Research using Animals Animal Welfare and Ethical Review Board (AWERB) Jane Prewett jane.prewett@warwick.ac.uk Deputy Director and Head of Research Governance, Research Support Services Secretary, Research Governance and Ethics Committee Secretary, AWERB April 2014

University Statement - Research using Animals http://www2.warwick.ac.uk/services/gov/atoz/rec/research_using_animals Committed to the highest ethical standards and standards of care and respect for animal welfare where the use of animals is essential. Highly experienced and qualified veterinary and animal care staff provide advice to staff and students involved in research using animals. Alternative methods to the use of animals are under constant development; animal procedures replaced with non-animal techniques wherever possible. All projects involving animals which are not subject to Home Office licensing, are scrutinised and approved by the Animal Welfare and Ethical Review Body (AWERB). The University through the AWERB ensures that: staff and students are trained and appropriately experienced that the potential benefits of the research outweigh the effects on the animals concerned promotion of the 3Rs (Replacement, Reduction and Refinement) Only when the AWERB is fully satisfied that these principles are being adhered to will proposals be approved and, where a licence is required, submitted to the Home Office for its approval.

AWERB Remit Members include: ELH (Chair)/NCO, NACWO, NVS, NTCO, NIO, PPL holders and a PIL holders spanning expertise in reproduction, virology, neurology and metabolic. Monitors the University‘s fulfilment of its obligations under ASPA and the associated Ethical Review Process and advises the ELH. Reviews any application for research involving animals that does not require a Home Office licence (New Unlicenced Form). Promotes the 3Rs (Replacement, Reduction and Refinement) and disseminate appropriate information through (e.g.) circulation of information and staff training. Advises the RGAEC on policy regarding the use of animals in research. Reports of each meeting go to the RGAEC and to the Home Office.

Research and testing using animals - Legislation Animals (Scientific Procedures) Act 1986 (ASPA) ASPA implemented by the Home Office in England, Scotland and Wales Act revised 1 January 2013 to transpose the European Directive 2010/63/EU on the protection of animals for scientific purposes. Act currently incorporates the changes made by Animals (Scientific Procedures) Act 1988 Amendment Regulations 2012 (SI 2012/3039) on 18 December 2012 to transpose Directive 2010/63/EU (working document for information only) ASPA is a Criminal Act and so can be enforced by prosecution through the Courts for offences against this law.

Research and testing using animals - Legislation Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 Published March 2014 (First draft published 29 January 2013) Explains what amended ASPA requires and provides detailed guidance to holders of Establishment Licences, Project Licences and Personal Licences. Provides guidance on severity classification and humane killing. Draft Code of Practice for all licensed establishments for the care and accommodation of animals Published 15 February 2013 for comment by 29 March 2013 Taken from Annex 3 to European Directive 2010/63/EU Sets out the standards which must be applied by all users , breeders and suppliers of animals from 1 January 2013 to 31 December 2016.

Ethical Background of the Animals (Scientific Procedures) Act 1986 The justification for the issuing of a Project Licence under this Act is based on the proportionality between the harm (possible animal suffering) and the benefit (the hoped for result of the proposed research): The Harm/Benefit Analysis Such legal justification is only conceded if there is no viable ‘in vitro’ alternative to animal use and carries with it the inviolable obligation to fully observe wherever possible the ethical principle of the 3Rs: The 3Rs: Replacement, Reduction, Refinement A licence cannot be granted if the work could be carried out without using animals (Replacement). The procedures authorised must cause the minimum possible suffering of the lowest sensitivity (Refinement) to the minimum number of animals (Reduction).

ASPA – Regulated Procedure A regulated procedure is a procedure if it is carried out on a protected animal* and may cause that animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by inserting a hypodermic needle according to good veterinary practice. Exceptions: Some methods of identification Clinical tests Various veterinary agricultural and husbandry practices Killing animals by ASPA Schedule 1 methods Certain non-technical regulated procedures can be delegated to non-licensees or may only be performed by a non-licensee in the presence of the Personal Licence Holder. * A protected animal is any living vertebrate other than man and living cephalopod. (The animal is regarded as continuing to live until permanent cessation of circulation or the destruction of the brain).

Two important ASPA Schedules Schedule 1 A List of humane methods for killing experimental animals The killing of an animal in keeping with this Schedule is not a regulated procedure and so no licence is needed. The person killing the animal must be competent in the specified method of killing and their name should appear on the register drawn up by the Establishment Licence Holder. Killing an animal in a Designated Establishment by a method not allowed for in Schedule 1 is a regulated procedure and must be performed under a personal and project licence. Schedule 2 This is the list of the animals used in research which must be obtained from designated breeding or supplying establishments. From 1 January 2013 this includes Zebra Fish.

ASPA – Applying for Licences There are three forms of ASPA licence authorisation which need to be in place to ensure the legal performance of a Regulated Procedure: Establishment Licence Project Licence Personal Licence The Project Licence is the means by which the authority is given for a Programme of Work involving Regulated Procedures on animals to be carried out in the Specified places by those who have an appropriate Personal Licence. The Project Licence sets out the work which may be performed and the justification for the work.

ASPA Establishment Licence Persons identified on an Establishment Licence: Establishment Licence Holder/Named Compliance Officer Named Animal Care & Welfare Officer (NACWO) Named Veterinary Surgeon (NVS) Named Information Officer (NIO) Named Training and Competence Officer (NTCO) There are 25 Standard Conditions on the Establishment Licence. Two important examples are: The areas within the establishment approved by the Secretary of State for the housing of protected animals or the performance of regulated procedures shall be maintained to at least the standards set out in the Home Office Code of Practice for the Housing and Care of Animals used in Scientific Procedures, except where variations are authorised by the Secretary of State. Unless authorised by the Secretary of State, there shall be no variation of the use of the approved areas of the designated establishment that may have adverse consequences for the welfare of the protected animal.

ASPA Project Licence The only purposes for which a Project Licence can be granted: the prevention or diagnosis or treatment of disease, ill-health or abnormality, or their effects, in man, animals or plants; the assessment, detection, regulation or modification of physiological conditions in man, animals or plants; the protection of the natural environment or modification of physiological conditions in man, animals or plants; the advancement of knowledge in biological or behavioural sciences; education or training otherwise in primary or secondary schools; forensic enquiries; the breeding of animals for experimental or other scientific use. The harm(cost) element of the harm/benefit is graded in the form of Bands of Severity, observed in practice by strict adherence to Limits of Severity. These Levels of Severity are: Non-recovery / Mild / Moderate / Severe. Refinement in the form of minimising the suffering of the animal is also achieved by the careful fixing of humane endpoints. The Project Licence Holder is committed to managing the whole programme of research so as to ensure the least amount of animal suffering, and must supervise personal licensees until competence is gained.

ASPA Personal Licence The Personal Licence allows a skilled person (personal licensee) to carry out a Regulated Procedure authorised in a Project Licence. The granting of a Personal Licence can involve requisite training, qualifications, sponsorship and supervision. Responsibilities of the Personal Licence Holder: The Care and Welfare of the animals on which they carry out Regulated Procedures. Awareness of the details of the Severity Limits etc of the Project Licence, within which they are operating. Provision, for the Inspector, of the appropriate information on cages/tank labels. There is a long list of Conditions.

Understanding Animal Research Declaration on Openness on Animal Research Concordat on Openness on Animal Research

University of Warwick Case Studies Discovering the causes of Alzheimers Test-tube models of epilepsy help advance the understanding of a common brain disorder How research at Warwick is helping to reduce lameness in sheep

Research Using Animals - Summary ASPA requires before a Project Licence is issued the Secretary of State must weigh the benefits to humans, other animals, or the environment against the costs to the animals involved (Harm / Benefit analysis). A licence cannot be granted if the work could be carried out without using animals (Replacement). The procedures authorised must cause the minimum possible suffering of the lowest sensitivity (Refinement) to the smallest number of animals (Reduction). Research using animals conducted outside of ASPA must meet the Harm Benefit Analysis and the 3Rs.