Sara Paradowski AEC Secretary Research Governance Unit
Slide 2
The Code The key to implementation of improved welfare of
animals used for scientific research in Australia is the Australian
Code of Practice for the Care and Use of Animals for Scientific
Purposes (2004) (the Code).
Slide 3
The Code The basic philosophy behind the Code is that it is
acceptable to use animals for scientific purposes provided that
this use can be justified and that the principles of the 3Rs -
Replacement, Reduction and Refinement are applied. The
justification is decided through weighing the benefits of using the
animals against the costs to the animals.
Slide 4
The Code Sections include: Responsibilities of institutions and
their AECs Responsibilities of investigators and teachers
Acquisition and care of animals in breeding and holding
facilities
Slide 5
The AEC The mechanism used to strike the balance between
benefits and costs of the use of animals for experimentation is the
Animal Ethics Committee (AEC). The primary responsibility of AECs
is to ensure that all care and use of animals is conducted in
compliance with the Code
Slide 6
The AEC The AEC: ensure that the use of animals is justified,
provide for the welfare of those animals and incorporate the
principles of Replacement, Reduction and Refinement (3Rs)
Slide 7
The AEC AECs fulfil their mandate by: Considering the ethical
implications of a project Assessing approved projects for
compliance Approving Standard Operating Procedures to ensure
consistency when performing procedures Monitoring animal housing
and animal care Inspecting animal housing and care facilities
Slide 8
Composition of AECs Chair Category A - Vet Category B -
Scientist Category C Animal Welfare Category D Lay Member Category
E Animal Tech (non-voting)
Slide 9
Activity 1 Why are these people necessary? Discuss in pairs the
role each category plays in the AEC and how each role ensures a
well rounded ethical review of each project.
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AEC To ensure all members of the AEC can understand your entire
application, the whole application including the procedures must be
in plain English.
Slide 11
Licensing The Prevention of Cruelty Act Victoria 1984 (the Act)
requires that the use of animals for Scientific Procedures be
conducted under a Scientific Procedures Premises Licence
(SPPL).
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What is a Scientific Procedure? Acquiring, demonstrating or
developing scientific knowledge or techniques Developing or testing
vaccines, substances or drugs Production of biological products for
use in research or teaching Breeding of a new strain or hybrid of a
genetically modified animal
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Licensing Use of the following animal types in Scientific
Procedures must be licensed: All fish and amphibians Mammals, birds
and reptiles above the mid-point in gestation Adult decapod
crustaceans Adult cephalopods.
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Breeding for Scientific Procedures The breeding of Specified
Animals in Victoria for use in Scientific Procedures must also be
licensed. Specified Animals are: Guinea pigs; Rats, mice, and
rabbits that are not bred in their native habitat; and Non-human
primates. Breeding of these animals for supply to other
institutions must be authorised by a Specified Animal Breeding
Licence (SABL)
Slide 15
The 3Rs Replacement Reduction Refinement
Slide 16
The 3Rs Principle The 3Rs Principle aims to address the ethical
dilemma created by the use of animals in research and teaching, by
ensuring animals which might suffer are only used when necessary
(Replacement), only the minimum number of animals are used to
achieve the objectives (Reduction) and to ensure any suffering and
pain caused by the work is minimised (Refinement).
Slide 17
The 3Rs The AEC needs to be convinced that serious thought has
gone into optimisation/minimisation of animal use and the
replacement of animals in projects. One area that is traditionally
weak in applications is the identification of potential
alternatives to animal use.
Slide 18
Replacement The Code states that techniques which totally or
partially replace the use of animals for scientific purposes must
be sought and used wherever possible. Replacement may be relative,
where animals are still required to provide cells or tissue, but
experiments are conducted in vitro such as tissue culture, perfused
organs and tissue slices.
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Replacement To address replacement properly in an application
you must demonstrate that you have researched other alternatives
and explain why they would not be useful in achieving your
aims
Slide 20
Reduction The Code requires that: studies are designed to be
scientifically and statistically valid only the minimum numbers of
animals are used studies should not be repeated unnecessarily.
Slide 21
Reduction Designing experiments to ensure maximum information
from minimum animal use. Please be aware that the reduction of
animals should not be implemented at the expense of greater
suffering of individual animals. This means that there must be a
balance between reducing animals and performing too many procedures
on one animal.
Slide 22
Reduction Examples of reduction in animals used in research and
teaching: Improved experimental design and statistical analysis
Techniques, such as imaging, which require smaller numbers of
animals Pilot studies, which may help define endpoints (refinement)
as well as indicating whether a particular course of study is worth
pursuing
Slide 23
Reduction To address Reduction properly in an application you
must include a clear description of: the number, species and strain
of animals required and their treatment groups the reasons why this
number is necessary (include results of statistical analysis and/or
previous studies) whether there is an opportunity for sharing of
tissues or animals (scavenging).
Slide 24
Refinement Studies should be designed to minimise or avoid both
distress and pain in animals. This means refining the way
experiments are carried out, to make sure animals suffer as little
as possible. This includes better housing and improvements to
procedures which minimise pain and suffering and/or improve animal
welfare. All investigators should be competent in the techniques
they will be performing.
Slide 25
Refinement Examples of Refinement are: Use of appropriate
anaesthesia and analgesia Radio operated devices can be implanted
to measure blood pressure, heart rate and activity levels so that
the animal does not have to be repeatedly caught and restrained.
Using reward systems, animals can also be trained to co-operate,
thereby reducing stress. Red plastic mouse houses provide mice with
areas within the cage to nest, hide and climb.
Slide 26
Refinement To address Refinement properly in an application you
must identify and justify the impact of all aspects of the project
on the animals wellbeing from the time it is obtained until the
project is completed and detail how that impact will be minimised.
An animal use flowchart assists with this process and allows the
AEC to assess exactly what is happening to each group of
animals.
Slide 27
Activity 2 Addressing the 3Rs Work in pairs to discuss the
provided scenarios. Decide whether the scenarios are classed as
Replacement, Reduction or Refinement (some may be more than
one)
Slide 28
Updated Website
http://www.svhm.org.au/research/governance/Pages/
Researchinvolvinganimals.aspx New Forms New Adverse Event Reporting
Procedure
Slide 29
A fundamental principle is never to assume that current
practice is best practice.
