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Unexpected Adverse Events – Unexpected and unplanned outcomes according to Australian Ethics Code

The Code defines UAE as an event that may have a negative impact on the wellbeing of any animals and was not foreshadowed in the approved project or activity. A UAE may result from different causes, including but not limited to:

  1. Death of an animal, or group of animals, that was not expected (e.g. during surgery or anaesthesia, or after a procedure or treatment)
  2. Adverse effects following a procedure or treatment that were not foreshadowed in the approved project
  3. The sudden death of any animal under an approved animal ethics protocol
  4. 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;
  5. Greater level of pain or distress is evident, beyond what was predicted during the planning of the project or activity;
  6. Power failures, inclement weather, emergency situations or other factors external to the project or activity that have a negative impact on the welfare of the animals

Unexpected Adverse Events – In relation to Animal Research at the University of Canberra

Below are some examples of UAEs in animal research that need to be immediately reported if they occur at the University of Canberra:

  1. More deaths or complications than described in the approved animal ethics protocol, e.g. 10% of animals died during the experimental procedure when a 5% fatality rate was expected and justified in the approved animal ethics protocol. The number or percentages of animals may refer to a single cohort or across a group of experiments.
  2. Facility or equipment failure compromising or possibly compromising animal welfare or the success of the activity, e.g. power loss to a facility means ventilated mouse cages don't receive fresh air, therefore animal exposure to ammonia levels could reach adverse levels; inability to irradiate animals on a particular day means that this critical part of the activity is not undertaken when animals are the right age, so there may be no justification to continue using these animals.
  3. Animal wellbeing is compromised due to a deficiency in routine husbandry practices, such as the provision of suitable food, water, bedding and housing conditions.
  4. An unexpected event that leads to termination of an ongoing animal experiment without the ability to collect useful data. For example, a tumour model where the tumour does not behave as expected or as detailed in the ethics protocol, or essential reagents run out during a long-term drug treatment resulting in use of animals without collection of data.

*Additional field work examples, including but not limited to:

o Thrown/injured pouch young that is either euthanased or brought into care

o Birds abandoning nests due to intervention by investigators e.g. to place monitoring equipment

o Death due to tracking equipment issues e.g. collar too tight or collar gets caught on a branch

o Animal injured/dies during handling and processing

o Traps left out and not checked in timeframe specified in approved application

o Animals dying in traps due to temperature extremes.