Unexpected adverse events

Summary

Definition: An Unexpected Adverse Event is an unforeseen event that may negatively impact animal wellbeing, not anticipated in the approved project or activity.
Immediate actions: Alleviate pain or distress, euthanise if necessary, and then inform the Chief Investigator immediately.
Reporting: Report the event to the Animal Ethics Committee (AEC) within 72 hours and submit a detailed report within seven days.
Necropsy: Conduct a necropsy (preferably done by a veterinarian) to help identify causes, and document findings clearly.
Continuation of work: Activities can continue if they do not cause ongoing negative impacts on animal wellbeing; any protocol changes must be approved by the AEC.

What is an Unexpected Adverse Event?

The Australian Code for the Care and Use of Animals for Scientific Purposes (current edition; “the Code”) defines an Unexpected Adverse Event as:

an event that may have a negative impact on the wellbeing of animals and was not foreshadowed in the approved project or activity.

This includes scientific use that results in a greater severity of impact than anticipated in the approved ethics application. Causes of unexpected adverse events can include, but are 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). This includes death prior to experimental work commencing and euthanasia of animals that were not used as planned and approved.
Adverse effects or other complications following a procedure or treatment that were not expected.
Adverse effects or other complications in a larger number of animals than predicted during the planning of the project or activity, based on the number of animals used, not the total number approved for the study.
A greater level of pain or distress than was predicted during the planning of the project or activity.
Factors external to the project such as power failures, inclement weather, emergency situations, or other factors that may negatively impact animal welfare. This includes animals needing to be being held longer than expected or needing to be replaced.

Further examples of Unexpected Adverse Events are available on Biosecurity Queensland’s webpage.

An adverse event is only considered ‘expected’ if it is detailed and justified in an ethics application and accepted by the Animal Ethics Committee (AEC). Information on expected adverse events should be provided in the Welfare Classification section of the UQ ethics application.

Responding to an Unexpected Adverse Event

The Chief Investigator of a research or teaching project is responsible for ensuring that Unexpected Adverse Events are appropriately managed, reported and resolved. If such an event occurs, the following actions are required:

Alleviate pain or distress in the animal(s). Where relevant, consult with a veterinarian and/or the animal facility manager as soon as possible. Managing animal welfare must take precedence over project completion.
If pain or distress cannot be alleviated, the animal should be euthanised.
Inform the Chief Investigator immediately.
Perform a necropsy exam if an animal has died or been euthanised to identify potential causes or contributing factors (see further directions below).
Seek advice where required from the Animal Ethics Coordinator and Veterinary Officer regarding the reporting process, event management, or risk mitigation.
Notify the AEC of the event within 72 hours (unless under exceptional circumstances, such as fieldwork). Initial notification can be via email to the Animal Ethics Coordinator and Veterinary Officer. Alternatively, submit an Unexpected Adverse Event form through MyResearch. Instruction for lodging a form are available on the MyResearch Systems Training Hub.
Submit a report within seven days of the event, even if supporting documents are not yet available, unless otherwise approved by the animal ethics administration or committee. An Unexpected Adverse Event report must be lodged through MyResearch as soon as possible and, where initial notification (within 72 hours) is via email, no greater than seven (7) days following realisation of the event.

Conducting a Necropsy Examination

Preferably performed by a registered veterinarian. Carcasses should be refrigerated at 0-4°C until the necropsy is performed. If delayed beyond 48 hours, freezing may be arranged in consultation with the veterinarian.
If a veterinarian is not available, an independent, competent person should perform the necropsy (this person cannot be a participant on the project).
If an independent person is not available, a trained and competent project participant should perform the necropsy. Ideally this person will not have been involved in the activity that is associated with the Unexpected Adverse Event (i.e., surgery or other procedure).
Obtain veterinary support, where possible and appropriate, via audio or video if a veterinarian is not performing the necropsy.
Record clear and objective observations in the necropsy report. Use the post-mortem/necropsy template (DOCX, 70.1 KB).
Send the necropsy report to a veterinarian for advice and review if conducted by a non-veterinarian. Within UQ Biological Resources facilities contact UQ Biological Resources Veterinary Services. For all other locations discuss with your local facility manager or contact UQ Veterinary Laboratory Services.
Justify to the AEC if a project participant performs the necropsy, even if they are a registered veterinarian (given the potential for a conflict of interest).
Necropsy may not be required if a diagnosis is made by a veterinarian or the cause of death is unequivocal. However, consider whether a necropsy may still reveal additional information to manage and mitigate risks. Justify the decision in the report and provide other evidence if no necropsy is performed (e.g., veterinary records, photographs).

Continuing Work After an Unexpected Adverse Event

Research or teaching activities can continue if they do not result in ongoing negative impacts on animal wellbeing beyond what was approved by the AEC. If there is a risk of ongoing negative impacts, the activity must cease. For advice, contact the Animal Ethics Coordinator and Veterinary Officer.

Any changes to the approved protocol resulting from the event must be approved by the AEC before being implemented.

Outcomes of an AEC Review

Unexpected Adverse Events often result from unavoidable situations or errors that do not represent negligence. The AEC review of an Unexpected Adverse Event seeks assurance of animal wellbeing and risk mitigation, and to identify systemic issues that need to be addressed. The Unexpected Adverse Event report allows the investigator to demonstrate refinement, or to confirm the appropriateness of the protocols, monitoring and management of animal welfare.

In some cases, the AEC may refer the matter for further assessment as a potential breach of the UQ Animal Ethics in Teaching and Research Procedure and relevant codes. This includes where the Unexpected Adverse Event results from intentional, reckless or negligent behaviour. Failure to report an Unexpected Adverse Event within the required timeframes also represents a potential breach.