ANIMAL WELFARE AND ETHICS UNEXPECTED ADVERSE EVENT PROCEDURE
RELEVANT LEGISLATION
Prevention of Cruelty to Animals Act 1986 (Vic)
Prevention of Cruelty to Animals Regulations 2008 (Vic)
Australian Code for the care and use of animals for scientific purposes (2013)
Australian Code for the Responsible Conduct of Research (2007)
Regulation 17.1.R8 - Code of Conduct for Research
SCOPE
This procedure applies to all research or teaching activity that involves the use of animals at the
University.
PROCEDURE
1. Principles
1.1 The University is committed to the ethical conduct of research and teaching activities that
involve the use of animals. The University will only use animals in research and teaching
activities where there is need for their use, and the activity has merit, integrity and
justifiable benefit.
1.2 The University is committed to minimising the impact on the welfare of animals used in
research and teaching whose lives and wellbeing are dependent on us as a result of our
pursuit of knowledge and learning.
1.3 In the use of animals in research and teaching, the University is committed to the
principles of:
1.3.1
Replacing the use of animals with alternatives wherever possible;
1.3.2
Reducing the number of animals used without jeopardising the statistical validity
of research results or teaching objectives and without placing an excessive
cumulative burden on individual animals; and
1.3.3
Refining research and teaching practice, and facilities in order to minimise
unexpected adverse impact on animals.
1.4 The University is committed to continuously improving the standards it sets for the welfare
and use of animals in research and teaching activities.
1.5 The University is committed to educating researchers with respect to advancements in
animal welfare, care and use standards.
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1.6 Unexpected adverse events involving animals used in research or teaching activities
should be acted on immediately and reported promptly.
2. Notification of unexpected adverse event
2.1 Anyone who discovers evidence of an unexpected adverse event involving animals in
research or teaching activities must notify the project supervisor and the Animal Welfare
Officer (AWO) immediately.
2.2 Upon discovery or notification of an unexpected adverse event, researchers, teachers,
project supervisors, people named on the relevant AEC approval, and AWOs must take
timely and appropriate action to protect the welfare of the animals, including euthanasia
or other veterinary interventions.
2.2.1
If an animal dies unexpectedly or is humanely killed due to an unexpected
adverse event, the AWOs or a similarly qualified person should conduct a
necropsy.
2.3 The AWO will determine if further veterinary or clinical intervention is required; if the
project should be suspended pending the results of further investigations; or if any other
action that should be taken to protect the welfare of the animals involved.
2.4 Once the welfare of the animals has been addressed and any other intervention
completed, the AWO must promptly inform the Manager, Animal Ethics and the Chair of
the relevant Animal Ethics Committee (AEC) of the event in writing.
2.5 The AWO, Chair (AEC) and Manager, Animal Ethics will determine if further investigation
and/or preparation of an unexpected adverse event report are necessary.
3. Investigation into unexpected adverse events
3.1 The AWO will investigate the event and any action taken. The aim of the investigation is
to determine the cause of the unexpected adverse event. The project supervisor will
cooperate with the AWO during this investigation.
3.2 The AWO will provide an update on the progress of the investigation of the unexpected
adverse event(s) to the relevant AEC.
4. Reporting of the unexpected adverse event
4.1 The project supervisor will prepare a report of the event using the Unexpected Adverse
Event Report Form. The AWO will provide comment.
4.2 The AEC will consider the report of the event and determine if any further action should
be taken. Consideration should be given to compliance with the relevant legislation and
policy.
4.3 OREI will provide a response to the project supervisor outlining any required further
actions.
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RELATED DOCUMENTS
Melbourne Animal Care and Use Standards
DEFINITIONS
Term
Definition
Unexpected adverse
event
An event that may have a negative impact on the wellbeing of
animals and was not foreshadowed in the approved project or
activity. An unexpected adverse event may result from different
causes, including but 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 effects 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
Animal
• 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.
Any live non-human vertebrate, that is, fish, amphibians, reptiles,
birds and mammals, encompassing domestic animals, purposebred animals, livestock, wildlife, and also cephalopods such as
octopus and squid.
Animal Ethics
Committee
As defined in the Australian Code for the Care and Use of Animals
for Scientific Purposes: a committee constituted in accordance
with the terms of reference and membership laid down in the Code
Animal Welfare Officer
A person or persons employed by the University to provide
oversight and expert assistance with the use of animals in
research and teaching. It includes Assistant Animal Welfare
Officers and others with responsibilities at the University level for
animal welfare
RESPONSIBLE OFFICER
The Deputy Vice-Chancellor (Research) is responsible for the development, compliance monitoring
and review of this policy and any associated schedules, procedures and guidelines.
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IMPLEMENTATION OFFICER
The Director, Office for Research Ethics and Integrity is responsible for the promulgation and
implementation of this policy in accordance with the scope outlined above. Enquiries about
interpretation of this policy should be directed to the Implementation Officer.
REVIEW
This policy is to be reviewed by XX/XX/XXXX.
VERSION HISTORY
Version
Approved By
Approval Date
1.0
Director, OREI
26 May 2014
Effective Date
Sections Modified
Consultation version
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Keywords
Animals, welfare, ethics, standards
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