Do I need ethics approval?
Ethics approval is required before any research or teaching involving animals can commence. This includes observation only studies, as the animals’ natural behaviour and environment may be disturbed as a result. The use of animal cadavers may also require prior ethics approval.
The definition of animal includes: any live non-human vertebrate (that is, fish, amphibians, reptiles, birds and mammals encompassing domestic animals, purpose bred animals, livestock, wildlife), adult decapod crustaceans and cephalopods.
Please contact the animal ethics office if you are unsure whether ethics approval is required.
What is AEEC?
The Australian National University's (ANU) Animal Experimentation Ethics Committee (AEEC) approves, monitors and regulates the use of animals in research and teaching carried out at ANU, and ensures that all research involving animals is conducted in accordance with the National Health and Medical Research Council's (NHMRC) Australian Code for the Care and Use of Animals for Scientific Purposes 8th Edition and the ACT Animal Welfare Act 1992. Other important guidelines include:
- The NHMRC Guidelines to Promoting the Wellbeing of Animals used for Scientific Purposes (2018)
- The NHMRC’s Best Practice Methodology in the Use of Animals for Scientific Purposes (2017)
- A Guide to the Care and Use of Australian Native Mammals in Research and Teaching (2014).
Copies can be found on the animal ethics website under Legislation and Guidelines.
For more information on the AEEC, please refer to a separate FAQ document about the AEEC.
What is ARIES used for in the animal ethics process?
For research staff to:
- To submit Biomedical and Wildlife Research Experimental protocols to the AEEC
- To submit Animal Ethics Annual Reviews
- To review who is listed on their protocol and who has been removed
- To check protocol expiry dates
For the ethics office to:
- Record amendments to the approved protocol
- Record AEEC decisions (new protocols and amendments)
- Record animal use numbers
- Run reports
How do I apply for a new proposal?
Animal Ethics protocol applications are entered directly into the ARIES Research Management System. User Support Information is available to assist with creating or updating a protocol. To start your ethics protocol, please login to ARIES.
Applications submitted in ARIES must be printed as a hard copy, and require original signatures. All proposals and amendment applications must be received by the Animal Ethics Officer by the set cut off day which falls towards the end of the previous month. For exact dates and times see Submission Deadlines on the animal ethics website. The AEEC meets on the 3rd Tuesday of every month except December.
Who is responsible for the protocol?
The Principal Investigator (PI) is responsible for the protocol as required by the Code which states: “Investigators must only consider using animals when they are satisfied that a case can be made that the proposed use is ethically acceptable, based on whether such use demonstrates the principles in Clause 1.1, and balancing whether the potential effects on the wellbeing of the animals involved is justified by the potential benefits (see Clause 1.3). Investigators should seek advice and information from relevant experts, including other experienced scientists, veterinarians, animal care staff, or specialists in laboratory animals, livestock or wildlife, when necessary.”
Who needs to be included on an application to the AEEC for a project? Can new people be added onto an approval if they join the project later on (e.g. a research assistant)?
All researchers that are responsible for any aspect of the protocol or will undertake any work under the protocol must be included. New people can be listed to a protocol at any time by completing the appropriate form and submitting it to Research Services. New co-investigator forms can be found under the forms section at https://services.anu.edu.au/research-support/ethics-integrity/animal-ethicspolicies-guidelines-training-and-forms
Principal investigators must ensure that new staff have read and understand the approved protocol, approval conditions and the Code. As well as ensuring new staff and students have undertaken the relevant training and assessment required to fulfil their obligations under the protocol and the Code.
Who can I ask for help with developing specific aspects of my proposal?
As noted above, the PI is responsible for the development of the protocol. Help can often best be obtained from other researchers who have used a similar regime, not necessarily at the ANU. Researchers are often following an established experimental regime from the academic literature. Publications rarely contain sufficient information and therefore direct contact with the author is recommended, particularly where, the expectation is to use the experiment as part of a comparative study with previous work. Under the Code PIs are responsible for pulling together the relevant information and expertise. Where veterinary guidance is needed this can be sought from the University Vet. Where new and difficult techniques of animal handling or experimentation are intending to be used an early discussion with the Vet is recommended. RSD is willing to provide initial guidance and will assist in sourcing specialist advice where possible. It must be noted that notwithstanding such inputs the protocol still needs to go through full AEEC processes and acceptance as required under the National Code.
Once my application is submitted, what happens next?
Your protocol will be circulated to the AEEC and they will be given an opportunity to provide electronic comments prior to the meeting. Where issues can be clarified ahead of the meeting then attempts are made to do so. The AEEC then considers all the comments in a quorate and formal meeting. As required under the Code attempts are made to reach agreement by consensus. Where possible protocols are approved subject to the changes to be agreed with the PI. The PI then receives the suggested changes and these are agreed with the PI out of session wherever possible. The AEEC does have the right to reject proposals out right. Where this happens the reasons for the decision will be clearly communicated to the PI. The AEEC may also place conditions on the approval; if investigators do not understand the conditions or don’t believe they can comply they must promptly notify the AEEC.
What if I need to make an amendment after the project has been approved?
Notice of any proposed changes or variations to an approved Protocol during the duration of that protocol must be approved by the AEEC. Such proposed changes might be for example, the addition of a technique, location, drug, strain or species not included in the original proposal. Any changes to animal numbers must be included. Major changes in direction of research will require a new proposal. For guidance as to whether an amendment or new proposal is relevant please email firstname.lastname@example.org outlining proposed changes. Amendments can be submit by completing the amendment form which can be found in the Forms Section on the animal ethics website.
What is an unexpected adverse event?
An unexpected adverse event is something that happens that has not been laid down in a protocol. If a protocol states that there are no expected deaths at a certain stage in the experimental process and one occurs then this is classed as an unexpected adverse event. Protocols need to be drafted in the same way as risk management plans seeking to identify possible outcomes and taking those into account.
What is an Annual Review?
The Principal Investigator is required to report on the progress of the research Protocol each year on the anniversary of the approval date. It is an AEEC requirement that all research is reviewed and approved annually, as per the code. Please login to ARIES to complete and submit your report or download and complete the ANU AEEC Annual Review Form.
What are my responsibilities with Animal Use Data?
The Principal Investigator is required to record the total number of animals used for each calendar year and provide the details upon request from the ethics office. This information is reported to various statutory bodies. Complete the Annual Numbers generic form and send to email@example.com.
What is a Study Expiry/Completion Report?
The Code requires that for projects that have been completed or discontinued, a report should be submitted to the AEEC as soon as practicable. Please download and complete the ANU AEEC Expiry/Completion Report and send to firstname.lastname@example.org.
How do I report animal welfare concerns?
Animal welfare concerns may include:
- departures from the humane and ethical treatment of animals in animal holding rooms, production rooms or, where appropriate, the laboratory.
- breaches of the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes.
Anyone concerned about the welfare of animals at the ANU should report their concerns to the Executive Officer of the ANU Animal Ethics Committee (email@example.com or T: 6125 4290). Please be assured that concerns will be treated confidentially and sympathetically. Any such concerns will be discussed at a full meeting of the Animal Experimentation Ethics Committee; membership of the Committee includes animal welfare and community representatives. Urgent matters should be referred to the veterinarian on-call 24/7 on 6125 1130.
Can I publically share media (e.g., photos) from my research?
Always keep your photographs, videos, research results and comments about your work secure. Do not post them on social media or pass them on beyond professional capacity. Social media accounts should only be used if they are an approved part of formally promoting your research and content must be moderated. For further information, contact the ANU Media Office (Strategic Communications and Public Affairs team, SCAPA, T: 612 57979).