• Section 1 - Preamble
• Section 2 - Purpose
• Section 3 - Scope
• Section 4 - Procedure
• Overview of complaints, grievances and non-compliance
• Non-compliance and complaints concerning the care and use of animals in teaching or research
• Reporting requirements
• Conscientious objections in the case of teaching activities
• Complaints concerning the process for independent external review
• Complaints concerning the animal ethics committee process or decisions
• Grievances between the Animal Ethics Committee and a Member of the Animal Ethics Committee
• Grievances between the Animal Ethics Committee and the Institution
• External avenue for appeal
• Section 5 - Non-Compliance

Section 1 - Preamble

(1) Charles Darwin University (‘the University,’ ‘CDU’) Animal Ethics Committee (AEC) is responsible for ensuring, on behalf of the University or any other organisation for which it acts, that all activities relating to the care and use of animals by the the University or any other organisation for which it acts are conducted in compliance with the Australian Code for the Care and Use of Animals for Scientific Purposes, 8th Edition 2013 (hereafter the Code), the Northern Territory (NT) Animal Protection Act 2018 and regulations, and the corresponding legislation in each State that the University is registered in.

(2) The Principal Investigator and all staff working on approved projects must carry out animal work with a high level of integrity, respectfully, and ethically; and must work in compliance with legislation, the Code, established guidelines and procedures, as well as in accordance with the AEC approval conditions.

(3) All participants must accept responsibility for their roles, actions and work on their project; however the Principal Investigator accepts overall accountability for project participants, the conduct of the project and the project’s outcomes.

(4) The welfare of animals must at all times remain a priority.

Section 2 - Purpose

(5) These procedures provide clear guidelines on the handling of complaints, grievances and non-compliance regarding the use of animals for scientific purposes. 

(6) These procedures ensure fair, effective, confidential processes that accord with procedural fairness and the principles of natural justice to all parties, whilst giving priority consideration at all times to the wellbeing of the animals. 

(7) This is a compliance requirement under the Code.

(8) Complaints will be treated confidentially, unless:

1. the University has an obligation to disclose details of the complaint by law
2. disclosure of details is required in the investigation to accord with procedural fairness and natural justice. Any request for anonymity will be discussed and explored as to whether the request is feasible.

Section 3 - Scope

(9) These procedures apply to all the University students and staff using animals for scientific purposes.

(10) These procedures also apply to any persons/organisations that use the services of the AEC. 

(11) These procedures do not apply to animal welfare complaints for animals not used for scientific purposes.

(12) Where research misconduct, as described in the Australian Code for the Responsible Conduct of Research, 2018, is a possibility, the matter will be referred to the Deputy Vice-Chancellor Research and Innovation (or relevant organisational head for external AEC users) and handled in accordance with the Responsible Conduct of Research Policy and Responsible Conduct of Research Procedure. 

Section 4 - Procedure

Overview of complaints, grievances and non-compliance

(13) This document outlines procedures for the following scenarios:

1. Non-compliance.
2. Complaints:
   1. concerning the care and use of animals in teaching or research
   2. conscientious objections in the case of teaching activities
   3. concerning the process for independent external review.
3. Grievances concerning AEC processes or decisions including:
   1. disagreements between the AEC and investigators 
   2. disagreemeents between AEC members
   3. disagreements between the AEC and the institution.

(14) Complaints regarding non-compliance, concerning the care and use of animals in teaching or research, or grievances with AEC processes or decisions should be made initially to the Animal Welfare Officer via phone or email. If the matter cannot be resolved in an informal manner, a written complaint should be submitted via email to the Research Integrity and Ethics team at ethics@cdu.edu.au. 

(15) In line with the Complaints Policy - Students and the Complaints Procedure - Staff, a three (3) step approach will usually be adopted in resolving complaints:

1. Step 1: Local Resolution
2. Step 2: Formal Complaint
3. Step 3: Appeal.

Non-compliance and complaints concerning the care and use of animals in teaching or research

(16) A non-compliance occurs when a person has not acted in accordance with: 

1. the Code,
2. the NT Animal Protection Act 2018 and Regulations, or other relevant state/territory welfare legislation, including conducting work with the relevant permits, or
3. the conditions of AEC approval. 

(17) Examples of non-compliance include:

1. unauthorised animal use (use of an animal species not approved; overuse of animals; conduct of a procedure that is not approved)
2. variation made to approved project details without AEC approval
3. failure to submit an annual report by the anniversary of the project approval date
4. unauthorised investigator performing animal procedure
5. failure to report unexpected advserse events
6. use of animal for scientific purposes without seeking AEC approval
7. use of animals continues after approval has been withdrawn or suspended.

(18) A non-compliance may be detected via numerous means including routine oversight of animals, facilities, or documentation; via media reports, conversations or hearsay; or via complaints. Complaints should be submitted to the Animal Welfare Officer, and where possible should be in writing including supporting documentation.

(19) It is the position of the AEC that the majority of animal welfare and non-compliance issues are unintentional and often easily rectifiable. Therefore, initial investigations will take the form of an informal inquiry to gather information and determine further action.

(20) Where the non-compliance/complaint relates to an activity that may affect an animal’s welfare or present a breach to legislation, activities must cease immediately and ethics approval may be withdrawn or project approval suspended.

(21) The Animal Welfare Officer will review the non-compliance/complaint and reach a resolution; or refer it to the AEC Chairperson, the AEC (or its Executive Committee (AECEC)), or the Deputy Vice-Chancellor Research and Innovation (or delegate) as appropriate. 

1. Review of a non-compliance/complaint may include, but is not limited to: review of documentation; discussions with project personnel; facility inspections; or animal health inspections (either by the Animal Welfare Officer, a registered veterinarian, or a nominated suitably qualified person). 
2. At any stage of the investigation process, the Chair and Animal Welfare Officer may decide to take immediate action in order to ensure animal welfare or prevent a recurrence of the non-compliance.
   1. A response may include ordering emergency treatment, relocation of animals, or the emergency euthanasia of animals if deemed essential for animal welfare.
   2. The actions taken may precede a response to the complainant, the alleged person/s involved, or the VC/licence holder/organisational head if deemed urgent. 
   3. Communication of required actions will be dispersed to all relevant parties as soon as practicable.
3. All non-compliances detected/complaints received and reviewed by the Animal Welfare Officer and the Chair will be reviewed by the AEC at the next quorate meeting. 

(22) Action resulting from investigation into a non-compliance/complaint may include, but are not limited to:

1. the project may continue with no changes
2. the AEC may decide for issues of a minor nature (such as administrative oversights), that a warning be issued only
3. the AEC may decide that modifications to a project or activity are required
4. the AEC may request further supportive material/documentation to be provided, or for animal health inspections and/or facility inspections to be conducted 
5. the approval for a project or activity may be suspended or withdrawn
6. the AEC may recommend disciplinary action.

(23) All non-compliances/complaints must be documented and reported. 

1. The Animal Welfare Officer should document records of non-compliance via a Non-Compliance Report. The Animal Welfare Officer must enter the details into the Non-Compliance Register maintained by the Ethics Office, Office of Research and Innovation, on behalf of the AEC. A non-compliance report will be submitted for AEC review to the next quorate AEC meeting (or the AECEC if required).
2. The Animal Welfare Officer should document records of complaints or welfare concerns via a Welfare/Complaint Report. The Animal Welfare Officer must enter the details into the Complaints and Animal Welfare Register maintained by the Ethics Office, Office of Research and Innovation, on behalf of the AEC. A welfare/complaint report will be submitted for AEC review to the next quorate AEC meeting (or the AECEC if required).

Reporting requirements

(24) The details of any serious non-compliance/complaint will be provided to the Vice-Chancellor and appropriate departmental management personnel (or relevant organisational head for external AEC users). This will include any incident that may have animal welfare implications, that may breach legislation, or that may have media implications/public interest. 

(25) For any events that may have an impact on animal welfare, a copy of the reports will be submitted to the NT Animal Welfare Authority (or relevant state governing body).

(26) Any suspected breaches of legislation will be reported to the NT Animal Welfare Authority in compliance with section 34B of the Animal Protection Act 2018.

(27) For projects involving collaboration with another institution, details are to be provided to the other institution’s animal ethics committee (or reporting should follow the relevant formal agreement in accordance with clause 2.6.4-2.6.7 of the Code).

(28) Non-compliance and complaint reports will be included in the AEC Annual Report. 

(29) The outcome of an investigation into a non-compliance/complaint should be relayed to:

1. the person making the allegation;
2. the investigator/s involved; and
3. the investigator’s supervisor/head of department. For investigators from external organisations using the AEC, the person responsible for the licence and the Director/Executive Officer of the organisation should be informed of the outcome.

(30) Where a resolution cannot be reached from the above procedures, the matter will be referred to the Deputy Vice-Chancellor Research and Innovation if required for formal resolution.

(31) Where a person is not satisfied with the outcome of a non-compliance/complaint, and resolution has not been achieved through CDU procedures, the person may refer the matter to an external body for appeal as outlined at clauses 49-50.

(32) Where a non-compliance/complaint occurs involving an external user of the AEC, the AEC may withdraw its services:

1. If the non-compliance or animal welfare issue is of a serious nature.
2. In cases of repeated episodes of non-compliance or animal welfare events.
3. Where the AEC is not satisfied that it can provide sufficient oversight of the project/s to ensure compliance and animal welfare.
4. In line with the requirements of the External User Deed. This may include immediate termination if a material provision of the Act or the Code is breached; or if a breach has occurred and has not been remedied within 30 days after receiving written notice to do so.

Conscientious objections in the case of teaching activities

(33) The University will develop a Conscientious Objection Procedure. Conscientious objections to the use of animals in teaching should follow the Conscientious Objection Procedure.

Complaints concerning the process for independent external review

(34) The University must conduct an independent external review as required by the Code.

(35) During the prelimary planning of the external review:

1. The external review panel must develop a process for the manner in which the review is to be conducted, in consultation with the University. This process should accord with the principles of natural justice.
2. Any appeal against the process of the review is to be negotiated between the external review panel and the Chair of the AEC, the Animal Welfare Officer and the Director Research. If negotiations are not successful, an alternative external review panel should be employed. 

(36) A person having a complaint regarding an independent external review should direct their concern to the AEC Chair in the first instance.

1. Complaints may be in relation to the process of the review, or any finding or decision of the review panel.
2. The AEC Chair should investigate the concern, and if the concern is deemed warranted, this should be submitted to a scheduled AEC meeting for review.
3. If the AEC supports the Chair’s findings that the concern is warranted, the concern is to be forwarded to the Deputy Vice-Chancellor Research and Innovation. 
4. If further resolution is required, the Deputy Vice-Chancellor Research and Innovation should forward the concern to the external review panel Chair.

Complaints concerning the animal ethics committee process or decisions

(37) In all cases, attempts should be made to resolve the issues through discussion or mediation.

(38) Grievances or complaints against the AEC should be made initially to the Animal Welfare Officer via phone or email. The Animal Welfare Officer will confer with the Chair of the AEC to try to resolve the grievance in an informal manner. If the nature of the grievance is regarding approval of a project or report, the investigator/complainant may be invited or can request to attend the next AEC meeting to answer any questions and discuss concerns. 

(39) If the grievance cannot be resolved, a written complaint should be submitted via email to the Research Integrity and Ethics team at ethics@cdu.edu.au. This complaint will be presented to the AEC at the next scheduled meeting, or if urgent, may be referred to the AECEC.

(40) Should a grievance not be resolved in the above manner, the complainant can lodge a written complaint to the Deputy Vice-Chancellor Research and Innovation (or delegate).

(41) The Deputy Vice-Chancellor Research and Innovation will look at the processes involved in the decision making, whether they were compliant with the Code, and that they are consistent with policies and procedures. The Deputy Vice-Chancellor Research and Innovation may also examine the practice in other AECs, and in some cases precedents. The complainant should outline the grounds of their complaint in relation to these points.

(42) The Deputy Vice-Chancellor Research and Innovation will provide written advice to both the Committee and the aggrieved person regarding the review of the matter. The Deputy Vice-Chancellor Research and Innovation may require the Committee to reconsider its decision or procedures in the light of the advice, or may endorse the decision or procedures of the Committee.

1. In the event that the Committee is required to reconsider its decision or procedures, the Committee must consider any advice given to it by the Deputy Vice-Chancellor Research and Innovation.
2. Any advice by the Deputy Vice-Chancellor Research and Innovation on the matter referred will be deemed to be the final advice of the Deputy Vice-Chancellor Research and Innovation on the matter.
3. The ultimate decision regarding the ethical acceptability of an activity lies with the AEC and must not be overridden (Clause 5.6, the Code).

(43) Should the applicant remain dissatisfied with the decision of the AEC, they may appeal to an external agency as per clauses 49-50.

Grievances between the Animal Ethics Committee and a Member of the Animal Ethics Committee

(44) Grievances may occur between the AEC and a member of the AEC over AEC processes or an action or decision made by the AEC. 

1. AEC decisions should be made by consensus as per clause 2.3.11 of the Code. 
2. Objections raised by an AEC member over a decision made or action taken during a meeting should be minuted to serve as a record of their views.

(45) If the member is not satisfied with the response of the AEC, they may lodge a formal complaint and request that the matter be reviewed by the Chair, and if appropriate, re-reviewed by the AEC. 

(46) If the member remains unsatisfied with the response, the complaint should be forwarded to the Deputy Vice-Chancellor Research and Innovation, and steps followed at clauses 40-43 above. 

Grievances between the Animal Ethics Committee and the Institution

(47) Grievances between the Institution and the AEC should be handled confidentially and all attempts should be made to resolve the issue locally through mediation and discussion.

(48) If the matter cannot be resolved, the matter should be referred to an appropriate external organisation as outlined below.

External avenue for appeal

(49) The outcome of an appeal is final and there are no further avenues of recourse within the University

(50) Where a person is dissatisfied with the outcome of an appeal, they may refer the matter to an appropriate external organisation, usually (but not limited to) the NT Animal Welfare Authority or the Ombudsman NT.

1. Persons may choose to take their appeal to other regulatory or statutory authorities, guided by their stated scope of power or jurisdiction.

Section 5 - Non-Compliance

(51) Non-compliance with Governance Documents is considered a breach of the Code of Conduct – Staff or the Code of Conduct – Students, as applicable, and is treated seriously by the University. Reports of concerns about non-compliance will be managed in accordance with the applicable disciplinary procedures outlined in the Charles Darwin University and Union Enterprise Agreement 2022 and the Code of Conduct – Students.

(52) Complaints may be raised in accordance with the Code of Conduct – Staff and Code of Conduct - Students.

(53) All staff members have an individual responsibility to raise any suspicion, allegation or report of fraud or corruption in accordance with the Fraud and Corruption Control Policy and Whistleblower Reporting (Improper Conduct) Procedure.