Reporting unexpected adverse events in the use of animals

The Australian code for the care and use of animals for scientific purposes (scientific use code) requires investigators to report any unexpected adverse event to the animal ethics committee (AEC).

The scientific use code defines an unexpected adverse event as an event that may have a negative impact on the wellbeing of animals and wasn't anticipated in the approved project or activity.

An unexpected adverse event 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 project or activity
• 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 have a negative impact on the welfare of the animals.

Examples of situations that require reporting include:

• deaths of animals not described in the proposal (e.g. 5 of 15 cattle die during road transport)
• complications not described in proposal (e.g. a type of anaesthetic doesn't provide adequate pain relief)
• more deaths or complications than described in proposal (e.g. 10% of animals die following surgery when a 5% fatality rate was expected and justified in the proposal)
• facility or equipment failure that compromises animal welfare or the success of the activity (e.g. power loss to facility means ventilated mouse cages don't receive fresh air–mice may suffer from build-up of ammonia)
• facility or management practices or investigator monitoring that are not meeting the animals' needs (e.g. birds have sore feet due to the type of flooring)
• facility, management or experimental procedures are having a greater negative welfare impact than was described and approved (e.g. cattle have significantly poorer feed intake or growth rates than expected).

When an unexpected adverse event report is not required

An unexpected adverse event report is not required if:

• the AEC knows that the adverse event may happen
• the event happened as expected and has been approved by the AEC.

Users of animals for scientific purposes should provide details of the type and extent of possible adverse events in their proposal (application) to the AEC. If the events happen as expected, they do not have to report them separately, unless additional reporting is a condition of AEC approval.

Investigators should check with their institution or AEC, because internal policy may require additional reporting.

Examples of situations that do not require reporting include:

• expected deaths of animals as described and approved in the proposal (e.g. losses of up to 5% of birds in intensive poultry trial if 5% incidental losses was described and approved in the proposal)
• outbreak and response to treatment of a disease or complication as described and approved in the proposal (e.g. Barber's-pole worms in sheep, respiratory disease or foot problems up to the expected severity in an expected number of cattle in a feedlot that resolved with routine care and management).

Information to include in an unexpected adverse event report

The scientific use code does not indicate what information you should provide in an unexpected adverse event report to the AEC.

Some adverse events that have a known cause, and all reasonable steps to lessen their occurrence have been taken, may require only a brief report and little or no further action. For example, you can report less significant events, or events which have no implications for current or future activities, simply as a brief email or phone message for the AEC to note (e.g. '6 cattle found dead alongside fence following electrical storm—presumably electrocuted').

You should report more significant or severe events in detail, particularly those that suggest modifications to underlying management, scientific procedure, facility or training are required.

Investigators, teachers and animal facility managers should seek advice from their institution or AEC on whether they require a brief or detailed unexpected adverse event report.

Detailed unexpected adverse event reports should include:

• the description of the event
• how the event and welfare of the animals are monitored and addressed
• the actual and potential impacts of the event on animal welfare
• the actual and potential impacts of the event on the aims and outcomes of the activity
• what immediate and long-term steps are being taken or considered to investigate causes and develop future prevention strategies.

Time frame for reporting an unexpected adverse event

Investigators are required to report unexpected adverse events promptly.

The scientific use code requires institutions to develop institutional guidelines for the care and use of animals, which includes guidance around prompt reporting to the AEC.

The actual timing of the unexpected adverse event report will depend on the investigator's access to the AEC (via phone, email or post) and the severity of the impact on the animals. Report severe events and events that have implications for current activities as quickly as possible.

If you don't have enough information to complete a detailed unexpected adverse event report immediately, consider providing a brief preliminary notification to the AEC to advise that you'll provide a fully detailed unexpected adverse event report later.

Reducing the need for unexpected adverse event reports

Unexpected adverse events reports are only required for adverse events that the AEC doesn't already know about and hasn't already approved.

You can reduce the likelihood of having to submit an unexpected adverse event report by advising the AEC in advance about the potential for adverse events.

AECs can be advised of potential adverse events by:

• investigators and teachers through activity proposals (applications) to the AEC
• animal facility managers through written procedures for the management of holding and breeding facilities.

Proposals and management procedures submitted to the AEC for approval should:

• identify all reasonably likely potential problems, issues, events that may negatively impact on the wellbeing of animals
• describe how these potential problems will be minimised, monitored for and managed.

If unexpected adverse events subsequently occur and are resolved as approved by the AEC, an unexpected adverse event report is not required.