Animal ethics

1. Download and complete relevant documents:
• AEC Application to Use Animals for Scientific Purposes
• AEC Approved SOP list (email animalethics@latrobe.edu.au for a copy of approved SOPs or log to LMS to access SOPs directly)
• AEC Standard Operating Procedure Template
• AEC Phenotype Report Template
• Training and assessment plan and competency form (See below for instructions)
• LARTF Monitoring Sheets [Intranet Access Only]
• LARFT Drug Formulary [Intranet Access Only]
• For field work conducted in WA please complete the DPIRD (WA) Notification Form 
2. Ensure all animal facilities nominated in your application are listed in the La Trobe University SPPL20343 (Scientific Procedures Premises Licence)_Updated November 20 2024.
3. If you are conducting fieldwork, reference the La Trobe University SPFL20472 (Scientific Procedures Fieldwork Licence) in your application.
4. Optional – consider contacting the LARTF Vet lartfvet@latrobe.edu.au and/or an Animal Ethics Advisor animalethics@latrobe.edu.au for support in completing your application.
5. Log in to the PRIME Researcher Portal to create a new Animal Ethics Application:
   1. Under Ethics Applications, click “+ New Animal Ethics Application”
   2. Add all researcher personnel listed in your application
   3. Upload all completed forms and study documentation (as separate documents)
   4. Click on “Submit to Research Office” by the relevant closing date (see below)

For help with training and feedback please see below:

1. Training opportunities
   • To schedule a personalised session with an Animal Ethics Advisor for help with your first submission, email animalethics@latrobe.edu.au
   • Complete  EIU_M3 - Introduction to Animal Ethics modules in LMS
   • Register for a mandatory Animal Ethics Induction or Refresher session via TRACR
2. If you would like to book a time to discuss your needs and preferred option/s please contact the Ethics, Integrity and Biosafety Team
   • animalethics@latrobe.edu.au
   • + 61 3 9479 3337

The committee meets once a month from February through December.  The current average times to approval are reflect below.

2024 Meeting Dates - New and deferred applications, major amendments, annual or final reports and unexpected adverse event reports

Subject-to and minor amendments

* Meeting dates may be subject to change without notice

The Ethics, Integrity and Biosafety (EIB) team and the Animal Ethics Committee (AEC) host quarterly Animal Ethics Induction and Refresher training sessions via Zoom for all staff and students.

This training is mandatory for:

1. Anyone listed as personnel on an AEC application.
2. Anyone involved in live animal work.

NOTE: New staff or students must enroll in an Induction session. Refresher training must be completed every 3 years post initial Induction training.

As per the Australian Code for the Care and Use of Animals for Scientific Purposes, 8th Edition 2013 (updated 2021), (the Code), all individuals involved in the care and use of animals must understand their responsibilities and the requirements of the Code (sections 2.1.8, 2.4.4 and 2.5.4.15). This includes the requirement to attend institutional AEC induction training.

How do I register?

1. Contact animalethics@latrobe.edu.au noting an expression of interest OR
2. If you are a LARFT user and have access to TRACR, enroll yourself in the relevant session.

If you do not have access to TRACR, you can submit a request via PRIME Support.

Upcoming training sessions:

*  Induction training includes information on researcher responsibilities under the Code and how to submit an application via PRIME.

Additional Resources:

The Australian and  New Zealand Council for the Care of Animals in Research and Teaching (ANZCCART) provides a free online course that covers the Australian Code and NZ Guide and welfare issues relating to animal use in research and teaching.

The Training and Assessment Form is to be used where a participant in an AEC-approved project requires training in a procedure and that training is not provided by La Trobe Animal Research and Teaching Facility (LARTF) staff. The form should be completed by the person providing the training.

Download the Training and Assessment Form [DOC 50KB]

The Competency Assessment Form is to be used for attesting to the competence of a person to perform a procedure or procedures listed on a Training and Assessment Plan that forms part of an AEC-approved project. The person providing the competency assessment will normally be the trainer named in the Training and Assessment Plan.

Download the Competency Assessment Form [DOC 49KB]

Where a person has been assessed as competent by another institution to perform a procedure or procedures that will form part of an AEC-approved project at La Trobe University, a Confirmation of Competency Form can be completed and submitted with the application for review by the La Trobe University Animal Ethics Committee.

Download the AEC Confirmation of Competency Form [DOC48 KB]

The Statement of Competency to Perform Procedures Involving Animals form is to be completed by persons who have previously been recognised by the La Trobe University Animal Ethics Committee as competent to perform procedures on animals. Once competence in those procedures is confirmed by the AEC, the person will be verified as competent in the procedures on the LARTF Training and Competency Register (TRACR).

Download the AEC Statement of Competency Form [DOC49KB]

The Animal Ethics Committee (AEC) at La Trobe University is comprised of representatives from the University, welfare organisations and the community and serves the following licensed Scientific Procedures Premises:

• School of Agriculture, Biomedicine and Environment
• School of Molecular Sciences
• School of Psychology and Public Health
• Murray Darling Freshwater Research Centre

The persons nominated under Section 26(2) of the Prevention of Cruelty to Animals Act 1986, to be responsible for any procedures carried out at the above-mentioned premises, are appointed by the Head of School/organisational unit. Read the AEC terms of reference.

Contact Us

All correspondence, enquiries and submissions should be addressed to Animal Ethics at animalethics@latrobe.edu.au.

• La Trobe staff members can access the AEC-approved SOP list from PRIME Researcher portal.
• To create new SOP(s), please use the AEC Standard Operating Procedures Template [DOC 58KB].

Complaints about a La Trobe University Research Project

Any interested person may make a complaint about the conduct of a research project. Such a complaint will be made in writing and submitted electronically via email.  A Complaints Form is available. The complaint should be forwarded to the attention of the Senior Manager, Ethics, Integrity and Biosafety, via Ethics, Integrity and Biosafety at eib@latrobe.edu.au. An acknowledgement of the complaint will be sent by a member of the Ethics, Integrity and Biosafety Team within two (2) business days of receipt of the complaint.

The Senior Manager, Ethics, Integrity and Biosafety, will review the complaint to determine if there is an apparent ongoing impact to animal welfare or an immediate risk to the environment (depending on the type of complaint received) that extends beyond those described in the approved ethics submission. If that is determined to be the case, the Senior Manager, Ethics, Integrity and Biosafety, will notify the Executive Director of the Research Office and advise the Principal Investigator to cease research activities until a review has been undertaken.

Where the complaint relates to activities that would normally require Ethics Committee or Review Body approval, the complaint will be considered by the Senior Manager, Ethics, Integrity and Biosafety, or nominee, and the Chair of the relevant Ethics Committee or Review Body, who will determine the level of investigation required in accordance with the relevant ethical guidelines.  Where further investigation is called for, the Ethics, Integrity and Biosafety Team and Chair will undertake a full risk-based monitoring investigation and prepare a report for the relevant Ethics Committee or Review Body. The report will detail the investigation and any findings and recommendations for further action.

The Ethics Committee or Review Body decides on any required actions and informs the relevant parties. These actions may include but are not limited to:

• a caution
• increased reporting requirements and/or monitoring by the Ethics, Integrity and Biosafety
• the requirement for amendments to the project
• suspension of ethical approval
• withdrawal of ethical approval.

Where the investigation finds that the complaint involves a breach of the relevant ethical guidelines, legislation or policy, the Senior Manager, Ethics, Integrity and Biosafety, will work with the relevant Ethics Committee or Review Body and/or School/Centre to avoid a recurrence.

Where the review or investigation finds that the breach of the relevant ethical guidelines may also represent a breach of the Australian Code or research misconduct, the Senior Manager, Ethics, Integrity and Biosafety, will refer it to the La Trobe University Designated Officer who will handle it in line with the La Trobe Research Misconduct Procedure.

Where the review or investigation determines the complaint to be unfounded or unsupported, the Senior Manager, Ethics, Integrity and Biosafety, will dismiss the complaint and the reason/s for dismissal will be provided to the complainant and to the committee.

Where the review or investigation finds that the complaint should be dealt with under other institutional provisions, the Senior Manager, Ethics, Integrity and Biosafety, will refer it on as appropriate.

The relevant Ethics, Integrity and Biosafety Secretariat will inform the researcher(s) in writing, of the result of and any actions arising out of the investigation, within five (5) business days.

The complainant will be advised by the relevant Committee Secretariat in writing of the outcome of the investigation of the complaint.

It is the responsibility of the Secretariat to update the records and the database of research proposals accordingly.

A summary of complaints will be included on the Ethics, Integrity and Biosafety regular report to the Research Graduate School Committee.

All Complaints will be recorded in the Ethics, Integrity and Biosafety Complaints Register.

Complaints will remain confidential.

Review Body Conduct Complaints

Where a complaint cannot be readily resolved by communication between the complainant and the Ethics Committee or Review Body, a complaint may be submitted to the Senior Manager, Ethics, Integrity and Biosafety, in writing via eib@latrobe.edu.au using the Ethics Integrity and Biosafety Complaints Form.

Following receipt of a complaint the Senior Manager or their nominee will seek further information from the relevant Ethics Committee or Review Body Chair; Ethics, Integrity and Biosafety Research Staff; or other relevant La Trobe staff or students as necessary to establish the veracity of the complaint, and whether any La Trobe University policies or procedures have been compromised.

The Senior Manager, Ethics, Integrity and Biosafety, or nominee will provide a report to the relevant Ethics Committee or Review Body and the complainant on the outcome of the investigation of the complaint and include a recommendation for any further actions.

The ultimate decision regarding the ethical acceptability of an activity lies with the relevant ethics committee and must not be overridden.

A summary of complaints will be included in the regular Ethics, Integrity and Biosafety report to the Research Graduate School Committee.

All Complaints will be recorded in the Ethics, Integrity and Biosafety Complaints Register.

Complaints will remain confidential.

For queries about this process, contact the Senior Manager Ethics, Integrity and Biosafety:

T: +61 3 9479 1443

E: animalethics@latrobe.edu.au

• The Code: The 8th edition of the Australian Code for the Care and Use of Animals for Scientific Purposes (2013).
• Use of  animals for testing cosmetics: Section 7 of the Australian Code for the Care and Use of Animals for Scientific Purposes prohibits the use of animals for testing cosmetics. La Trobe University strictly adheres to this ban and does not use animals for testing finished cosmetic products or chemical ingredients, except where the proposed use of animals is justified for purposes beyond cosmetics.
• In Victoria, the use of animals for research and teaching is regulated by Part 3 of the Prevention of Cruelty to Animals Act 1986 (POCTA) and the Prevention of Cruelty to Animals Regulations 2019.
• Guidelines to promote the wellbeing of animals used for scientific purposes: The assessment and alleviation of pain and distress in research animals: Released by the NHMRC in June 2008 to accompany the Code.
• Animal Welfare Victoria website
• Department of Energy, Environment and Climate Action (DEECA) website
• ANZCCART: The Australian and New Zealand Council for the Care of Animals in Research and Teaching.
• RSPCA: Royal Society for the Prevention of Cruelty to Animals.
• AVMA Guidelines on Euthanasia
• Code of Practice for the Housing and Care of Laboratory Mice, Rats, Guinea Pigs and Rabbits
• National Centre for the Replacement Refinement & Reduction of Animals in Research
• Australian and New Zealand Laboratory Animal Association
• NHMRC Statement on the forced swim test in rodent models: The LTU AEC has endorsed the NHMRC position and will not approve applications using the forced swim test
• NHMRC Statement on smoke inhalation procedures in rodent models

Reporting

La Trobe University reports it's animal use statistics, annually, to all State regulatory bodies with winch we posses a licence to use animals for scientific purposes.

All Principal Investigators that have used animals for their research in a calendar year are required to provide their animal use reports to the EIB when requested.

Audits

Undergoing audits enables the University to evaluate and improve our processes and procedures to ensure we consistently meet our legal responsibilities.

In October and November 2022, Animal Welfare Victoria conducted an audit of La Trobe University to monitor compliance with Part 3 of the Prevention of Cruelty to Animals Act 1986 (POCTA Act). This included an inspection of all premises listed on the Scientific Procedures Premises Licence.

The scope of the audit included reviewing selected documents and records, facilities and equipment relating to the Licence conditions, Animal Facility Manager and Animal Facilities.

Several non-compliances were identified during the audit, all of which have now been resolved.

La Trobe University is currently engaged in an Independent External Review of it's operations in 2024 fulfiillment of its obligations under Section 6 of the Code for the Care and Use of Animals for Scientific Purposes.

All submissions to the Animal Ethics Committee must be made through PRIME. If you would like assistance with PRIME or would like to provide feedback on your experience, please see below:

1. Training opportunities:
   • Schedule a personalised session for help with your first submission through the Portal;
   • Attend PRIME daily drop in session: Occurs daily at midday https://latrobe.zoom.us/j/84849823999
2. If you would like to book a time to discuss your needs and preferred option/s please contact the Ethics, Integrity and Biosafety Team:
   • animalethics@latrobe.edu.au
   • + 61 3 9479 3337

Amendments to AEC-approved projects can only be granted if the amendment is minor and there is no significant change to the direction of the study.

Amendments may include (1) a change in animal numbers, (2) change in procedures / techniques, (3) an addition / removal of investigators, (4) an extension of the study duration or (5) administrative changes. Please refer to Guidance on review and process of amendment requests (PDF 144KB) for more information.

How do I submit an amendment?

1. Complete AEC Request for Amendment Form (DOC 60KB) (last updated 10.09.2020)
2. Prepare a tracked and clean copy of all updated documents
3. Log in to  PRIME Researcher portal to create a new amendment request:
   1. To find your ethics project click on “My Ethics Approvals” tile and select the Ethics Approval Number you wish to modify,
   2. At the top of the ethics record click the “down” arrow and click “Create Modification”
   3. Upload completed Request for Amendment form and updated documentation (including tracked and clean copies)
   4. In the progress bar at the top of the page select "Review by Research Office" and then click "Mark as Current Status" to the right.

Annual and Final Reports

**NOTE: If your project has expired you will not be able to upload your progress report in PRIME, please email your completed report form to animalethics@latrobe.edu.au. A Research Ethics and Biosafety Advisor will upload it and will update your milestone on your behalf.**

Principal investigators must submit an annual report by the anniversary date of an AEC project approval and a final report within three (3) months of conclusion of an AEC-approved project.

How do I submit an annual/final report?

1. Download and complete the Annual Report Form (DOC 60KB) (last updated 10.09.2020) or Final Report Form (DOC 62KB) (last updated 10.09.2020)
2. Log in to  PRIME Researcher portal to lodge an annual/final report:
   1. To find your ethics project click on “My Ethics Approvals” tile and select the Ethics Approval Number you wish to submit an annual or final report for,
   2. At the top of the ethics record click the “down” arrow and click “Create Annual Report” or “Create Final Report”
   3. Upload completed annual/final report
   4. In the progress bar select "Review by Research Office" and then click "Mark as Current Status" to the right.

AEC Approved Guides

• AEC Guide for What Projects Need AEC Approval
• AEC Guide for Wildlife Researchers
• AEC Guide to citizen science
• AEC Guide for Fin Clipping

External Guidelines

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

Supplementary Information

• Animal Ethics Guide on the 3Rs

Review of applications before submission to AEC

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.

Use of plain English

• 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.

Specific application sections

• 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 available on the on the AEC website. The AEC must approve animal-related SOPs before use. When updating SOPs it is recommended to include references to the Code section 3.3 Specific procedure 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.
• Genetically modified mouse strains: consider using abbreviated names rather than the full description including all the genetic alterations
• 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.
• 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.
• 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.

• Determine if your project requires AEC approval:
  • AEC Guide to What Project Needs AEC Approval
  • AEC Guide for Wildlife Researchers
  • AEC Guide to Citizen Science
• Ensure you download the AEC application form from the AEC website to ensure you are using the latest version.
• All aspects of the application are correct and clear i.e. you say what you are going to do.
• There are no discrepancies between sections of your application, particularly with respect to animal numbers, monitoring and timelines.
• Plain English language is used throughout, to the extent possible.
• A glossary is provided where scientific language is unavoidable and can be explained.
• Easy to read and easy to understand protocol that describes the ‘whole life’ of the animals and addresses the impact of both individual procedures and the total welfare of the animal and the collective group.
• Although not recommended, if used, ‘cut and paste’ from other applications must be relevant to the current proposal.
• All sections are considered, boxes appropriately ticked, and information provided.
• Approved and current SOPs are used, so AEC does not need to look through those aspects for every project.
• Persons are LARTF-trained and competent in common procedures.
• Consider the 3Rs when determining animal numbers you plan to use in your project:
  • Animal Ethics Guide to the 3Rs
• Expected Mortality Rate (EMR) is considered to reduce need to report UAEs. 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.
• For amendment requests, requested changes for variations should be added to all relevant sections of the original application - those changes must be highlighted or tracked changes should be used for applications in MS Word format.  If using asterisks, ensure asterisks for former variations are removed. Furthermore, when seeking amendments, update relevant information e.g. staff/students no longer associated with the project are removed.
• When submitting an amendment request, resubmit any supporting documents including timelines or flow charts, monitoring sheets and any relevant documents attached as an appendix.
• For researchers submitting Honours student projects it is recommended to submit these as early as possible, preferably by October/November prior to starting, or submit to the first meeting of the year.

The Code defines 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 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
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
• 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’.

It is the view of the LTU AEC that breeding of animals should be in separate proposals to experimental use of animals, unless otherwise justified (e.g. only small numbers of breeding animals for limited time periods).

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. time extension (provided all approved activities still meet best practice / ethical standards);
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).

When submitting a request for amendment, all the relevant documents must be provided including the revised application, timelines or flow diagram, monitoring sheet and any relevant documents (refer to ‘What additional documents need to be submitted to the AEC when submitting an application?').

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. 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.

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.

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. A template letter is available under the template section.

Honours students are usually not considered as suitable to be primary contacts due to the significant amount of responsibilities. It is also not appropriate for long term projects. However, the AEC will consider justification if believed essential.

The AEC will consider approving a ‘total’ number of animals (and not specifically per strain) in a breeding-specific application but new strains will need to be added through amendments, with an accompanying phenotype report, if appropriate.

• 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.

At each AEC meeting the AEC considers

• New applications
• Researcher responses to applications previously considered
• Amendments to AEC-approved projects
• Standard operating procedures
• Phenotype reports
• Adverse event reports and associated pathology reports
• Incidents, protocol deviations and other suspected non-compliances
• Emerging trends in animal welfare to improve AEC member learning and development
• Presentations from invited researchers on issues of concern to AEC members
• Outcomes of monitoring research and facilities

Meetings can last over 6 hours and involve review of over 1,000 pages of information.

Is this project/activity ethically acceptable (and can therefore be approved)?

• Has sufficient evidence and argument been provided, based on the scientific merit of the project, the ethical principles of the Code and sufficient justification of potential benefits to animals, humans or the environment and acceptable effects on animal welfare and well-being?
• What answers to questions or clarifications are needed for further consideration about whether the project can be considered ethically acceptable?

If ethically acceptable and therefore ‘approvable’

• Are there any conditions that the AEC needs to apply?
• What answers to questions or clarifications are needed for the project to be formally approved?

So, when the AEC approves

• It has thoroughly reviewed all aspects of the application.
• It expects that you will conduct the research according to the AEC-approved application.
• Any unexpected adverse events, non-compliances including protocol deviations are reported.

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.

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.

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.

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 AECxxxxx 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]