An Unexpected Adverse Event Is Any Event That Is Not Described Within an Approved Animal

/ RESEARCH ETHICS & INTEGRITY | ANIMAL ETHICS
UNEXPECTED ADVERSE EVENT REPORT
INTRODUCTION

An unexpected adverse event is any event that is not described within an approved animal ethics project, orwas expected but has occurred at a frequency or severity in excess of that forecast, and whichimpacts negatively on the wellbeing of the animal(s).This can be a single or cumulative event, and will normally involve unexpected mortality, morbidity or injury. This includes sudden deaths, and husbandry-related accidents (such as flooding).

In all cases, it is a University Animal Ethics Committee requirement that all unexpected adverse events be reported to the Animal Welfare Officer (AWO)immediately,or as soon as reasonably possible, who will provide advice on how to respond and manage the event.

This form must be used to report any unexpected adverse event that has a negative impact on the wellbeing of the animal.Note that reporting of unexpected adverse events is mandatory, as perthe Code(Clause 2.4.34 (ii)).

Once completed, this form must be signed by the Project Supervisor and emailed to the AWO.

AWO contact details:Mobile: 0466 528 856

Office: (03) 8344 7567

Email:

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ADDITIONAL INFORMATION

All unexpected adverse events are to be dealt with immediatelyby the responsible researchers, Animal Facility management and the AWO. The purpose of the Unexpected Adverse EventReport is to summarise, for the relevant Animal Ethics Committee and, when applicable, the University Animal Welfare and Ethics Committee, the unexpected adverse event and actions being taken. Discuss with the Animal Welfare Officer if any additional information or actions are required, such as provision of training records, performing a necropsy or additional animal monitoring.

Additional information relating to management of unexpected adverse events can be found on the Research Ethics & Integrity website (

1.Project Details

Ethics ID: Approval Date:

Title:

Project Supervisor Name:

Project Supervisor Contact Details:

Department/Faculty:

Responsible AEC:

2.Unexpected Adverse Event Details

Date and time of Unexpected Adverse Event:

What happened to the animal(s)? (e.g. the animal(s) died; the animal was sick and recovered)

3.Animal Details

Animal(s) affected by the unexpected adverse event (Add more columns if more than one species):

Type/Species
Breed/Strain
Identification number (if applicable)
Sex
Age
Number affected/Total number of animals
Location/Animal Facility
4.Describe the work with which this unexpected adverseevent is associated

Talk about the specific element of your project work within which the unexpected adverseevent occurred.

5.How did this unexpected adverseevent affect the animals and what was the final outcome?
6.Chronological timeline of events(A timeline or table may be useful)

Outline the history leading up to, during and after the unexpected adverseevent. Document the steps taken to manage the unexpected adverseevent, including any supportive care offered or interventions (including humane euthanasia). Be sure to include dates and times of what occurred, the procedures or treatments performed, and by whom. Describe what actions were advised and taken under consultation with the AWO, including details of when the AWO was contacted in relation to the event, and if there was a delay in contacting the AWO, describe why. If a necropsywas completed, complete Appendix I of this form. If a necropsy was not performed or not required, describe why.

7.Do you know how/why this unexpected adverse event happened?

Is the cause of morbidity/mortality known? If YES, give details. If NO, what is/are the likely causes?

8.Explain briefly the fate, health and status of any remaining animals.
9.What immediate and long-term actions are being taken to prevent a recurrence?

Actions may include, but are not limited to, experimental design modification, changes to housing, or additional researcher training.

10.Is there any other information, comments or ongoing information you can provide in relation to this unexpected adverseevent?

Information may include, but is not limited to, prior history/reports, ongoing events/issues, monitoring sheets, standard operating protocols (SOPs) and other pertinent information.

11.Sign-off

Report completed by:

Contact details:

SIGNED (PROJECT SUPERVISOR):

*Digital signature accepted for electronic submissions

DATE:

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UNEXPECTED ADVERSE EVENT REPORT
APPENDIX I. NECROPSY REPORT

As stated in the Code (Clause 3.1.25), when an animal dies unexpectedly, or is humanely killed due to unforeseen complications, a necropsyshould be performed.

Use this form to provide details of the necropsy.

NecropsyReport

Date necropsy performed:

Animal number/ID and Gender:

Research project:

Ethics ID:

Necropsy performed by:

Gross Necropsy Findings:

Body weight / Last recorded live weight:
If relevant, last recorded Body Condition Score (BCS):
Date of last recorded live weight/BCS:
Weight at death:
Nutritional state:
Preservation state:
Hydration state:
Pregnancy status:
Integumentary system
Musculoskeletal system
Cardiovascular system
Respiratory system
Genital system
Alimentary system
Urinary system
Hematopoietic system
Nervous system
Endocrine system
Special senses (Eye, Ear)
Summary

Tissue samples collected:

Further tests Requested and Awaiting Results:

☐Histology / ☐Bacteriology / ☐Parasitology / ☐Toxicology / ☐Other – describe

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