• Section 1 - Background and Purpose
• Section 2 - Scope
• Section 3 - Policy Statement
• Section 4 - Procedures
• Part A - Relevant Legislation and Guidelines
• Part C - AEC Terms of Reference
• Part D - Operating Guidelines
• Part E - Researcher Responsibilities
• Part F - Field Work and Observational Studies
• Part G - Multi-Centre Research
• Part I - Unexpected Adverse Events and Complaints
• Section 5 - Definitions

Section 1 - Background and Purpose

(1) The use of live non-human vertebrates and higher-order invertebrates in research and teaching is governed by State legislation and the NHMRC Australian Code for the Care and Use of Animals for Scientific Purposes, 8th Edition, 2013 (the Code). The Department of Jobs, Precincts and Regions (DJPR) has oversight of animal ethics committees in the State and inspects animal facilities and the operation of animal ethics committees on a regular basis.

(2) La Trobe University has set in place policies and procedures to ensure that animal usage in La Trobe university and studies carried out by La Trobe staff conform to the Code, legislative requirements and current best practice. The La Trobe University Animal Ethics Committee (AEC) has responsibility for approving all teaching and research involving animals at any campus, and for approving fieldwork and wildlife studies undertaken off-campus.

Section 2 - Scope

(3) Refer to the Research Integrity Policy.

Section 3 - Policy Statement

(4) Refer to the Research Integrity Policy.

Section 4 - Procedures

Part A - Relevant Legislation and Guidelines

(5) The use of live non-human vertebrates and higher-order invertebrates for research and teaching is governed by the Australian Code for the Care and Use of Animals for Scientific Purposes (8th Edition, 2013), and by the Victoria Prevention of Cruelty to Animals Act 1986 and regulations. The latter is enforced by the relevant government authority. For projects undertaken in the field, interstate, or at other institutions, La Trobe University investigators need to comply with the appropriate permit requirements and seek approval, when necessary, from other animal
ethics committees.

(6) The University is the licence holder for the Scientific Procedures Premises Licence (SPPL) issued for La Trobe University by the relevant government authority in Victoria.

Part B - Role of the Animal Ethics Committee

(7) All use of live non-human vertebrates and higher-order invertebrates for research and teaching is reviewed by the AEC. No animals are used in teaching or research without written Animal Ethics Committee (AEC)approval. The AEC:

1. applies the principles outlined in the Code in determining whether the use of animals can ethically be approved;
2. ensures that provision is made for the welfare of all animals used in teaching and research;
3. oversees compliance with the principles of Replacement, Reduction and Refinement described in the Code; and
4. monitors and inspects all animal facilities and comments on plans for changes and developments to animal holding areas.

(8) Policy support and secretariat to the AEC is provided by the Research Office by the Ethics, Integrity and Biosafety.

Part C - AEC Terms of Reference

(9) The AEC terms of reference comply with those specified in the Code. As a subcommittee of the Research and Graduate Studies Committee (RGSC), the AEC reports on a regular basis to the RGSC. The Terms of Reference are publicly available on the Ethics, Integrity and Biosafety website.

Part D - Operating Guidelines

(10) AEC operating guidelines, regarding applications, training, record keeping, animal displays and field-based teaching and research are displayed on the AEC web site.

Part E - Researcher Responsibilities

(11) All activities, including projects, that involve the care and use of animals for scientific purposes must:

1. be subject to ethical review, approval and monitoring by an AEC
2. commence only after approval has been granted by an AEC
3. be conducted in accordance with the AEC approval
4. cease if approval from the AEC is suspended or withdrawn

(12) Researchers must fulfill all responsibilities listed under Section 2.4 of the Australian Code for the Care and Use of Animals for Scientific Purposes (8th Edition, 2013), and by the Victoria Prevention of Cruelty to Animals Act 1986 and regulations.

Part F - Field Work and Observational Studies

(13) Fieldwork will often require, in addition to AEC approval, permission from other state or territory government authorities. Copies of permits will be lodged with the AEC prior to the commencement of field work. The AEC or its authorised delegate may inspect field work from time to time.

(14) No observational studies involving animals will take place without approval from the AEC.

Part G - Multi-Centre Research

(15) Where applications involve more than one institution, a letter of understanding will be drawn up between the La Trobe AEC and any other AEC's involved, clearly identifying each party’s responsibility in the planned work, and detailing arrangements to protect the welfare of all animals involved. When La Trobe University staff conduct work with animals held solely by another institution, and when that work is subject to approval by that Institution’s Animal Ethics Committee, the researchers must notify the La Trobe University AEC.

Part H - Reporting Requirements to the AEC

(16) Annual Progress Reports: Principal Investigators of AEC approved projects must submit an Annual Progress Report to the AEC as a condition of project approval. Principal Investigators who fail to submit a Progress Report by the due date may have their project suspended until a report has been received and reviewed by the AEC.

(17) Final Reports: All Principal Investigators of AEC approved projects must submit a Final Report within three months of the expiry date or conclusion of their project as a condition of project approval. Final Reports are reviewed by the AEC and kept by the University as an official record from the Principal Investigator regarding the outcome of all animals used or produced during the approval period.

(18) Annual Reporting to Government Authorities on Animal Use: Principal Investigators of AEC approved projects must submit an annual Animal Usage Report to the relevant state or territory government authority prior to the required date as a condition of project approval. It is the responsibility of the licence holder to complete and submit the return, however this task may be delegated to the Senior Animal Ethics Officer.

Part I - Unexpected Adverse Events and Complaints

(19) For processes outlining Unexpected Adverse Events and Complaints please refer to the AEC website.

(20) Allegations of research misconduct, including evidence of animal research conducted without ethics approval, must be dealt with according to the La Trobe University Research Misconduct Procedure.

Part J - Monitoring of AEC Approved Projects

(21) According to the Code, monitoring means measures undertaken to assess, or to ensure the assessment of, the wellbeing of animals in accordance with the Code. Monitoring occurs at different levels (including those of investigators, animal carers and animal ethics committees). All activities, including projects, that involve the care and use of animals for scientific purposes must be subject to ethical review, approval and monitoring by an AEC.

(22) The purpose of AEC monitoring is to ensure that the care and use of animals for scientific purposes is conducted in compliance with the Code, and in accordance with the AEC approval.

(23) The monitoring visits will be conducted in partnership with the researchers. Prior to project auditing, the purpose and process of the auditing should be clearly communicated to the researchers. It is also an opportunity for the researchers to meet members of the AEC, share their work and ask any questions.

(24) Monitoring will depend on the degree of risk that arises from the research and should be proportionate to that risk and will focus on existing AEC approved projects that involve:

1. the performance of commonly occurring procedures
2. intrusive experimental procedures on animals
3. projects that have been identified to cause moderate to serve impact on animal welfare, and
4. projects that have history of significant unexpected adverse event (s) and/or non-compliance event(s).

(25) The monitoring process will be carried out by the AEC Chair, representative from EIB, and any volunteering AEC members (including at least one Category C or D member).

(26) The auditing process may include more than one of the following, on a case-by-case basis:

1. Documentations/Record keeping check (desktop check can be conducted by the Senior Animal Ethics Advisor to prepare the visit)– Animal usage, animal transportation record, competency record, updated SOPs, MSDS, cross check personnel and procedures listed in approved application/amendment;
2. Face-to-face meeting with project Chief Investigator and any other Co-Investigators (on request) – Discussion around project progression, difficulties encountered, update on animal welfare status etc.;
3. Laboratory/facility visit – Animal housing, observation of daily operation, demonstration of specific procedure (on request), monitoring records;
4. Field research and research at remote sites- researcher may demonstrate by video or photographs selected field procedures and equipment used.

(27) Monitoring performance (including auditing, inspection and any corrective action) will be documented and communicated to the researchers.

(28) Results of performance monitoring including close out of any corrective actions will be reported to the Animal Ethics Committee.

(29) Any concerns of research integrity and any potential breaches will be reported to the Manager, Ethics, Integrity and Biosafety.

Section 5 - Definitions

(30) For the purpose of this Procedure:

(31) Animal:

1. a live member of a vertebrate species including any -
   1. fish or amphibian that is capable of self-feeding; or
   2. reptile, bird or mammal, other than any human being or any reptile, bird or other mammal that is below the normal mid-point of gestation or incubation for the particular class of reptile, bird or mammal; or
2. a live adult decapod crustacean, that is -
   1. a lobster; or
   2. a crab; or
   3. a crayfish; or
3. a live adult cephalopod including -
   1. an octopus; or
   2. a squid; or
   3. a cuttlefish; or
   4. a nautilus

(32) Animal Ethics Committee (AEC): a committee constituted in accordance with the terms of reference and membership laid down in the Australian Code for the Care and Use of Animals for Scientific Procedures (8th Edition, 2013).

(33) Animal facilities: places where animals are kept and/or used, including yards, paddocks, tanks, ponds, cages, laboratories and buildings.

(34) Animal welfare: The Code defines an animal’s welfare as an animal’s quality of life, which encompasses the diverse ways an animal may perceive and respond to their circumstances, ranging from a positive state of wellbeing to a negative state of distress.