As part of its compliance with Canadian Council on Animal Care (CCAC) requirements, the University has established a post-approval monitoring program to audit approved animal use applications and to provide support for continuing education to ensure consistency of practices with approved animal use applications and University policy and procedures. Recognizing that University research is built on scholarly integrity and trust, the starting point for post-approval monitoring is that researchers will, with very few exceptions, adhere to the activities described in their animal use applications. Consequently, post-approval monitoring will most often involve information exchange about procedures that work well, continuing education about areas that are problematic and assessments of novel issues so that best practices inform all animal care and use.
Post approval monitoring enables Principal Investigators (PIs), Animal Care and Use Committees (ACUC), animal services units and the University to assess animal care and use in practice and to close any gaps between those practices and approved animal use applications. The University’s post approval monitoring program is based on collaborative and collegial processes that incorporate information from many sources, including animal use applications, animal health programs, ACUC site visits, veterinary rounds, incident reports, self-assessments, laboratory visits by staff engaged in the University Animal Policy and Welfare Program and other reports.
Once an animal use protocol has been approved, there are a variety of routine activities that help ensure that the actual animal care and use is consistent with what the ACUC has approved. Animals are checked at least daily by either the research personnel or the staff working in the animal services units. Their health and welfare is monitored by observing food and water consumption, behaviour, activity levels, and health status, as well as agreed to measures associated with specific procedures. Veterinarians conduct regular rounds of the animals under their supervision and are available for consultation as needed by the researchers. These regular animal husbandry activities are a significant component of the University’s post-approval monitoring program.
Six months after ACUC approval is issued to a new protocol, a self-assessment checklist is generated. These self-assessments prompt researchers to ensure that all staff are listed on the AUP and have appropriate training, that emergency contact information is current and to amend their animal use protocols if changes have been implemented since approval. These self-assessments, as well as the AUP approval letters, remind researchers of the importance of post-approval monitoring and the resources available to them.
If there are health or distress issues with an animal, for instance, equipment failure that affects animal welfare or a procedure does not go as planned, then the researcher, their staff, or the animal services unit should create a record of the event, detailing the causes and effects and how the situation has been mitigated. These post approval events can be reported to the ACUC through ARISE (via the PAM Log tab). Animal health issues and unexpected morbidity and mortality are not immediate signs of problems with an animal use protocol. By reviewing these reports, the ACUCs may be able to observe issues/ trends not visible at the protocol level. Similarly the ACUCs may be in a position to suggest alternate practices. Most importantly, amendments and annual reports will be considered in the full context of how the research was conducted over the past year.
In addition to annual reports and amendments, the University’s Post-Approval Monitoring Program also includes formal and informal audit processes. The ACUCs carry out annual facility tours and Environment, Health and Safety conduct laboratory inspections. As well, PAM reviewers and the PAM coordinator carry out unannounced laboratory walk-throughs. These promote the PAM program and expectations, remind researchers of day-to-day working issues that might not be top-of-mind when preparing an AUP and provide on the spot advice and guidance. The PI of every lab that is visited in this way receives a follow-up letter noting problems that were observed (if any) and commending good practices. Formal PAM audits, both random and for cause, involve a detailed review of the full AUP and all SOPs, a lab visit and, if necessary, observation of any procedures. Following a proportionate risk model, studies involving a higher category of invasiveness, complex or novel procedures, alternate animal housing or identified by the ACUC as requiring additional follow-up, are more likely to be audited.