Animal Ethics Reporting Requirements

The continuation of approval for ongoing projects is subject to receipt and review of annual reporting.

• See annual reporting for details on how to submit.

Reporting on project activity provides additional details to assist the AEC, and provides evidence of compliance with the Australian Code for the care and use of animals for scientific purposes.

Investigators maintaining breeding colonies of animals are required to maintain animal production records and provide the Animal Ethics Committee with annual animal statistics reports. E.g. animal breeding record spreadsheets may be of assistance.

The Investigator will report in a timely manner to the AEC on the phenotype* of any genetically modified animal strain that is used as part of a scientific project via the (1) phenotype report.

This will require timely submission of records of clinical observations made on a representative sample of the animals, using the following sheets, as appropriate:

• (2) GM animal clinical record sheet
• (3) GM litter monitoring sheet

Following consideration of the information, the AEC may approve further use of the strain or may request a revision of the proposal.

In addition to the phenotype report, the requirement to promptly report unexpected occurrences of animal morbidity or mortality to the committee applies to these projects.

Investigators maintaining breeding colonies of genetically modified animals are required to maintain animal productions records and provide the committee with annual animal statistics reports. E.g. animal breeding record spreadsheets may be of assistance.

* the sum of the physical, behavioural and physiological characteristics of an animal

The Animal Ethics Committee may make random inspections of animal holding facilities, laboratories and experiments in order to determine compliance with the approval conditions.

The Animal Welfare Officer may inspect animal holding areas and laboratories and generally monitor the transportation, condition and treatment of animals to ensure compliance with prescribed codes of practice and with the requirements of the committee, as well as respond to emergencies with respect to the conditions of animal use.

If you are required to report on a pilot study to the AEC, please use the pilot study report form and send to the Animal Ethics Committee Secretary.

What is an unexpected adverse event?

An unexpected adverse event is any event that has a negative impact on the morbidity or causes mortality of an animal that was not specified as a possible outcome in the approved animal ethics application or exceeds the frequency or severity of impacts forewarned in the approved animal ethics application.

Reporting an unexpected adverse event

All unexpected adverse events must be reported by the researcher to the Animal Welfare Officer immediately and this must be within 24 hours of the event. In the event that this is not possible, the Manager of the relevant Animal Facility must be contacted. A post-mortem examination must be performed following an unexpected adverse event that results in mortality. Due to rapid autolysis in smaller animals, this must be done within 12 hours of death to be useful.

A written report of all unexpected adverse events must be submitted by the researcher to the Animal Ethics Committee using the adverse event report form as soon as possible, but must be within 5 days of the event occurring. The report should be supplemented by supporting documentation (e.g. necropsy report, laboratory results, Clinical Record Sheets) but the report to the AEC should not be delayed pending receipt of such documentation, which may be forwarded as available.