Managing Your Protocol

How does COVID-19 affect my research?
The University Research Continuity Working Group is assessing the impact of COVID-19 on ANU research. Please refer to the University COVID-19 ethics advice and check the COVID-19 news page regularly for updates.

On this page:

Animal Ethics Forms

Forms for changes and reporting can be found in the ‘Reference Documents’ box on the right.

 

Changing your protocol

If you receive new licences or permits from government bodies, or they are renewed during the term of the protocol, please send a copy to the Animal Ethics team.

Amendments

Any proposed changes to an approved protocol (for example, new techniques, drugs, strains or species, or changes to animal numbers) need to be approved by the AEEC before they can go ahead. Major changes to the research direction can't be covered by an amendment; you may need to submit a new application. If in doubt, email animal.ethics@anu.edu.au for advice.

Amendments and extensions to protocols need to be submitted by the same submission dates as new applications. Please complete the Amendment Application Form (Part B) linked in the sidebar and email it to animal.ethics@anu.edu.au.

Extensions

A three-month extension to your protocol end date can only be granted once and only under exceptional circumstances. To request a three-month extension, you must apply using the Animal Ethics Amendment Form (Part A), with sufficient explanation to the Committee why an extension is required.

  • You cannot apply for an extension if your protocol has already expired. We strongly recommend that you apply at least one AEEC meeting cycle prior to your protocol end date to allow enough time.
  • If you are granted an extension, no new work can be undertaken during the extension period. This includes amendments.
  • No further extensions can be granted.

If you have any questions, please contact the Animal Ethics Team on animal.ethics@anu.edu.au.

Adding investigators or changing nominees

To add researchers to your protocol, please complete the "New Investigator Form" linked in the sidebar and email it to animal.ethics@anu.edu.au. All staff and students who will do work under the ethics protocol should be listed on the ethics protocol.

Please ensure new investigators have done all relevant training, and have read and understood the approved protocol, approval conditions and the Code. ANU students and new staff members will need to make sure their ARIES account has been activated. If not, they will need to complete an ARIES account request form as well.

Changing location

If the location of the work changes after your application has been approved, you must:

  1. amend your AEEC protocol (using the Animal Ethics Amendment Form) to include the new location, and
  2. modify your research permits with government departments.

You cannot start work at the new location until you have AEEC and Government approval. 

Contact the Animal Ethics Team (animal.ethics@anu.edu.au) to confirm and to arrange an inspection if required. You will need to allow time before the move and for inspection arrangements to be made.
 

Unexpected Adverse Events (UAEs)

"UAE" refers to when something happens which was not foreseen in the approved protocol, and which has or may have a negative impact on animal wellbeing. If an unexpected adverse event occurs during the course of your research, you must Act, Inform and Report (AIR). These steps are mandatory as required by the Code.

  • Act: The immediate welfare of the animals is paramount. Remove any obvious hazards; alleviate immediate unexpected pain and distress in the animal.
  • Inform:
    • Notify the ANU Veterinarian ASAP on Ph: 612 51130 (Emergency veterinary assistance, 24/7 on call phone number).
    • Contact the Principal Investigator
    • Contact the animal facility manager (where relevant)
  • Report the UAE to the Animal Experimentation Ethics Committee:

If something happens and you are not sure what to do or whether it is a UAE, please contact the ANU Veterinarian:

  • Emergency veterinary assistance (24/7 on call) Ph: 612 51130
  • ANU Vets Ph: 612 58102 or 612 55392 during business hours for non-urgent matters
  • Animal Ethics Office: Ph: 612 52465 or animal.ethics@anu.edu.au

For more information on UAEs, please see the Procedure for managing and reporting unexpected adverse events under Related Links in the right-hand sidebar.

 

Reporting Requirements

Annual Review

Under the Code, researchers must provide yearly updates on the progress of their research project in accordance with the approval, including the number of animals used to date. The AEEC reviews these at their monthly meetings and formally approves the protocols for continuation.

The Annual Review must be completed on the one-year anniversary of an approved protocol’s start date. You can complete the annual review within your protocol in ARIES, or you can email the "Annual Review Form" through to animal.ethics@anu.edu.au

Animal Use Numbers

Annual animal use numbers are also requested by email at the end of each calendar year. The animal use numbers must capture the total number of animals used under an approved protocol that was valid during that year, regardless of whether the protocol was valid for one day or the whole year. 

This report is different to the Annual Review - ANU needs to provide the state and territory governments with usage numbers for each calendar year, in order to maintain the AEEC’s licences for ANU research to continue to be conducted in the ACT and interstate.

When filling out this report please include the species, the number of animals used and the state or territory where the animals were used. If overseas, please note the country. 

 

A note on sharing media

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 sharing. 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).

 

Expiry or completion of your protocol

Updated April 2021

When your research project is completed or your research project expires (whichever comes first), you will need to submit a final Expiry/Completion Report to the AEEC as soon as practicable. This report is a requirement of the Code (2.4.34.4).

If the project needs to continue past the expiry date, you will need to put in a renewal application (see below). An Expiry/Completion report must still be completed for projects to be renewed.

Expiry/Completion Report

For projects that have been completed (either at the 3 year mark or earlier) or discontinued, you need to submit a final Expiry Report to the AEEC as soon as practicable. This is required by the Code. On the completion or discontinuation of your project, please complete the Expiry Completion Report form and email it to the Animal Ethics Team.

This report is a requirement of the Code. You still need to submit an Expiry Report even if the research project is being renewed (see below). Please note the Expiry Completion Report also includes your annual animal numbers for the year of expiry/completion.

Renewing your approval

Animal ethics protocols expire three years after approval. To renew your protocol, you must reapply for ethics approval through ARIES.

Your new application should incorporate any information from prior Q&A and amendment requests, as well as any updates to your methodology.

Please ensure you submit your application for renewal with sufficient time ahead of your expiry date to ensure uninterrupted continuation of your project – we recommend at least two AEEC meetings prior. This will help to speed up the review process.

When your renewal application is approved, you must still complete an Expiry/Completion report for your previous protocol.

Extensions

An extension to your protocol end date can only be granted once for a maximum of three months, only under exceptional circumstances. Please see Changes to Your Protocol above.

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