The Principal Investigator (PI) should establish the need for an IACUC protocol by reviewing relevant policies and guidelines (see IACUC Guidelines and Policy Statements) and then obtain any required federal or state permits. PIs using animals on campus must consult with the Animal Care Facility Manager regarding available facilities and procedures before submitting an application. Animals cannot be used or procured for a project until the protocol has been approved by the IACUC. PIs who are proposing animal work that also involves potential biohazards or zoonotic diseases, controlled substances, radiation or radioactive isotopes should consult with the appropriate safety officer before completing their application and if necessary, submit a Cayuse IACUC request.
All individuals (PIs/staff/students) who handle or directly assist with the care of vertebrate animals must be screened for potential health risks associated with working with animals. The PI must complete the Job Duty portion of the Medical Referral Job Duty
and then email a copy of the form to all individuals who will handle animals. Each worker will then complete the first page of the form and then email it to EHS (email@example.com). EHS will email the form to our contracted medical provider (Kaiser), who will then contact each worker to assess potential risks and if necessary, schedule a health visit. In addition, all workers must complete an online CITI training course on using animals in research. All personnel must provide evidence of CITI training and be medically cleared to handle animals before a protocol can be approved. Because this process can take several weeks, PIs must ensure that worker begin training and submit the Medical Referral form immediately after the protocol application is submitted, to avoid delays in beginning work.
To begin the protocol application process, the PI should log on to the Cayuse IACUC online application system and gather the necessary information. Staff or students involved in a project must be listed in the Personnel section. Be sure that all sections are completed and that, for all literature reviews, the database(s) searched, key words used, the date the search was done and dates covered by the search are all provided. PIs are urged to use the Excel template provided for the initial submission or for the continuation submission to construct the table describing the number of animals to be used. Moreover, it is the responsibility of the PI to ensure that all personnel receive appropriate protocol-specific training and to maintain documentation of that training in their research laboratories. All individuals planning to work in the CSUF vivarium rooms must be trained by the Animal Facility Specialist prior to entering those facilities.
PIs are strongly encouraged to contact the IACUC chair for pre-review of their completed Draft application prior to submitting it through Cayuse. The chair will provide feedback to the PI and suggest changes before it is submitted for formal IACUC review. After the PI has modified the application in response to the chair’s comments, the PI will digitally sign the assurance in Cayuse and submit the application.
The coordinator will distribute the application to the IACUC for review. IACUC review and approval normally takes about 6 weeks. If approval is needed sooner, the PI should notify the IACUC chair at the time of pre-review.
Based on the review, the chair will inform the PI of the changes that are needed for the application to be approved. The PI must address the committee’s comments in Cayuse by re-submitting the application with changes that address these comments. The PI’s response and changes will then be re-routed to IACUC, which must approve of all the changes before the protocol can be approved.
Once the application is approved and all certifications received, an automated email notification will be sent to the PI. The PI’s department chair will also be notified by the IACUC office.
Approvals are valid for three years, but protocols must be reviewed annually by submitting a Continuing Review request through Cayuse. After three years, work that is ongoing must be renewed by submitting a De Novo protocol application through Cayuse. When all work on a project is completed, PIs must close the protocol in Cayuse.
If a protocol needs to be modified, the proposed changes must be submitted as an Amendment request in Cayuse. Amendment requests must be reviewed and approved by the IACUC prior to beginning work. The PI must describe the Reason for the Change in detail in the online application. Minor changes, i.e., that are not considered significant as defined by NIH-OLAW and USDA, such as personnel changes, may be approved solely by the IACUC Chair, but must still be submitted via Cayuse IACUC.
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