Processes for Managing Animal Welfare and Non-compliance Concerns

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 non-compliance 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.

Consequences of Non-compliance

Subsequent actions of the ACUC may include:

Implement measures to correct the problem and prevent recurrence;
Counseling, such as meeting with the PI and research team;
Issuing warning letters;
Mandating specific training aimed at preventing future incidents;
Monitoring by the ACUC or its delegates (PAM Coordinator, Veterinarian) of research, testing, or training that involves animals;
Revocation of privileges to provide animal care or to conduct research, testing, or training procedures that involve animals, pending compliance with specific, ACUC-mandated conditions;
Suspension of the protocol(s);
Notifying the Department Chair and the Associate Dean (Research) of its actions;
Recommending that REO and/or the Associate Dean (Research) initiate a complaint under the Research and Scholarship Integrity Policy which may lead to institutional sanctions;
Notifying funding or regulatory agencies, as required.

Serious Incidents

Serious incidents of animal care non-compliance are very rare and may involve situations where animals are left to be in pain, distress or suffering, without veterinary care or where the health and welfare of the animals is seriously compromised by inadequate housing, maintenance or monitoring of the animals in question.

If an incident of non-compliance occurs requiring immediate suspension of the protocol(s), the University Veterinarian, in consultation with the Chair of Animal Care and Use Committee, will provide written notice to the PI and his/her delegates, the relevant Director and/or animal facility manager and the ACUC as soon as possible (typically within 1 working day). The University Veterinarian will then communicate to the PI within 72 hours whether the ACUC will extend the suspension beyond this initial period. The Animal Care and Use Committee has a duty to act as expeditiously as possible.
The University Veterinarian, the Director of the appropriate animal services unit and the Chair and other members of the relevant Animal Care and Use Committee will arrange to meet the investigator at the earliest possible time to conduct a fact finding meeting and to determine an initial course of action to deal with the situation, its causes and consequences. The initial course of action will be developed at the first meeting and may be elaborated at subsequent meetings or as additional facts concerning the incident emerge (see step 3 in the section below). If the risk of repeated non-compliance is considered to be high, the initial course of action may include temporary suspension of the active protocol. This means that the investigator cannot conduct any new research work under the suspended protocol until the incident is reviewed by the full ACUC. A quorum of the ACUC will make the final determination of the seriousness of the incident and of subsequent courses of action.

Chronic Problems of Non-compliance or Contravention of Animal Care or Use Standards

Chronic problems of recurring or continued non-compliance are most often reported through Post-Approval Monitoring site visits, Animal Care and Use Committee site visits or the clinical veterinarian reports, but can be reported by anyone.
The details of the chronic issue(s) will be discussed by the ACUC at the next meeting. The ACUC will notify the PI in writing of the reported non-compliance. An initial meeting of a subcommittee of the ACUC with the PI will be arranged as soon as possible to resolve the problem. If there is a subsequent recurrence of problems either associated with one particular animal care protocol or with several animal care protocols involving the same PI, a letter will be sent to the PI outlining the concerns and the ACUC will arrange to meet the investigator at the earliest possible time to conduct a fact finding meeting.
In the event that a member of the ACUC is the PI named in the incident, the ACUC will arrange to meet the investigator at the earliest possible time to conduct a fact finding meeting. However, any subsequent discussion of the issue and the course of action to be taken will be conducted confidentially by the ACUC in the absence of that member.
The ACUC may recommend one or more courses of action in dealing with the resolution of chronic non-compliance issues. Measures must be taken by the ACUC to ensure that humane treatment and animal welfare problems are effectively dealt with and will not reoccur. These may include, but are not limited to:
1. temporary suspension of an active protocol,
2. permanent suspension of a single protocol, or
3. temporary or permanent suspension of all protocols held by the PI.
If the problems are deemed to be largely due to actions of facility animal care staff responsible for the care of the animals in question who are not under the direct supervision of the investigator, the ACUC will document the problem to the University Veterinarian and the Director of the relevant facility, and the Directors will take appropriate action to correct, re-train or remove the staff member(s) responsible.

Documentation

Verified details of the circumstances of serious incidents of noncompliance or chronic noncompliance will be retained on file in ARISE and with the Research Ethics Office, and the Principal Investigator in question will receive a copy.
A formal letter containing the details of the ACUC recommendations will be sent to the PI with copies to the Chair, Head or Dean of the investigators academic unit. If the ACUC permanently suspends an investigator's research protocols, copies will also be sent to the VP Academic/Provost, and this could lead to initiation of a research and scholarship misconduct investigation process for the PI (see UAPPOL Research and Scholarship Integrity Policy).

Reactivation of a Suspended Protocol

Depending on the nature of the non-compliance incident(s), suspension of a protocol (temporary or permanent) means that the investigator is either prohibited from conducting any further research work under the suspended protocol or any new research work under the suspended protocol (one of these two options will be spelled out in the meeting with, or letter to, the PI).
In all cases where a protocol is suspended, a quorum of the ACUC will outline the steps that must be taken to have the protocol reinstated. Requirements for reactivation of a suspended protocol will vary depending on the nature of the incident(s).
In some cases, reactivation can occur once the ACUC receives a letter indicating that the PI will comply with the ACUC recommendations. In other cases the ACUC may require that the PI and/or members of their lab receive further training, either didactic or hands-on, to ensure competency in humane conduct of research, prior to or in conjunction with resumption of protocol activities.
The ACUC may also require follow-up visits and reports on the conduct of the reinstated research protocol by the veterinary staff, the PAM Coordinator, or a subcommittee of the ACUC. The PI may also be asked to meet with the full ACUC or subcommittee of the ACUC to discuss the noncompliance situation and corrective measures, and to provide further information in the form of a follow up report or visit.
In some cases, reactivation may not be advised. In some cases after permanent suspension an investigator may only be permitted to transfer grants and activities to another lab which may continue to conduct his/her research with no hands on, direct involvement by the PI or his/her personnel
PIs are expected to fully and sincerely cooperate in the review process. In the event of non-cooperation by the investigator with the ACUC Chair, the ACUC, the University Veterinarian and/or his/her delegates approved by the ACUC, the ACUC may withdraw approval for all protocols belonging to a PI until the cooperation is received.

Breaches of compliance that cannot be corrected by the ACUC working with the concerned animal users and veterinary/animal care staff will be referred to the Office of the Provost according to the Research and Scholarship Integrity Policy. The Office of the Provost is responsible for communication about sanctions that will be taken by the administration in the event of serious breaches of compliance.