The Post-Approval Monitoring (PAM) program is in place to ensure that projects are undertaken in practice as approved in principle by the Animal Care Committee (ACC). The University of Guelph PAM program is comprised of several components. For a full description of this program please refer to the ACC Guidelines on Post-Approval Monitoring.
Below is a brief description of the five main elements in the PAM program at the University of Guelph.
1. Animal Care Committee Site Visits and Monitoring
The ACC conducts at least one scheduled site visit to each University of Guelph animal facility every year, and will conduct two such visits when a facility is not in compliance with the Animals for Research Act, or has serious outstanding recommendations from the ACC or the Canadian Council on Animal Care (CCAC).
At facility site visits ACC members assess the condition of the animals, the state of the animal care and housing facility, and the management practices and procedures. The standards set out by the CCAC form the base for expected conditions and animal care practices in the facility. ACC members meet with facility management and staff and tour all areas of the facility that support animals. This includes animal housing rooms, procedure rooms, feed and bedding storage, supply storage and laboratories. An ACC site visit report is generated from each visit with observations, recommendations for improvement, and commendations for excellence.
At an ACC review meeting or following report of an animal incident, the ACC may determine that additional monitoring of selected AUPs is required. This monitoring includes site visits by ACC members to the relevant animal facility. The decision to monitor selected projects may be based on the level of experience of the research team, unfamiliar or invasive procedures, or reported incidents occurring on an ongoing project. A report will be generated following the ACC visit(s) to the facility.
2. Animal Incident Reports and Unusual Concerns
An Animal Incident Report (AIR) must be filed with the ACC for every incident involving an animal listed on an AUP that is outside of the expected conditions of that AUP. Upon filing, AIRs are reviewed by the ACC and the Veterinary Director with follow-up as required to resolve the issue or concern.
In determining whether or not an observed phenomenon comprises an animal incident, the following criteria must be considered:
- The number of animals involved - Is the number affected greater than what would normally be expected in the group of animals being observed?
- Emergence of a pattern or trend - similar to the first criterion but subtly different i.e. if an event that, on it’s own, doesn’t qualify as an incident occurs again several days in a row, then an incident report is required.
- Whether the observed morbidity/mortality is expected in terms of what has been approved for a given study - If substantially more animals are affected than what has been predicted and/or groups that are not supposed to be affected, i.e. control groups, are showing effects, then an incident report is required.
- Whether the morbidity/mortality arises from spontaneous disease/injury, unrelated to current experimental conditions - Incident reports are required when the rate of disease or injury is higher than expected.
If, at any time, there is doubt as to whether or not to submit an AIR, the default action is to submit. Alternatively, contacting the Veterinary Director with the Office of Research (Dr. Marcus Litman, firstname.lastname@example.org) or the Assistant Director of ACS (Dr. Anna Bolinder, email@example.com) for consultation is also an option.
In the case of unusual concerns, staff or students may report directly to the ACC (firstname.lastname@example.org). These concerns are addressed as per the ACC Guidelines on Concerns and Complaints in the Animal Care and Use Program.
3. Standard Operating Procedures
Standard Operating Procedures (SOPs) are a set of written instructions that document and inform a routine or repetitive activity. Animal holding facilities are required to keep up-to-date SOPs that describe routine husbandry and care procedures for the animals held in the facility.
If a PI plans to follow facility SOPs for all animal husbandry, handling and hands-on procedures in the research project, he/she may indicate in the AUP submission that facility SOPs apply. If, however, the research project is planned to entail animal care practices or animal procedures that diverge from the facility SOPs, these protocol-specific procedures must be clearly described, justified, and approved in the applicable AUP.
Facility SOPs are authored by the manager of the facility, a staff member familiar with the procedures, or by the facility veterinarian. SOP drafts are forwarded to the ACS office and then reviewed by the ACC. SOPs must be reviewed and updated every three years or when substantial procedural changes occur. SOPs may also be reviewed as a result of a request from an ACC site visit, an inspection by the Chief Veterinary Inspector with the Ontario Ministry of Agriculture and Food, or from a CCAC assessment visit recommendation.
For invasive animal procedures (e.g. surgeries) the involvement of a veterinarian is particularly important and is mandatory during the review of SOPs.
4. Standards of Veterinary Care
It is required by provincial law, and by the CCAC, that certain standards for veterinary involvement at institutions using animals in science are met. The Canadian Association for Laboratory Animal Medicine (CALAM) Standards of Veterinary Care prescribe that each institutional animal holding facility must have a formal arrangement to ensure veterinary services are readily available at all times to meet both routine and emergency needs. At the University of Guelph, all animal facilities receive a visit at least once yearly by the designated facility veterinarian. It is expected that the facility veterinarian will be in the facility more frequently as part of his/her role in working together with the facility staff to ensure optimal health and wellbeing of the animals held therein.
Regular visits to the animal facilities are followed by written reports. These may occur after each of the visits – or after the yearly officially documented veterinary site visit. The veterinary site visit reports must document that the facility, its operation, and the health and wellbeing of the animals were observed and discussed. Recommendations for improvement are noted and these may result in new SOP development or revision of existing facility SOPs. Participation in SOP development and review is one of the key responsibilities of the facility veterinarian. The veterinary reports from the visits are submitted to the Veterinary Director, who carries the overall responsibility of the institution’s veterinary care program.
5. Provincial Inspections and CCAC Assessment Visits
In Ontario, the use of animals in research and teaching falls under the Ontario Animals for Research Act administered by the Ontario Ministry of Agriculture, Food and Rural Affairs (OMAFRA) and based on a system of registration of research facilities. The objectives of the Act are to maintain a minimum standard of care and wellbeing for all animals used in science and to protect research animals from unnecessary pain. Under the provisions of the Act, non-compliance leads to loss of facility registration and prevents the use of that facility for animals for a period of one year. An institution my re-apply for registration after the year has passed. The Chief Veterinary Inspector with OMAFRA makes unannounced annual inspection visits to all registered animal-holding facilities. The resulting inspection report addresses encountered deficiencies and required improvements. The report states whether or not the inspected facility is in accord with provincial legislation.
The CCAC is a national agency funded in part by the Tri-Agency Framework. The Tri-Agency Framework is made up of the Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council of Canada (NSERC), and Social Sciences and Humanities Research Council of Canada (SSHRC). In order for the University of Guelph to receive research funding from these federal agencies, CCAC certification is mandatory. The University’s Animal Care and Use Program is assessed every three years through CCAC assessment visits conducted by peers from other institutions around the country. Each institution is assessed on its implementation of CCAC policies and guidelines and other CCAC-recognized standards. If successful, a Certificate of Good Animal Practice is issued.