citations: 134

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rowid hash_id code kind repeat desc narrative
134 81ac6b26610c7758 2.31(d)(8)   0 Institutional Animal Care and Use Committee (IACUC). On November 09, 2022, after a Post-Approval Monitoring (PAM) survey it was determined that the Principal Investigator used the saphenous vein for blood collection and infusion. The saphenous vein was not approved for use under Protocol SW-006. Members of the PAM survey group also identified that piglets in Experiment 1 did not receive the intravenous infusions of the test article after the first MRI. After a Post Approval Mentoring (PAM) survey on February 3, 2023, members of the IACUC determined that the Principal Investigator did not follow protocol FE-006. The IACUC identified the following: - Ferrets did not receive dexamethasone as described for surgical procedures in the approved protocol. - Ferrets were administered ketamine and xylazine for anesthesia instead of sodium pentobarbital. - Blood samples were not taken at P30 two hours after test article administration as described in the approved protocol. - During terminal procedures, ferrets received isoflurane overdose followed by perfusion. According to the protocol, pentobarbital should be administered prior to perfusion. - Three ferrets assigned to Protocol FE-006 were used under FE-008. The Principal Investigator did not transfer the three ferrets over to protocol FE-008. The procedures for the three ferrets were conducted on 01/20/23, 01/24/23, and 01/18/23 under protocol FE-008. Proposed activities and proposed significant changes in ongoing activities that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the research facility. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC. Corrected before the time of inspection through corrective action plans and protocol amendments.