By the end of this course, trainees will be able to:

• Understand national and EU legal frameworks regulating animal use in research.

• Recognise legal requirements for establishments, projects, and personnel involved in scientific procedures.

• Identify roles and responsibilities of key personnel and institutional bodies (e.g. Animal Welfare Bodies, national committees).

• Apply ethical principles, including harm-benefit assessment and the Three Rs, to the planning and conduct of animal research.

• Classify and evaluate the severity of procedures and understand regulations regarding re-use and humane endpoints.

• Understand the legal basis for humane killing of animals used or bred for scientific purposes.

• Navigate local institutional procedures for compliance, project licence management, and animal welfare.

Below is the complete list of learning outcomes for this course. Each outcome corresponds to the EU Education and Training Framework.

This course addresses learning outcomes from Modules 1, 2, 9, and 11.

Module 1 – National and EU Legislation

• 1.1 Identify and describe the national and EU laws and guidance which regulate the scientific use of animals and in particular the activities of those carrying out scientific procedures involving them.
• 1.2 Identify and describe related animal welfare legislation.
• 1.3 Describe the authorisation that is needed before acting as user, breeder or supplier of laboratory animals and especially the authorisation required for projects and where applicable individuals.
• 1.4 List sources of information and support that are available (regarding national legislation).
• 1.5 Describe the role of the personnel mentioned in Article 24, 25 and 26, and their statutory duties and other responsibilities under the National Legislation.
• 1.6 Describe the roles and responsibilities of the local animal welfare bodies and the national committee for the protection of animals used for scientific purposes.
• 1.7 Indicate who is responsible for compliance at an establishment and how this responsibility may be exercised (e.g. through the local AWB).
• 1.8 Describe when a procedure becomes regulated under National legislation (minimum threshold of pain, suffering, distress or lasting harm).
• 1.9 Indicate who bears primary responsibility for the animals undergoing procedures.
• 1.10 List which species, including respective stages of development that are included in the scope of the Directive / National law.
• 1.11 Indicate the circumstances in which animals under the scope of the Directive should be humanely killed or removed from the study to receive veterinary treatment.
• 1.12. Describe the legislative controls over the killing of animals bred or used for scientific procedures.

Module 2 – Ethics, animal welfare and the Three Rs (level 1)

• 2.5 Describe how the law is based on an ethical framework which requires 1) weighing the harms and benefits of projects (the harm/benefit assessment) 2) applying the Three Rs to minimise the harm, maximise benefits and 3) promote good animal welfare practices.
• 2.8 Describe the concept of harms to animals including avoidable and unavoidable suffering, direct, contingent and cumulative suffering.
• 2.9 Describe the severity classification system, and give examples of each category. Describe cumulative severity and the effect this may have on the severity classification.
• 2.10 Describe the regulations regarding re-use of animals.

Module 9 – Ethics, animal welfare and the Three Rs (level 2)

• 9.3 Recognise that there are ethical limits to what it is considered permissible to do under the Directive and that even within these legal constraints, there are also likely to be national and institutional differences in this respect.
• 9.4 Explain that legislation requires that the justification for programmes of work is assessed by weighing potential adverse effects on the animals against the likely benefits; that harms to animals must be minimised, and benefits maximised.

Module 11 – Design of procedures and projects (level 2)

• 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.
• 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.