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

1. How to Relate the Code to Your Research – the 3R’s Sara Paradowski – AEC Secretary Research Governance Unit

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).

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 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.

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

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

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 (3R’s)

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

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)

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.

10. AEC • To ensure all members of the AEC can understand your entire application, the whole application including the procedures must be in plain English.

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).

12. 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

13. 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.

14. 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)

15. The 3R’s • Replacement • Reduction • Refinement

16. 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).

17. The 3R’s • 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.

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.

19. 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

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.

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.

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

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).

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.

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.

26. Refinement • To 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.

27. Activity 2 • Addressing 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)

28. Updated Website http://www.svhm.org.au/research/governance/Pages/Researchinvolvinganimals.aspx • New Forms • New Adverse Event Reporting Procedure

29. A fundamental principle is never to assume that current practice is best practice.