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.

Changes to Your Protocol

Amendments (including Extensions)

Amendments and extensions to protocols need to be submitted by the same submission dates as for new applications. 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

Change of 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.

Work must not commence at the new location prior to AEEC and Government approval.

If your licences or permits are received or renewed during the term of the protocol, a copy must be sent to the Animal Ethics team.

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

If an Unexpected Adverse Event (UAE) occurs, 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: Report the UAE to the Animal Experimentation Ethics Committee

If you are unsure, 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 report is a report to the Animal Experimentation Ethics Committee (AEEC) required under the Code. It must be completed on the one year anniversary of an approved protocol’s start date. 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 required 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.

The University must provide these numbers to the state and territory governments in order to maintain the AEEC’s licences for ANU research to continue to be conducted in the ACT and interstate.

The species, the number of animals used and the Australian state or territory where the animals were used must be reported. 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, a report is to be submitted to the AEEC as soon as practicable. This is required by the Code. Complete this report upon the completion or discontinuation of your project, and email it to the Animal Ethics Team. If an approved study has not commenced, this report must still be completed.

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: Amendments (including Extensions) above.

 

Renewal

Animal ethics protocols expire three years after initial 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.

 

Assistance

Please visit the Resources, Training and Support page for ways that you can get help with your Animal Ethics protocol.

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