Animal ethics
Researchers who use live non-human vertebrate and higher-order invertebrate animals for experimental or teaching purposes are bound by the Australian Code for the Care and Use of Animals for Scientific Purposes, the Prevention of Cruelty to Animals Act 1986 (POCTA) and Regulations and other relevant Australian State and Commonwealth legislation together with the La Trobe University Research Animal Ethics Procedure. All research has additional obligations under the Australian Code for the Responsible Conduct of Research and the La Trobe University Research Integrity Policy and the Research Governance Policy.
More information can be found on the Ethics, Integrity and Biosafety Research Integrity Hub.
All research and teaching projects involving live non-human vertebrates and higher-order invertebrates must be reviewed and approved by the La Trobe University Animal Ethics Committee (AEC) before they begin. You can read more about the scope and functions of the AEC in the AEC Terms of Reference 2024.
Read about our commitments to openness about our use of animals in research and teaching.
Please contact the Ethics, Integrity and Biosafety team if you would like to discuss application requirements and your project.
+61 3 9479 3337
2024/2025 University Shutdown Period Emergency Contact (December 24 2024 - January 01 2025) :
Dr Mukesh Raipuria
+61 449 627 747
Getting your project approved
How to Apply
- 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
- Under Ethics Applications, click “+ New Animal Ethics Application”
- Add all researcher personnel listed in your application
- Upload all completed forms and study documentation (as separate documents)
- Click on “Submit to Research Office” by the relevant closing date (see below)
For help with training and feedback please see below:
- 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
- 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
Time to Approval
The committee meets once a month from February through December. The current average times to approval are reflect below.
2021 | 2022 | 2023 |
---|---|---|
40 Projects | 37 Projects | 32 Projects |
28.8 Days | 29.5 Days | 42.8 Days |
Meeting Closing Dates
The monthly meeting of the full committee will review the following items:
- New and Deferred Applications
- Review of new applications/SOPs/PTRs submitted for approval
- Review of deferred applications/SOPs/PTRs that require further consideration
- Major Amendments
- Evaluation of significant changes to existing approved projects, protocols or phenotype reports
- Annual or Final Reports
- Review of progress reports for ongoing projects (annual)
- Review of final reports upon project completion
- Unexpected Adverse Event Reports
- Evaluation of reports detailing unexpected adverse events or outcomes during the course of research
The weekly out-of-session meetings will review:
- Subject-to re-submissions
- Minor amendments
Optional Pre-Review: You can request a pre-review of your draft application via email to animalethics@latrobe.edu.au. Submission of the documents to be reviewed can be via PRIME or email.
NOTE: All submissions and pre-review requests must be in by midday on the submission deadline.
2024 Meeting Dates
Full Committee Meetings
Pre-review cut-off (optional) | Submission Deadline | Meeting Date |
---|---|---|
Midday Thursday, 19 September 2024 | Midday Thursday, 26 September 2024 | Thursday, 10 October 2024 |
Midday Friday, 25 October 2024 | Midday Friday, 1 November 2024 | Thursday, 14 November 2024 |
Midday Friday, 22 November 2024 | Midday Friday, 29 November 2024 | Thursday, 12 December 2024 |
Out of Session Meetings
Closing Date | Meeting Date |
---|---|
Wednesday – every week NOTE: advise animalethics@latrobe.edu.au if your application requires urgent attention | Wednesday the following week |
2025 Meeting Dates
Full Committee Meetings
Pre-review cut-off (optional) | Submission Deadline | Meeting Date |
---|---|---|
Friday 31 January 2025 | Friday 07 February 2025 | Thursday 20 February 2025 |
Friday 28 February 2025 | Friday 07 March 2025 | Thursday 20 March 2025 |
Friday 28 March 2025 | Friday 04 April 2025 | Thursday 17 April 2025 |
Friday 02 May 2025 | Friday 09 May 2025 | Thursday 22 May 2025 |
Friday 30 May 2025 | Friday 06 June 2025 | Thursday 19 June 2025 |
Friday 27 June 2025 | Friday 04 July 2024 | Thursday 17 July 2025 |
Friday 01 August 2025 | Friday 08 August 2025 | Thursday 21 August 2025 |
Friday 29 August 2025 | Friday 05 September 2025 | Thursday 18 September 2025 |
Thursday 25 September 2025 | Friday 03 October 2025 | Thursday 16 October 2025 |
Friday 31 October 2025 | Friday 07 November 2025 | Thursday 20 November 2025 |
Friday 28 November 2025 | Friday 05 December 2025 | Thursday 18 December 2025 |
Out of Session Meetings
Closing Date | Meeting Date |
---|---|
Wednesday – every week (starting 15 January 2025) NOTE: advise animalethics@latrobe.edu.au if your application requires urgent attention | Wednesday the following week |
* Meeting dates may be subject to change without notice
Animal Ethics Induction - Mandatory
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:
- Anyone listed as personnel on an AEC application.
- 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 Animal Code), all individuals involved in the care and use of animals must understand their responsibilities and the requirements of the Animal 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?
- Contact animalethics@latrobe.edu.au noting an expression of interest OR
- If you are a LARTF 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:
Animal Ethics Induction Date* | Animal Ethics Induction Time | Animal Ethics Refresher Date | Animal Ethics Refresher Time | ||
---|---|---|---|---|---|
1 | Tuesday 19 March 2024 | 2 - 5pm | 1 | Thursday 14 March 2024 | 3:30 - 4:30pm |
2 | Wednesday 5 June 2024 | 12 - 3pm | 2 | Wednesday 5 June 2024 | 11 am - 12pm |
3 | Tuesday 8 October 2024 | 2 - 5pm | 3 | Tuesday 8 October 2024 | 1 - 2pm |
4 | Wednesday 27 November 2024 | 2 - 5pm | 4 | Wednesday 27 November 2024 | 1 - 2pm (Cancelled) |
5 | NIL | NIL | 5 | Friday 6 December 2024 | 1 - 2pm |
* 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 Animal Code and NZ Guide and welfare issues relating to animal use in research and teaching.
Training and Assessment of Competency
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 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 AEC.
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 AEC 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 TRACR.
Download the AEC Statement of Competency Form [DOC49KB]
Animal Ethics Committee (AEC)
The La Trobe AEC 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.
Standard Operating Procedures (SOPs) & Phenotype Reports (PTRs)
AEC Approved SOPs and PTRs
- You can access a list of AEC approved SOPs and PTRs from the PRIME Researcher portal.
- If you want to use an existing AEC approved SOP or PTR in your project, list the SOP and/or PTR in your application to use animals for scientific purposes.
- NOTE: The version of the SOP listed in your AEC approved project application form must be the version used for all procedures conducted under that application unless a modification request is submitted for approval of an updated version of the SOP.
New SOP & PTR Submissions
- To create new SOP(s), please use the AEC Standard Operating Procedure Template.
- To create new PTR(s) please use the AEC Phenotype Report Template
- New SOPs and PTRs must be submitted for review by the AEC as a stand alone submission in PRIME
- Check the PRIME Researcher portal to ensure there are no existing SOP/PTRs
- Log in to the PRIME Researcher Portal to create a new Animal Ethics Application:
- Under Ethics Applications, click “+ New Animal Ethics Application”
- Enter the SOP Title/Phenotype Name under “Ethics Application Title”
- Change the “Record Type” to SOP/Phenotype Report
- Upload a completed SOP/Phenotype Report and any supporting documents in the “Documents” tab
- Select “Review by Research Office” and “Mark as Current Status” in the progress bar at the top of the screen to submit
Feedback and Complaints
La Trobe University Research Project Complaints
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 eib@latrobe.edu.au. You will receive an acknowledgment of the complaint 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 a participant’s, animal’s welfare, or 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 will notify the Executive Director of the Research Office and subsequently 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, 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 guidelines. Where further investigation is called for, the Ethics, Integrity and Biosafety Team will undertake a full risk-based monitoring investigation and prepare a report for relevant leadership. 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 relative to participant safety, animal welfare and environmental impact and informs the relevant parties. These actions may include but are not limited to:
- a caution
- increased reporting requirements and/or monitoring
- the requirement for modifications 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 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 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 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 will refer it on as appropriate.
The Ethics, Integrity and Biosafety team 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 Ethics, Integrity and Biosafety team in writing of the outcome of the investigation of the complaint.
The Ethics, Integrity and Biosafety committee Secretariat will 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 and Graduate Studies 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, 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 and Graduate Studies 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 1383
E: eib@latrobe.edu.au
Legislation, Codes and Guidelines
- 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
Institutional Reporting and External Review
Reporting
La Trobe University reports its animal use statistics annually to all State regulatory bodies where we hold 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 annually or upon request to EIB.
External Review
Undergoing external review 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 external review (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 review included selected documents and records review, facilities and equipment inspection relating to the Licence conditions, and relevant interviews with Animal Facility Managers, researchers and others.
Several non-compliances were identified during the review, all of which have now been resolved.
La Trobe University underwent an Independent External Review by EthiQualia from August through October 2024. This Review covered the AEC operations and was in fulfillment of its obligations under Section 6 of the Code for the Care and Use of Animals for Scientific Purposes.
Managing post-approval requirements
Post Approval Submissions through PRIME Researcher Portal
All post approval submissions relating to an AEC approved project must be made through PRIME. If you would like assistance with PRIME or would like to provide feedback on your experience, please see below:
- Training opportunities:
- Schedule a personalised session for help with your first submission by sending a request to animalethics@latrobe.edu.au
- Register for a mandatory Animal Ethics Induction session via TRACR
- 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
Modifications to approved AEC projects
Modifications to AEC-approved projects can only be granted if the modification is minor and there is no significant change to the direction of the study.
Modifications 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 modification requests for more information.
How do I submit a modification?
- Complete AEC Request for Amendment Form
- Prepare a tracked and clean copy of all updated documents
- Log in to PRIME Researcher portal to create a new amendment request:
- To find your ethics project click on “My Ethics Approvals” tile and select the Ethics Approval Number you wish to modify,
- At the top of the ethics record select “Create Modification” from the drop down menu
- Upload a completed request for amendment form and a clean and tracked copy of the previously approve application form containing the requested modification in the "Post approval documents" tab
- 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 to submit.
Annual and final reports
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?
- Download and complete the Annual Report Form or Final Report Form
- Log in to PRIME Researcher portal to lodge an annual/final report:
- 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,
- At the top of the ethics record select “Create Annual Report” or “Create Final Report” from the drop down menu
- Upload a completed annual/final report in the "Post approval document" tab
- In the progress bar select "Review by Research Office" and then click "Mark as Current Status" to the right to submit.
Unexpected Adverse Events & Non-Compliance
Unexpected Adverse Events (UAEs)
Investigators are required by law to provide prompt notification of any unexpected adverse event to the research projects approving AEC (see Clause 2.4.34 (ii) of the Australian Code).
UAEs must be reported to the AEC within 24hrs of the incident (or as soon as practicable for field work where investigators may not have mobile phone access within 24 hours of the incident) by email to animalethics@latrobe.edu.au.
An Unexpected Adverse Event Report Form should then be submitted promptly via PRIME once all subsequent follow-up actions/investigations have been completed.
NOTE: If your animal is housed in LARTF, notify the LARTF Facility Manager and the relevant area LARTF staff member of the UAE and follow any additional LARTF protocols as directed.
How do I submit a UAE Report on PRIME?
- Download and complete the Unexpected Adverse Event Report Form
- Log in to PRIME Researcher portal to lodge an UAE report:
- To find your ethics project click on “My Ethics Approvals” tile and select the Ethics Approval Number you wish to submit an UAE Report
- At the top of the ethics record select “Create UAE/Safety Report” from the drop down menu
- Upload completed UAE Report and any other relevant documentation in the "Post approval documents" tab
- In the progress bar select "Review by Research Office" and then click "Mark as Current Status" to the right to submit.
Non-Compliance Reporting
If animal facility staff, academics, other staff or students have any enquiries or concerns about a non–compliance with the Animal Code or AEC approval, or have concerns about the well-being of animals held at La Trobe for use in breeding, research or teaching, these concerns should be reported to the Senior Coordinator, Animal Ethics and Biosafety who will on-refer it to the appropriate person or committee.
For self reported non-compliances, the Principal Investigator may use the Unexpected Adverse Event Report Form to make a report via PRIME.
Please contact the Senior Coordinator, Animal Ethics and Biosafety for further advise on reporting a non-compliance.
T: +61 3 9479 3337
E: animalethics@latrobe.edu.au
FAQs and Guidelines
Guides, Guidelines and Supplementary Information
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
How do I submit a successful AEC application?
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.
Guide to Completing Specific Sections of the Application Form
- 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.
How do I ensure my application is appropriate for AEC review?
- Determine if your project requires AEC approval:
- Make sure:
- To always 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.
- To use plain English language throughout, to the extent possible.
- Provide a glossary of terms where scientific language is unavoidable and can be explained.
- To use easy to read and easy to understand protocols 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 the 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:
- 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.
What is the definition of an animal?
- 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
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
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’.
Do I need to separate my breeding applications from my experimental applications?
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).
What is a minor amendment (that can be considered in between monthly AEC meetings)?
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:
- Examples included 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 where the impact to the animals is the same or less than originally approved;
- opportunistic diagnostic or veterinary activities intended to benefit the animals;
- re-activation of paused projects.
To this LTU AEC will also consider the following as minor amendments:
- removal of personnel;
- time extension (provided all approved activities still meet best practice / ethical standards);
- 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);
- 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;
- 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;
- addition of a new collaborator with appropriate competency records;
- 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);
- 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;
- 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:
- 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.
- 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.
- 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.
- 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.
- 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).
What other documents are required for an amendment request?
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?').
What is an expected mortality rate?
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.
Why do I need to supply annual and final reports and what happens to them?
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 additional documents need to be submitted when submitting an application?
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.
What should I consider if I intend to use privately owned 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.
Can honours students be primary contact?
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.
How do I add a new strain to a Breeding application?
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.
Do I need to provide details for intermediate strains generated as part of my breeding strategy?
- 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.
What does the AEC do during its meetings?
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.
What does the AEC consider in reviewing applications?
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.
What happens when I am co-investigator on a project that does not involve LTU premises or animals on premises?
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:
- Log in to PRIME Researcher portal to create a new Externally Approved Application:
- Under Ethics Applications, click “+ New Externally Approved Application”
- Add all researcher personnel
- Upload all completed forms and study documentation (as separate documents)
- 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.
Do I need approval for Human-focused research involving animals?
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.
What do I need to consider for AEC approval of revised SOPs?
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.
Do I need to submit a fieldwork notification?
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.
Which procedures / training are offered by LARTF?
Please refer to the LARTF website.
How can I attest competency?
- 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.
How many amendments can I have before it is considered a new project?
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.
What do the AEC look for when monitoring research, laboratories and facilities? Do I need to supply information for inspections?
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.
Do all researchers and students need to attend LTU animal ethics induction sessions? When are these held? What does the AEC consider in reviewing applications?
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
Do I have to specify the species in my project title?
Where possible, the AEC recommends specifying the species within the project title.
Do I have to provide information about the type of the project?
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.