Justification and ResponsibilitiesAustralian code for the care and use of animals for
scientific purposes, 8th Edition, 2013 (the Code). The Code is
available at www.nhmrc.gov.au/guidelines/publications/ea28 emphasises a duty of care that demands a genuine commitment to the
welfare of the animals used in research, a respect for the contribution the
animals make to research, and a desire to promote the well-being of
animals.The Governing Principles as stated in the Code are:
1.1 Respect for animals must underpin all decisions and actions involving
the care and use of animals for scientific
purposes. This respect is demonstrated by:
(i) using animals only when it is justified
(ii) supporting the wellbeing of the animals involved
(iii) avoiding or minimising harm, including pain and distress, to those animals
(iv) applying high standards of scientific integrity
(v) applying Replacement, Reduction and Refinement (the 3Rs) at all stages of animal care and use:
(a) the Replacement of animals with other methods
(b) the Reduction in the number of animals used
(c) the Refinement of techniques used to minimise the adverse impact on animals
(vi) knowing and accepting one’s responsibilities.
1.2 The care and use of animals for scientific purposes must be subject to ethical review.
1.3 A judgement as to whether a proposed use of animals
is ethically acceptable must be based on
information that demonstrates the principles in Section
1.1, and must balance whether the potential
effects on the wellbeing of the animals involved is
justified by the potential benefits.
1.4 The obligation to respect animals, and the
responsibilities associated with this obligation, apply
throughout the animal’s lifetime, including
acquisition, transport, breeding, housing, husbandry,
use of the animal in a project, and provisions for
the animal at the conclusion of their use.
Section 1 also outlines the importance of accepting responsibilities:
1.31 Institutions, AECs, and people involved in any
aspect of the care and use of animals for scientific
purposes must be aware of and accept their
responsibilities (see Section 2), and act in accordance
with the Code.
1.32 All activities, including projects, that involve the care and use of animals for scientific purposes must:
(i) be subject to ethical review, approval and monitoring by an AEC
(ii) commence only after approval has been granted by an AEC
(iii) be conducted in accordance with the AEC approval
(iv) cease if approval from the AEC is suspended or withdrawn.
The Three R'sThe DPIPWE AEC applies the Code to all animal research applications. An
important component of the AEC assessment is whether the application
incorporates the major principles of the Code, the 'Three R's' - Replacement,
Reduction and Refinement.
Encapsulated in the Code is the need in scientific and teaching activities to consider:
- the Replacement of animals with other methods;
- the Reduction in the number of animals used; and
- the Refinement of techniques used to reduce the adverse impact on animals.
1.18 Methods that replace or partially replace the use
of animals must be investigated, considered and,
where applicable, implemented.
1.19 Before the
use of animals is considered, all existing information relevant to the proposed
including existing databases, must be examined.
Replacement techniques that must be considered
include the use of epidemiological data; physical
and chemical analysis; computer, mathematical
and inanimate synthetic models; simulations; in
vitro systems; non-sentient organisms; cadavers;
and clinical cases.
1.20 Opportunities to replace the use of animals must be
kept under review during the lifetime of
a project. Where relevant and applicable, the
outcome of this review must be implemented in
current projects and taken into account in planning
1.21 The number of animals used in a project must
be the minimum necessary to achieve the proposed
aim(s) and to satisfy good statistical design. The
use of too few animals may invalidate the
experimental result and result in wastage of
1.22 The number of animals used may be reduced by
the appropriate re-use of individual animals.
The benefits of reusing animals must be balanced
against any adverse effects on their wellbeing,
taking into account the lifetime experience of the
individual animal. Re-use of animals requires
particular justification and specific AEC approval.
1.23 Activities involving the use of animals must
not be repeated within a project or between projects
unless such repetition is essential for the purpose
or design of the project (e.g. sound experimental
design, statistical analysis, corroboration by the
same or another investigator).
1.24 Reducing the number of animals used should not
result in greater harm, including pain and
distress, to the animals used.
1.25 All possible steps must be taken to reduce
factors that are not part of the experimental design of
the project and are known to contribute to
variability of experimental results, including the use
of animals of known genetic, biological and
behavioural background. Reduction of experimental
variables may result in reduced animal use.
1.26 Where practicable, tissue and other biological
material from animals being killed must be shared
among investigators or deposited in a tissue bank
for subsequent distribution.
1.27 Breeding of animals must be managed to avoid
or minimise the production of excess animals.
A new line of animal should not be generated if a
similar suitable animal line is available to the
investigator. When a new animal line is generated,
the colony should be made available as a
source for other investigators as appropriate.
1.28 Steps must be taken at all times to support
and safeguard animal wellbeing. The effectiveness of
strategies for supporting and safeguarding animal
wellbeing must be kept under review during the
lifetime of activities, including projects. Where
relevant and applicable, the outcome of this review
must be implemented in current activities and taken
into account in planning future activities,
1.29 People who care for and use animals must ensure that
(i) procedures are performed competently
(ii) they are competent in the procedure they perform or
(iii) are under the direct supervision of a person who is competent to perform
1.30 The duration of activities must be no longer
than required to meet the aim(s) of the project, and
must be compatible with supporting and safeguarding
animal wellbeing. Animals must not be held
for prolonged periods as part of an approved
project before their use without AEC approval.