Guidelines for the Conduct of Animal Ethics Committees
Guidelines for Animal Ethics Committee (AEC) Members in Victoria
Approval of scientific procedures
The Prevention of Cruelty to Animals Act 1986 (the Act) and Regulations require that Animal Ethics Committee (AEC) approval be received before Scientific Procedures are performed in Victoria. That approval must be given by an AEC that is nominated on the licence issued. An exception is if AEC approval is formally delegated to another AEC.
The Licence Nominee should be satisfied that AEC approval has been given before:
- members of their institution conduct scientific procedures anywhere in Victoria, or
- people from another institution conduct scientific procedures at their premises or
- visiting overseas investigators or students conduct work with the approval of the institution.
Levels of response to new applications
The following guidelines are suggested to assist AECs with standard procedures for responding to new applications. The AEC may have 4 levels of response:
- accepted without modification,
- accepted with conditions; that is, when the Committee makes a decision about alterations to the activities proposed in the application and the agreed modifications to the project are to be recorded in the minutes as a decision of the Committee. The investigator should be made aware that exact conformity with those alterations is a condition of approval and the conditions of approval noted in the letter of approval or by incorporating the modifications in the application,
- accepted with modification to the satisfaction of the Executive. In this case the applicants must resubmit their application incorporating the modifications and or additional information requested by the Committee. The Committee must then consider the potential impact of the information on the wellbeing of the animals involved. For information with potentially high animal welfare impact (justification for inducing pain in the absence of analgesia, single housing for social species, queries as to why valid alternatives are not used), the information must return to the full AEC for appraisal. If the Committee are satisfied with the changes, they can then approve the application,
- rejected, may be re-submitted.
The AEC may delegate to the Executive authority to approve minor amendments ONLY. For example;
- addition of suitably experienced personnel
- minor changes to procedures: where "minor" is defined as any change that has little or no impact on the wellbeing of the animals involved in the project; for example, verifying dose rates for drugs, needle sizes, routes of administration.
- opportunistic diagnostic or veterinary activities intended to benefit the animals
- re-activation of paused projects
Please remember that the Executive must constitute at least one independent member (ie. at least a Category C or D member). The Executive cannot approve new projects nor major modifications.
All such minor amendments must be recorded and subject to ratification by the full AEC at the next meeting. The AEC may also place conditions on approval of a project. For example, the AEC may require six monthly progress reports, limited initial animal numbers etc. Regardless, final project approval or rejection should be a clear decision by consensus and promptly conveyed to the applicant.
Approval for breeding animals
Approval by an AEC for breeding animals may be included in either a) an individual project application for conducting 'scientific procedures' or b) Standard Operating Procedures (SOPs) for well established and routine practices; and procedures associated with breeding 'specified animals'.
In line with Australian Code of Practice for the Care and Use of Animals for Scientific Purposes 2004 (the Code), the Act and Regulations require that 'practices or procedures to be conducted on specified animals which involve the surgical, medical or physical treatment of specified animals or the extraction or derivation of any tissue, material or substance from the body of a specified animal must be approved and monitored by the Animal Ethics Committee'.
The following guide is provided for the requirement and form of AEC approval required for breeding animals:
- Individual project applications are for any practices and procedures involving the introduction of a Genetically Modified (GM) line not previously held by the institution and/or the creation or breeding of new lines of GM animals, congenics, mutants or cloned animals or novel use of breeding procedures as these activities are considered scientific procedures. Refer also to the Code sections 3.3.79 and 3.3.56-3.3.64.
- An SOP is required for established or routine practice or procedures associated with breeding of non-GM specified animals and well phenotyped and understood GM specified animals.
GM lines of specified animals that are initially novel to the institution may over time become established. Reporting to the AEC on the outcome of phenotype testing and other relevant data, including measures put in place to monitor and care for animals that develop adverse side effects is essential to allow an assessment of the status of breeding animals. Using this information, the AEC can determine the transition of the status of these animals from breeding of novel animals to established breeding stock, and thus the requirement for approval by method a) or b).
When phenotypes are well understood, phenotype reports should be made to the AEC including information on monitoring of and care for animals displaying adverse affects due to the modification.
Monitoring of facilities
The Code states that AEC members should inspect all animal housing and laboratory areas regularly and record their findings (Section 2.2.29). Where an institution nominates an AEC based outside Victoria, it is required to demonstrate in the Terms of Reference (TOR) how this requirement will be fulfilled.
Approvals by an interstate AEC / remote monitoring
Interstate AECs must provide details of how they intend to fulfil their monitoring responsibilities, as outlined in section 2 of the Code, when approving and forwarding a fieldwork notification to the Department of Economic Development, Jobs, Transport and Resources (DEDJTR) Licensing and Audit Branch. This may include delegation of monitoring to a Victorian AEC or suitable proxy (e.g. a veterinarian, wildlife ranger or Category C person), digital images or video plus annual report of activities and any adverse events. If welfare and liability concerns remain, there is the additional option of approval by both an interstate and a relevant Victorian AEC. This may be particularly pertinent for projects involving wildlife studies on crown land.
Scavenging versus secondary use of animals versus re-use of animal
Scavenging is the use of an entire animal or organ or tissue from an animal already killed as part of an AEC approved project. It may also involve the use of surplus project or breeding animals that have already been humanely killed. It is inherent that there is no additional impact on the animal and thus AEC approval is not required.
In line with the principles of Reduction and Replacement, 'scavenging' is strongly encouraged. Institutions should implement strategies to promote scavenging whenever possible. For example, project application templates should routinely ask whether animals/tissues will be available for scavenging, a strategy should be developed to communicate to internal investigators and potential external bodies available dead animals/tissues as appropriate, and the use of scavenged animals for surgical or other teaching activities should be considered in the first instance.
Secondary use, however, has the potential to cause additional impact on a live animal and AEC approval is required. For example, if a project involves procedures under anaesthesia for a particular purpose, and an additional procedure is requested to be done for another purpose, the additional procedures would be considered secondary use and should be considered as an independent project application. That application would need to indicate all the procedures to which the animals would be subjected.
Re-use of animals may involve using one cohort of animals to be firstly a control group and then, after the appropriate interlude, a treatment group. This 're-use' of animals should be considered together in one project application and the cumulative impact on the animals considered. Alternatively re-use of animals may involve a number of totally separate projects, and thus life histories records on animals are essential to enable assessment of the cumulative impact on these animals.
Minimising the production of surplus laboratory animals
The following principles for minimising the production of surplus animals are recommended:
- ensuring that, where scientists have exacting and specific requirements for animals, this is scientifically justified
- discouraging small, in-house rodent breeding colonies wherever possible (and where this does not add to welfare costs) and particularly for commonly available species and strains
- encouraging sharing and cryo-preservation of 'tick-over' strains
- ensuring full cooperation between users, both those that use animals under a license and those that use ex vivo tissues or organs (i.e. scavenging)
- finding uses (within or outside the institution) for surplus animals
- planning projects as far in advance as is reasonably possible so as to enable the optimum management of animal colonies.
Please note that there may be some restrictions on the scavenging of genetically modified animals. Please refer to the relevant Institutional Committee and/or Office of Gene Technology Regulator (OGTR) for guidance.
DEDJTR developed a self-audit protocol that will support AECs in fulfilling the requirements of the Code (Section 2.2.40), that each AEC must submit an annual report to the institution for which it acts. The report should include reviewing the operation of the AEC and detailing numbers of applications, types of applications, numbers of animals, adverse incidents, site inspections etc. conducted by the AEC. In addition, the Code requires that the chairperson meet with the Institution representative of Licence Nominee to discuss the progress of the AEC and any incidents and/or recommendations the AEC has to ensure the institution continues to comply with the Code and the Act.