Unexpected Adverse Event Includes but Is Not Limited To

Unexpected Adverse Event Includes but Is Not Limited To

Introduction

The 8th Edition of the Australian code for the care and use of animals for scientific purposes states that “Investigators must take steps at all times to safeguard the wellbeing of animals by avoiding or minimising known or potential causes of harm, including pain and distress, to the animals (Clause 2.4.18).

Steps include;

  • Taking prompt action based on the monitoring and assessment of animal wellbeing, in accordance with intervention points and humane endpoints approved by the ACEC.
  • Taking prompt action, including alleviating pain and distress and promptly notifying the ACEC, in response to unexpected adverse events and emergencies, in accordance with the UNSW Research Ethics Procedure and ACEC policies and procedures. Alleviating unanticipated pain and distress must take precedence over an individual animal reaching the planned endpoint of the project, or the continuation or completion of the project. If necessary, animals must be humanely killed without delay.

Unexpected adverse event includes but is 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 events 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 study,
  • 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.

In addition, when an animal dies unexpectedly, or is euthanased due to unforeseen complications, a necropsy should be performed by a competent person (Clause 3.1.25).

To comply with the Code, the UNSW Animal Care and Ethics Committee requires that all deaths which occur under an approved project are promptly reported.

Chief Investigator
Project Title
ACEC Approval Number
Species and strain
Location of Animals
Date of Incident
Date of Report
Summary of circumstances:

Outcome of Incident

Yes / No / Number of Animals
Mortality / ☐ / ☐
Euthanasia / ☐ / ☐
Recovery (experiment continued) / ☐ / ☐
Experiment Terminated / ☐ / ☐ / Date:
Other (explain)

Necropsy details

Name of person who conducted the necropsy:
Relationship to this study: / Contact Veterinarian☐
Member of Project Research Team☐
Other (please provide details)☐
Summary of results from necropsy (please also attach the necropsy report):

Have you or do you plan to amend the protocol? Yes ☐No ☐

Have you or do you plan to submit a request for modification?Yes ☐No ☐

Future actions/precautions to be followed based on this incident:
Name and Title (please print)
Contact details:
Signature:
Date:
Top View