• Section 1 - Purpose
• Background
• Scope
• Section 2 - Policy
• Accreditation
• Animal Ethics Committee
• Training of Animal Research Personnel
• Research planning and proposals
• Conflict of interest
• Data management
• Research outputs
• External or collaborative research involving Macquarie University staff or students
• Monitoring of approved research
• Conclusion of animal use and Rehoming
• Review and Reporting
• Ethics review services for third parties
• Complaints and Non-Compliance
• Section 3 - Procedures
• Section 4 - Guidelines
• Section 5 - Definitions

Section 1 - Purpose

(1) The purpose of this Policy is to outline how Macquarie University fulfils its responsibilities relating to the ethical and humane use of animals for scientific purposes. The implementation of this Policy and its related procedures and guidelines will facilitate compliance with relevant legislation, promoting high quality research and teaching while minimising risk to the University.

Background

(2) Macquarie University (the University) is committed to remaining at the forefront of research and teaching within an ethical and accountable model of animal use, including actively supporting development, validation and adoption of replacement methods and emerging non-animal technology.

(3) The University promotes a culture of care that recognises animal sentience, staff wellbeing, ethical reflection and a continuous improvement beyond minimum compliance requirements.

(4) The University will maintain a program of Openness on animal research in accordance with its commitment to transparency in the use of animals for research, as a signatory of the ANZCCART Openness Agreement on Animal Research and Teaching in Australia.

(5) The use of animals for scientific purposes at the University is governed by the NSW Animal Research Act 1985 and Animal Research Regulation 2021, the Animal Research Amendment (Right to Release) Act 2022 and Animal Research Amendment Bill 2024, incorporating the Australian Code for the Care and Use of Animals for Scientific Purposes 2013 (The Code). These documents detail the responsibilities of all Animal Research Personnel, animal research institutions and animal ethics committees with respect to animal research and teaching.

(6) The use of animals for scientific purposes at the University is informed by the NHMRC Australian Code for the Responsible Conduct of Research, 2018, the CIOMS-ICLAS International Guiding Principles for Biomedical Research Involving Animals 2012, the NHMRC Best Practice Methodology in the use of animals for scientific purposes 2017, the NHMRC Statement on Sex, Gender, Variations of Sex Characteristics and Sexual Orientation in Health and Medical Research 2024 and the NHMRC Good Institutional Practice Guide 2025.

(7) All research conducted under the auspices of the University must comply with the Macquarie University Code for the Responsible Conduct of Research.

(8) The University is committed to ensuring there is justification for animal use in research and teaching. It does this by promulgating the three general principles of research animal use - the 3Rs:

1. Replacement – utilising techniques that replace the use of animals where possible;
2. Reduction - using no more than the minimum number of animals necessary in each project; and
3. Refinement – avoiding or minimising pain and distress, improving well-being.

Scope

(9) This Policy covers the breeding, holding and use of animals for the purpose of research or teaching, and applies to all staff, students, visiting academics, volunteers and other personnel involved in all aspects of animal research or teaching under the affiliation of, or in collaboration with, the University.

Section 2 - Policy

Accreditation

(10) The University will:

1. ensure it has current accreditation as an Animal Research Establishment in NSW, and other jurisdictions where appropriate; and
2. only supply animals for research or teaching, either within the University or elsewhere, when it has a current NSW Animal Suppliers License and in accordance with the conditions of that licence.

Animal Ethics Committee

(11) The University will:

1. maintain an Animal Ethics Committee (AEC) as required by legislation, with an agreed Terms of Reference and procedures;
2. ensure, through the AEC, that all animal research and teaching at the University complies with the relevant legislation and national and international guidelines and codes;
3. provide the AEC with resources and the authority to fulfil its terms of reference and operate as set out in the relevant legislation and national and international guidelines and codes;
4. employ a registered Veterinarian to assist the AEC to monitor animal welfare and compliance with The Code;
5. respond effectively to recommendations from the AEC to ensure that all animal research within the University remains in accordance with the relevant legislation and national and international guidelines and codes; and
6. maintain formal governance and assurance reporting for its animal use, including regular oversight of welfare standards, incidents and compliance trends.

Training of Animal Research Personnel

(12) The University will:

1. ensure that appropriate training and competency assessment pathways are available to all personnel involved in the use or care of animals for research and teaching;
2. ensure that training promotes an appreciation of the ethical issues associated with the use of animals for scientific purposes; and
3. provide mechanisms for periodic reassessment and refresher training to support ongoing competency.

(13) Personnel involved in the use or care of animals for research and teaching must:

1. complete required training and competency assessments before undertaking animal-related procedures, or within any institutionally approved timeframe where training occurs concurrently with initial supervised involvement;
2. maintain current competency through periodic reassessment and refresher training as required by the AEC; and
3. promptly notify their supervisor and/or the AEC if they no longer hold the skills or competency required for an approved procedure.

Research planning and proposals

(14) Researchers requiring approval of their research via the University AEC review process must:

1. apply for AEC review; and
2. identify only one Chief Investigator (CI)/Principal Investigator (PI) for each project who takes overall responsibility for the research, who is:
   1. a continuing staff member of Macquarie University; or
   2. fixed term staff members only with approval from the AEC via animal.ethics@mq.edu.au.

(15) Researchers collaborating with third parties to conduct research must notify the University of the arrangements for animal research ethics review (per clauses 26-28).

(16) Where available and appropriate, researchers should use standardised planning guidelines - for example, the PREPARE guidelines (Planning Research and Experimental Procedures on Animals: Recommendations for Excellence) in accordance with the NHMRC Best Practice Methodology in the Use of Animals for Scientific Purposes (2017).

(17) Researchers are encouraged to pre-register hypotheses, methodology, and primary statistical analysis plans in public registries (e.g. OSF or Animal Study Registry) prior to starting. This prevents publication bias and clearly separates exploratory findings from confirmatory results.

Use of Artificial Intelligence

(18) Artificial Intelligence (AI) tools, including Generative AI may be used to support or enhance the preparation of ethics applications. Their use must strictly comply with the Responsible and Ethical Use of Artificial Intelligence Policy, national guidelines and sector standards.

(19) Researchers must maintain human oversight and are wholly responsible for the accuracy, integrity, and ethical acceptability of any application materials produced with the assistance of Generative AI.

(20) Substantial use of Generative AI (for content creation, analysis, idea generation, or synthesis) must be clearly disclosed in the ethics application, specifying the type of AI tool used and its role. Disclosure is not generally required for minor editorial support (e.g., grammar correction) but is mandatory when AI meaningfully affects the research design or the narrative.

Conflict of interest

(21) Researchers and committee members must declare and manage any actual, potential or perceived conflict of interest, including any financial or other interest or affiliation that relates to the research, per the Conflict of Interest Policy.

Data management

(22) Researchers must maintain comprehensive records of their research in accordance with their approved project and/or their data management plan, including records of animal care, use, and welfare monitoring as required under the Australian Code for the Care and Use of Animals for Scientific Purposes, and in compliance with the University's Research Data Management Policy.

Research outputs

(23) In research outputs associated with AEC approval, including any external AEC under a collaborative arrangement, researchers must include a statement identifying the institutional or licensing committee that reviewed the research. This statement must include the Animal Research Authority (ARA) approval number.

(24) Where available and appropriate researchers should use standardised reporting such as the ARRIVE guidelines 2.0 (Animal Research: Reporting of In Vivo Experiments) when reporting or publishing results - in accordance with the NHMRC Best Practice Methodology in the use of animals for scientific purposes 2017.

(25) Researchers should publish null, negative or inconclusive findings to prevent redundant animal use across the institution or elsewhere.

External or collaborative research involving Macquarie University staff or students

(26) Where a project is to be conducted at, or in collaboration with, an external research institution, a formal agreement should be entered into between the institutions, outlining their respective responsibilities. Such agreements must address quality assurance and reporting mechanisms, as well as renewal or termination arrangements, in accordance with the Research Third-Party Arrangements Policy and the Research Collaboration with Third Parties Procedure.

(27) Researchers must notify the University's AEC in advance of any collaborative animal research projects they are involved in, regardless of whether the research is conducted in Australia or overseas.

(28) Notifications must be submitted to the AEC via the Forms for Research Applications (FoRA) System at the earliest possible opportunity, either prior to project commencement, or prior to a researcher's involvement where this begins after the project has started. No scientific or teaching activity involving animals may commence until it has been approved, or approval delegated, by the relevant AEC.

(29) Animal research conducted overseas by, or on behalf of, Macquarie University researchers must comply with Australian legislation and The Code.

Monitoring of approved research

(30) The University and the AEC may employ a variety of approaches to monitor approved research and to verify compliance. This may include internal reviews of documentation, inspection of sites and/or interviews or meetings with animal researchers and animal care staff.

Conclusion of animal use and Rehoming

(31) Researchers and the AEC must consider appropriate opportunities to rehome animals at the conclusion of their use for Scientific Purposes. Researchers are required to seek AEC approval and follow species-specific requirements in accordance with The Code, legislation and scientific licensing.

Review and Reporting

(32) The University will:

1. require researchers to submit applications for research and teaching protocols, progress, final and other reports as required by The Code and applicable legislation, to the AEC;
2. ensure the AEC reviews all new and ongoing activities, to determine whether the proposed or continued use of animals is justified by assessing the scientific/educational value of the project against the potential impacts on the welfare of the animals involved;
3. ensure the AEC meets its responsibilities with respect to reporting as outlined in The Code and detailed by ARRP;
4. ensure that independent external review of its compliance with The Code is carried out at least every four years;
5. ensure that an annual report of the University’s relevant activities is submitted to ANZCCART in accordance with the University's commitment as an institutional signatory to the ANZCCART Openness Agreement on Animal Research and Teaching in Australia; and
6. maintain central records on animal use, approvals, incidents, training, compliance and corrective actions.

Ethics review services for third parties

(33) Subject to the availability of resources and capacity, and at the discretion of the Director, Research Ethics and Integrity and the University’s AEC, the University may provide ethics review services to third parties, on a fee-for-service basis, in accordance with the University’s AEC fee schedule. Factors taken into consideration may include whether:

1. the proposed research aligns with University research priorities, policies, and values;
2. the University has an existing contractual agreement or formal arrangement with the third party; and
3. the third party demonstrates they do not have access to an appropriately constituted AEC within their own organisation.

Complaints and Non-Compliance

(34) The University will maintain transparent procedures for the prompt reporting and management of unexpected adverse events or complaints arising from the use of animals for scientific purposes, in accordance with the Animal Ethics Committee Terms of Reference and Complaints and Non-Compliance Procedures, licensing requirements, The Code and relevant legislation.

(35) Information or a complaint that raises a potential breach of the Macquarie University Code for the Responsible Conduct of Research may be referred for management in accordance with the Macquarie University Research Code Complaints, Breaches and Investigation Procedure.

(36) Researchers must:

1. Report any unexpected adverse event to the AEC promptly, in accordance with The Code and the AEC's reporting requirements;
2. Provide a preliminary notification to the AEC where full details of an adverse event are not yet available, followed by a detailed report as soon as practicable; and
3. Cooperate with any AEC review, investigation, or corrective action arising from an adverse event or non-compliance.

Section 3 - Procedures

(37) Nil.

Section 4 - Guidelines

(38) Nil.

Section 5 - Definitions

(39) The following definitions apply for the purpose of this Policy:

1. Animal means as defined in The Code - “any live non-human vertebrate (that is, fish, amphibians, reptiles, birds and mammals encompassing domestic animals, purpose-bred animals, livestock, wildlife) and cephalopods.” The University includes embryos and foetuses that have progressed beyond half the gestation or incubation period and larvae that are capable of independent feeding, as well as immature forms of animals undergoing any research procedure which then go on to develop to the above stage or beyond.
2. Animal Ethics Committee (AEC) means the Committee established, as required by the NSW Animal Research Act 1985, to advise the Vice-Chancellor on animal ethics. The AEC reports through the Deputy Vice-Chancellor (Research) and is constituted in accordance with the Macquarie University AEC’s Terms of Reference and membership laid down in The Code.
3. Animal Research Personnel means anyone involved in the care or use of animals that are used for scientific purposes, including during their acquisition, transport, breeding, housing and husbandry.
4. Animal Research Review Panel (ARRP) means a statutory body created by the Animal Research Act 1985 to provide advice to the NSW minister on the use of animals in research and teaching.
5. National Health and Medical Research Council (NHMRC) means Australia's peak body for supporting health and medical research; for developing health advice for the Australian community, health professionals and governments; and for providing advice on ethical behaviour in health care and in the conduct of health and medical research, including research involving the use of animals.
6. Scientific Purposes means (as defined in The Code) – “all activities conducted with the aim of acquiring, developing or demonstrating knowledge or techniques in all areas of science, including teaching, field trials, environmental studies, research (including the creation and breeding of a new animal line where the impact on animal wellbeing is unknown or uncertain), diagnosis, product testing and the production of biological products”.
7. The Code means the Australian Code for the Care and Use of Animals for Scientific Purposes, 8^th edition 2013 (updated 2021, currently under review 2026).