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:

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

 

Changing your protocol

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

Amendments (including extensions)

Amendments and extensions to protocols need to be submitted by the same submission dates as new applications. Please complete the "Amendment Application Form" linked in the sidebar and email it to animal.ethics@anu.edu.au. For extension requests please use part A of the amendment form; for all other types of amendment use part B. 

If you are requesting an extension, you must ensure that the extension is approved before the expiry date of your protocol. Only one 3-month extension can be granted to a protocol. In addition, the Committee are unable to consider any amendments to the original protocol for the extension period. For urgent assistance, contact animal.ethics@anu.edu.au.

Adding investigators or changing nominees

Please complete the "New Investigator Form" linked in the sidebar and email it to animal.ethics@anu.edu.au. For ANU students and new staff members, please also make sure their ARIES account has been activated. If not, they will need to complete a New User 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)

If an Unexpected Adverse Event occurs during the course of your research, the researcher must Act, Inform and Report. 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:
    • Fill in the "Unexpected Adverse Event Reporting Form" from the right-hand sidebar and submit this to animal.ethics@anu.edu.au
    • Reports must be received by the AEEC within 72 hours of the event occurring. Investigators working in remote locations must submit the written report within 10 days.

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 UAE Procedure.
 

Reporting Requirements

Annual Review

The Annual Review is a report to the Animal Experimentation Ethics Committee (AEEC), as required under the Code. It 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.

The annual review provides the AEEC with details on the progress of the 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.

Animal Use Numbers

Annual animal use numbers are 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 note the species, the number of animals used and the state or territory where the animals were used. Animals used overseas must also be reported. 
 

Expiry or completion of your protocol

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) or if it never actually began. Please note the Expiry Completion Report also includes your annual animal numbers for the year of expiry/completion.

To extend your protocol, please see Changes to Your Protocol above.
 

Renewal

Animal ethics protocols expire three years after approval. The AEEC will accept amendment requests for up to three months' extension of approval (see the Amendments section above). To renew your protocol for longer than three months, you must resubmit your protocol through ARIES. When doing so, please ensure that you submit the most recent version of the protocol, including updates from prior Q&A and amendments. Submit your application for renewal with sufficient time ahead of your expiry date to ensure uninterrupted continuation of your project.
 

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