Animal Ethics Guidelines and FAQs

• AEC Guide for What Projects Need AEC Approval
• AEC Guide for Wildlife Researchers
• AEC Guide to citizen science
• AEC Guide for Fin Clipping
• Animal Ethics Guide on the 3Rs

• NHMRC Statement on the forced swim test in rodent models
• NHMRC Statement on smoke inhalation procedures in rodent models

In order to reduce the questions or concerns AEC may raise with you, the AEC encourages researchers to

• Seek peer review of each application.
• Seek review of each application by a person not associated with science to ensure your application can be understood.
• Check all sections of the application to ensure animal numbers are consistent.
• Check that each section of the application form has been addressed including correct box ticking where relevant.

• Researchers need to use plain English throughout their applications. This is particularly important in sections describing welfare burden on animal, in flow charts and timelines. The AEC encourages you to seek review of your application by a person not associated with science to improve use of plain English.
• Always read through your applications, use spelling and grammar checkers where possible, and get others (particularly those named on the application) to read through and make corrections before submission.

• s1.6 - SOPs - Where do I find the link for the list of current SOPs?
  • La Trobe staff members can access the AEC approved SOP list from the Researcher Portal (PRIME) by clicking on the SOP & Phenotype report tile on the home page. This will tell you which SOPs and Phenotype reports are currently approved.
  • To create new SOP(s) or Phenotype Report, please use the AEC Standard Operating Procedures Template and submit for AEC approval as per the instructions on the "Getting your project approved" tab of this website.
  • The AEC must approve animal related SOPs before use.
  • When updating SOPs it is recommended to include references to the Animal Code section 3.3 Specific procedures and other relevant guidance.
• s1.7 - Animal numbers
  • Ensure your description of animal numbers is consistent throughout your application, particularly in s1.7, 2.5 [Reduction], 3.1 [General methodology] and in your timelines. This is a common error in applications.
  • Should potential by-catch be included in the numbers?
    • You should include specific comments about potential by-catch -  and possible endangered, threatened or sensitive species eg platypus. Any  incident related to by catch should be reported by submitting as unexpected adverse event reports and seeking amendments to ensure the incident does not reoccur.
• s1.7 - Animal numbers - Genetically modified animal strains:
  • Consider using abbreviated names rather than the full description including all the genetic alterations.
  • Ensure requisite Phenotype Reports have been submitted for approval by the AEC.
• s1.7 - Animal numbers – Wildlife:
  • When providing numbers for wildlife studies where animals are either only observed or captured quickly and for immediate release, supply over-estimated numbers or put “All species encountered”.
• s1.8 - Source/s of Animals:
  • For common strains, the AEC recommends specifying commercial suppliers and internally bred as sources.
• s4 – Emergency procedures:
  • if procedures are listed as emergency procedures eg euthanasia in section 6 to be carried out by investigators, they need to be identified specifically as a procedure in sections 4.4 consistent with section 6.
• s4 – Monitoring:
  • Where relevant, use standard LARTF anaesthesia and surgical monitoring sheets. These forms are available from the LARTF intranet.
• s4 - Relief from pain or inflammation:
  • Whilst carprofen, a non-steroidal anti-inflammatory drug is often listed, it can be in limited supply, so the AEC suggests you add the option of meloxicam, as an alternative NSAID. LARTF veterinarians can advise on dose / volume / rate.
• s4, s5.4, s5.5 :
  • The AEC asks researchers to take care in the words and phrases used. The phrase ’euthanasia’ should be used where an animal has been assessed as reaching a humane endpoint or other significant welfare concerns arise. ‘Humane killing’ should be used when animals reach the project’s end point. When describing the fate of animals, do not use the words ‘sacrifice’ and ‘culling’.
• s5 - Animal Housing
  • To allow flexibility in where animals are housed, please describe animal housing at the highest level e.g. LARTF housing approved in the SPPL appropriate to species, rather than describing specific rooms.
  • Make sure to check the most up to date SPPL to ensure the facility you intend to work in is on the licence.

The Animal Code defines an animal as: any live non-human vertebrate (that is, fish, amphibians, reptiles, birds and mammals encompassing domestic animals, purpose-bred animals, livestock, wildlife) and cephalopods (e.g. squid, octopus).

The Animal Code states that when embryos, foetuses and larval forms have progressed beyond half the gestation or incubation period of the relevant species, or they become capable of independent feeding, the potential for them to experience pain and distress should be taken into account. The Prevention of Cruelty to Animals Act - In Part 3 of the Act, animal means

• a live member of a vertebrate species including any
  • fish or amphibian that is capable of self‑feeding; or
  • 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
• a live adult decapod crustacean, that is a lobster or a crab or a crayfish
• a live adult cephalopod including an octopus or a squid or a cuttlefish or a nautilus

It is the view of the AEC that the relationship between pre- and post-flexion in fish and their ability to self-feed has not been clearly established. So, Researchers should justify inclusion of fish in protocols related to their self-feeding status, not their flexion development.

The LTU AEC considers research involving embryos, foetuses and larval forms that have progressed beyond half the gestation or incubation period of the relevant species, or they become capable of independent feeding to be ‘animals’.

Researchers are encouraged to clearly nominate an Expected Mortality Rate (EMR) usually linked to specific procedures or a specific phenotype that may be associated with specific Adverse Events (AE). For AEC to consider an EMR, list the adverse events expected and rationale for the EMR you have proposed, If the AEC accepts the proposed EMR then researchers are responsible for monitoring the numbers of animals experiencing that AE (or group of AEs) in comparison to the total numbers approved in the protocol. Researchers, then, only need to report UAEs when that EMR is exceeded.

You should maintain a record to ensure EMR is not reached. This record should be made available to the AEC for monitoring and audit purpose.

Where relevant the AEC expects the following additional documents:

• Phenotype reports – either preliminary, in progress or final;
• Training and Assessment Plans;
• Competency records;
• Research publications that support use or validate procedures used;

Clear timelines for each group of animals.

Applications in which privately owned animals are to be used (including livestock, pets etc) will need to meet the conditions listed in s2.4.28 of the Code to:

• ensure that all people involved in the care and use of such animals are aware of and accept their responsibilities relating to the animals
• ensure that people responsible for the daily management of the animals during the project are familiar with and understand the Code, and are competent

provide the owner of the animal with a document, to be included in the application to the AEC, clearly stating the details and duration of the owner’s responsibilities. The owner should acknowledge their acceptance of these responsibilities in writing.

• Ensure that your breeding strategy is outlined in the phenotype report of the final strain to be generated and list intermediate strain/s if any that will be generated as part of the breeding strategy.
• Provide details for the best handling and monitoring of intermediate generations e.g. known or expected characteristics of the intermediate genetically modified animal strain (i.e., behavioural, physiological, reproductive and developmental characteristics and/or predisposition to disease) generated as part of the breeding strategy.

Applications in which privately owned animals are to be used (including livestock, pets etc) will need to meet the conditions listed in s2.4.28 of the Code to:

• ensure that all people involved in the care and use of such animals are aware of and accept their responsibilities relating to the animals
• ensure that people responsible for the daily management of the animals during the project are familiar with and understand the Code, and are competent

provide the owner of the animal with a document, to be included in the application to the AEC, clearly stating the details and duration of the owner’s responsibilities. The owner should acknowledge their acceptance of these responsibilities in writing

You must notify the AEC and provide your approval documents. This can be done by submitting your documents through PRIME by following the steps below:

1. Log in to  PRIME Researcher portal to create a new Externally Approved Application:
2. Under Ethics Applications, click “+ New Externally Approved Application”
3. Add all researcher personnel
4. Upload all completed forms and study documentation (as separate documents)
5. Click on “Submit to Research Office”

The Code (s2.4.9) states that Investigators must notify the AEC in writing if they are involved in collaborative studies using animals at another institution, or if they are named in an application to the AEC of another institution. The AEC will formally ‘note’ your notification at their next meeting.

On a case-by-case basis the AEC considers the involvement of animals in human-focused research. Until we know the particulars of each case, it is uncertain whether AEC approval is needed or otherwise. The AEC will consider potential impacts on animals outside of their normal life.

When submitting SOPs for AEC approval submit with ‘tracked changes’ from the previous version to enable AEC to view what changes are proposed. It is also recommended to the Code section 3.3 for Specific procedure and other relevant guidance.

The Victorian government advised in early 2020 that there is now no requirement for Victorian institutions with AECs to submit fieldwork notifications to Animal Welfare Victoria.

Interstate based AECs approving projects to be conducted in Victoria are still required to submit fieldwork notifications.

Please refer to the LARTF website.

• If you claim to be appropriate to train in a technique or procedure in a Training and Assessment Plan: The proposed trainer should provide evidence that they are recognised as being competent in that technique and that they have performed the technique at least 20 times in the past three years. This could be by reference to AEC-approved projects in which they have performed the technique. As an alternative, outline the basis of your claim that you are competent to train in this technique.
• If you are attesting to the competency of another person to perform a technique or procedure: A person attesting to someone’s competency must themselves be competent in that technique, have performed the technique at least 20 times in the past three years and have observed the person performing that technique at least 5 times under supervision. As an alternative, outline the basis of your claim that you are suitable to attest to this person’s competency.

All researchers and student are required to attend LTU animal ethics induction sessions. If you require an induction session please email your request for a session to animalethics@latrobe.edu.au.

The AEC must approve amendments to AEC-approved projects before such amendments are put in place. The Code describes minor amendments that can be considered by an AEC Executive between monthly, formal, quorate AEC meetings.

The Australian Code is prescriptive in what can be considered a minor amendment that can be considered by an AEC Executive between formal and quorate AEC meetings. A minor amendment may include a change to an approved project or activity where the proposed change is not likely to cause harm to the animals, including pain and distress.

Animal Welfare Victoria provide examples of minor amendments:

1. Examples included addition of suitably experienced personnel;
2. 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 where the impact to the animals is the same or less than originally approved;
3. opportunistic diagnostic or veterinary activities intended to benefit the animals;
4. re-activation of paused projects.

To this LTU AEC will also consider the following as minor amendments:

1. removal of personnel;
2. the first time extension (provided all approved activities still meet best practice / ethical standards). Please note that all other time extensions qill require submission to an AEC monthly meeting;
3. change to the number of animals required to ensure that results are statistically significant (for example, because planned breeding produced too few of a required strain) or to replace animals whose results cannot be included (perhaps as the result of an adverse event);
4. performance of a procedure already approved for the project on one strain of animal to a different strain, provided the change of strain has no impact on the outcome of the procedure and that the new strains is covered under your IBC approval;
5. addition of a new strain to a breeding application where no resultant changes are needed to the monitoring or to procedures that may need to be performed on the animals;
6. addition of a new collaborator with appropriate competency records;
7. update to the list of procedures to be performed by an investigator named on the project, where that investigator is listed on TRACR as competent in the additional procedure(s);
8. any amendment that has been explicitly recommended by a quorate meeting of the AEC. An example of the last point would be where the AEC has considered an Adverse Event Report and recommended that specific changes be made to the project. Provided the Chief Investigator agrees to the changes, as specified by the AEC, the revised application may be approved by the AEC Executive;
9. a person’s competence to perform a procedure where no exercise of judgement is required (for example, competency is confirmed by an authorized person at another institution or a trainer confirms that a person has met AEC-approved assessment criteria for the performance of a procedure). The following rules apply:
   1. Confirmation of competency assessments based on satisfactory completion of an AEC-approved Training & Assessment Plan do not need to be reviewed and approved by the AEC or AEC Executive.
   2. Confirmations of competency from another institution with its own AEC (received on the AEC-approved Confirmation of Competency form) do not need to be reviewed and approved by the AEC or AEC Executive.
   3. Competencies claimed by La Trobe staff and students and external personnel, other than those covered by 1 and 2 above, need to be reviewed and approved at an AEC and not by AE Executive.
   4. Approval of Training and Assessment Plans can be approved by the AEC Executive that includes a Category A member of the AEC when the pain and distress that may be experienced by the animals is minimal.
10. Phenotype Reports may be approved by the AEC Executive, again expanded to include a Category A member of the AEC, where the phenotype requires no new measures to be introduced than have already been approved for the associated project(s).

Annual reports

Submitting annual reports is a condition of AEC approval. The AEC at its monthly meetings considers each annual report, checking on progress and animal numbers used. You may be notified if the AEC has concerns about your annual reports.

Final reports

Submitting a final report for each AEC-approved project is a condition of AEC approval. The AEC at its monthly meetings considers each final report, checking on your assessment of the success of the project and any issues encountered and the animal numbers used. You may be notified if the AEC has concerns about your final report.

What should be considered is not necessarily the number of amendment but rather whether the amendment requests are covered under the initial aim/s of the project.

Monitoring inspections may include examination of:

• animal holding facilities;
• animal health and welfare;
• research procedures;
• animal identification and care records;
• research records.

You may be asked to supply information or attend meetings related to AEC inspections of laboratories, facilities or research.

LARTF standard drug doses and dilutions [PDF 152KB]

Where possible, the AEC recommends specifying the species within the project title.

Yes, the AEC appreciates information that provides context to the projects.

e.g. if it is an Honours project; or a long-term project that carries on from approved Project AEC etc

SOP 0081 Ageing rodent monitoring sheet [PDF 156KB]

SOP 0081 Generic rodent monitoring sheet [PDF 89KB]

SOP 0081 Rodent monitoring sheet for tumour models [PDF 101KB]

SOP 0081 Rodent monitoring sheet post surgery [PDF 90KB]

SOP 0178 Post-irradiation monitoring sheet [PDF 102KB]

The ANZCCART Openness Agreement on Animal Research and Teaching in Australia is a voluntary commitment that organisations can sign to show their dedication to enhancing transparency in the use of animals for research or teaching purposes.

The Openness Agreement was introduced at the ANZCCART Conference on August 10, 2023, where 32 organisations were recognised as Inaugural Signatories or Supporters.

La Trobe University is proud to be an inaugural signatory to the ANZCCART Openness Agreement, highlighting our commitment to transparency and ethical conduct in research and teaching involving animals.

We understand that the use of animals in research and teaching can be polarising and we respect the diversity of perspectives within our institution and in the broader community, and in becoming a signatory, we affirm our dedication to being open about the nature, purpose and extent of the use of animals in our research and teaching activities.

La Trobe University pledges to meet all four commitments in the Openness Agreement:

Commitment 1. We will be open about our involvement in the use of animals in research or teaching.

In working towards this Commitment, we will:

• Aim to ensure our communications provide accurate descriptions about the potential benefits, harms, limitations and ethical considerations regarding our use of animals.
• Take steps to ensure that our staff (and students, where applicable) are aware of our involvement in the use of animals in research or teaching.
• Be prepared to respond to all reasonable enquiries and if there are partnerships with non-signatory organisations or issues of confidentiality or commercial sensitivity, we will be as open as possible while respecting these constraints.

Commitment 2. We will enhance our communications with the media and the public about our use of animals in research or teaching.

In working towards this Commitment, we will:

• Provide a publicly available statement with information about our involvement in the use of animals in research or teaching. The statement will be unique to our organisation, easily accessible on our website, and available within 12 months of becoming a Signatory or Supporter.
• Include information about our use of animals in research or teaching in communications and media releases when it has played a significant role in an aspect of our work. Where appropriate, this may also include images or video.
• Support discussion of our use of animals in research or teaching with the media and the local or broader communities.
• Provide a point of contact for information about our use of animals in research or teaching.

Commitment 3. We will be proactive in providing opportunities for the public to find out about research or teaching involving animals.

In working towards this Commitment, we will:

• Consider ways to facilitate public engagement and understanding around the use of animals in research or teaching.
• Include, where relevant, information about the role of animals in research or teaching when participating in talks or public events.
• Contribute to efforts to provide more comprehensive explanations and ensure the accuracy of information regarding the use of animals in research or teaching.

Commitment 4. We will report annually on our efforts to improve openness in our use of animals in research or teaching.

In working towards this Commitment:

• We will provide an annual summary to ANZCCART each year highlighting our efforts to meet each of these Commitments and any new initiatives aimed at greater openness.
• We understand that ANZCCART will publish an annual update on progress in openness and no more than three years after its publication, ANZCCART will review the Openness Agreement and its impact in consultation with stakeholders and amend it if necessary.