RSPCA Road Map: A Practical Guide for Reducing Severe Suffering in Animal Research, Slides of Literature

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FOCUS ON SEVERE SUFFERING

PART 1: INTRODUCTION AND

PROSPECTIVE REVIEW

Road Map

Resource Pack

st

edition. November 2015

Page 1 of 2

RSPCA Road Map resource pack

Guidance for facilitators This set of slides was prepared by the Research Animals Department of the RSPCA, and is intended primarily as a practical guide for UK Animal Welfare and Ethical Review Bodies (AWERBS) or other bodies that establishments may set up to address severe suffering locally. The aim is to help them focus on reducing and avoiding severe suffering within their establishments. The resource is intended to be accessible to all members of AWERBs or other committees, including Named Persons, lay members, animal technologists and researchers, each of whom may have been members for some time or may be relatively new to their role. Some members may thus be very familiar with the information and approaches set out in these slides, whereas the materials, technical details and processes mentioned will be less well known to others. Each slide has associated notes which provide a guide to the points you can make while giving the presentation, but the intention is for you to use your own script rather than read the notes as they are. Please contact the Research Animals Department if you would like to receive an editable version of this resource or any additional information: research.animals@rspca.org.uk Intended context for the slide set The slide set aims to help establishments focus on and address procedures that may (or do) cause severe suffering, with the aim of reducing or entirely avoiding severe suffering. Some form of internal body should be formed that can audit projects and procedures, identify those that do or may cause severe suffering and establish a process to address this. Depending on the nature of the establishment, its culture and internal processes, this could be done by the AWERB, a dedicated 3Rs sub-group, or a special review body set up for the purpose. Suitable members may include the researcher undertaking the project, the Named Veterinarian, the Named Animal Care and Welfare Officer, the Named Information Officer, the local Home Office Inspector and the lay or independent member of the AWERB. In addition, it may be of value to include one or more external experts (with specific animal welfare, Three Rs or scientific knowledge) especially if the project will include novel ‘models’ or procedures. Whatever the format of the body undertaking the review, it should have a designated facilitator to provide leadership and ensure that its conclusions are implemented, reviewed and followed up. It should also communicate with and report to the AWERB, as several of the AWERB’s tasks are directly related to the Road Map. The approach is also linked to the legal requirements of Directive 2010/63/EU and the Animals (Scientific Procedures) Act 1986 with respect to reducing suffering, so implementing the Road Map is a positive way to help ensure compliance with the letter and spirit of the legislation, as well as defining and reinforcing local values with respect to reducing suffering and improving welfare. For example, the slide set intended for use at the prospective review stage aims to ensure an in- depth and focused discussion on the animal’s potential experience and how this could be refined, but the outcome would not necessarily have to be extensively detailed in the protocol sheet of the final application form. The main aim is for the AWERB, or equivalent body, to fulfil its tasks in the context of avoiding and reducing severe suffering, e.g. by acting as a discussion forum and advising on the application of the Three Rs.

RSPCA Road Map resource sheet 1 – to complete before the project has started Predicted lifetime experiences (not including procedures) Project licence number Protocol number Factor Experience of the animal Welfare issues Ways of mitigating these Sourcing Transport Marking for identification Biopsy for genotyping Housing, husbandry and care

RSPCA Road Map resource sheet 1 – to complete before the project has started Capture, handling and restraint Humane killing Note: This sheet should be edited and tailored to the species and different factors that may apply under different circumstances. Factors may need to be added, edited or deleted.

RSPCA Road Map resource sheet 1 – to complete before the project has started Biopsy for genotyping N/A Housing, husbandry and care Mice are housed in groups of 3 in standard mouse cages with litter, refuges, nesting material and chew blocks. Cages are cleaned weekly. Space restrictions in standard size caging. Some fighting observed, especially in males, after cage cleaning. House mice in (empty!) rat cages to provide more space. Trial transferring some litter (not nesting material) from the soiled to the clean cage. Supply males with extra nesting material and remove refuges. Review cage cleaning intervals. Capture, handling and restraint Mice are caught and restrained by the tail. Research indicates that this is distressing and causes anxiety. Catch mice in cupped hands or tunnel – see NC3Rs resource. Humane killing Moved within home cage to chamber where they are exposed to a rising concentration of carbon dioxide. Stress of being moved to chamber. Distress due to ‘air hunger’ as concentration increases. Move to anaesthetising with minimally invasive gaseous agent before switching to CO 2. Research possibility of introducing CO 2 into home cages if housed in IVC. Note: This example is for guidance only and intended to give an indication of some of the points and factors that could be discussed when conducting this part of the review.

RSPCA Road Map sheet 1: Lifetime experiences – guidance notes Below are examples of the kinds of questions you might like to consider with respect to the factors listed in sheet 1. For further information, see also RSPCA Lay Members’ Handbook pages 32- (refinement). Sourcing – where will the animal come from? If an external breeder, how do the standards of housing, husbandry and care compare with those at the user establishment? At what age are juvenile animals separated from the dam (‘weaning’)? How does ‘weaning’ age compare with good practice guidelines, other facilities, and/or the age at which they would separate in the wild (as appropriate)? If bred in-house, at what age does separation from the dam take place? What measures are in place to ensure that supply meets demand and wastage is minimised? (If there are any surplus animals, what happens to them and why?) Transport – is this avoided wherever possible, or are journeys refined so as to minimise stress? Are recovery times following transport adequate from both animal welfare and scientific aspects? Marking for identification – is this minimally invasive and fully refined? Biopsy for genotyping – is the minimum amount of tissue taken, or could non-invasive techniques be used? Could biopsy be combined with identification (e.g. ear punching in rodents)? Housing – is a good quality and quantity of space provided, with appropriate group housing (for social animals), environmental enrichment and adaptations for animals affected by procedures (if necessary)? Husbandry and care – is this sympathetic to the animals’ behavioural and sensory adaptations, e.g. are light regimes appropriate for the species, does cage cleaning try to accommodate scent markings and is sufficient recovery allowed before procedures? Capture, handling and restraint – is it recognised that these can be stressful and are all suitably refined, including minimising episodes of restraint or using positive reinforcement training? The UK NC3Rs has a resource on this topic. Humane killing – has the least distressing method been chosen, or has the ‘default’ at the establishment been selected? Could the technique be refined? It is important to keep up with current good practice in relation to refining all of the above, acknowledging that ranges of experience and knowledge are required to identify, interpret, implement and evaluate refinements. A designated individual such as the Named Information Officer or the AWERB/AWB should be responsible for ensuring that new information on refinement, animal behaviour and biology, and relevant scientific developments is available for review within the facility. RSPCA September 2015

RSPCA Road Map resource sheet 2 – to complete before the project has started

RSPCA Road Map resource sheet 2 – to complete before the project has started Focus on procedures Project licence number (^) 70/ Protocol number (^2) What does this study involve doing to the animals? What will the animals experience? How much suffering might it cause? What might make it worse? How will suffering be reduced to a minimum? Adverse effects and indicators of these Methodology and interventions Humane endpoints Administration of rheumatoid arthritis inducer Capture and restraint – distress. Aggression, vocalisation, unwilling to be caught. Administration i.d. or s.c. – pain. Flinching, vocalisation, aggression. Pain or ulceration around injection site. Attention to site, reduction in nest quality, body weight/food Competent, empathetic capture (e.g. not by tail) and handling, habituate to handling and restraint. Use gaseous anaesthesia for i.d.; inject into rump, not tail base (if tail base is painful, restraint by the tail will hurt). Minimise volumes and doses, use multiple sites if large volumes. Ensure injectate formulated to minimise adverse effects Inject into rump (less risk of ulceration); never inject into the foot; if attention paid to site Humane endpoints with respect to administration of inducer in general:

• Ulceration that is painful, shows no signs of healing or becomes infected.
• If an ulcer reaches >5 mm, the vet or senior animal technologist should be informed and consulted about treatment. Animal should be humanely killed if no signs of healing within 3 days.

Slide 1 Road Map resource pack: Focus on severe suffering This set of slides was prepared by the Research Animals Department of the RSPCA, and is intended primarily as a practical guide for Animal Welfare and Ethical Review Bodies (AWERBs) or other institutional animal care and use committees, to establish a mechanism towards reducing and avoiding severe suffering within their establishments. The resource is intended to be accessible to all members, each of whom may have sat on the AWERB or committee for some time, or may be relatively new to their role. Some members may thus be very familiar with the information and approaches set out in these slides, whereas the materials, technical details and processes mentioned will be less well known to others. Each slide has associated notes which provide a guide to the points you can make while giving the presentation, but the intention is for you to use your own script rather than read the notes as they are. Please read the Guidance for Facilitators before giving this presentation. You can contact the Research Animals Department if you would like to receive an editable version of this resource or any additional information: research.animals@rspca.org.uk 1

Slide 2 Background: Why focus on severe suffering? Ethical reasons: All levels of suffering are of concern to those involved with animal research. However, severe suffering is of special concern to many people and reducing this will address ethical and animal welfare issues, improve the harm- benefit balance and can often also inspire refinements for use in less severe procedures. Legal reasons: Directive 2010/63/EU requires pain, suffering, distress and lasting harm to be minimised, so tackling severe suffering will help the establishment to comply with the Directive in letter and in spirit. Scientific reasons: All forms of suffering – pain or distress – lead to physiological responses as the animal attempts to cope. These responses can increase the variability in an assay or procedure, potentially even confounding the data. 2

Slide 4 The role of the AWERB An effective AWERB is integral to a good culture of care. The Home Office Guidance to the ASPA lists the following tasks for the UK AWERB (in section 10.5):

• promote awareness of animal welfare and the 3Rs;
• provide a forum for discussion (and development of ethical advice to the establishment licence holder) on all matters related to animal welfare, care and use at their establishment;
• support named persons, and other staff dealing with animals, on animal welfare, ethical issues and provision of appropriate training;
• help to promote a ‘culture of care’ within the establishment All of these are vitally important with respect to creating an environment in which refinement can be effectively implemented and severe suffering avoided or reduced. [Further information: See section 2 of the RSPCA/LASA Good Practice Guidelines: Home Office requirements.] 4

Slide 5 More on specific AWERB tasks that are relevant to addressing severe suffering The Home Office Guidance to the ASPA also lists the AWERB tasks that are required by the Directive and ASPA (section 10.4). The minimum tasks relevant to tackling severe suffering are to:

• advise staff dealing with animals in the licensed establishment on matters related to the welfare of the animals, in relation to their acquisition, accommodation, care and use;
• advise on the application of the 3Rs, and keep the establishment informed of relevant technical and scientific developments;
• establish and review management and operational processes for monitoring, reporting and follow-up in relation to the welfare of animals housed or used in the licensed establishment; and
• follow the development and outcome (retrospective review) of projects carried out in the establishment, taking into account the effect on the animals used; and to identify and advise on elements that could further contribute to the 3Rs. An additional task that may be allocated under the ASPA is to assist with the retrospective assessment of relevant projects carried out at their establishment. This resource aims to help AWERBs fulfil these tasks for their establishments. [Further information: See section 2 of the RSPCA/LASA Good Practice Guidelines: Home Office requirements; see also example 2 on page 40 of the RSPCA Lay Members’ Handbook, which sets out potential actions to address severe suffering.] 5

Slide 7 The procedural aspect The next element of the ‘Road Map’ principle is to audit the severity of procedures planned or undertaken at the establishment, with the aim of reviewing those that may be, or are, severe. This can take place before the project starts (prospective severity assessment), during a project (ongoing or mid-term reviews) or at the end of a project (actual severity assessment). The approach to each of these assessments as set out in this resource is intended to complement, and in some instances form part of, the requirements of the ASPA. The aim at each stage is slightly different:

• prospective severity assessment aims to prevent or avoid severe suffering wherever possible, and to ensure that effective welfare assessment protocols and humane endpoints are in place – this can be part of the process of preparing the project application for submission to the Home Office;
• ongoing, interim or mid-term reviews aim to see whether adverse effects were accurately predicted, to evaluate whether severe suffering is occurring, and to identify ways in which it may be possible to avoid this for the remainder of the project;
• actual severity assessment aims to see whether adverse effects were accurately predicted, to evaluate whether severe suffering occurred, and to identify refinements that can be applied to future projects and disseminated more widely. This can be done as part of the retrospective review required for all procedures with a ‘severe’ severity limit. Note: the slides addressing prospective severity assessment follow this introductory section; the other two sections are currently in preparation. (^7)