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 [Function Specific for Function B]  This module provides a relevant level of understanding of the national and international legal and regulatory framework within which projects are constructed and managed, and of their legal responsibilities. The trainee must be able to identify, understand and respond appropriately to the ethical and welfare issues raised by the use of animals in scientific procedures generally, and specifically within their own programme of work. These have been addressed in Module 2. The trainee should be able to develop, direct and control a programme of work in order to achieve its stated objectives, while ensuring compliance with the terms and conditions of any regulation governing the project. This includes implementation of the Three R’s throughout the programme of work. Learning outcomes relating to Reduction are addressed in Module 2.

Learning Outcomes Trainee should be able to:

(i) Legal issues

11.1. Describe in detail the main components of the national legislation regulating the scientific use of animals; in particular, explain the legal responsibilities of those designing procedures and projects (Function B staff) and those of other persons with statutory responsibilities under the national legislation (e.g. the person responsible for compliance, veterinarian, animal care staff, training officers).

11.2. List the key purposes of other relevant EU and international legislation and associated guidelines that impact on the welfare and use of animals. This includes Directive 2010/63/EU and legislation/guidelines relating to: veterinary care, animal health, animal welfare, genetic modification of animals, animal transport, quarantine, Health & Safety, wildlife and conservation.

(ii) Good scientific practice

11.3. Describe the principles of a good scientific strategy that are necessary to achieve robust results, including the need for definition of clear and unambiguous hypotheses, good experimental design, experimental measures and analysis of results. Provide examples of the consequences of failing to implement sound scientific strategy.

11.4. Demonstrate an understanding of the need to take expert advice and use appropriate statistical methods, recognise causes of biological variability, and ensure consistency between experiments.

11.5. Discuss the importance of being able to justify on both scientific and ethical grounds, the decision to use living animals, including the choice of models, their origins, estimated numbers and life stages. Describe the scientific, ethical and welfare factors influencing the choice of an appropriate animal or non-animal model.

11.6. Describe situations when pilot experiments may be necessary.

11.7. Explain the need to be up to date with developments in laboratory animal science and technology so as to ensure good science and animal welfare.

11.8. Explain the importance of rigorous scientific technique and the requirements of assured quality standards such as GLP.

11.9. Explain the importance of dissemination of the study results irrespective of the outcome and describe the key issues to be reported when using live animals in research e.g. ARRIVE guidelines.

(iii) Implementing the Three Rs 1

11.10. Demonstrate a comprehensive understanding of the principles of replacement, reduction and refinement, and of how these ensure good science and good animal welfare.

11.11. Explain the importance of literature and internet searches, discussion with colleagues and with relevant professional bodies in identifying opportunities for applying each ‘R’

11.12. Describe relevant sources of information relating to ethics, animal welfare and the implementation of the Three Rs.

11.13. Explain how to use different search tools (e.g. EURL ECVAM Search Guide, Go3Rs) and methods of search (e.g. Systematic reviews, meta-analysis).

11.14. Describe examples of alternative methods and research strategies that replace, avoid or complement the use of animals in different types of research programme.

11.15. Identify, assess and minimise all of the welfare costs to animals throughout the animals’ lifetime (including adverse effects relating to sourcing, transport, housing, husbandry, handling, procedures and humane killing); Explain and give examples of welfare assessment protocols.

11.16. Define and apply appropriate humane end-points; establish suitable criteria to identify when the humane endpoint has been reached

11.17. Describe possible conflicts between Refinement and Reduction ( the case of re-use) and the factors that need to be considered to resolve this conflict

11.18. Define the requirements for, and controls on, re-homing of animals; identify any relevant re-homing guidelines

(iv) Responsibilities

11.19. Explain the need to be aware of local arrangements relating to project licence management, e.g. procedures for ordering animals, accommodation standards, disposal of animals, safe working practices and security, and the actions to take in the event of unexpected problems arising with any of these.