Unexpected adverse events (UAE)

A UQ Unexpected Adverse Event Form must be submitted after any unexpected event that may have a negative impact on animal wellbeing.

Completed forms must be lodged via MyResearch. Instruction for how to lodge and Unexpected Adverse Event form are available on the MyResearch Systems Training Hub.

What is an Unexpected Adverse Event?

The Australian Code for the Care and Use of Animals for Scientific Purposes (current edition; “the Code”) defines an Unexpected Adverse Event as “an event that may have a negative impact on the wellbeing of animals and was not foreshadowed in the approved project or activity”. This definition should be considered to include scientific use that has resulted in a greater severity of impact than that expected.

The Code identifies that unexpected adverse events may result from different causes, including but not limited to:

• death of an animal, or group of animals, that was not expected (e.g. during surgery or anaesthesia or after a procedure or treatment),
• adverse effects following a procedure or treatment that were not expected,
• adverse effects in a larger number of animals than predicted during the planning of the project or activity, based on the number of animals actually used, not the number approved for the study,
• a greater level of pain or distress than was predicted during the planning of the project or activity,
• power failures, inclement weather, emergency situations or other factors external to the project, or activity that has a negative impact on the welfare of the animals.

Further examples of unexpected adverse events are presented on Biosecurity Queensland’s webpage.

After an adverse event

If an adverse event occurs during the course of your project the following course of action is required:

• Alleviate pain or distress in the animal/s.
• This must take precedence over the completion of the project. If pain or distress cannot be alleviated, the animal should be euthanised.
• If you are not the Chief Investigator of the project, you must inform the Chief Investigator immediately.
• Where relevant, consult with a veterinarian and/or the animal facility manager, as soon as possible.
• Ensure a necropsy exam is performed if an animal has died or been euthanised. This is important to help identify the potential cause, or contributing factors, to the animal’s condition. 

Who conducts the necropsy exam?

• It is preferred, given their training and expertise that the necropsy be performed by a registered veterinarian (note: carcasses should be refrigerated 0-4°C, until a necropsy is performed).
• If a veterinarian is not reasonably available, it is still important that the necropsy occurs. In this circumstance, someone that is competent and not a participant on the project (an independent person) should perform the necropsy. 
• If an independent person is not reasonably available (e.g. after hours, or in a remote location), it is still important that the necropsy occurs. In this circumstance, a project participant should perform the necropsy. 
• For all necropsy reports it is important that clear and objective observations are recorded. Download the post-mortem/necropsy template here (DOCX, 65.4 KB)
• If the necropsy is conducted by a non-veterinarian, the necropsy report should be sent to a veterinarian to seek their advice and review of your observations. Within UQBR facilities please contact UQBR Veterinary Services. For all other locations please discuss with your local facility manager or contact UQ Veterinary Laboratory Services.
• If the necropsy was conducted by a project participant (including if that participant is a registered veterinarian), some justification should be provided to the AEC as to why this was appropriate (given the potential conflict of interest).

After an adverse event (continued)...

• If advice is required in relation to the reporting process, management of the event, or risk mitigation, consult with the Animal Ethics Unit Coordinator or Veterinary Officer.
• Report the unexpected adverse event to the Animal Ethics Committee (AEC).
• This should be done as soon as possible, and no greater than seven (7) days following realisation of the event (even if supporting documents, such as a necropsy report, are not yet available).

Can I continue with my work?

When an unexpected adverse event occurs, scientific use activities associated with that event must cease if their continuation is likely to result in ongoing negative impacts to animal wellbeing, beyond that previously considered and approved by the AEC.

For example, in an ecology study if you are catching native mice and you find that one of the type of traps being used is unexpectedly injuring the occasional mouse, you cannot ethically continue to use these traps. The AEC must review the event, including measures taken to mitigate the risk of reoccurrence. You can only recommence use of the traps if, as an outcome of their review, the AEC find it to be ethically acceptable.

It is not considered ethically acceptable to enable your potential scientific outcomes to take precedence over maintaining the state of animal wellbeing previously considered and approved by the AEC.

For advice on this matter contact the Animal Ethics Unit Coordinator or Veterinary Officer.