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An introduction to animal research regulation checkpoints

How can we ensure animal experiments are replaced at every available opportunity within the current regulatory framework? One way is to strengthen the processes that govern animal research to ensure those involved use every opportunity to review and challenge animal research license applications.

Within the regulatory system of animal research, there are several opportunities to assess animal research license applications and check the necessity and ethics of the proposed project. These checkpoints in the system, if implemented correctly, should ensure animal research does not happen if there are alternative, non-animal approaches available or the potential harm to the animals is deemed unethical when weighed against the potential benefits of the research outcomes.

Implementation of the 3Rs is a legal requirement under the Animal (Scientific) Procedures Act 1986 (ASPA) in order to obtain approval for the licenses needed to conduct animal research in the UK. ASPA is legislation to protect animals used in regulated scientific procedures across the UK. When the 3Rs are planned into research and applied correctly, they should ensure that research using live animals is only carried out when there are no alternative ways of obtaining the required data or answering the research question. Where no alternatives are available and animals are deemed necessary, researchers must ensure that their studies use the fewest animals possible and refine procedures to ensure the least amount of pain, discomfort and suffering.

Read NC3Rs 3Rs guidance for project license applicants.

The onus is on the researcher who will be the project license holder, to ensure that the 3Rs are correctly implemented and that the experiment has robust methodology. There are, however, systems in place, as stipulated by ASPA, to help ensure these requirements are met, both at the establishment level, where the project will be taking place, and at the Government level to ensure the conditions of ASPA have been met including the correct implementation of the 3Rs.

Establishment level and Animal Welfare Ethical Review Board’s

Under ASPA, there is a requirement that every establishment (in the UK or EU) carrying out regulated procedures on protected species must have an Animal Welfare and Ethical Review Board (AWERB). These establishments are mainly universities but can also be commercial organisations such as drug companies, contract research companies, non-profit making organisations, government departments or public health organisations. The core purpose of the AWERB is to review all proposals involving animal research within an establishment, and provide advice on the standards of welfare, and ethical decisions. All project licensing requests are critically assessed to ensure the 3R’s have been applied, and that the harm-benefit analysis (ie does the expected benefit of the research for humans outweigh the suffering that will be caused to the research animals by the project) has been sufficiently weighed and explained before licenses are submitted to the Home Office. In 2020, there were 3024 project licenses in force and no project licenses were rejected by the Home Office. As well as supporting improvements in science and animal welfare AWERBs also contribute to fostering a ‘culture of care’ within establishments, which is supposed to protect the welfare of the animals being used and those who work with animals. Many organisations including LASA (Laboratory animals Science Association) and the Royal Society for the Prevention of Cruelty to Animals (RSPCA) conduct training and produce resources to support AWERBS. AWERBs meet several times a year, although there is not a set number of times required under ASPA, and it is not a paid role.

Read the RSPCA & LASA document Guiding principles on good practice for Animal Welfare and Ethical Review Bodies. The RSPCA AWERB Directory contains a range of useful resources for AWERBs.

AWERBs consist of a range of experts, which must include at a minimum one of the Named Animal Care and Welfare Officers, the Named Veterinary Surgeon, and a member who can give scientific input. The Named Training and Competence Officer, as well as the Named Information Officer must be actively engaged with the AWERB. The rest of the AWERB is expected to consist of a range of scientific members including license holders, a statistician, and an independent chairperson. AWERBs are also encouraged to have ‘lay members’ who have no vested interest in the research and can provide independent input.  Home office Inspectors can also attend AWERB meetings. Once project licenses have been approved by the establishment AWERB, they are sent to the Animals in Science Regulation Unit (ASRU) of the Home Office for review and approval.

Named persons

All individuals that are responsible for the care and welfare of animals used within research must be listed on the establishment license. These are called named persons, and the roles include:

  • Named Veterinary Surgeon (NVS) – The NVS is a member of the Royal College of Veterinary Surgeons, who has expertise in laboratory animal medicine, specifically for the species being used within the establishment. The NVS advise on the impact of experimental procedures on the health and welfare of animals, advise on the implementation of the 3R’s, ensure veterinary care can be provided whenever needed, and control and supply any medication for use on animals.
  • Named Animal Care and Welfare Officer (NACWO) – The NACWO’s are responsible for the day-to-day care and welfare of the animals within the establishment. This includes ensuring each species has appropriate housing and high standards of husbandry, having knowledge of animal behaviour in order to recognize signs of pains and distress and having knowledge of the humane methods of euthanasia under schedule 1 of ASPA
  • Named Training and Competency Officer (NTCO) – The NCTO is responsible for ensuring that anyone that deals with the animals used within the establishment is adequately educated and trained to undertake their role, including supervision of individuals until they are competent to complete their role alone. It is also their responsibility to ensure continuing training and development takes place to maintain expertise.
  • Named Information Officer (NIO) – The NIO is responsible for ensuring that anyone dealing with animals within the establishment has access to any information they require. This includes information about specific species, regulations, the 3Rs, and procedures.

Read the LASA (Laboratory Animal Scientists Association), LAVA (Laboratory Animals Veterinary Association) and IAT (Institute of Animal Technologists) document ‘Guiding Principles for Named Persons’.

The RSPCA AWERB Directory contains a range of useful resources for AWERBs.
The RSPCA and LASA have also produced a document Guiding Principles on the operation of Animal Welfare and Ethical Review Bodies.

Government level – The Home Office

The Animals in Science Regulation Unit (ASRU) is the department within the Home Office that oversees the implementation of ASPA and regulates animal research practices within the UK. It consists of inspectors, licensing officers, and a policy and admin group. Project licenses are reviewed by Home Office inspectors in a similar way to the AWERBs, in which the scientific relevance of their research and implementation of the 3R’s is reviewed. All Home Office inspectors are veterinary or medical practitioners with experience of biomedical research and roles are often advertised on the Government website.

ASRU produces a yearly report in which the number of licenses approved is stated but does not currently state the number of applications that were rejected. However, most project license applications are successful at this level, as they have already been reviewed by the establishment AWERB prior to this.

Some projects also require a retrospective assessment where information is submitted to, and reviewed by, the institution AWERB after completion of the project, this is reported back to the Home Office. Projects that currently require retrospective assessment include those that use primates, cats, dogs or horses, and projects that include procedures classified as ‘severe.’ You can read more about this in the Government document Guidance on the Operation of ASPA.


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