• Section 1 - Purpose and Context
• Section 2 - Definitions
• Section 3 - Policy Statement
• Section 4 - Procedures
• Complaints, Breaches, Appeals and Non-Compliance
• Section 5 - Guidelines

Section 1 - Purpose and Context

(1) The University recognises that research involving animals is governed by ethical principles embedded in codes, legislation and University policy documents.

(2) These Procedures cover the current processes and mechanisms in place to ensure that the use of animals in teaching and/or research studies at or associated with the University is justified, and that there is strong evidence to ensure the wellbeing of animals.

(3) These procedures adhere to the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes, 2013 (updated 2021), and NSW State legislation, including the Animal Research Act 1985 (NSW) and Animal Research Regulation 2021 (NSW).

(4) These procedures apply to all staff and students at the University and affiliated Centres and Institutes involved in animal research and teaching in Australia and overseas.

(5) The University requires that any teaching and/or research that involves the care and use of animals and are performed by staff/students in the name of the University and/or using the University's resources, aligns with the University's mission and values.

(6) The principles of Replacement, Reduction and Refinement (the 3Rs) must be considered for all proposed stages of animal care and use, including whether it is possible to replace animals with other methods, whether the proposed numbers of animals can be reduced, and whether techniques can be refined to support and safeguard the wellbeing of the animals.

Section 2 - Definitions

(7) For the purpose of these procedures, definitions that apply can be found in the Responsible Conduct of Research Policy and Policy DDS Glossary, in addition to the following:

1. Amendment means requested changes to an approved research project that must be approved by the Animal Care and Ethics Committee (ACEC) that may include:
   1. addition/removal of staff or students to the research team
   2. change of animal species and/or numbers
   3. extension of study duration
   4. changes to protocol/procedures
   5. any other minor changes to the approved project
2. Animal means any non-human vertebrate animal, that includes a fish, amphibians, reptiles, birds and mammals (domestic animals, purpose-bred animals, livestock, wildlife) as well as cephalopods in accordance with the
   Australian Code of Practice for the Care and Use of Animals for Scientific Purposes, 2013 (updated 2021).
3. Animal Care and Ethics Committee (ACEC) means the University's Animal Ethics Review Committee constituted in accordance with the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes, 2013 (updated 2021).
4. Animal Research Authority (ARA) is an authority issued for each research project prior to commencement and following project approval by the ACEC.
5. Chief Investigator (CI) means the person who takes responsibility for the conduct of the animal research according to the protocol issued by the University ARA in the role of ‘person with ultimate responsibility’ as defined in the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes.
6. Distress means that an animal is in a negative mental state and has been unable to adapt to stressors to sustain a state of wellbeing. Distress may manifest as abnormal physiological or behavioural responses, a deterioration in physical and psychological health, or a failure to achieve successful biological function. Distress can be acute or chronic and may result in pathological conditions or death.
7. Ethics mean the framework in which actions can be considered as good or bad, right or wrong. Ethics is applied in the evaluation of what should or should not be done when animals are proposed for use, or are used, for research or teaching purposes.
8. Harm means the negative impact on the wellbeing of an animal (including pain and distress).
9. Investigator means any person who uses animals for research or teaching purposes and can include researchers, teachers, undergraduate and postgraduate students involved in research projects and people involved in product testing, environmental testing, production of biological products and wildlife surveys.
10. Pain means an unpleasant sensory and emotional experience associated with actual or potential tissue damage. It may elicit protective actions, result in learned avoidance and distress, and modify species-specific traits of behaviour, including social behaviour.
11. Scientific purpose means 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.
12. Teaching activity means any action or group of actions undertaken with the aim of achieving a scientific purpose, where the scientific purpose includes imparting or demonstrating knowledge or techniques to achieve an educational outcome in science, as specified in the relevant curriculum or competency requirements.
13. Unexpected adverse event means any unexpected event related to approved activities that may have a negative impact on the wellbeing of the animals used for research or teaching. This does not include cases where adverse animal welfare occurrences are explicitly part of the approved protocol (e.g., desired disease-relevant phenotypes or experimental outcomes).

Section 3 - Policy Statement

(8) This Policy should be read in conjunction with the Responsible Conduct of Research Policy.

Section 4 - Procedures

(9) Where staff/students intend to use animals for research or teaching purposes, an animal ethics application form must be submitted to the ACEC for review and approval.

(10) Applications for observational-only research that involves no direct animal interaction (e.g., no handling, trapping, spotlighting or environmental enrichment) are assessed by the Animal Ethics Office (by the Animal Welfare Officer and Animal Ethics Officer) internally, out-of-session, who will determine:

1. if the application qualifies as an observational study and provide feedback and approval,
2. or if the application requires full review by the ACEC.

(11) Work with animals can only commence after the required approvals and research authorities, and any scientific licences are in place.

(12) Research/teaching activities involving the use of animals is only approved when the use of these animals is justified by the potential benefits to:

1. the animal
2. human health
3. increasing knowledge gained in a particular area of research
4. meeting relevant learning outcomes from teaching activities
5. the environment and
6. where there is strong evidence that the wellbeing of the animals will be supported at all times.

(13) Researchers must avoid or minimise harm (including pain and distress) to the animals involved, and endeavour to apply high standards of scientific integrity.

(14) The ACEC reviews activities that involve the care and use of animals for research and teaching purposes at the University using the follow process:

1. The ACEC application:
   1. University staff or students intending to use animals for scientific purposes must complete the Animal Ethics Form found on the Research Services website.
   2. The applicant (Chief Investigator) must seek the approval of the animal facility manager (where a University animal facility will be used for the purposes of the proposed project) and the School Dean or Director, Research Institute, prior to submitting.
   3. The ACEC meet monthly from February to December, to review animal research ethics proposals.
   4. The ACEC determine whether further information is required regarding the welfare of the animals involved and determine if the application can be approved.
   5. Animal ethics approvals are granted for a maximum of three years, subject to approval of annual reports, in accordance with industry standards.
   6. Work with animals can only commence when the necessary permissions have been obtained including the letter of approval, ARA (It is an offence under Part V of the Animal Research Act 1985 (NSW) to conduct animal research without a valid Animal Research Authority), scientific permits and licences, and relevant animal ethics training requirements have been met (see Animal Ethics Training Requirements at Western Sydney University on the Animal Ethics webpage).
2. Ongoing reporting by the Chief Investigator who must:
   1. provide an annual progress report (available on the Research Services website) for an approved project, regardless of the duration of ACEC approval for the project
   2. ensure progress reports are submitted in a timely manner and that animal work will not continue until a new ARA is issued(i.e., the Chief Investigator must ensure the progress report is submitted to, and
      approved by the ACEC prior to the ARA expiry date). Note that in accordance with the Animal Research Act 1985 (NSW), an ARA can only be issued for a 12-month period and must be renewed annually during
      the life of any approved project that runs for more than 12 months. Renewal of the ARA is conditional
      upon submission of a satisfactory annual progress report to the ACEC
   3. promptly notify the Animal Welfare Officer or Animal Ethics Officer of any unexpected adverse events (within two working days)
   4. provide a final report (available on the Research Services website) within four weeks of completion or discontinuation of the project
   5. ensure amendments to the approved application are approved by the ACEC before the amendments are adopted
   6. report on the creation and maintenance of genetically modified animals
   7. provide any other reports as required by the ACEC
   8. display the ARA at the site where the animal work is conducted with the research team emergency details clearly visible.
3. Amendments must be submitted by the Chief Investigator using an amendment form application (available on the Research Services website) to make any of the following changes to an approved research project:
   1. addition/removal of staff or students to the research team
   2. changes to protocol/procedures
   3. extension of study duration (maximum of three years total duration)
   4. change of animal species and/or numbers (up to 10% of the approved number)
   5. any other minor changes to the approved project.

(15) Animal ethics approval is also subject to satisfactory annual progress review, and the final report for review and approval at the completion of the study.

(16) The University requires all unexpected adverse events to be reported to the Animal Welfare Officer or Animal Ethics Officer within two working days of the occurrence (forms available on the Research Services website).

(17) Some research projects may require Human Ethics and/or Biosafety and Radiation Safety approval prior to
commencing work. In these instances, refer to the Responsible Conduct of Research Policy and/or the Biological and Gene Technology Work Safety Policy.

(18) Research projects involving Schedule 4D and Schedule 8 substances (i.e., drugs of dependence) require
licencing and authorization from NSW Health (refer also to the Health Safety and Wellbeing Procedures - Alcohol and Drug Control).

(19) Under Part 2 of the Biodiversity Conservation Act 2016 (NSW), a scientific licence is required for a research, education or conservation project that is likely to harm protected native animals or an animal that is a threatened species or part of an endangered population or a threatened ecological community – this does not include invertebrates (except threatened species), or fish as defined under the Fisheries Management Act 1994 (NSW).

(20) A scientific licence will be valid only when ethics approval has been granted. The Chief Investigator can apply for state and territory permits from the appropriate governing bodies (e.g., NSW Department of Planning and Environment).

(21) For studies involving Bird and Bat Banding (refer to Department of Climate Change, Energy, and Environment and Water), project approval and relevant permits from the Australian Bird and Bat Banding Scheme (ABBBS) are required. Different classes of Bird and Bat banding permits exist depending on the level of authority required by the applicant (i.e., researcher or student). Application for a permit can commence independently of the ethics application process and is required with an approved ethics application prior to conducting any work that involves banding of birds or bats.

Complaints, Breaches, Appeals and Non-Compliance

(22) The complaints procedure is outlined on the Research Ethics and Integrity webpage. Members of the public, students and staff may contact the ACEC through the Animal Ethics Office if they have any concerns, appeals or complaints regarding the use of animals.

(23) Where an incidence of non-compliance or breach of the Code/legislation is suspected, a report must be lodged by following the procedure outlined in the Researcher non-compliance document available on the Research Ethics and Integrity webpage.

(24) Researchers can appeal the decision regarding a breach of the ACEC in writing by contacting the email address on the Animal Ethics Office webpage.

Section 5 - Guidelines

(25) External Guidance/Legislation:

1. Australian Code of Practice for the Care and Use of Animals for Scientific Purposes, 2013 (updated 2021)
2. Animal Research Act 1985 (NSW)
3. Animal Research Regulation 2021
4. Australian Code for the Responsible Conduct of Research, 2018
5. Biodiversity Conservation Act 2016 (NSW)
6. Fisheries Management Act 1994 (NSW)
7. Prevention of Cruelty to Animals Act 1979 (NSW).

(26) Resources:

1. Western Sydney University Animal Ethics webpage
2. Western Sydney University Animal Ethics Forms webpage
3. NSW Government Animal Ethics Infolink (NSW Department of Primary Industries and Animal Research Review Panel).

(27) For information on Research Integrity and Ethics, see the Research Services website.

(28) For information on non-compliance, see Research Services - Researcher Non-compliance webpage

(29) For information on the Complaints procedure, refer to the Research Services - Complaints procedure webpage.

(30) For information on Bird and Bat Banding, refer to the Department of Climate Change, Energy, and Environment and Water.