25. Routine veterinary practice and clinical veterinary research

Introduction

25.1  The purpose of this guidance is to provide practical assistance to help members of the profession better understand what constitutes routine veterinary practice (RVP), empowering those in practice to make their own judgements about routine veterinary practice and clinical veterinary research (CVR) in the course of their day-to-day practice.

What this guidance covers

25.2  This guidance, plus the additional FAQ includes a set of questions that veterinary surgeons and organisations can ask themselves to help establish whether a proposed procedure, series of procedures or study is routine veterinary practice, clinical veterinary research or whether, alternatively, it should be regulated under the Animals (Scientific Procedures) Act 1986 (ASPA). The guidance includes specific information relating to undertaking blood transfusions, the taking of samples for official purposes, and how RVP applies when dealing with emergency cases.

25.3  The guidance also covers when an Animal Test Certificate (ATC) is required from the Veterinary Medicines Directorate (VMD) in relation to the veterinary clinical trial of a medicine.

Who this guidance is for

25.4  This guidance is intended to help all registered veterinary surgeons, registered veterinary nurses, veterinary students and organisations to recognise when they are undertaking RVP. Further, it will be useful for veterinary surgeons proposing to use new procedures or treatments in individual clinical cases, as these cases will often be at the boundary between what is RVP and what is CVR.

25.5  The guidance is relevant to any individual veterinary surgeon or organisation involved in veterinary research, whether practice or laboratory based, including the legislative regulators, who will need to determine whether ASPA licencing is required for their work. It may be particularly useful for those carrying out practice-based research outside a university or other research centre, to help define clinical veterinary research under certain circumstances and provide guidance on where to access relevant advice on e.g. Home Office regulation, VMD Animal Test Certificates.

25.6  The guidance is relevant to teachers in veterinary schools and intra and extra mural practices, who will need to consider whether procedures carried out on animals for the purposes of clinical teaching amount to RVP, CVR or would require ASPA authority.

Definitions

25.7  Routine veterinary practice (formerly ‘recognised veterinary practice’) is defined as procedures and techniques performed on animals by veterinary surgeons (or veterinary nurses under their direction) in the course of their professional duties, which ensure the health and welfare of animals committed to their care. These can be thought of as the routine, established, procedures undertaken on animals every day.

25.8  Clinical veterinary research (CVR) is when routine procedures are undertaken for the benefit of the animal/s, with the concurrent intention to generate new knowledge that benefits animals, such as developing new procedures, improving a diagnosis, changing a routine procedure, or comparing existing procedures.

25.9  To establish whether something is CVR, the intention for undertaking the procedure, as well as the overall context, needs to be considered. What is regarded as routine in relation to a specific veterinary clinician, clinical setting, patient, species or condition at one point in time, may not be regarded as ethically acceptable, nor constitute, routine veterinary practice if carried out by a different veterinary clinician in a different clinical setting, in relation to a different patient, species or condition, and/or at a different point in time.

25.10  An intervention that is unnecessary for an animal’s veterinary treatment and is being done for an experimental or other purpose, would not be routine veterinary practice or clinical veterinary research. The following are not normally considered to be RVP or CVR:

a. Clinical investigations that would not be for the benefit of that animal.
b. Experiments using animals primarily for research, where the procedure is not necessary for the animal’s veterinary treatment.
c. Withholding routine treatment.
d. Deliberately exposing animals, including those used in unprotected control groups, to trauma or infectious agents where there is a risk to health and wellbeing.
e. Use of an animal in teaching, if the procedure would not normally be used to teach acts of veterinary surgery as defined in section 27 of the Veterinary Surgeons Act 1966.

When to consider RVP and CVR

25.11  In many cases in day-to-day practice, it will be clear that a proposed procedure is routine veterinary practice, as it will involve carrying out an established treatment, or method of diagnosis, to an animal under the veterinary surgeon’s care for an entirely therapeutic reason. There will be a strong expectation of benefit to the animal, and a level of harm that will normally be less than, or no more than, the current accepted method of treatment or diagnosis.

25.12  Even where a procedure is usually deemed to be routine veterinary practice, this does not automatically mean that it is ethically acceptable in all circumstances. Consideration needs to be given to all the factors, including whether the procedure or treatment is supported by relevant background evidence, whether consultation and agreement/consent of the owner has taken place, and whether the clinician has appropriate background knowledge and experience. Before proceeding, an overall assessment should be made as to whether it is justified in all the circumstances of the case.

25.13  Some cases will fall into a grey area at the borderline between routine veterinary practice, clinical veterinary research, and experimental procedures regulated under ASPA. For example, there may be both a research and a therapeutic purpose, or the use of a new or improved treatment or procedure may be proposed. In other cases, while the animal itself may not directly benefit there may an overall benefit for the larger group (herd, flock, breed). In these cases, veterinary professionals and organisations should refer to the FAQs that accompanies this guidance or defer to the RCVS Routine Veterinary Practice Sub-Committee for advice (details below).

Clinical veterinary research and ethics review (effective from 1 September 2022)

25.14  Clinical veterinary research should be subject to ethics review. The RCVS/BVA joint Working Group on Ethical Review for Practice-Based Research found that “a pragmatic threshold for the need for formal ethical review is any study where consent from the owners or keepers of an animal would be expected to be obtained before including that animal in that study” (Section 7.1, page 11 of 24). It is also essential that the interests of the animals, owners, and other stakeholders are considered, as well as an evaluation of the costs and benefits of the proposed work.

25.15  For practice based CVR, the extent and nature of any ethics review should be proportionate to the scale of any harms, other risks and benefits that may be involved to animals or their owners/keepers.

25.16  Ethics review should be sought for all studies where one would be expected to obtain permission from the owner/keeper of an animal prior to being enrolled, or when consent is needed for use of previously collected samples or the use of data from an animal.

25.17  Veterinary surgeons, registered veterinary nurses and veterinary students conducting clinical veterinary research outside the scope of a university, other institute of further education and/or in an industry context and not covered by Home Office licensing under ASPA or other appropriate ethics review bodies may seek ethics review from the RCVS Ethics Review Panel (ERP) or another appropriate panel (e.g. a recognised institutional veterinary ethics review committee).

25.18  The RCVS ERP will not consider applications involving research requiring an ASPA licence and will only consider applications where the study is considered to be clinical veterinary research.

25.19  For further information about seeking ethics review from the ERP, please see the Ethics Review Panel page.

Dealing with emergency cases

25.20  Emergency cases are those where a patient has come in requiring emergency treatment, and where unusual and unpredictable complications occur in the course of routine veterinary treatment.

25.21  Emergency cases presented to a veterinary surgeon in the course of their professional duties may be approached differently to non-emergency cases for the purposes of routine veterinary practice. For example, a review of literature, the opinions of an ethics committee, or extensive colleague consultation may not be possible. Veterinary surgeons should keep in mind that the boundary between routine veterinary practice and clinical veterinary research is often based on the intention, and they should be able to justify the decisions they make.

Undertaking blood transfusions

25.22  Taking blood from healthy donors with the permission of the owner and with the intention of administering the blood or its products to a recipient is routine veterinary practice where there is an immediate or anticipated clinical indication for the transfusion. Such a clinical procedure would be acceptable on the scale of an individual veterinary practice or between other practices in the locality. However, the collection of blood for the preparation of blood products on a larger commercial scale for general therapeutic use in animals may require licences under the ASPA; this larger commercial scale activity would also need to be licensed under the Veterinary Medicines Regulations.

25.23  It would generally not be considered routine veterinary practice for sedation to be used to enable the donation of blood from any animal, this is because sedation breaches the Home Office guidelines about the threshold of pain (‘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’), under the Animal (Scientific Procedures) Act 1986. The exception to this general rule would apply in an emergency, where the donor and recipient animals are both known to the veterinary surgeon and therefore, they are able to make an assessment as to whether the harm caused to the donor animal is outweighed by the benefit to the recipient.

Taking samples for official purposes

25.24  When a sample is required for a veterinary public health reason, to be considered RVP, there needs to be explicit government involvement or direction. For example, the sample must be requested by an authority for an official purpose, such as disease detection or import/export. The same applies for blood samples and vaccinations which are required for export health certificates. In any case, the direction from the government must be species-specific.

25.25  Where a forensic sample is required from a live animal, this is generally considered for the benefit of that animal as the sample will help the investigation of disease or neglect. Alternatively, a court order could be obtained.

When to consider regulation under ASPA

25.26  When a procedure is carried out on a protected animal for a scientific or educational purpose 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 then authorisation under ASPA must be sought. Additionally, when a procedure is used on a sick animal and there is no intended benefit to the animal, or for other animals with a similar condition, authorisation under ASPA must be sought.

Examples of procedures that may require an ASPA licence include:

a. acts of commission, for example an action such as dosing or sampling; or
b. act of deliberate omission, for example withholding food or water; or
c. acts of permission, for example the natural breeding of animals with harmful genetic defects.

25.27  The above is subject to the following exemptions:

a. Clinical veterinary research and routine veterinary practice (also known as non-experimental clinical veterinary practices);
b. Non experimental agricultural practices and practices undertaken for the purpose of recognised animal husbandry;
c. The administration of a medicine for research purposes in accordance with an Animal Test Certificate (veterinary clinical trials); and
d. Certain procedures done for the purpose of identifying animals.

25.28  Procedures that do not fall within one of the exemptions listed above may require a licence under ASPA. Failure to comply with Home Office regulations by deliberately misinterpreting the exemptions will be treated as an infringement of ASPA and may also be regarded as serious professional misconduct and subject to investigation by the RCVS including the possibility of disciplinary action.

25.29  Procedures that cause less pain, suffering, distress or lasting harm than the lower threshold and that are connected with clinical veterinary research should still be subject to ethics review.

25.30  For more information about ASPA and obtaining a Home Office licence, see the Home Office’s Guidance on the Operation of ASPA.

When an Animal Test Certificate is required

25.31  An ‘Animal Test Certificate’ (ATC) is required in order to carry out a veterinary clinical trial (clinical veterinary research) of a veterinary medicinal product. A veterinary clinical trial must be completed to obtain marketing authorisation for a veterinary medicinal product, and is required by the Veterinary Medicines Regulations 2011. The medicine(s) used during a veterinary clinical trial might include a veterinary medicine under development, an authorised human medicine, or a veterinary medicine currently authorised for use in another species or condition. All procedures applied to animals during the course of a trial must be consistent with routine veterinary practice.

25.32  ATCs are issued by the Veterinary Medicines Directorate, and permit:

a. the use of a veterinary medicine during a veterinary clinical trial, including outside of the terms of its marketing authorisation;
b. the procurement and supply of that medicine;
c. the import of any medicine specified in the certificate in accordance with the conditions of that certificate;
d. the produce from treated animals to enter the food chain, if appropriate;
e. the use of randomisation and/or blinding within the study protocol; and
f. the administration of a placebo product, or comparison with a control group.

25.33  There are two types of Animal Test Certificate: an ATC and ATC-S.

a. An ATC is required for pharmaceutical companies and veterinary researchers wanting to conduct veterinary field trials to generate data to support a marketing authorisation application - an ATC may also be required by veterinary researchers wishing to conduct a non-commercial clinical trial of a product that does not meet the criteria for an ATC-S.
b. An ATC-S is required for small-scale non-commercial trials, which investigate the safety and/or efficacy of a human or veterinary medicine.

25.34  To carry out the clinical trial of a veterinary medicine, for example to generate pivotal data for the purposes of medicines licensing, you may require an Animal Test Certificate. For more information about ATCs, see www.gov.uk/guidance/animal-test-certificates

The use of animals in clinical teaching

25.35  Under the terms of the Veterinary Surgeons Act, the RCVS is responsible for monitoring veterinary education and professional training and is well placed to give guidance to the profession on ways in which animals are used in clinical teaching. The responsibility for the animals’ welfare lies with the supervising veterinary surgeon, and any ‘unnecessary suffering’ would be in breach of UK animal welfare legislation and subject to possible prosecution.

25.36  Veterinary graduates will have been properly trained at the time of registration and continuing professional development is a professional obligation for veterinary surgeons throughout their careers. The training will, in most instances, be achieved using clinical cases where there will be an individual veterinary surgeon responsible to the animal and the owner.

25.37  The teaching of skills to veterinary students is controlled by the Veterinary Surgeons (Practice by Students) (Amendment) Regulation 1993 made under the Veterinary Surgeons Act 1966. Such use of animals applies to all veterinary students and is the responsibility of the clinicians in charge. The procedures and techniques are limited to those that would be undertaken by the supervising veterinary surgeon in the course of their professional duties. The purpose is not experimental or scientific, but the student may acquire competence in those techniques that they will use as a qualified veterinary surgeon.

25.38  Animals used for training and teaching purposes would normally be those presented to veterinary surgeons in the course of their professional activities.

25.39  Open discussions with colleagues at the local level should be encouraged. The ethics review process in the veterinary schools required under ASPA would be a suitable forum for considering the ethical issues on the appropriate use of animals in clinical teaching.

25.40  The use of cadavers for teaching is encouraged. If, having obtained the owner's informed consent, the animal is euthanised by overdose of an anaesthetic agent and confirmed as dead by the cessation of the circulation, the cadaver can be used for teaching purposes. This preparation would be routine veterinary practice.

25.41  Perfusion of living animals before death to obtain fixed anatomical specimens is not considered routine veterinary practice and must be regulated under ASPA.

25.42  Acts of veterinary surgery may be carried out on animals by veterinary surgeons to train non-veterinary surgeons in certain procedures covered by Schedule 3 or Exemption Orders made under the Veterinary Surgeons Act. For example, veterinary nurses, and technicians employed in cattle embryo transfer teams.

Further advice

RCVS

25.43  The RCVS Routine Veterinary Practice Sub-Committee is available to advise practising veterinary surgeons or veterinary nurses whether a proposed procedure, treatment or test is routine veterinary practice and/or clinical veterinary research. The Sub-Committee has regard to current veterinary practice in the UK and elsewhere in the world, relevant RCVS advice and advice issued by other organisations, including the Home Office and the VMD. It is for the RCVS to provide advice and guidance to its members on what is RVP and CVR. However, it is recognised that the Courts will ultimately interpret the law, and that RCVS guidance cannot cover all current situations and must continue to evolve.

25.44  For further information in relation to RVP and/or CVR or advice on whether a particular proposed procedure would be covered by this guidance, please contact the Secretary to the Sub-Committee via [email protected].

25.45  For further information in relation to ethics and scientific review of proposed clinical veterinary research studies, please contact the Secretary to the Panel via [email protected].

Home Office

25.46  For general enquiries about obtaining a licence under ASPA from the Home Office in relation to procedures with an experimental, other scientific or educational purpose, contact the Home Office on phone 020 7035 0477 or email [email protected].

25.47  For more information about ASPA and obtaining a Home Office licence, see the Home Office’s Guidance on the Operation of ASPA.

Veterinary Medicines Directorate

25.48  For further information in relation to obtaining an ATC in order to conduct a veterinary clinical trial of a veterinary medicinal product, contact the VMD on 01932 336911 or email [email protected].

25.49  The VMD’s guidance on ATC/ATC-S is available at https://www.gov.uk/guidance/animal-test-certificates