IACUC Protocol Application and Review Process

  1. Establish the need for an application for an IACUC protocol. 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. All individuals (faculty/staff/students) who handle or directly assist with the care of captive vertebrate animals must complete a Medical Health QuestionnaireOpens in new window , which will be reviewed by Environmental Health and Safety (EHS) for potential conditions that might be exacerbated by contact with animals. The Principal Investigator on the IACUC protocol must also submit an Animal Handler Job Duty formOpens in new window , which describes the type of work to be done and the possible health risks to personnel. As with CITI training, the forms must be approved and any follow-up training or treatment must be completed before any work with animals can begin.
  3. Download and complete a Request for Approval of Animal Care and UseOpens in new window application for an IACUC protocol. 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.
  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 responding to any pre-review comments, the lead PI submits one copy (Word or PDF) of the protocol application to the coordinator as an email attachment. The application must be signed and dated by all listed PIs (signatures of students and staff are not required), indicating they have read and agree to the contents in the application, and they have reviewed the CSUF IACUC Handbook. 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 6 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 reviewed annually using the shorter Continuation/Completion formOpens 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.