PIL A & B Training Modules & Learning Outcomes

Module 1: Legislation  (Module L)

Module 1 Description

This module provides a relevant level of understanding of the national and international legal and regulatory framework within which projects involving animals are constructed and managed and of the legal responsibilities of the people involved, i.e. those carrying out procedures on animals; designing procedures and projects; taking care of animals; or killing animals, and may cover other relevant legislation.

Module 1 Learning Outcome

Trainees should be able to:

i. Identify and describe the law and guidance which regulate the scientific use of animals and in particular the activities of those carrying out scientific procedures involving them.

ii. Identify and describe related animal welfare legislation.

iii 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.

iv. List sources of information and support that are available (regarding national legislation).

v. Describe the role of the NACWO, NIO, NTCO and NVS mentioned, and their statutory duties and other responsibilities under the ASPA.

vi. Describe the roles and responsibilities of the local animal welfare bodies and the national committee for the protection of animals used for scientific purposes.

vii. Indicate who is responsible for compliance at an establishment and how this responsibility may be exercised (e.g. through the local AWERB).

viii. Describe when a procedure becomes regulated under ASPA (minimum threshold of pain, suffering, distress or lasting harm).

ix. Indicate who bears primary responsibility for the animals undergoing procedures.

x. List which species, including respective stages of development that are included in the scope of the ASPA.

xi. Indicate the circumstances in which animals under the scope of ASPA should be humanely killed or removed from the study to receive veterinary treatment.

xii. Describe the legislative controls over the killing of animals bred or used for scientific procedures

Module 2: Ethics, Animal Welfare and the 3Rs (Level 1) (Module E1)

Module 2 Description

This module provides guidance and information to enable individuals working with animals to identify, understand and respond appropriately, to the ethical and welfare issues raised by the use of animals in scientific procedures generally and, where appropriate, within their own programme of work. It provides information to enable individuals to understand and to apply the basic principles of the 3Rs.

Module 2 Learning Outcomes

Trainees should be able to:

i. Describe the differing views, within society, relating to the scientific uses of animals and recognise the need to respect these.

ii. Describe the responsibility of humans when working with research animals and recognise the importance of having a respectful and humane attitude towards working with animals in research.

iii. Identify ethical and animal welfare issues in their own work and be aware and able to reflect on the consequences of their own actions.

iv. Recognise that compliance with ethical principles may contribute to the long-term trust and acceptance in scientific research from the general public.

v. 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 3Rs to minimise the harm, maximise benefits and 3) promote good animal welfare practices.

vi. Describe and discuss the importance of the 3Rs as a guiding principle in the use of animals in scientific procedures.

vii. Explain the Five  Domains and how these apply to laboratory species

viii. Describe the concept of harms to animals including avoidable and unavoidable suffering, direct, contingent and cumulative suffering

ix. Describe the severity classification system, and give examples of each category. Describe cumulative severity and the effect this may have on the severity classification.

x. Describe the regulations regarding re-use of animals.

xi. Describe the importance of good animal welfare including its effect on scientific outcomes as well as for societal and moral reasons.

xii. Describe the need for a culture of care and the individual’s role in contributing to this.

xiii. Describe relevant sources of information relating to ethics, animal welfare and the implementation of the 3Rs.

xiv. Be aware of different search tools  and methods of search.

Module 3.1: Basic and Appropriate Biology – Species Specific (Theory) (part of Module PIL AB (Theory))

Module 3.1 Description

This module provides an introduction to the basic principles of animal behaviour, care, biology and husbandry. It incorporates information in relation to anatomy and physiological features, including reproduction, behaviour and routine animal husbandry and enrichment practices. It is not intended to provide more than the minimum background information which is needed for someone to be able to begin work under supervision. Following this module practical training, under supervision.

Following this module, practical training under supervision should provide each individual with the expertise and skills needed for them to carry out their particular role. Practical training requirements will, inevitably, differ according to role.

Module 3.1 Learning Outcomes

Trainees should be able to:

i. Describe basic anatomy, physiology, reproduction and behaviour of the relevant species.

ii. Recognize and describe life events that have the potential to cause suffering including sourcing, transport, housing, husbandry, handling and procedures (on a basic level).

iii. Indicate how good welfare can promote good science: e.g. explain how the failure to attend to biological and behavioural needs may affect the outcome of procedures.

iv. Indicate how husbandry and care may influence experimental outcome and the number of animals needed e.g. example where the place in the room influences the outcome, hence randomisation.

v. Describe the dietary requirements of the relevant animal species and explain how these can be met.

vi. Describe the importance of providing an enriched environment (appropriate to both the species and the science) including social housing and opportunities for exercise, resting and sleeping.

vii. When relevant to the species, recognise that there are different strains, and that these can have different characteristics which can affect both welfare and science.

viii. When relevant to the species, recognise that alterations to the genome can affect the phenotype in unexpected and subtle ways, and the importance of monitoring such animals very carefully.

ix. Maintain and interpret accurate, comprehensive records of animals held in the animal facility, including the wellbeing of the animals

Module 3.2: Basic and Appropriate Biology – Species Specific (Practical) (part of Module PIL A (Skills))

Module 3.2 Learning Outcome

i. Be able to approach, handle/pick up and restrain an animal and return it to its cage/pen in a calm, confident and empathetic manner such that the animal is not distressed or caused harm.

Module 4: Animal Care, Health and Management – Species Specific (Theory) part of Module PIL A  (Theory))

Module 4 Description

This module provides information on various aspects of animal health, care and management including, environmental controls, husbandry practices, diet, health status and disease. It also includes relevant basic learning outcomes relating to personal health and zoonoses.

Module 4 Learning Outcomes

Trainees should be able to:

i. Describe suitable routines and husbandry practices for the maintenance, care and welfare for a range of animals used in research, to include small laboratory species and large animal species where appropriate.

ii. Describe suitable environmental and housing conditions for laboratory animals, how conditions are monitored and identify the consequences for the animal resulting from inappropriate environmental conditions.

iii. Recognise that changes to or disruption of circadian or photoperiod can effect animals.

iv. Describe the biological consequences of acclimatisation, habituation and training

v. Describe how the animal facility is organized to maintain an appropriate health status for the animals and the scientific procedures.

vi. Describe how to provide water and an appropriate diet for laboratory animals including the sourcing, storage and presentation of suitable foodstuffs and water

vii. List the methods, and demonstrate an understanding of appropriate, safe and humane handling, sexing and restraint of one or more named species for common scientific procedures.

viii. Name different methods for marking individual animals and state an advantages and disadvantage for each method.

ix. List potential disease risks in the animal facility, including specific predisposing factors which may be relevant. Name methods available for maintaining appropriate health status (including use of barriers, different containment levels use of sentinels as relevant to the species).

x. Describe appropriate breeding programmes

xi. Describe how genetically altered animals can be used for scientific research and the importance of monitoring such animals very carefully.

xii. List the correct procedures for ensuring health, welfare and care of animals during their transport.

xiii. List potential human health hazards associated with contact with laboratory animals (including allergy, injury, infection, zoonosis) and how these can be prevented

Module 5: Recognition of Pain, Suffering and Distress – Species Specific (part of module PIL A (Theory)

Module 5 Description

This module prepares individuals to be able to identify normal condition and behaviour of experimental animals and enable them to differentiate between a normal animal and one which is showing signs of pain, suffering or distress which could be a result of factors including environment, husbandry or the effect of experimental protocols. It will also provide information regarding severity classifications, cumulative severity and the use of humane endpoints.

Module 5 Learning Outcomes

Trainees should be able to:

i. Recognise normal or desirable behaviour and appearance of the individuals in the context of species, environment and physiological status.

ii. Recognise abnormal behaviour and signs of discomfort, pain, suffering, or distress, as well as signs of positive well-being and principles of how pain, suffering and distress can be managed.

iii. Discuss factors to be considered and methods available for assessing and recording the welfare of animals e.g. score sheets.

iv. Describe what a humane end point is. Identify criteria to be used to set humane endpoints. Define action to be taken when a humane endpoint is reached and consider possible options for refining methods to finish at an earlier endpoint.

v. Describe the severity classifications included in ASPA and give examples of each category; explain cumulative severity and the effect this may have on the severity classification.

vi. Describe the circumstances when anaesthesia or analgesia may be necessary to minimise pain, suffering, distress or lasting harm 

Module 6.1: Humane Methods of Killing (Theory) (Module K (Theory))

Module 6.1 Description

This module provides information on the principles of humane killing and the need to have someone available, at all times, who is able to kill an animal quickly and humanely if required. The module will include information and descriptions of the different methods available, details of the species for which these methods are suitable and information to help trainees compare the methods permitted and determine how to select the most appropriate method.

Module 6.1 Learning Outcomes

Trainees should be able to:

i. Describe the principles of humane killing (e.g. what constitutes ‘a good death’)

ii. Describe the different methods by which the relevant animals are allowed to be killed, the influence different methods can have on scientific outcomes, and how to select the most appropriate method.

iii. Explain why someone competent to kill animals should be available at all times (whether care staff or person carrying out procedures)

Module 6.2 Description

This module provides practical training to reflect the information and principles delivered in module covering Human Methods of Killing (theory) and will involve practical training in the appropriate methods for the species and suitable methods of confirming death.

Module 6.2 Learning Outcomes

i. Proficiently and humanely carry out euthanasia using appropriate techniques on relevant species of laboratory animals

ii. Demonstrate how death is confirmed and how cadavers should be processed or otherwise disposed of.

Module 6.3: Humane Methods of Killing - Stand-alone module for those who only perform killing of animals by Schedule 1 methods (Module KD)

Module 6.3 Description

This module has been designed for those who only perform the role of killing of animals by schedule 1 methods and is a pre-requisite for this role which can be delivered in place of a number of other modules for anyone who will only be involved in the humane killing of animals. This module combines Learning Outcomes from the modules relating to legislation, ethics and the 3Rs with practical animal handling, safe working practices and the theory and practical elements of the humane killing modules.

Module 6.3 Learning Outcomes

Legislation, 3Rs and ethics (i.e. subset of Modules L and E1)

i. Describe the regulatory framework for the scientific use of animals and in particular controls relating to the conduct of humane killing and confirming death – including role of named persons and the Animal Welfare Body

ii. Recognize differing societal views about the scientific use and humane killing of animals 

iii. Have an understanding of the ethical principles underlying the use of animals and of their own role in contributing to the ‘culture of care’.

iv. Relate ways in which the 3Rs can be applied to the humane killing of animals 

Species specific handling

v. Demonstrate appropriate techniques for the safe and competent handling of relevant species. Be able to approach, handle/pick up and restrain an animal and return it to its cage/pen in a calm, confident and empathetic manner such that the animal is not distressed or caused harm. Explain the importance of transporting animals correctly and safely.

vi. Describe the normal and abnormal behaviour and the behavioural requirements of relevant species and be able to recognise and discuss strategies for minimising and responding to occurrences of pain, suffering and distress.

vii. Describe in outline the basic biological and husbandry needs of relevant species.

Safe working practices

viii. Discuss the importance of correct storage and handling of chemical agents used for humane killing and maintaining hygiene in the workplace.

ix. Describe the correct procedures to deal with accidental exposure or spillage.

x. Describe the basic hygiene rules and relate these to the workplace.

xi. Relate the importance of correct disposal of different categories of waste (clinical waste, hazardous waste and normal waste) and describe appropriate strategies.

xii. Explain how engineering solutions combined with personal protection equipment can minimise exposure to laboratory animal allergens preventing sensitisation.

xiii. Identify clinical symptoms commonly associated with allergy to laboratory animals.

xiv. Describe what is meant by zoonosis, and explain why contact with different species (in particular non-human primates) constitutes a potential human health hazard.

Species specific humane killing

xv. Describe the principles of humane killing (e.g. what constitutes ‘a good death’)

xvi. Describe the different methods by which the relevant animals are allowed to be killed, the influence different methods can have on scientific outcomes, if relevant, and how to select the most appropriate method.

xvii. Explain why someone competent to kill animals should be available at all times (whether care staff or person carrying out procedures)

xviii. Proficiently and humanely carry out euthanasia using appropriate of techniques on relevant species of laboratory animals

xix. Demonstrate how death is confirmed and how cadavers should be processed or otherwise disposed of.

Module 7: Minimally Invasive Procedures Without Anaesthesia – Species Specific (Theory) part of Module PIL A (Theory))

Module 7 Description

This module provides an introduction to the theory relating to minor procedures. It provides information about appropriate methods of handling and restraint and describes appropriate techniques for injection, dosing and sampling relevant to the species. It should provide information sufficient for individuals to understand what will be required of them before they go on to trained in the practical aspects of these skills whilst under supervision.

Module 7 Learning Outcomes

Trainees should be able to:

i. Describe appropriate methods and principles to be followed when handling animals (including methods of manual restraint and use of restricted environments).

ii. Describe the biological impact of procedures and restraint on physiology.

iii. Describe refinement opportunities for procedures and restraint e.g. through training (using positive re-enforcement), habituation and socialisation of animals.

iv. Describe techniques/procedures including, for example, injection, sampling and dosing techniques (routes/volumes/frequency), dietary modification, gavage, tissue biopsy, behavioural tests, use of metabolic cages.

v. Describe how to perform minor techniques and relate appropriate sample volumes and sampling frequencies for the relevant species.

vi. Describe the need for rigour and consistency in conducting scientific procedures and the correct recording and handling of samples.

vii. Describe appropriate methods for the assessment of the welfare of animals with respect to the severity of procedures and know what appropriate action to take.

viii. Recognize that refinement is an on-going process and know where to find relevant, up-to-date, information.

ix. Describe the biological consequences of transport, acclimatization, husbandry conditions and experimental procedures on the species concerned and describe how these can be minimised.

Module 8: Minimally Invasive Procedures Without Anaesthesia – Species Specific (Skills) (part of Module PIL A (Skills))

Module 8 Description

This module delivers practical elements of training relevant to Module covering minimally invasive procedures without anaesthesia – species specific (theory). Practical training for minor procedures can be taught through a number of methods using different tools which are available and designed for the purpose (this is likely to include synthetic animal models and the use of cadavers). The module should be designed in such a way that it will enable the trainee to attain a level of proficiency such that, when commencing work under supervision, s/he should cause no pain, suffering, distress or lasting harm to the animal.

Module 8 Learning Outcomes

Trainees should be able to:

i. Select and explain the best methods for common procedures (such as blood sampling and application of substances) including route/volume/ frequency as appropriate.

ii. Demonstrate that s/he can handle and restrain the animal in the best position for the technique.

iii. Perform minor techniques under supervision, in a manner that does not inflict unnecessary pain, suffering, distress or lasting harm.