Background: In 1986, the Animals (Scientific Procedures) Act 1986 (ASPA) replaced the Cruelty to Animals Act 1876, which had up until then protected animals used for ‘vivisection’ in the UK. ASPA itself was amended in 2013 to ensure the full implementation of EU Directive 2010/63/EU, the European Union legislation ‘on the protection of animals used for scientific purposes’, which is considered to be one of the most stringent ethical and welfare standards worldwide. ASPA allows (and controls) legitimate studies using animals in a framework designed to ensure that the potential harms to the animals are justified by the likely benefits of the research. While most veterinary surgeons working in clinical situations do not set out to perform ASPA-regulated research, a desire to improve clinical outcomes for their patients or for the wider population means that, at times, they may approach or even cross the line from recognised veterinary practice into procedures or activities that require regulation under ASPA, the Veterinary Medicines Regulations (VMR) or other legislation.
Aim of the article: This article provides information on the legislation that exists to protect animals in research and explains how ASPA can affect all veterinary surgeons, and not just those working in research, due to its intersection with the Veterinary Surgeons Act and VMR.
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Ngaire Dennison qualified from the University of Cambridge in 1993 and initially worked in general veterinary practice before becoming a named veterinary surgeon (NVS) and subsequently working as an Animals (Scientific Procedures) Inspector. Since 2015 she has had a combined role as an NVS, named training and competency officer and named information officer (NIO) at the University of Dundee. She is currently senior vice president of the Laboratory Animals Veterinary Association (LAVA).
Anja Petrie qualified from the University of Giessen, Germany, in 1996. After gaining a doctorate in veterinary medicine from the University of Bern, Switzerland, she worked in a small animal clinic in Hassloch, Germany. She is one of the NVSs at the University of Aberdeen, the NVS for the University of St Andrews and the NIO for the University of Aberdeen. She is a past president of LAVA.
Key learning outcomes
After reading this article, you should understand:
Which legislation exists to protect animals in research;
The definition of an experimental procedure;
That a practitioner undertaking a technique commonly performed in veterinary practice for a research purpose may need to do so under the Animals (Scientific Procedures) Act (ASPA);
How ASPA controls scientific work;
That a procedure such as blood sampling, which is performed by vets, may not always be recognised veterinary practice and who to contact if you are unsure.
Animals (Scientific Procedures) Act
The Animals (Scientific Procedures) Act 1986 (ASPA) (Anon 2018) is what is known as an ‘enabling’ Act and is administered by the relevant UK Competent Authority (Box 1). ASPA licences are required if specified types of ‘protected’ animals are used for defined scientific purposes (Box 2) and the experimental procedures using these animals cross the threshold for regulation. Without the Act, those performing scientific studies using animals in which any harm occurred could be prosecuted under other legislation, for example, the Animal Welfare Act.
Who administers the Animals (Scientific Procedures) Act?
The Animals (Scientific Procedures) Act (ASPA) is administered in Great Britain by the Animals in Science Regulation Unit, which is located within the Home Office. This is because departments such as Defra and the Department for Business, Energy and Industrial Strategy commission research that, on occasion, involves the use of animals, while the Home Office does not, thus avoiding a potential conflict of interest between units within the same department.
In Northern Ireland the Act is administered by the Department of Health.
Permissible scientific purposes under the Animals (Scientific Procedures) Act 1986
Translational or applied research that aims for the:
Avoidance, prevention, diagnosis or treatment of disease, ill health or other abnormality, or their effects, in man, animals or plants
Assessment, detection, regulation or modification of physiological conditions in man, animals or plants
Improvement of the welfare of animals or of the production conditions for animals reared for agricultural purposes
Development, manufacture or testing of the quality, effectiveness and safety of drugs, foodstuffs and feedstuffs or any other substances or products, with one of the aims mentioned above for translational or applied research
Protection of the natural environment in the interests of the health or welfare of man or animals
Research aimed at preserving the species of animal subjected to regulated procedures as part of the programme of work
Higher education or training for the acquisition, maintenance or improvement of vocational skills
ASPA defines a protected animal as ‘any living vertebrate other than man and any living cephalopod’. Fetal, embryonic and larval forms of these animals are also covered, with mammals, birds and reptiles protected from a point two thirds of the way through gestation or incubation. Cephalopods are protected from when they hatch and fish (Fig 1) and amphibia (Fig 2) from when they are capable of feeding independently. Great apes are banned from use in research under ASPA.
An experimental procedure is regulated under ASPA if it may cause pain, suffering or distress of lasting harm that is equivalent to, or more than, ‘the introduction of a needle in accordance with good veterinary practice’. If the likely level of harm of a procedure is unknown, then unless evidence is presented to the contrary the ‘benefit of the doubt’ is given to the animal and the procedure is regulated. Procedures may include acts of commission such as adding possibly harmful substances to a diet, injecting drugs or experimental surgery, or acts of omission such as withdrawing food or withholding treatment. Modifying an animal’s genes or breeding genetically altered animals (Fig 3) is regulated if there is any potential for harm.
Legal controls of scientific work using animals
ASPA controls scientific work at three levels:
Place (establishment licence [EL]);
Programme of work (project licence);
Person performing procedures (personal licence).
There are a number of conditions attached to each type of licence that must be met by the licensee. These include requirements to implement the 3Rs (refinement, reduction and replacement) at all times (Fig 4), to meet minimum housing and care standards (Fig 5), for the competence of individuals to be achieved, maintained and regularly assessed, and for certain functions to be performed by a number of ‘named persons’. One of these is the named veterinary surgeon, who is responsible for providing advice on the health, welfare and treatment of animals kept under the authority of an EL (Box 3). The role is complex and has special supplementary guidance provided by the RCVS (RCVS 2020a). Another condition of the EL is that all scientific use of animals is reviewed ethically. This is performed as one function of the mandated Animal Welfare and Ethical Review Body.
Main responsibilities of a named veterinary surgeon
Advise on the treatment of clinical conditions, anaesthesia regimens and appropriate pain relief
Implement appropriate health monitoring and advice on biosecurity, and advise on the transport of animals
Provide comprehensive veterinary cover, including out of hours services
Comply with the legal requirements as expected by the Veterinary Medicines Regulations
Provide independent advice on welfare matters to all involved in animal research
Be an instrumental part of the Animal Welfare and Ethical Review Body
Advise on implementation of the 3Rs (refinement, reduction and replacement) with the aim of minimising animal suffering and reducing the number of animals used, while ensuring scientific data are still of high quality
Assessing the likelihood of suffering if an animal is to be kept alive after an experiment
Assessing the lifetime experience of an animal in the event of reuse
Although most work regulated under ASPA takes place within establishments that are specifically licensed to allow research using animals (eg, universities, contract research organisations and pharmaceutical companies), the Act also applies to qualifying procedures (ie, those involving protected animals used for a scientific purpose) at places other than licenced establishments (POLES). POLES are defined within a programme of scientific work that justifies why the particular POLE is needed and can include farms, the general countryside (Fig 6) and veterinary practices. It is not the location that defines whether work is regulated but the purpose of the procedure being performed and the potential level of harm caused by it (Fig 7).
Importance of ASPA to all veterinary surgeons
All veterinary and human medicines, vaccines and devices used by practitioners are developed and tested for safety in animals. If this work is performed in the UK, the relevant animals are protected by ASPA, although the requirements to perform testing (eg, for safety and efficacy) are set out in other legislation. In addition, in areas of science such as gene function, immunology and cell function and dysfunction (including neoplasia) the fundamental research required to develop new targets for novel therapies currently uses animal models for some aspects of the work. Therefore, it is important for all vets to be aware of ASPA as it has the potential to intersect with:
3Rs – replacement, reduction and refinement
Replacement is using non-animal alternative methods, reduction is using as few animals in experimental procedures as possible and refinement is ensuring that the least harmful methods are used in any study that involves animals.
Animal Welfare and Ethical Review Body
The Animal Welfare and Ethical Review Body (AWERB) is tasked with performing a number of duties including advising on the acquisition, care and use of animals, the 3Rs and related technical and scientific developments, and reviewing internal processes relating to the use of animals within an establishment. The AWERB must follow the development and outcome of projects that use animals and advise on rehoming schemes. There are a number of additional recommended duties as well, such as promoting a culture of care (RSPCA and Laboratory Animal Science Association [LASA] 2015).
Licences are legal documents granted by the Animals in Science Regulation Unit for Great Britain on behalf of the Secretary of State, and the Department of Health, Northern Ireland (devolved regulation). There are three types:
Establishment licence (EL);
Project licence (PPL), which authorises a specified programme of work for a particular scientific purpose. A PPL can only be granted for a maximum of five years and gives details of what procedures may be performed, the allowed purposes of any work and the humane endpoints that must be applied;
Personal licence (PIL), which authorises an individual to perform defined types of experimental procedure on defined types of animals where a PPL exists that authorises work of that type. A PIL is granted indefinitely but must be reviewed at least every five years.
Named persons are individuals whose names appear within an EL and who have specific legal functions and responsibilities under the Animals (Scientific Procedures) Act (ASPA). The roles are:
Named veterinary surgeon – responsible for the veterinary and health care of all animals within an establishment;
Named animal care and welfare officer – responsible for the day-to-day care and welfare of the animals;
Named training and competency officer – responsible for ensuring all personnel working with animals are appropriately trained for their role and are competent;
Named information officer – responsible for putting in place systems to ensure that up-to-date relevant information on care, husbandry, the 3Rs, and so on, is readily available to those dealing with animals;
Named person responsible for compliance – responsible for ensuring that all requirements of ASPA are met.
The Veterinary Surgeons Act (VSA) where clinical research is being undertaken;
Work proceeding under the Veterinary Medicines Regulations;
The requirements of EU legislation for the implantation and testing of medical devices (Directives 90/385/EEC, 93/42/EEC and 98/79/EEC) and related testing standards.
Marking of animals primarily for identification, veterinary clinical trials (work covered by an animal test certificate obtained from the Veterinary Medicines Directorate [VMD]) and non-experimental clinical veterinary and agricultural practices are specifically excluded from regulation under ASPA. The RCVS defines non-experimental veterinary practices (also known as recognised veterinary practice [RVP]) as ‘procedures and techniques performed on animals by veterinary surgeons in the course of their professional duties, which ensure the health and welfare of animals committed to their care’. A further definition given is: ‘The clinical investigation and management of the health or welfare of animals is generally considered to be recognised veterinary practice when it involves an intervention which is of direct benefit to the animal or its immediate peer group’ (RCVS 2020b).
The RCVS also provides a flow chart and some brief examples to help vets understand when a procedure may cease to be an act of veterinary surgery (RCVS 2011). Some of the most common areas where the VSA and ASPA may begin to overlap is around the use of ‘spare’ blood from clinical cases for research programmes (Box 4), comparing different treatments (Box 5) and novel procedures (Box 6).
‘spare’ blood from clinical samples
Blood sampling requires the insertion of a hypodermic needle or cannula into a vein and, therefore, if performed for a scientific purpose, is above the threshold for regulation under the Animals (Scientific Procedures) Act.
Standard practice in many species is for appropriately sized vacutainers to be used to collect blood. These tubes are standard sizes and the vacuum (designed to enable rapid collection) means that a full tube of blood is generally collected. By comparison, collection using a needle and syringe often results in a slower, more controlled withdrawal of blood, meaning volumes closer to those required are collected and there is less ‘spare’ blood. When specific volumes of blood are needed to prevent degradation of a sample (eg, in tubes coated with anticoagulants), the blood volume required is predefined. However, modern diagnostic methods often require only µl of blood, leaving significant amounts of ‘spare’ blood.
Blood left over after analysis from clinical samples – with the correct owner permissions as appropriate – is a great source of material for research purposes and may prevent the need for other animals to be sampled specifically and reduce the overall potential for animal harm; the use of such blood is easy to support ethically. However, deliberately taking additional blood in significant volumes above that which would be taken from other animals with similar clinical conditions for the same diagnostic test(s) to meet the needs of a research programme (eg, by choosing a larger size of vacutainer) has the potential to cause additional harm to the animal being sampled through prolonged restraint, the insertion of additional needle sticks or even due to the volume of blood removed. This harm is being caused to answer a scientific/research question and is not being undertaken for the benefit of the individual. In some cases, the information gained may allow the treatment of other animals within the immediate peer group (eg, a herd of cattle), but unless there is a clinical plan of action based on these results it is likely that this is not recognised veterinary practice; it is being performed for another purpose beyond the scope of the Veterinary Surgeons Act.
For many diseases, especially those of unknown aetiology, multiple potential treatment options that appear to provide similar clinical outcomes may be available. A clinician may wish to compare two treatments to detect whether one is superior in a particular circumstance, for example, in a younger cohort of animals or in a particular breed.
In considering whether the work falls under the Veterinary Surgeons Act, a number of questions should be considered:
Are all animals being treated believed to be getting a treatment for which there is evidence it will be as least as effective as the current ‘standard’ treatment?
Is a novel compound being used that is not authorised for treatment of the clinical condition in this or other species?
Is any group being given placebo or vehicle only?
Is any group not being provided with a standard level of treatment?
Are any additional samples (blood or tissue) being taken from the live animal during the study beyond those required to inform clinical decision making?
Is any animal being exposed to an infection deliberately?
Are any animals being given a treatment that would not usually receive one?
Are any animals being treated beyond the point at which the clinician would usually recommend euthanasia?
If the answer is ‘no’ to the first question above and ‘yes’ to any of the others, advice should be sought from the Animals in Science Regulation Unit or Veterinary Medicines Directorate as to whether this may constitute a scientific study under the Animals (Scientific Procedures) Act or a clinical trial. The RCVS should also be consulted as to whether the treatment remains within recognised veterinary practice.
Surgery and other types of procedure have always been modified and developed further over time as part of a clinician’s aim to improve on current outcomes. However, it is important to consider whether the procedure concerned might fall into the experimental category. Questions that might help to identify this include:
Is there a recognised procedure that has shown success in this type of case in this species or a similar species? If yes, what is the justification for the change?
Has anything similar to what is being planned been performed successfully in this species or a similar species? If not, why not and what considerations have been given to the chance of a successful outcome?
Has the implant/material(s) to be used been shown to be safe in animals (or man) before use in this clinical case? If not, what evidence of safety is there for the product(s) to be used?
Has a harm–benefit/ethical evaluation been performed? Who benefits?
The RCVS guidance (RCVS 2020b) indicates that recognised veterinary practice does not include either experiments using animals primarily for research where the procedure is not part of normal veterinary clinical practice or a veterinary clinical investigation (section 25.8, subsection a), or clinical investigations that would not be for the benefit of that animal or its immediate group (section 25.8, subsection d). It is essential that both aspects are considered.
If independent ethical advice is not available locally, the RCVS ethics review panel is available for consultation (RCVS 2020c).
Interface between legislation
ASPA exists to protect animals used in research by providing a framework that ensures that animals are only used when there is no alternative, their use is ethically acceptable and that they are used in a way that will cause the least possible pain and suffering in studies designed to give meaningful and robust results. The process involves mandatory ethical review of whether the work is justified and should be undertaken, and, if so, under what circumstances. The regulator (ie the Animals in Science Regulation Unit [ASRU] in Great Britain and the Department of Health in Northern Ireland) must perform a harm–benefit analysis that considers possible harms and the likely outcomes, and from this conclude that work can be authorised. Outcomes from research are expected to be of high quality and undergo critical review so that they can inform ongoing studies, support regulatory data packages, share learning/improve procedures or be published.
At a time when reproducibility and research validity are being questioned (Schulz and others 2016, Hunter 2017, Macleod and Mohan 2019), the issues of ethical consideration, optimal experimental design and transparent reporting of outcomes (including negative results) should be addressed clearly, irrespective of the legislation the work is performed under.
Clinicians should be aware that what would normally be RVP, if performed for a reason other than the direct and immediate benefit of an individual or close group of peers, may cease to be allowed by the VSA. Put simply, the same technique(s) performed for a non-clinical purpose is not necessarily an act of veterinary surgery.
Veterinary surgeons should consider seeking advice when they are contemplating taking additional samples to aid research (be it clinical or other) and when weighing up the use of non-standard treatments or surgical methods. Sources of advice include the RCVS, the ASRU and the VMD. Vets should always ask themselves what the purpose of the planned procedure is and who will benefit from it. If the answer to the second question is not ‘the animal itself’, they should reflect on why they are taking the particular course of action planned and whether it remains an act of veterinary surgery.
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