits and review policies and guidelines that are associated with your project or the types of animals you are studying (see IACUC Guidelines and Policy StatementsOpens in new window ). PIs who are proposing work involving potential biohazards or zoonotic diseases, controlled substances, radiation or radioactive isotopes should consult with the appropriate safety officer before completing their application. PIs working with animals on campus should consult with the Director of Animal Care regarding available facilities and proposed procedures before completing their applications. The IACUC cannot approve a protocol unless appropriate animal care facilities are available for the number and species of animals. Animals cannot be obtained until the associated protocol has been approved by the IACUC.
  2. Download and complete an application for an IACUC protocol (see IACUC FormsOpens in new window ). The PI of an IACUC protocol must be a CSUF faculty member . If staff or students are involved in a project, they must be listed on the line of the application for Other Investigator(s)/Student(s). Be sure that all sections are completed and, if literature searches are done, the PI must list the database(s) searched, key words used, the date the search was done and dates covered by the search.
  3. Ensure that all individuals listed on the protocol application complete the required CITI training. A copy of the completion certificates must be included with the protocol application. No protocols can be approved until all of the CITI training certificates have been received by the coordinator.
  4. PIs are strongly encouraged to submit a draft of the completed protocol application via email to the IACUC chair for pre-review. If this is sent directly to the coordinator, it should be forwarded to the chair. The chair may suggest changes and return the application to the PI before it is reviewed by the IACUC.
  5. After pre-review, the PI must submit a signed original and three hard copies of the protocol to the coordinator, and also email a copy to the coordinator. The application (and eventual protocol) will be given a number indicating whether it is for instruction (I) or research (R) and the year that it is approved. This protocol number should be used in subsequent correspondence.
  6. The coordinator distributes the application to the IACUC for review. IACUC review and approval normally takes about six weeks. If, for some reason, approval is needed sooner, the PI should inform the IACUC chair at the time of submission.
  7. Based on the review, the chair will inform the PI if the protocol is approved or what changes must be made for the application to be approved. The PI must address the reviewers’ and chair’s comments, either in a memo or a revised protocol application that addresses the comments. The PI’s response will then be sent out to the reviewers, who must approve of the changes before the protocol can be approved.
  8. Once the committee has approved the application, the chair will send a signed approval letter and a copy of the final protocol to the PI. A copy will be kept on file in the coordinator’s office. IACUC approval letters may be required by federal granting agencies prior to funding a project.
  9. Protocols are approved for up to three years, but they must be approved annually using the shorter Continuation/Completion form (see IACUC FormsOpens in new window ). After three years, protocols must be renewed using the standard protocol application form. When all work on a project is completed, the protocol must be closed by completing the relevant sections of the Continuation/Completion form.
  10. If any changes (“amendments”) to the protocol must be made during the year, i.e., between continuations, the proposed changes must be submitted by the PI in writing to the IACUC chair, and must be reviewed and approved by the IACUC prior to implementation. The PI must describe the changes in as much detail as in a protocol application. Minor changes, i.e., that are not considered significant as defined by NIH-OLAW and USDA, may be approved by the IACUC Chair.