WCHN ANIMAL ETHICS COMMITTEE

ANIMAL UNEXPECTED ADVERSE EVENT REPORT

The purpose of this form is to allow Chief Investigators of an approved animal project to uniformly notify the AEC of any and all unexpected/unplanned adverse events that may occur during the course of their experiment.

Examples of adverse or unexpected effects may include:

  • Death of an animal or group that was not expected within the scientific protocol.
  • Adverse effects following a procedure that was not expected examples but not limited to diarrhoea, vomiting, respiratory difficulty etc.
  • Level of pain or distress was not predicted during the planning of the project.

It is a requirement of the NHMRC code of practice that the AEC be notified of all adverse events within 48hrs of such eventsoccurring.

The reporting of adverse events not only assists researchers in maintaining viability in their science by identifying and remedying the variables but also assists both the AEC and the Animal House in their commitment to the ongoing well being of all animals within their care and to ensure, where possible, further deaths or suffering do not occur

Chief Investigator
AEC Project Number / Total number of animals approved for the project?
Total number of animals used to date in the project? / Total number of animals used in this current procedure?
Details of the Animal(s) involved in this incident (ie:Species, strain, age).
Date of event and estimated time elapsed from animals death and discovery of carcass
Brief description of event. Include (if any) procedures being performed at the time
User/handler at time of event (if applicable)
Report completed by
(name & contact details) / Date of report

PROVIDE A BRIEF DESCRIPTION OF EXPERIMENTAL PLAN. Include the observational frequency requirements of the experimental plan and what stage of the project the animal were involved in at the time of the event.

SOURCE OF PROBLEM (please tick relevant box):

Human Error / Mechanical Error / Disease/Bacterial or Viral / Nutritional / Other

If other, please state: ......

......

......

DESCRIBE THE CIRCUMSTANCES LEADING UP TO THE ADVERSE EVENT:

ACTIONS TAKEN FROM THE TIME EVENT WAS NOTICED – indicate date and by whom:

CAUSE OF THIS ADVERSE EVENT:all adverse events must be thoroughly investigated, if warranted, this will include a necropsy of animal/s. Please forward an investigation outcome report to the AEC as soon as complete. This report can provide the initial details and a follow up report can be sent when necropsy results are known.

REPORTED TO: / DATE / TIME / METHOD OF REPORTING
Chief Investigator
Animal Facility Manager
Animal Facility Staff
AEC through Secretary
OUTCOME OF ADVERSE EVENT / YES / NO / NUMBER OF ANIMALS
Unplanned mortality
Unplanned euthanasia
Unplanned illness with recovery (experiment continued)
Project suspended pending AEC approval of refinement / Date if ‘yes’
Project terminated / Date if ‘yes’
Other – please detail
RESULTS OF NECROPSY / Attach copy or provide details where/when available

PROPOSED ACTIONS TO CORRECT AND PREVENT FURTHER ADVERSE EVENTS:

Completed report should be submitted to the Executive Officer, CYWHS AEC as soon as possible and within 48hours of the date of event.

Signature: ...... Date:......

Print name:......

OFFICE USE ONLY

Date forwarded to AEC Executive (by AEC Secretary):

H:\RESEARCH\AEC\FORMS~FORM letters CYWHS AEC\AEC Forms Current\Unexpected Adverse Event Report Form V6 CURRENT.doc