The University has established the Post-Approval Monitoring Procedure to ensure animal care and use in practice is consistent with approved animal use applications and best practices. Research processes are dynamic and animal use in research poses particular challenges. Concerns may arise for a number of reasons, including knowledge gaps, protocol drift, inadequate record-keeping, equipment failures, communication problems and human error and may be identified by a PI, research team member, veterinary or animal care staff, ACUC members and others. Many of these concerns can be resolved quickly and effectively through collaborative work by the animal support services staff and the research team and then reported to the ACUC via the Post-Approval Monitoring log.
Protocol non-compliance occurs when the animal use protocol approved by the ACUC is not followed. Examples of non-compliance include use of more animals than approved in the AUP, performing unapproved surgery or other procedures, using unapproved anesthetics, failure to provide analgesics as approved, administering unauthorized agents, or unauthorized persons participating in a research project. The University Animal Policy and Welfare Committee (UAPWC) is the body responsible for determining and working to correct breaches of compliance with approved animal use protocols and SOPs. When faced with protocol noncompliance, the University’s first response should be to find a way to bring the protocol into compliance. In practice, UAPWC has delegated responsibility to the ACUCs to make the initial assessment of non-compliance and to find ways to rectify the situation.
If allegations of protocol noncompliance are verified, the ACUC can require corrections and impose specific conditions for continued animal use, as needed, per University policy and CCAC requirements. A clearly minor and unintentional misinterpretation of an institutional requirement that has not created a welfare problem for an animal is an example of where a verified allegation of protocol non-compliance might lead to an explanation and correction of the situation but no further sanction.