Frequently asked questions
Why and when approval is needed, the review and approval process
Why do I need animal ethics approval
The University of Melbourne takes its responsibility to animal welfare very seriously. Through its animal ethics system, the University strives to uphold and further best practice in animal-based science, while reflecting the expectations of the broader community. All proposed work is assessed in accordance with state and federal guidelines and legislation, and a particular emphasis on the ‘3Rs’; Replacement, Reduction and Refinement. Our goal is to only use animals in well-designed and argued research and teaching.
From a researcher’s perspective, animal ethics review provides institutional backing and moral validation for studies involving animals, as well as an opportunity to improve the rigour and quality of projects.
When do I need animal ethics approval?
Are you using (or impacting) an animal?
Performing scientific procedures including killing, handling, affecting the habitat of, or otherwise interacting with an animal always requires animal ethics approval. Even observational studies may require animal ethics approval (because they have the potential to interfere with an animal’s behaviour or habitat). In determining whether approval is required, consider whether any aspect of the life or death of the animal would be affected by the scientific activity.
Is the work for a scientific purpose?
Any new, or ongoing, research or teaching activity using animals always requires animal ethics approval. Routine veterinary care and agricultural practice do not require ethics approval. Where the category of the proposed use is unclear, consult the Office of Research Ethics & Integrity (OREI).
Is approval required for work using the species in question?
Under Victorian legislation approval to use animals for scientific purposes is only required for species defined under Part 3, Section 25 of the Prevention of Cruelty to Animals Act 1986. According to this definition, animal means:
(a) a live member of a vertebrate species including any -
(i) fish or amphibian; or
(ii) 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
(b) a live adult decapod crustacean, that is -
(i) a lobster; or
(ii) a crab; or
(iii) a crayfish; or
(c) a live adult cephalopod including -
(i) an octopus; or
(ii) a squid; or
(iii) a cuttlefish; or
(iv) a nautilus;
What are my professional and legal obligations when using animals?
The use of non-human vertebrate animals for research and teaching in Victoria is directed by State legislation, codes of practice, guidelines and University policy. The key regulatory provisions in Victoria can be found within the Prevention of Cruelty to Animals Act 1986 (“the Act”) and the Prevention of Cruelty to Animals Regulations 2008. Under the Act, University departments and faculties that carry out procedures using live animals must have a Scientific Procedures Premises Licence (SPPL), issued by the Victorian Department of Economic Development, Jobs, Transport and Resources (DEDJTR). Animal ethics committees (AECs) review, approve and monitor the research and teaching projects that emanate from these licensed premises.
The core document directing researchers, teaching staff and AECs in all aspects of scientific animal use is the National Health & Medical Research Council (NHMRC) Australian Code for the Care and Use of Animals for Scientific Purposes (8th Edition, 2013). The Code defines how animal work should be overseen and monitored, and identifies general principles governing the ethical and humane use and care of animals within science. AECs, guided by DEDJTR requirements, apply these principles to animal ethics approval and monitoring within the University.
Who reviews my application?
All new animal ethics applications (and any subsequent amendments) must be reviewed and approved by an animal ethics committee (AEC) before work can begin. The Animal Ethics Team, a unit of the Office of Research Ethics and Integrity (OREI), administers the University’s animal ethics system and processes. The Animal Ethics Team is the first point of contact for all matters relating to animal ethics, as well as the conduit for communication with the AECs.
AECs are established under the National Health & Medical Research Council’s (NHMRC) Australian Code for the Care and Use of Animals for Scientific Purposes (8th Edition, 2013), which includes guidance on membership and terms of reference. According to the Code, AECs must include the following categories of membership:
- Category A: A qualified veterinarian
- Category B: A practising scientist, working with animals
- Category C: A representative of an animal welfare organisation
- Category D: A layperson who is independent of the institution (and who is none of the above)
In addition, the following non-members regularly attend meetings to provide guidance and expertise:
- Animal facility staff members
- Animal Welfare Officers (AWOs)
The University has established four AECs, which are grouped by Scientific Procedures Premises Licence (SPPL) and research or teaching type. These AECs, named for their associated academic divisions, are as follows:
- The Anatomy & Neuroscience, Pathology, Pharmacology & Therapeutics and Physiology AEC
- The Biochemistry & Molecular Biology, Dental Science, Medicine (RMH), Microbiology & Immunology and Surgery (RMH) AEC
- The Faculty of Science AEC
- The Faculty of Veterinary and Agricultural Sciences AEC
The work of the AECs is overseen by the University’s Animal Welfare & Ethics Committee (AWEC). As a governance committee, AWEC also reviews University policy and procedure as it relates to research and teaching using animals.
How long does the application review take?
There is no definitive answer to this question; the time taken for an animal ethics application to be reviewed depends on a number of factors, including animal ethics committee (AEC) meeting schedules, work proposed, application type, application quality and researcher revision time. As such, there are a number of things to consider when planning your project.
AECs meet every month (except January and July), and deadlines for application submission are ten business days prior to each meeting. In planning your project, you should keep an eye on these dates so that you don’t miss a submission deadline. Note, animal ethics applications will not be accepted after the relevant submission deadline except where there is an animal welfare concern.
Ultimately, application quality is the greatest determinant of review time. Well-prepared applications, proposing well-argued and designed research or teaching projects require less review. For this reason, it’s important to take time and effort in preparing your application; review the guidance material provided on the OREI website, refer to the Animal Care & Use Standards, and consult your colleagues, animal facility staff, the Animal Ethics Team and Animal Welfare Officers (AWOs).
New applications, especially those proposing new or complex procedures, require a great deal of consideration from the AECs and as such, multiple reviews may be required. Amendment applications on the other hand generally propose minor changes, and are typically reviewed more quickly.
Following a meeting, the AEC secretary prepares feedback on the review of your application. Feedback typically consists of a review ‘outcome’, and in some cases, a list of revisions required to the application. The Office of Research Ethics & Integrity (OREI) aims to provide all feedback within five business days of the meeting. This allows at least five business days before the next submission deadline, should revisions be required. It is important that you complete these revisions and resubmit the application as soon as you’re able, as missing a submission deadline can prolong the application’s review by at least one month.
Lastly, ethical review takes time, so it’s important to plan ahead. It’s always best to submit your application as early as possible, and allow time for revision and resubmission, prior to your planned commencement of the work.
How long is animal ethics approval valid for?
How long is animal ethics approval valid for?
Work using animals cannot commence until you receive a formal notification of approval. Notifications make reference to the application’s ID number, title, and approving AEC, as well as outlining any conditions of approval. Animal ethics projects are granted approval for a period of three years from the initial date of approval. At any time, you may check your application’s start and end dates in Themis.
Approval is limited to your application’s scope, and any variation to your proposal must be reviewed by an Animal Ethics Committee (AEC) through an amendment application. While amendments may alter the conditions of approval, they do not automatically extend the period of approval.
Can I extend my project’s period of approval?
You may request an extension if, due to circumstances outside of your control, your project is unable to be completed within the initial period of approval. Such instances may include staff absence due to maternity leave or illness, and unavailability of animals or equipment. As with all other variations to the original conditions of approval, extension requests must be reviewed by an AEC (or its delegate) through an amendment application.
What is an unexpected adverse event?
What is an unexpected adverse event?
An unexpected adverse event is any event that has a negative impact on the wellbeing of animals under your care, and which was not anticipated, or has occurred at a frequency or severity in excess of what was anticipated as outlined in your animal ethics project.
When should I report an unexpected adverse event?
All unexpected adverse events must be reported to the Animal Welfare Officer (AWO) and relevant animal facility manager (AFM) immediately. Further courses of action will then be determined based upon the specifics of the event.