Compliance Framework
Compliance Driver
Animal Research Act 1985 (NSW)
Classification
Level 3
Centrally managed, local area(s) requirement.
Associated Legislation
Associated Standards
None
Associated Codes
Associated Information
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Administrative Information
Administrative Body
NSW Department of Primary Industries
Administrative Name
Animal Welfare Unit
Administrative Address
Mailing Address
Locked Bag 21
Orange NSW
Australia, 2800
Physical Address
161 Kite Street
Orange NSW
Australia, 2800
Administrative Phone
02 6391 3725
02 6391 3149
Administrative Email
animal.welfare@dpi.nsw.gov.au
Administrative Website
https://www.dpi.nsw.gov.au/animals-and-livestock/animal-welfare
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General Introduction
VC Compliance Delegate
Chris Armstrong, Deputy Vice-Chancellor Research
Compliance Coordinator
Sarah Model, Animal Ethics Officer
Business Units Impacted
Overview
The objective of the Animal Research Act 1985 is to protect the welfare of animals used in connection with research by requiring persons or organisations carrying out animal research or supplying animals for research to be authorised under this Act and by regulating the carrying out of animal research and the supply of animals for research by those persons or organisations.
Authorisations under this Act may be granted only for recognised research purposes. Recognised research purposes include purposes involving the use of animals for research, teaching, testing and the production of biological products.Compliance Obligations
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1. Accreditation as an Animal Research Establishment
Description
UNE must hold current accreditation from NSW Department of Primary Industries (DPI) to operate as a research establishment and lawfully carry on the business of animal research. Accreditation requires demonstrating appropriate governance, facilities, animal care standards, veterinary support, staff competency, and compliance systems. UNE must comply with any conditions imposed on its accreditation and notify DPI of any material changes to its operations, facilities, or AEC.
Impacts
Operating without valid accreditation is an offence under section 46(1) of the Act. Maximum penalty: 160 penalty units for a corporation (the highest penalty under the Act). This is an executive liability offence under section 58: directors or persons involved in management can be held personally liable if they knew (or ought to have known) the offence would be committed and failed to take reasonable steps to prevent it. Breaching accreditation conditions may result in caution, reprimand, or regulatory action by DPI. DPI may suspend or cancel accreditation under section 16, issue prohibition orders under section 22, or impose additional conditions. This would result in seizure of animals, prohibition on conducting animal research, inability to obtain research funding requiring animal research, loss of research capacity, and significant reputational harm.
Responsible Manager
Chris Armstrong, Deputy Vice-Chancellor Research
Coordinating Officer
Sarah Model, Animal Ethics Officer
Coordinating Unit
Research Services
Oversight Committee/Group
Animal Ethics Committee
Business Units Impacted
Obligation Framework
Associated Legislation
Associated Standard
None
Associated Code
Associated Information
None
Management Tools
Rule
Code of Conduct for Research Rule
Emergency Management Plan
Firearms Rule
Records Management Rule
Work Health and Safety (WHS) Rule
Policy
Social Media Policy
Terms of Reference (Vice-Chancellor approved) - Animal Ethics Committee
WHS P007 Incident/Hazard Reporting and Investigation Protocol
Protocol
None
Procedure
None
Guideline
None
Other Websites
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2. Compliance with the Australian Code for the Care and Use of Animals for Scientific Purposes
Description
UNE must ensure all animal research is conducted in accordance with the Australian Code for the Care and Use of Animals for Scientific Purposes (8th edition, 2013) (the Code). This includes ensuring animals are used only when justified, replacement, reduction, and refinement (3Rs) principles are applied, animal welfare is protected, procedures minimize pain and distress, housing and care meet standards, and competent, trained personnel conduct procedures. The AEC must ensure compliance with the Code in all its decisions and monitoring activities.
Impacts
Non-compliance with the Code may constitute a breach of ARA conditions or accreditation conditions, attracting penalties under sections 24 and 26 (up to 250 penalty units for individuals or 500 penalty units for corporations). The AEC may suspend or cancel ARAs under section 8, and DPI may suspend or cancel UNE's accreditation under section 16. Serious non-compliance may result in prosecution, prohibition orders under section 22, seizure of animals, animal welfare concerns, loss of research funding, inability to publish research in reputable journals (as most journals require Code compliance), reputational damage, and loss of public trust in UNE's research practices. Directors and officers may face personal liability under section 58 for executive liability offences or as accessories under section 58A if they aided, abetted, or were knowingly concerned in the offence.
Responsible Manager
Chris Armstrong, Deputy Vice-Chancellor Research
Coordinating Officer
Sarah Model, Animal Ethics Officer
Coordinating Unit
Research Services
Oversight Committee/Group
Animal Ethics Committee
Business Units Impacted
Obligation Framework
Associated Legislation
Associated Standard
None
Associated Code
Associated Information
None
Management Tools
Rule
Code of Conduct for Research Rule
Emergency Management Plan
Firearms Rule
Records Management Rule
Work Health and Safety (WHS) Rule
Policy
Social Media Policy
Terms of Reference (Vice-Chancellor approved) - Animal Ethics Committee
WHS P007 Incident/Hazard Reporting and Investigation Protocol
Protocol
None
Procedure
None
Guideline
None
Other Websites
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3. Establishment and Maintenance of an Animal Ethics Committee (AEC)
Description
UNE must establish and maintain an Animal Ethics Committee (AEC) with membership, functions, and procedures compliant with the Act and Australian Code for the Care and Use of Animals for Scientific Purposes. The AEC must consider, approve, monitor, and review all animal research conducted at or by UNE, determine applications for ARAs, and ensure compliance with the Code and any conditions imposed on accreditation. Establishing and maintaining a duly constituted AEC is a prerequisite for gaining and holding accreditation as a research establishment.
Impacts
Failure to establish or maintain a compliant AEC may result in suspension or cancellation of UNE's accreditation as a research establishment under section 16 of the Act. Non-compliance with AEC requirements under sections 13 and 20(2)(a) may attract regulatory sanctions including prohibition on approving or conducting animal research, loss of research funding, and reputational damage. UNE would be unable to fulfill its obligations to monitor animal welfare and research compliance, and could face prosecution under section 46(1) for unlawfully carrying on the business of animal research without proper governance structures. Maximum penalty: 160 penalty units for a corporation. This is an executive liability offence under section 58 exposing directors and senior management to personal liability.
Responsible Manager
Chris Armstrong, Deputy Vice-Chancellor Research
Coordinating Officer
Sarah Model, Animal Ethics Officer
Coordinating Unit
Research Services
Oversight Committee/Group
Animal Ethics Committee
Business Units Impacted
Obligation Framework
Associated Legislation
Associated Standard
None
Associated Code
Associated Information
None
Management Tools
Rule
Code of Conduct for Research Rule
Emergency Management Plan
Firearms Rule
Records Management Rule
Work Health and Safety (WHS) Rule
Policy
Social Media Policy
Terms of Reference (Vice-Chancellor approved) - Animal Ethics Committee
WHS P007 Incident/Hazard Reporting and Investigation Protocol
Protocol
None
Procedure
None
Guideline
None
Other Websites
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4. Animal Research Authority (ARA) Requirement
Description
UNE must not conduct, or permit the conduct of, animal research unless an Animal Research Authority (ARA) has been granted by an Animal Ethics Committee (AEC) for that research. All animal research activities must be covered by a current, valid ARA that specifies the species, numbers, procedures, and purposes approved. UNE may only issue an ARA to an individual researcher upon the recommendation of its AEC.
Impacts
Conducting animal research without a valid ARA is an offence under section 24 of the Act. Maximum penalty: 250 penalty units for an individual or 500 penalty units for a corporation. This is an executive liability offence under section 58: a director or person involved in management can be held personally liable if they knew (or ought to have known) the offence would be committed and failed to take reasonable steps to prevent it. This may also result in suspension or cancellation of existing ARAs (section 8), suspension or cancellation of UNE's accreditation as a research establishment (section 16), prohibition orders (section 22), reputational damage, loss of research funding, and inability to conduct future animal research. Individual researchers may also face prosecution and penalties.
Responsible Manager
Chris Armstrong, Deputy Vice-Chancellor Research
Coordinating Officer
Sarah Model, Animal Ethics Officer
Coordinating Unit
Research Services
Oversight Committee/Group
Animal Ethics Committee
Business Units Impacted
Obligation Framework
Associated Legislation
Associated Standard
None
Associated Code
Associated Information
None
Management Tools
Rule
Code of Conduct for Research Rule
Emergency Management Plan
Firearms Rule
Records Management Rule
Work Health and Safety (WHS) Rule
Policy
Social Media Policy
Terms of Reference (Vice-Chancellor approved) - Animal Ethics Committee
WHS P007 Incident/Hazard Reporting and Investigation Protocol
Protocol
None
Procedure
None
Guideline
None
Other Websites
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5. Animal Care, Veterinary Support, and Rehoming Obligations
Description
UNE must ensure animals used in research receive appropriate veterinary care, health monitoring, and are housed and maintained according to standards in the Code. This includes providing suitable housing, environmental enrichment, nutrition, hygiene, monitoring for signs of pain or distress, implementing humane endpoints, and ensuring prompt veterinary treatment or humane euthanasia when required. A suitably qualified veterinarian must be available to provide advice and care. Specific obligations for cats and dogs: UNE must take reasonable steps to prepare cats and dogs kept for research for rehoming, including providing appropriate exercise, enrichment, socialization, and training (section 54B). UNE must take all reasonable steps to rehome any cat or dog used in research once the research concludes or after the animal has been kept for 3 years, whichever is sooner (unless an extension is approved by the Animal Research Review Panel) (section 54C). These rehoming obligations are conditions of UNE's accreditation under section 54G.
Impacts
Impacts:
Inadequate veterinary care or failure to maintain welfare standards may constitute animal cruelty under the Prevention of Cruelty to Animals Act 1979 as well as breaches of the Animal Research Act 1985. This may result in animal suffering, suspension or cancellation of ARAs under section 8, suspension or cancellation of accreditation under section 16, prosecution under sections 24 or 26 (maximum penalties: 250 penalty units for individuals or 500 penalty units for corporations), prohibition orders under section 22, reputational damage, loss of research funding, and ethical breaches. Failure to take all reasonable steps to rehome cats or dogs is a specific offence under section 54C(1) (maximum penalty: 30 penalty units), and constitutes a breach of accreditation conditions under section 54G, which may lead to caution, reprimand, suspension, or cancellation of accreditation. Serious welfare failures may attract significant public and media scrutiny, potential criminal charges under animal welfare legislation, and loss of social license to conduct animal research. Directors and officers may face personal liability as accessories under section 58A for rehoming offences if they aided, abetted, or were knowingly concerned in the failure to comply.
Responsible Manager
Chris Armstrong, Deputy Vice-Chancellor Research
Coordinating Officer
Sarah Model, Animal Ethics Officer
Coordinating Unit
Research Services
Oversight Committee/Group
Animal Ethics Committee
Business Units Impacted
Obligation Framework
Associated Legislation
Associated Standard
None
Associated Code
Associated Information
None
Management Tools
Rule
Code of Conduct for Research Rule
Emergency Management Plan
Firearms Rule
Records Management Rule
Work Health and Safety (WHS) Rule
Policy
Social Media Policy
Terms of Reference (Vice-Chancellor approved) - Animal Ethics Committee
WHS P007 Incident/Hazard Reporting and Investigation Protocol
Protocol
None
Procedure
None
Guideline
None
Other Websites
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6. Inspection, Monitoring, and Compliance with Directions
Description
UNE must permit authorized inspectors from NSW DPI to enter premises at any reasonable time, inspect facilities and animals, examine records and documents, and investigate compliance with the Act, Code, and accreditation conditions. UNE must not obstruct, hinder, or impede inspectors in the exercise of their functions, and must comply with lawful requirements from inspectors to produce animals, equipment, or documents. The AEC must conduct regular inspections of animal facilities and monitor compliance with ARAs. UNE must comply with any directions, improvement notices, or recommendations issued by inspectors or DPI, within specified timeframes.
Impacts
Obstructing, hindering, or impeding an inspector is an offence under section 53 of the Act (maximum penalty: 30 penalty units). Failing to comply with a requirement from an inspector to produce an animal, equipment, or document is an offence under section 50(2) (maximum penalty: 30 penalty units). Failure to comply with directions may result in further enforcement action including caution, reprimand, suspension or cancellation of accreditation under section 16, prohibition notices under section 22 preventing animal research, prosecution, seizure of animals, reputational damage, and loss of research capacity. Repeated or serious non-compliance may escalate to criminal proceedings and higher penalties. Directors and officers may face personal liability as accessories under section 58A if they aided, abetted, or were knowingly concerned in obstruction offences.
Responsible Manager
Chris Armstrong, Deputy Vice-Chancellor Research
Coordinating Officer
Sarah Model, Animal Ethics Officer
Coordinating Unit
Research Services
Oversight Committee/Group
Animal Ethics Committee
Business Units Impacted
Obligation Framework
Associated Legislation
Associated Standard
None
Associated Code
Associated Information
None
Management Tools
Rule
Code of Conduct for Research Rule
Emergency Management Plan
Firearms Rule
Records Management Rule
Work Health and Safety (WHS) Rule
Policy
Social Media Policy
Terms of Reference (Vice-Chancellor approved) - Animal Ethics Committee
WHS P007 Incident/Hazard Reporting and Investigation Protocol
Protocol
None
Procedure
None
Guideline
None
Other Websites
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7. Competency, Training, and Supervision of Personnel
Description
UNE must ensure that all personnel involved in animal research, care, or use possess appropriate qualifications, competencies, training, and experience for their roles as required by the Code. Researchers and animal care staff must be adequately trained in animal handling, procedures, anesthesia, analgesia, euthanasia, and recognition of pain and distress. Personnel must work under appropriate supervision until competency is demonstrated. The AEC must be satisfied that investigators and institutions have the necessary skills, experience, and resources before approving ARAs. UNE must maintain systems to assess and document competency, provide ongoing training, and ensure personnel only undertake procedures for which they are competent.
Impacts
Use of inadequately trained or supervised personnel may constitute a breach of ARA conditions or accreditation conditions, potentially attracting penalties under sections 24 and 26 (up to 250 penalty units for individuals or 500 penalty units for corporations). This may result in compromised animal welfare, non-compliance with the Code, increased risk of adverse events including animal injury or death, suspension or cancellation of ARAs under section 8, suspension or cancellation of accreditation under section 16, potential prosecution, prohibition orders under section 22, reputational damage, and ethical concerns. Poor animal welfare outcomes due to incompetent personnel may result in loss of public trust, research funding, mandatory reporting to the Animal Research Review Panel, and regulatory intervention. Directors and senior management may face personal liability under section 58 (executive liability) if they failed to ensure adequate training systems were in place despite knowing or ought to have known of the risk.
Responsible Manager
Chris Armstrong, Deputy Vice-Chancellor Research
Coordinating Officer
Sarah Model, Animal Ethics Officer
Coordinating Unit
Research Services
Oversight Committee/Group
Animal Ethics Committee
Business Units Impacted
Obligation Framework
Associated Legislation
Associated Standard
None
Associated Code
Associated Information
None
Management Tools
Rule
Code of Conduct for Research Rule
Emergency Management Plan
Firearms Rule
Records Management Rule
Work Health and Safety (WHS) Rule
Policy
Social Media Policy
Terms of Reference (Vice-Chancellor approved) - Animal Ethics Committee
WHS P007 Incident/Hazard Reporting and Investigation Protocol
Protocol
None
Procedure
None
Guideline
None
Other Websites
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8. Prohibition of Unauthorized or Non-Approved Research Activities
Description
UNE must ensure that no person conducts animal research outside the scope of an approved ARA, uses animal species or procedures not approved in an ARA, exceeds approved animal numbers, conducts research at non-accredited locations (unless specifically approved), or otherwise deviates from approved research protocols without prior AEC approval via amendment. Any proposed changes to approved research must be reviewed and approved by the AEC before implementation. UNE must not unlawfully supply animals for research purposes or keep animals with the intention of using them for animal research without being properly accredited.
Impacts
Conducting unauthorized or non-approved research is an offence under section 24 of the Act (maximum penalty: 250 penalty units for individuals or 500 penalty units for corporations). Keeping animals with the intention of using them for animal research without being an authorized person is an offence under section 47A(1) (maximum penalty: 30 penalty units, with potential seizure of animals). Unlawfully supplying animals for research is an offence under section 48(1) & (2) (maximum penalty: 160 penalty units for a corporation). These are executive liability offences under section 58: directors or persons involved in management can be held personally liable if they knew (or ought to have known) the offence would be committed and failed to take reasonable steps to prevent it. This may result in prosecution of individuals and the institution, immediate suspension or cancellation of the ARA under section 8, suspension or cancellation of UNE's accreditation under section 16, prohibition orders under section 22, seizure of animals, loss of research funding, mandatory reporting to funding bodies (including NHMRC, ARC), reputational damage, loss of public trust, and potential exclusion from future animal research. The AEC may also report serious breaches to DPI and the Animal Research Review Panel under section 11.
Responsible Manager
Chris Armstrong, Deputy Vice-Chancellor Research
Coordinating Officer
Sarah Model, Animal Ethics Officer
Coordinating Unit
Research Services
Oversight Committee/Group
Animal Ethics Committee
Business Units Impacted
Obligation Framework
Associated Legislation
Associated Standard
None
Associated Code
Associated Information
None
Management Tools
Rule
Code of Conduct for Research Rule
Emergency Management Plan
Firearms Rule
Records Management Rule
Work Health and Safety (WHS) Rule
Policy
Social Media Policy
Terms of Reference (Vice-Chancellor approved) - Animal Ethics Committee
WHS P007 Incident/Hazard Reporting and Investigation Protocol
Protocol
None
Procedure
None
Guideline
None
Other Websites
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9. Notification, Reporting, and Record-Keeping Obligations
Description
UNE must maintain accurate and comprehensive records of all animal research activities for prescribed periods, including: (a) ARAs granted, amendments, and AEC decisions; (b) animal use statistics (species, numbers, procedures, severity); (c) adverse events and animal welfare concerns; (d) applications from independent researchers (section 25C(3)); (e) all lethality tests approved by the AEC or a subcommittee (section 56A(1)); and (f) detailed records for each cat or dog kept for research, including steps taken to prepare for and achieve rehoming, communications with rehoming organizations, and final placement details (section 54F). UNE must submit copies of records to the Secretary (for independent researcher applications) and the Animal Research Review Panel (for lethality tests) within one month after the end of the reporting period. UNE must also submit annual reports to NSW DPI on animal use statistics and AEC activities. Records must be made available for inspection by authorized inspectors. The AEC must notify DPI and the Animal Research Review Panel of significant animal welfare concerns, non-compliances, or adverse events as required.
Impacts
Failure to keep required records is an offence under section 25C(3) (independent researcher applications), section 56A(1) (lethality tests), and section 54F (cat and dog rehoming records). Maximum penalties: 30 penalty units for corporations (sections 25C and 56A) or 20 penalty units for corporations (section 54F). Failure to provide copies of records within required timeframes is an offence under section 25C(4) and section 56A(2) (maximum penalty: 30 penalty units for a corporation). Failure to maintain adequate records, provide information to inspectors, or submit required reports may also constitute an offence under section 28 (obstruction or failure to comply with inspector requirements, maximum penalty: 100 penalty units for individuals or 200 penalty units for corporations). This may result in caution, reprimand, suspension or cancellation of accreditation under section 16, inability to demonstrate compliance during inspections or audits, loss of research funding, reputational damage, and inability to fulfill accountability and transparency obligations. Knowingly providing false or misleading information is an offence under section 55 (maximum penalty: 30 penalty units). Directors and officers may face personal liability as accessories under section 58A if they aided, abetted, or were knowingly concerned in record-keeping offences. Record-keeping failures for cat and dog rehoming also constitute a breach of accreditation conditions under section 54G.
Responsible Manager
Chris Armstrong, Deputy Vice-Chancellor Research
Coordinating Officer
Sarah Model, Animal Ethics Officer
Coordinating Unit
Research Services
Oversight Committee/Group
Animal Ethics Committee
Business Units Impacted
Obligation Framework
Associated Legislation
Associated Standard
None
Associated Code
Associated Information
None
Management Tools
Rule
Code of Conduct for Research Rule
Emergency Management Plan
Firearms Rule
Records Management Rule
Work Health and Safety (WHS) Rule
Policy
Social Media Policy
Terms of Reference (Vice-Chancellor approved) - Animal Ethics Committee
WHS P007 Incident/Hazard Reporting and Investigation Protocol
Protocol
None
Procedure
None
Guideline
None
Other Websites
Compliance Overview