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Adverse Events

Unexpected Adverse Event (UAE) Reporting.

This applies to all University of Canberra (UC) research or teaching activities that involve the use of animals as approved by the UC Animal Ethics Committee (AEC). It applies only to unexpected adverse events (UAEs), not events detailed and approved within a current animal ethics approval. It is a condition of approval on all animal ethics protocols that in accordance with sections 2.4.18 (ix) and 2.4.34 (ii) of the NHMRC’s Australian code for the care and use of animals for scientific purposes 8th Edition 2013 (the Code), investigators must promptly notify the UC Animal Ethics Committee (AEC) of any UAEs that have or have the potential to impact on animal wellbeing. Reporting of UAEs in a timely manner is mandatory in order to ensure timely investigation and provision of veterinary support to prevent further occurrences and improve animal welfare outcomes.

Reporting is critical to identifying where improvements can be made, positively contributing to the continuation of the research. Early reporting also assists with recall accuracy of the event. There is an expectation that reasonable care and due diligence will be undertaken at all times where research involves the use of animals. Information provided in UAE reports will be circulated to the AEC in accordance with the Code and the UC UAE Procedure. Once the UAE has been reviewed by the AEC, the Chief Investigator (CI) will receive communication as to whether any further action is required.

What is an Unexpected Adverse Event (UAE)?

The Code defines a 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:

* 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 foreshadowed in the approved project;

* the sudden death of any animal under an approved animal ethics protocol;

* 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 is evident, beyond what 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 have a negative impact on the welfare of the animals

UAE in a research context at UC

A UAE occurs when there is an event that has had, or may have had, a negative impact on the wellbeing of animals, or affected the intended usage of animals, which was not foreseen in the approved animal ethics protocol. Some examples of situations that are defined as unexpected adverse events include:

* 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.

* 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.

* Animal wellbeing is compromised due to a deficiency in routine husbandry practices, such as the provision of suitable food, water, bedding and housing conditions; for further definitions see Appendix I.

* 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 resulting in death of animal

o Animals dying in traps due to temperature extremes.

Reporting an Unexpected Adverse Event

The UC AEC Unexpected Adverse Event online report form needs to be completed. After logging in with you UC log in detail, researchers can click “create project” and then select “AEC Adverse Event form” in the drop-down list. This must be completed and submitted online within 72 hours of the occurrence of an UAE (this time frame includes weekends and public holidays). Investigators working in remote locations must make every effort to notify the UC Ethics office (AnimalEthicsCommittee@canberra.edu.au) as soon as possible and submit the online report as soon as they are able to.