AEC Management of Animal Non-compliance Events Procedure

Purpose

The purpose of this document is to detail the course of action when a potential non-compliance with an approved AUP is identified.

The University of Otago, its personnel and officers are subject to the Animal Welfare Act 1999 (AWA) and are obliged to ensure that research, testing and teaching (RTT) involving animals do not contravene the AWA.

The use of animals at the University of Otago must be carried out in accordance with the University’s Code of Ethical Conduct for the use of animals in RTT (CEC) and the AEC-approved animal use protocol (AUP). Failure to comply with the AUP is a non-compliance.

Any changes / deviations on an approved AUP regarding personnel, techniques or manipulations must be applied for via a modification, which is assessed by the AEC to avoid a non-compliance.

Organisational scope

This guideline applies to all animal users named on University of Otago AUPs.

Definitions

AEC

Animal Ethics Committee

APCO

Animal Practices and Compliance Officer

AUP

Animal Use Protocol

AWA

Animal Welfare Act 1999

CEC

University of Otago Code of Ethical Conduct for the Use of Animals for Research, Testing and Teaching

HOD

Head of Department

IARMS

Integrated Animal Research Management System

NAEAC

National Animal Ethics Advisory Committee

PI

Principal Investigator on AUP

RTT

Research, Testing and Teaching

Content

1. Responsibility and Authority

   1. The AEC has the responsibility to ensure the highest ethical standards are upheld for the manipulation and use of animals on approved AUPs at the University of Otago under the authority of the CEC. Authority has been delegated to the Animal Welfare Officer (or designee) and the Animal Practices and Compliance Officer (APCO) for animal welfare and AUP compliance monitoring. The Animal Welfare Officer and APCO have the responsibility to:
      1. stop any procedure that they consider to be causing unnecessary distress or pain to the animal.
      2. stop any animal use that they believe deviates from any approved use, which involves any non-approved procedure, or which causes unforeseen distress to an animal.
      3. humanely euthanase an animal if it is considered necessary.
         iv.report any failure to comply with the approved AUP.

2. Sources of potential non-compliance reports

   1. A potential non-compliance can be reported by anyone but will often be reported by the Animal Welfare Officer through clinical case reports, by the APCO through site visits or through adverse event reporting by animal facility staff or researchers.
   2. Potential non-compliances may be a one-time incident or repeated incidents indicating a more chronic issue with animal care. Some potential non-compliances may also not have an impact on animal welfare.

3. Procedure

   1. Upon receiving report of a potential non-compliance event, the Animal Welfare Officer (or designee) or APCO will immediately conduct an initial investigation to determine if it is:
      1. a potential non-compliance with no impact on animal welfare.
      2. a potential non-compliance with an impact on animal welfare.
   2. In the case of (i.), the APCO will prepare an initial report, send it to the PI, and to the next AEC monthly meeting, to determine/confirm the non-compliance severity. A copy of the AEC’s decision will also go to the PI in a timely manner, to allow the PI to prepare a response letter for the AEC monthly meeting. Timeframe: within 5 days of meeting minutes being approved a letter from the AEC should be send to the PI.
   3. In the case of (ii.), which may involve the Animal Welfare Officer (or designee) or APCO temporarily suspending work on part/all of the AUP and/or immediate treatment or euthanasia of animals, and ensuring there is no ongoing risk of adverse events or other welfare concerns, the APCO will immediately alert the Chair of the AEC by phone and follow up with a written report to the AEC Chair (or designated member) and to the PI.
   4. The AEC Chair, or nominee, will contact the PI as soon as practical by email, to address the key concern(s). The email will detail the immediate course of action, or to address the key concern(s) in the first instance with the response time required (normally within 1–7 days). A copy of the letter or email, and any subsequent correspondence, will be provided to the Animal Welfare Office, the AEC Secretary and to the PI’s Head of Department (HOD) and the relevant facility manager.
   5. At the next full committee meeting, the AEC will review the reports and assess the significance of the event. The final minutes of such a meeting will be distributed to all personnel involved for comment and revision. The AEC will review any discussions/correspondence held with the PI and make a recommendation to the most appropriate course of action. This may include:
      1. A meeting between the PI and AEC or a subcommittee to discuss the concerns in detail and plan remedial measures.
      2. Amendment to the application.
      3. Reviewing and updating procedure.
      4. Training or retraining staff.
      5. Suspension of RTT work.
   6. The PI will be asked to address all concerns within a time frame specified by the AEC.
   7. The PI, HOD and Animal Welfare Office will be advised in writing by the AEC of the outcome.

4. Determining the level of non-compliance

   1. Non compliances are considered minor, major or critical and are discussed below:
   2. Minor non-compliance: A deviation from the CEC, AEC project approval or AEC approved process which is not likely to reduce the ability to meet acceptable Animal Welfare Act, CEC or AEC requirements is considered minor.
      1. Usually there will be nil or minimal impact on animal welfare, for example:
      2. Changes to timelines with no impact on project outcomes.
      3. Minor deviation to a manipulation with no impact on welfare, such as equipment used.
   3. Major non-compliance: Significant deviation from the CEC, AEC project approval or AEC approved process where maintenance of Animal Welfare Act, CEC or AEC requirements is considered a major non-compliance. This may (or may not) include a direct and adverse impact on animal welfare. For example:
      1. Personnel carrying out manipulations who are not trained or competent, and are not under the supervision of a trained person.
      2. Personnel who are not named on the AUP carrying out manipulations, but still trained and competent.
      3. Change in applicant/ principal investigator.
      4. Change in facilities/location especially when the AEC has not monitored the site.
      5. Enrolling extra animals when these will be subject to invasive manipulations.
      6. Extra manipulations on animals without AWO oversight or AEC approval.
      7. Deviation from the approved procedures described in the AUP that consequently negatively impacts animal welfare.
      8. Failing to monitor animals as described in the AUP.
      9. Failing to report adverse events immediately.
      10. Repeated minor non-compliances.
   4. Critical non-compliance: Severe deviation, omission or breaching the Animal Welfare, CEC, AEC project approval or AEC approved process with a direct and adverse effect on the welfare of the animal. This may include a direct and adverse effect on animal welfare, for example:
      1. Beginning animal work prior to an AUP being approved.
      2. Not following approved analgesia protocols resulting in adverse animal welfare.
      3. Unapproved changes to a surgical procedure resulting in poor animal welfare.
   5. Critical and Repeated Major noncompliance will be managed as follows:
      1. The PI will be notified in writing by the AEC within 24 hours that their AUP may be suspended.
      2. The same investigative process will be initiated as outlined above.
      3. The PI will be advised by the AEC that any further non-compliance events will result in withdrawal of all their AUPs and their access to the facilities will be removed. The AWO, APCO and Head of Department (HOD), and the CEC Holder will be copied into all correspondence with respect to this notification.
      4. If the AUP is withdrawn, the HOD and CEC Holder will be notified.
      5. HR and MPI may be involved.
      6. Any reinstatement of an AUP will be considered by the AEC, following discussions with the HOD involved.

5. Suspension and reactivation

   1. Depending on the nature of the non-compliance event, suspension of an AUP means that the PI is either prohibited from conducting any further research work or any new research work under the suspended AUP. This will be made clear in written correspondence from the AEC to the PI, who must inform other signatories on the AUP.
   2. The management of animals under the AUP will need to be considered with due regard for animal welfare and occasionally may result in animals being culled.
   3. In all cases where an AUP is suspended, the AEC will clearly outline the steps that must be taken to have the AUP reinstated in writing. Requirements for reactivation of a suspended AUP will vary depending on the nature of the incident.
   4. In some cases, reactivation can occur once the AEC has received a letter from the PI indicating compliance with the AEC recommendations. In other cases, the AEC may require that the PI and/or members of the research team receive further training, either didactic or hands-on, to ensure competency prior to or in conjunction with the resumption of AUP activities.
   5. The AEC may also require follow-up visits and reports on the conduct of the reinstated AUP, by the Animal Welfare Officer (or designee), APCO, AEC Chair or a subcommittee.
   6. In rare occasions where reactivation is not granted (AUP is terminated), a PI may be permitted to transfer activities to another suitably qualified PI with an approved AEC AUP.

6. Notifications and appeals

   1. Copies, notifications and reports on the outcome of significant non-compliance events and any AUP suspension will be provided to the appropriate Dean, Pro-Vice-Chancellor (PVC), Deputy Vice-Chancellor (Research and Innovation) and the Health and Safety and Ethics Compliance Committee.
   2. The PI may appeal the decision of the AEC by addressing their concerns in a written request to the Deputy Vice-Chancellor Research and Innovation, in the first instance.

7. Non-compliance with legislation or regulations

   1. If an individual appears to have committed an offence against the Animal Welfare Act 1999, the University will conduct an investigation and disciplinary procedures will be implemented, as considered necessary. The Chair will report to the AEC, Deputy Vice Chancellor (Research and Innovation) and the Head of Department for further action if warranted, including the involvement of regulatory authorities. The AEC may also consider whether disciplinary measures are required. Such a process would follow the Allegations of Misconduct in Research Procedures.
   2. The Responsible Practice in Research - Code of Conduct outlines the standards of conduct expected of all staff and students undertaking and supervising research at the University of Otago
   3. Non-compliance with legislation or regulations (including non-compliance with the CEC) as determined by the AEC or another competent authority within the University of Otago, will be reported to MPI by the AEC or by the DVC (R&E) (on behalf of the Code Holder).

8. Animal Welfare Act Penalties

   1. There are significant penalties for people who commit offences against the Animal Welfare Act (1999). These can be referred to in the Animal Welfare Act (1999) Section 119 – Penalties.

Related policies, procedures and forms

• Animal Ethics Committee
• University of Otago Code of Ethical Conduct for the use of animals (PDF)
• NAEAC Good Practice Guide for the Use of Animals in Research, teaching and Testing (2019) (PDF)
• Animal Welfare Act 1999

Contact for further information

If you have any queries regarding the content of this Procedure or need further clarification, contact:

Sandra Willis
Animal Practices and Compliance Officer
Email sandra.willis@otago.ac.nz

or

Donna Hendry
Research Integrity Manager
Email donna.hendry@otago.ac.nz