FAQs About the Animal Ethics Committee

​​​​This page has been prepared for users of the Department of Primary Industries, Parks, Water and Environment (DPIPWE) Animal Ethics Committee, and contains information about the application process, application forms, what happens after approval, AEC policies and guidelines and contains the answers to frequently asked questions. When preparing new applications or reporting against current projects, it is important that you read the information contained on this page. 

 

Background


1. Why do​​ I need​ An​​​imal Ethics Com​​mittee (AEC) approval?

The humane treatment of animals is a community expectation embodied in law.

AEC approval is a legal requirement for scientific activities involving the use of animals.
The Department's Animal Ethics Committee derives its authority from two sources, each with a slightly different but overlapping focus and different legal status:
  1. the Australian Government National Health and Medical Research Council Australian code for the care and use of animals for scientific purposes, 8th Edition (2013, "the Code")​, which provides the framework for national consistency in the humane care and use of animals for any scientific purpose, and sets out the functions and practices of animal ethics committees; and
  2. The Tasmanian Animal Welfare Act 1993, which sets out the legal framework to ensure the welfare of animals used for any purpose, including for research, in Tasmania. The Code has been approved as the relevant Code of Practice under the Act.
Under the Act, a person must not carry out any animal research unless they do so as part of an institution licensed under Part 4 of the Act (Section 27). A licence will not be granted unless the institution has a properly constituted animal ethics committee (AEC)**. It is also a condition of its licence that an institution must not commence animal research until the research is approved by the AEC (Section 30(3) of the Act).

The Department is a licensed institution has established its AEC in accordance with the Code to oversee internal projects. The DPIPWE AEC also provides services to some licensed institutions in Tasmania that do not have their own AEC, and where the research proposed is in the public interest.

Section 27 of the Act does not apply to:
  1. the owner of an animal who conducts observational studies on the animal; or
  2. a person who administers veterinary treatment to an animal for the welfare of the animal; or
  3. a person who conducts normal animal management operations.
All animal use for scientific purposes - which covers the acquisition, development or demonstration of knowledge or techniques in any area of science including research, teaching, field trials, product testing, diagnosis, the production of biological products and environmental studies - must be conducted in accordance with the Code. The purpose of the Code is to ensure the humane care of animals used specifically for scientific purposes.

** Note: The Act uses the term "Animal Experimentation Ethics Committee" but the Code refers to "animal ethics committee", and this is the normal usage.

2. Who n​​​ee​​​​ds AEC approval?

If you are proposing to carry out animal research as defined in the Animal Welfare Act 1993 (the Act) you must obtain AEC approval prior to undertaking this research.

The definition of 'animal research' under the Act is as follows:
"animal research" means a procedure, test, experiment, inquiry or study on an animal which -
  1. is undertaken to develop, demonstrate or acquire knowledge, or techniques, in an area of science or teaching; and
  2. is likely to have a significant adverse effect on the welfare of the animal."
The DPIPWE webpage on Animal Research provides useful guidance on "What is animal research?", and "What is an animal?".

Projects may require AEC approval for other reasons including:
  • internal and collaborating institution policy or programs;
  • conditions of funding;
  • publishing rules; or
  • permit requirements.
The AEC may also consider proposals to use animals for purposes, such as teaching, demonstrations, environmental studies or field trials.

It is your responsibility as investigator to check whether your project needs AEC approval for legal or any of these other reasons. 

3. Wha​​t if​​ I do not​​ have AEC approval?

If you do not have AEC approval and you are conducting research with animals as defined in the Act, you may be in breach of the law, particularly Sections 8 (Cruelty to animals) and 9 (Aggravated cruelty) of the Act.

You are protected from Sections 8 (Cruelty to animals) and 9 (Aggravated cruelty) if you are conducting research which is carried out:
  1. with the approval of the Animal Experimentation Ethics Committee; and
  2. in accordance with any procedures approved by the Animal Experimentation Ethics Committee; and
  3. in accordance with a Code of Practice relating to animal research.
There may be serious consequences of failing to obtain AEC approval before carrying out research, scientific studies or teaching with animals, such as: inability to publish results or conduct further research; disciplinary action under the State Service Code of Conduct; or prosecution under the Animal Welfare Act 1993, potentially resulting in a fine and/or custodial sentence.

4. What if I​ hav​​e already carried out my project? Will the AEC consider approving my project retrospe​​ctively?

No, the AEC will not consider approving any project retrospectively. It is the responsibility of the investigators to ensure that they have all necessary approvals before carrying out a project using animals.

5. What​​​ ha​​ppens if my project is being conducted jointly under the auspices of at least two instit​​utions?

If staff from more than one institution are participating in your project, you will need to consider your obligations to the AECs of all participating institutions. AECs from each participating institution may need to approve and be kept informed of your project or the institutions may agree that one AEC could be the 'lead' AEC and keep the other AEC(s) informed.

There may need to be an agreement between each institution to ensure that all parties involved are aware of and can meet their respective responsibilities under the requirements of the Code and relevant legislation.
 

6. W​ho co​mprise​​​s the AEC?

The Animal Welfare Act 1993 requires AECs to be properly constituted in accordance with the Code. The Code requires the AEC to have a membership that will allow it to fulfil its Terms of Reference. The AEC must comprise at least four persons, including a separate person appointed to each of four categories.

  • A (a person with qualifications in veterinary science and with experience relevant to the activities of the institution...)
  • B (a suitably qualified person with substantial recent experience in the use of animals in scientific or teaching activities...)
  • C (a person with demonstrable commitment to, and established experience in, furthering the welfare of animals, who is not employed by or otherwise associated with the institution...)
  • D (a person who is both independent of the institution and who has never been involved in the use of animals in scientific or teaching activities...).
  • The AEC must also have a Chair, who may or may not be an additional member of one of the categories of membership.

    Application and Approval Processes

    7. How do I ap​​​p​​ly ​​for AEC approval?

    If you are required to have AEC approval to use animals in your project, contact the AEC.

    DPIPWE investigators and investigators from other institutions with permission to access the DPIPWE AEC can download an application form from the AEC Forms webpage.

    When drafting your application, it is important to remember that most AEC members are non-scientists. Thus, to ensure that all AEC members are provided with sufficient information to participate in the assessment of applications, it is essential that they are written in plain English. Where the use of scientific language is unavoidable, applicants must ensure that a suitable lay description or glossary of terms is provided.

    Internal applications must be submitted via your General Manager to the General Manager, Biosecurity Tasmania, who will determine whether the proposed research activity constitutes animal research, pursuant to the Animal Welfare Act 1993. If AEC consideration is deemed to be required, applications will be forwarded to the AEC Executive Officer for processing.

    External applications can be submitted directly to the AEC Executive Officer, by either:
    Please note that incomplete or unsigned applications will not be accepted.

    8. Do I need to​​​ have my app​​lication submitted by a particular date?

    Yes. The AEC meets every six weeks to consider applications and reports in-session. The deadline for submissions is two weeks prior to each meeting. The AEC Meeting Roster lists upcoming meeting dates and submission deadlines. Please note that applications received after a submission deadline has closed will be considered in the next period, and this will need to be taken in to account when planning a research project. Applications will only be considered for late acceptance should there be extenuating circumstances.

    At the discretion of the AEC, urgent applications may be considered out-of-session, only should the immediate use of animals be required for the diagnosis of unexplained and severe disease outbreaks, or morbidity/mortality in animals or people. All other applications will be considered at in-session meetings only.

    9. What happe​​ns ​once my application is submitted?

    The Chief Investigator will receive an email from the AEC Executive Officer to confirm receipt of the application and advise of the AEC number allocated to the project. If you do not receive this confirmation, it is best to contact the AEC Executive Officer to ensure your application was received.

    Applications are circulated to AEC members prior to each AEC meeting. Any questions raised will be forwarded to the Chief Investigator for response. The Chief Investigator may be invited to attend an AEC meeting to provide further information on a research project.

    In reviewing applications, the AEC will refer to the Code, the Act, any other relevant guidelines and standards developed for the ethical treatment of animals. Approval will only be granted to research projects for which animals are essential and justified and which conform to the requirements of the Code and the Act. The AEC will take into consideration factors including ethics, the impact on the animal or animals and the anticipated scientific and educational value.

    After considering an application, the Committee will make one of four decisions:
    • "Approved": The proposed use of animals is approved and work using animals may commence.
    • "Approved with conditions": The proposed use of animals is approved and work may commence. However, the Committee has placed additional restrictions, requirements or conditions on the approval, which must be adhered to.
    • "Not approved (further information required)": The Committee views the application favourably, however, cannot approve the proposed use of animals until further satisfactory information is provided and considered.
    • "Not approved": The proposed use of animals is not approved. Resubmission of the application unchanged will not change the outcome.
      If the application is approved, the Chief Investigator will be issued with an Animal Research Approval Certificate, which they must retain for their records. The Approval Certificate outlines the conditions for each project, and these must be adhered to as approval may be withdrawn for projects that do not comply with the conditions outlined.  If the application is not approved, the Chief Investigator will be informed and avenues for reconsideration or appeal discussed.

    10. Why d​​o applications get​ rejected?

    The Code states that the AEC can only approve those scientific and teaching activities that conform to the requirements of all relevant sections of the Code and legislation.

    In determining whether a proposal meets the requirements of the Code, the AEC must assess if the proposed use of animals in the research or teaching activity is justified. For the criteria used to assess justification for the project, see section 1.1 of the Code. The AEC must consider whether the principles of Replacement, Reduction and Refinement have been considered and can be adhered to. Proposals that do not meet these requirements cannot be approved. These principles are explained in the section on 'The 3 Rs'.

    11. What do​es an Animal Research A​​​pproval Certificate cover?

    AEC approval covers everything that has been detailed in your original application. If any aspects of the your project differ from that detailed in your original application, you need AEC approval to modify your project, which can be sought by submitting an Application to Modify an Approved Project form (see Questions 17 to 19 below).

    The AEC is not responsible for considering other permits that your project might need. For information about other permits, see Scientific permits (fauna).

    12. For ho​​w long can​ approval be granted?

    Whilst there is no minimum for approval, there is a maximum of three years. If your approved project is going to continue past three years, you will need to get separate approval for the second and/or later stage(s). To do this you must submit a Final Report for your current project, as well as a new application for the next three years or the remainder of your project. You will need to consider the AEC's meeting schedule to ensure continuity of approval for your project.

    13. When can I st​​​art​ my project?

    You can commence your project once you receive your Animal Research Approval Certificate, which has been signed by the AEC Chair, as long as you have already received any other permits which your project might need.

    Once your project is approved

    14. What are th​​e ​​​obligations of investigators?

    Conducting your project
    As an investigator, you are responsible for ensuring that your project complies with the Act and the Code. This includes complying with the conditions of your institution's animal research licence, and the conditions of AEC approval for projects.

    The Code defines an investigator to be 'any person who uses animals for scientific purposes' and states that 'investigators and teachers who use animals for scientific purposes have personal responsibility for all matters relating to the welfare of these animals. They have an obligation to treat the animals with respect and to consider their welfare as an essential factor when planning or conducting projects.'

    Investigators who are also employees of the State Service as defined in the Tasmanian State Service Act 2000 must comply with the State Service Code of Conduct and the State Service Principles.

    R​​eporting
    The Code and the standard conditions of approval for an AEC project require investigators to keep the AEC informed of all project developments through reports, including:
    • Annual reports (for projects lasting more than 12 months; these must be submitted no later than one month prior to each anniversary of approval)
    • A final report, upon conclusion of the project or its approval period (including if the project is completed or abandoned early)
    • Annual animal usage report for each (calendar) year of the project
    • An Adverse Incident Report, should an incident occur (see Question 20)
    Upon considering these reports, the Code provides that "an AEC may determine, on the basis of the report and further consultation with the investigator, that the may continue, be suspended, require modification or be discontinued".

    The AEC can also require other reporting through conditions on Animal Research Approval Certificates.

    15. How will my pro​​​ject be monitored?

    The Code gives the AEC responsibility for ensuring, on behalf of institutions, that all care and use of animals is conducted in compliance with the Code. Monitoring and reporting requirements are set out in sections 2.3.17 to 2.3.29. At any time during the project the AEC may ask for further information from the Chief Investigator so that the AEC can ensure compliance.

    The AEC may invite investigators to give presentations on their project at face-to-face meetings. The majority of these presentations are not mandatory; however, they do provide a good opportunity for you as investigator to meet the AEC and answer questions on your project.

    AEC monitoring visits to inspect project site(s) and animal handling practices are another way the AEC may seek further information about your project and ensure that the use of animals is consistent with what the AEC has approved. The AEC may also ask the AEC Animal Welfare Officer to conduct a monitoring visit to selected projects.

    Given the need for the AEC to be able to contact Chief Investigators, it is important that during all active stages of your project that you are easily contactable. If you are required to take a leave of absence during an active period, you must nominate an alternative Chief Investigator to take your place in the intermediate period. This must be done via an amendment request. See also Question 16.

    16. How do I make a c​​​hange to my p​​roject once it has been approved?

    Approval from the AEC is based on the information provided in your application. Any changes to your project must be approved by the AEC prior to implementation. This includes, but is not limited to:
    • numbers of animals used;
    • species of animals used;
    • additional equipment or techniques;
    • additional locations where animals are sourced from or where the activities are to take place; and
    • additional investigators working on your project.
    To make any changes to your project, you must submit an Application to Modify an Approved Project form, which is available on the AEC Forms webpage. This request to modify your project will be considered by the AEC in the same way that an application is, and you will be notified of the AEC's decision in writing.

    Failure to seek prior AEC approval to change your project parameters may be seen as a breach of the Code of Practice and of your project's Animal Research Approval Certificate, and may result in AEC approval being withdrawn for your project.

    17. My project may need other investigators who are not listed on my application form. Can additional investigators​​​ work on projects with​​out needing AEC approval?

    People who use animals for scientific or teaching purposes, and who have not been approved by the AEC, may be in breach of the Animal Welfare Act 1993 if they conduct a procedure, test, experiment, inquiry or study on an animal.

    The Code (section 2.4.8) requires proposals to contain the names of all personnel involved with the project, their role and details of the experience and training that qualifies them to perform specific procedures on target animals of an approved project.

    If investigators other than those listed on an application form and approved by the AEC are required to use animals for scientific or teaching purposes, the Chief Investigator must notify the AEC and submit an application to modify the project. See also Question 16.

    18. What is an adverse incident? And what are the consequence​s of reporting or not reporting one?​

    An adverse incident is any unexpected event that impacts or may impact negatively on the welfare of an animal in the care of investigators, teachers and animal facility managers. The AEC Operating Procedures further define adverse incidents as including: animal escapes; unexpected illness, injury or death; emergency treatment or euthanasia; or accidents to investigators.

    The Code requires that investigators, teachers and animal facility managers should promptly notify the AEC of any unexpected, adverse events. Every Animal Research Approval Certificate issued by the DPIPWE AEC also contains a condition that adverse incidents, including unexpected deaths, must be reported to the AEC Executive Officer as soon as practicable, with a written report to be provided within seven days of the incident. These reports are considered by the AEC out-of-session, and decisions tabled at the next meeting.

    If you are unsure whether or not an adverse incident has occurred, please contact the AEC Executive Officer, and it will be at the discretion of the AEC as to whether or not an adverse incident report is required.

    Failure to report an adverse incident within seven days is contrary to your Animal Research Approval Certificate. In the absence of notification of adverse incidents, the AEC is unable to fulfil its obligations to DPIPWE or other licensed institutions, to ensure that all care and use of animals by those institutions is conducted in compliance with the Code.

    The AEC Operating Procedures​ provide that, on receiving an Adverse Incident Report, the AEC Executive Officer circulates the report to the AEC members, who may request additional information.

    If they consider it warranted, the AEC may suspend or cancel the project or amend the conditions of the Approval Certificate. The Chief Investigator will be notified of the AEC's decision by the Chair, and the Chair will also provide a report to the head of the investigator's institution on the adverse incident.
     

    19. What if I do not comply with th​​​e Act, the Code,​​ or my project's Animal Research Approval Certificate?

    Failure to comply with your project's Animal Research Approval Certificate may result in the AEC withdrawing or suspending their approval of your project.

    Failure to comply with the Act or Code in delivering your project will jeopardise your institution's ability to conduct animal work and compromise your professional standing and that of others involved. Failure to comply also may compromise your reputation within the community and could result in prosecution for you and/or your institution.

    Please see the AEC Operating Procedures for more information on compliance.

    20. Does the AEC help personnel involved in the care and use of animals for scientific purposes learn more about their obliga​ti​​ons under the Act and the Code?

    The AEC holds regular information sessions for investigators involved in animal research or other scientific and teaching activities using animals. All Chief Investigators of current projects are invited to attend an information session and asked to ensure the attendance of other investigators on their approved projects. Attendance is mandatory for DPIPWE staff.

    To find out about the next information session, contact the AEC Executive Officer.

    Contact

    AEC Executive Officer
    GPO Box 44
    1 Franklin Wharf
    Hobart TAS 7001
    Phone: 03 6165 3144
    Email: executiveofficer.aec@dpipwe.tas.gov.au

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