citation_inspection: 133

During a Post Approval Monitoring (PAM) review for Study A conducted on August 1, 2022, the IACUC representative noticed the principal investigator was conducting a nerve injury pilot study using 12 swine. The pilot study was not described in the IACUC approved protocol. This pilot study included fewer weeks of post-operative monitoring and additional behavioral trials not included in the protocol. Additionally, there was little or no documentation of monitoring parameters and post-operative care for the swine as required in the protocol. A corrective action plan has been developed and implemented and the protocol amendment is pending IACUC review. Correct by November 30, 2022. On December 20, 2021, the IACUC noticed the Principal Investigator's annual report for ferret Study B described additional experimental procedures that included monitoring internal body temperature and initiating a righting and withdrawal reflex procedure to test the effects of study compounds on the animal. These procedures were were not outlined in the protocol reviewed and approved by the IACUC. Corrected at the time of inspection by corrective action plan and an IACUC approved amendment. Principal investigators must submit proposals involving the use of animals that include the appropriateness of the species and number of animals to be used, a rationale for their use, and a complete description of all procedures that will be performed. Submitting such significant changes allows the IACUC to approve procedures to ensure animals are not subject to unnecessary pain or distress. This inspection and exit interview were conducted with facility representatives. This inspection was conducted 10/11/2022 to 10/13/2022. Additional Inspectors: GLORIA MCFADDEN, VETERINARY MEDICAL OFFICER n