What is an unexpected adverse event (UAE)?
An UAE is an event that is unexpected and was, therefore, not foreshadowed in the application approved by the Flinders University Animal Welfare Committee (AWC). UAEs may be caused by, but are not limited to, the following:
- Death of an animal, or group of animals, that was not expected or was prior to planned death (e.g. during surgical procedure, during anaesthesia, following a procedure or treatment);
- Adverse effects following a procedure or treatment that were not expected. Examples of clinical signs that may develop include, but are not restricted to, diarrhoea, vomiting, respiratory difficulty, collapse, abdominal swelling, rapid weight loss;
- If at any point in the project, the percentage of morbidity or mortality exceeds the stated amount in the application, this constitutes an UAE;
- A greater level of pain or distress than was predicted during the planning of the project; or
- Power failures, inclement weather etc. that impact on the welfare of the animals.
Reporting an UAE
Following an UAE, the Animal Welfare Officer must be immediately notified (within 24 hours of the incident) via phone (0450 424 143) with a follow-up email (email@example.com). In the event that you are unable to contact the Animal Welfare Officer, you should contact the manager of the relevant animal facility AND the Animal Ethics Officer (firstname.lastname@example.org).
A post-mortem examination MUST be performed following an unexpected adverse event according to the post-mortem examination guidelines document.
An UAE Report must be submitted to the Animal Ethics Officer within 3 working days. UAE Report forms can be accessed by logging into ResearchNow Ethics & Biosafety through your Okta dashboard. ResearchNow Ethics & Biosafety will need to be added to your Okta dashboard via the "+ Add Apps" green button (top right) in the first instance.
The report must include the following information:
- Summary of circumstances leading up to the adverse, unexpected event;
- Actions taken from the time the problem was noticed;
- Results of the post-mortem examination, if available, where animals have died; and
- Proposed actions to prevent or correct the specific or probable cause of the problem
Attach all Clinical Record Sheets (CRS) and Maintenance Monitoring Sheets (MMS) relating to the affected animals, even if they do not appear to include any useful information.
Clause 2.5.5 of the Australian Code for the Care and use of Animals for Scientific Purposes, 8th edn, 2013 requires investigators, teachers and animal facility managers to promptly notify the Flinders University Animal Welfare Committee (AWC) of any UAE that may impact on the wellbeing of an animal in their care.
In addition, in the event that an animal dies unexpectedly or is euthanized due to unforeseen complications, a post-mortem examination must be performed by a person with appropriate qualifications and/or experience or the Animal Welfare Officer, and the AWC must be notified promptly (See clause 3.3.24). Requirements of the Code are also embedded in the Animal Welfare Act 1985 under Part 4 – ‘Teaching and research involving animals’. More generally, all persons involved in the care of animals used for scientific purposes have a duty-of-care towards those animals to take action to minimize pain and suffering. This means that anyone who notices that an animal is showing signs of distress should report it immediately to the Animal Welfare Officer (0450 424 143 or email@example.com) AND the Chief Investigator (CI).