How to Relate the Code to Your Research – the 3R’s

Sara Paradowski – AEC SecretaryResearch Governance Unit

The CodeThe 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).

The CodeThe 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 3R’s - Replacement, Reduction and Refinement are applied. The justification is decided through weighing the benefits of using the animals against the costs to the animals.

The CodeSections include:

Responsibilities of institutions and their AECsResponsibilities of investigators and teachersAcquisition and care of animals in breeding

and holding facilities

The AECThe 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

The AECThe AEC:

ensure that the use of animals is justified,provide for the welfare of those animals andincorporate the principles of Replacement,

Reduction and Refinement (3R’s)

The AECAECs fulfil their mandate by:Considering the ethical implications of a

projectAssessing approved projects for complianceApproving Standard Operating Procedures to

ensure consistency when performing procedures

Monitoring animal housing and animal careInspecting animal housing and care facilities

Composition of AECsChairCategory A - VetCategory B - ScientistCategory C – Animal WelfareCategory D – Lay MemberCategory E – Animal Tech (non-voting)

Activity 1Why 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.

AECTo ensure all members of the AEC

can understand your entire application, the whole application including the procedures must be in plain English.

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).

What is a Scientific Procedure?Acquiring, demonstrating or developing

scientific knowledge or techniquesDeveloping or testing vaccines, substances or

drugsProduction of biological products for use in

research or teachingBreeding of a new strain or hybrid of a

genetically modified animal

LicensingUse of the following animal types in Scientific Procedures must be licensed:

All fish and amphibiansMammals, birds and reptiles above the mid-

point in gestationAdult decapod crustaceansAdult cephalopods.

Breeding for Scientific ProceduresThe 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; andNon-human primates.

Breeding of these animals for supply to other institutions must be authorised by a Specified Animal Breeding Licence (SABL)

The 3R’s ReplacementReductionRefinement

The 3R’s Principle

The 3R’s 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).

The 3R’sThe 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.

ReplacementThe 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.

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

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.

ReductionDesigning 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.

ReductionExamples 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

ReductionTo 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).

RefinementStudies 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.

RefinementExamples of Refinement are:

Use of appropriate anaesthesia and analgesiaRadio 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.

RefinementTo address Refinement properly in an

application you must identify and justify the impact of all aspects of the project on the animal’s 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.

Activity 2Addressing the 3R’s

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)

Updated Website

http://www.svhm.org.au/research/governance/Pages/Researchinvolvinganimals.aspx

New FormsNew Adverse Event Reporting Procedure

A fundamental principle is never to assume that current

practice is best practice.