Managing Your Protocol

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.

Amendment applications

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 AEC before they can go ahead.

If major changes to the research direction can't be covered by an amendment; you may need to submit a new protocol/ application. If in doubt, email animal.ethics@anu.edu.au for advice.

An amendment can be applied for in REMS. See REMS SharePoint site for amendment application steps.

Justification for your amendment must be included in the application.

Once the amendment is approved, your protocol will have a new version number and can be tracked in your REMS protocol record using the ‘History’ tab. The most recent version of your approved protocol with all approved changes will be the version that shows in the REMS system.

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

Extension applications

A three-month extension to your protocol end date can only be granted once and only under exceptional circumstances. It is therefore strongly recommended that all replacement protocols are applied for at least two meetings prior to the approved end date to ensure a smooth transition covering any animals in care without an extension being required.

To request a three-month extension, you need to apply following the REMS amendment application process with sufficient explanation/justification to the Committee as to why an extension is required.

See REMS SharePoint site for amendment application steps.

Extension period operates with some slight differences from a standard protocol, please note:An application for an extension must be approved before the commencement of the extension period. You therefore cannot apply for an extension if your protocol has already expired. We strongly recommend that you apply for the extension at least one AEC 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. Any amendments to the approved protocol must be submitted and approved before the original end date/before the extension period commencement.

No further extensions can be granted. If work needs to continue past the extension end date, a new protocol must be applied for. If there are animals in care this must be done as soon as possible to ensure a smooth transition.

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

Adding investigators or changing Primary Investigator or Nominee

All staff and students (other than staff undertaking basic animal care) who will do work under the ethics protocol must be listed on that protocol. They can be added by following the REMS amendment application process if joining after a protocol has been approved.

For new investigators of any category:

1. Ensure all new investigators have done all relevant training, and have read and understood the approved protocol, approval conditions and the Code.
2. Add the new investigator to the PI’s team in REMS and select their role in the team
3. Add the team member to the relevant project in REMS and select their role in the project
4. Add the project member to the respective form, following the REMS amendment application process
5. Upon approval, ensure all new members complete their sign off, to acknowledge their agreement to the role.
6. Check if any additional sign offs are required for the application.

See REMS SharePoint site for adding a new investigator and amendment application steps.

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

Changing location

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

1. amend your AEC protocol to include the new location following the REMS amendment application process, and
2. modify your research permits with government departments.

See REMS SharePoint site for amendment application steps.

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

If location change includes a new animal holding facility, contact the Animal Ethics Team (animal.ethics@anu.edu.au) to confirm and to arrange an AEC New Facility Inspection if required. You will need to allow time before the move for inspection arrangements to be made. The ACT Government Vet may also need to visit the facility for approval which the Animal Ethics Team  can assist with arranging.
 

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 an ANU Vet ASAP on Ph: 612 51130 (Emergency veterinary assistance, 24/7 on call number, leave contact name and number if vet on another call.).
• Contact the Principal Investigator/s of affected protocol/s
• Contact the animal facility manager (where relevant)

Report:

To report the UAE to the Animal Ethics Committee (AEC):

• Fill in the "REMS Unexpected Adverse Event form.using the “+ Add Form’ button in the relevant protocol.
• Reports must be received by the AEC within 72 hours of the event occurring.
• Investigators working in remote locations must submit the written report within 10 days.
• An ANU Vet or the Animal Ethics Team will be in touch if further information or follow up actions are required

See REMS SharePoint site for UAE reporting steps.

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

• Emergency veterinary assistance (24/7 on call) Ph: 612 51130 (leave a message with return phone number)
• ANU Vet Services Office Ph: 612 58102 or vetservices.ris@anu.edu.au during business hours for non-urgent matters
• Animal Ethics Office: Ph: 612 52465 or animal.ethics@anu.edu.au during business hours for non-urgent matters

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

Animal Ethics Reporting Forms

Forms for reporting can be found in REMs within your protocol record. Select the blue “+ Add Form” button to find and select the form required.  Report forms include:

• Annual Report
• Final Report
• Unexpected Adverse Event (UAE) Report
• Animal Use Report
• Other AEC Protocol Reports (in development)

See REMS SharePoint site for Reporting.

If you have any questions or require more time for report submission, contact the Animal Ethics Team on animal.ethics@anu.edu.au

Annual Report

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 AEC 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 REMS by selecting the “+Add Form” button.REMs and selecting the “Annual Report” form

See REMS SharePoint site for Reporting.

Annual Reports are due within four weeks of the anniversary date of your protocol.
 

Animal Use Report

Annual animal use numbers are collected for each calendar year and are required by

1. 31 January of the following year during the protocols ‘life cycle’, and
2. Within two weeks of a protocol’s completion, discontinuation or expiry/end date

The report form is on REMS. In your protocol record you select the “+ Add Form” button and select the “Animal Use Report” form. See REMS SharePoint site for Reporting.

The animal use numbers must capture the total number of animals usedunder an approved protocol that was active during that year, regardless of whether the protocol was valid for one day or the whole year. This includes any animals added by amendment. This report is different to the Annual Report - ANU needs to provide the state and territory governments with usage numbers for each calendar year, in order to maintain the AEC’s licences for ANU research to continue to be conducted in the ACT and interstate.

When filling out this report please follow the prompts to include the species, the number of animals used and the state or territory where the animals were used. In REMS the forms have been designed to include each state/territories animal use reporting questions when that State or Territory is selected. You can select all states/territories you are working in within the one form for your reporting.

If you have an overseas project, you can note the country using the international option. 

If you did not use any animals under your approved protocol/s, please note this on the form as ZERO and also submit.

If you need clarification on what to include, please refer to the 'ANU Animal Usage Accounting Standards' for the agreed ANU animal use accounting methods.  This will outline which animals need to be included in your animal use numbers each calendar year.

Unexpected Adverse Event Report

If they occur, all unexpected adverse events (UAEs must be reported to the within 72 hours.

The report form is on REMS. In your protocol record you select the “+ Add Form” button and select the “Unexpected Adverse Event” form. See REMS SharePoint site for Reporting.

For further information see Unexpected Adverse Events (UAEs) above.

Other AEC Protocol Reports

For pilot and first experiment testing within a protocol and for high risk protocol procedures, the AEC may require additional reporting as part of a protocol’s approval. The Committee will advise if, what and when these reports are required via a protocol approval condition.
 
Currently these types of protocol reports are submitted to the AEC via email to animal.ethics@anu.edu.au. An online report form is planned to be added to the set of REMS animal ethics reports. Once this form is available in REMS, you can submit the form in your protocol record by selecting the “+ Add Form” button and selecting the form. See REMS SharePoint site for Reporting.
 

Final Report

When your research and/or teaching project is completed, discontinued or your protocol expires (whichever comes first), you will need to submit a Final Report to the AEC as soon as practicable, ideally within 4 weeks of the expiry or completion date.

This report is a requirement of the Code (2.4.34.4); that the AEC receives and reviews reports at the end of a project for all animal ethics protocols.

If the project needs to continue past the expiry date, you will need to put in a renewal application (see protocol renewal information below). A Final Report must still be completed for projects to be renewed.

To submit in REMS select the “+ Add Form” button and select the “Animal Use Report” form. See REMS SharePoint site for Reporting.

Final Reports are due within two weeks of the completion, discontinuation or expiry date of your protocol.

Animal Use Numbers when completing a project:
In REMS, you will need to complete both an Animal Use Report as well as a Final Report, for the animal use data collection. 
 

If Primary Investigator (PI) and leaving the University

• If you are leaving the University and your animal ethics protocol will no longer be in use, please ensure you contact the Animal Ethics Team prior to departing to formally close your protocol*
• Complete both the Final Report and the Animal Use Report for your animal ethics protocol.
• If you are working with GMOs, you also need to contact the rDNA Officer to complete the required rDNA closure procedures and reporting.
   

* If you are transferring your project to another PI, please contact the Animal Ethics Team animal.ethics@anu.edu.au and submit an amendment in REMS to change PI. See section above: Adding investigators or changing Primary Investigator and/or Nominees

Renewing your protocol

Animal ethics protocols expire three years after approval. To renew your protocol, you must reapply for ethics approval through REMs. There are instructions on how to do so available on our Animal Ethics Application Process page and in the REMS SharePoint site.

Your new application should incorporate any information from the current protocol’s AEC review ‘Q&A’ and any amendment requests. It is expected with a new application that continued animal model use along with all related SOPs/methods are reviewed prior to resubmission to incorporate any updates to meet current best practice at time of your application.

 You can find this information regarding your current protocol in REMS, as the program has been designed for it to be incorporated into the final version (prior versions can be found in the REMS History Tab). For protocols that have been transferred from ARIES to REMS, you can refer to your protocol and any amendment approval PDF(s) as well as the transferred information for your protocol in REMS.

If need assistance, please contact the Animal Ethics Team on animal.ethics@anu.edu.au.

Please ensure you submit your application for renewal with sufficient time ahead of your expiry date to ensure uninterrupted continuation of your project particularly if you have animals in care needing to be transferred. We recommend at least two AEC meetings prior. This will help to speed up the review process and help to enable timely replacement.

When your renewal application is approved, you must still complete an Final Report for your previous protocol. See Final Report information above.

Sharing and securing your research 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 or any media queries, contact the Media and Communications team via their 24/7 media hotline, +61 2 612 57979, or via media@anu.edu.au.