VN 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 requires regulation 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 some of the situations when an Animal Test Certificate (ATC) may be required from the Veterinary Medicines Directorate (VMD) in relation to the use of medicine during a veterinary clinical trial.

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 CVR under certain circumstances and provide guidance on where to access relevant advice on Home Office regulation via the Animals in Science Regulation Unit (ASRU), or Animal Test Certificates through the VMD.

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 and techniques are undertaken for the direct clinical benefit of the animal/s concerned, with the secondary intention to generate new knowledge for the future that potentially benefits the animal/s involved, such as developing new procedures, improving a diagnosis, changing a routine procedure, or comparing existing procedures. CVR should have the intention of a good outcome for the animal/s involved.

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, scientific, or other purpose, would not be routine veterinary practice or clinical veterinary research. The following are not normally considered to be RVP or CVR:

1. Clinical investigations that would not be for the benefit of that animal.
2. Experiments using animals primarily for research, where the procedure is not necessary for the animal’s veterinary treatment.
3. Withholding routine treatment.
4. Deliberately exposing animals, including those used in unprotected control groups, to trauma or infectious agents where there is a risk to health and wellbeing.
5. Use of an animal in teaching, if the procedure would not normally be used to teach acts of veterinary surgery as defined in 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 be an overall benefit for the larger group (herd, flock, breed). In these cases, veterinary professionals and organisations should refer to the FAQ that accompanies this guidance or defer to the RCVS Routine Veterinary Practice Sub-Committee for advice (details below).

Clinical veterinary research and ethics review 

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 potential 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  More information about seeking ethics review from the ERP can be found here.

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 may 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.

Collection of blood for subsequent transfusion

25.22  Taking blood from healthy donors with the informed consent of the owner and with the intention of administering the blood or its products to a recipient animal 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.

25.23  For there to be an ‘immediate or anticipated clinical indication’ for the transfusion the recipient must be identified at the time of collection. Where there is no identified recipient, or where the blood is taken from the donor based on an estimate of the demand, the donation is classified as blood banking and the guidance in paragraphs 24 and 26 should be followed.

25.24  The collection of blood for the preparation of blood products on a larger scale, including storage and supply of those blood products (i.e., blood banking) for transfusion in animals must be done in accordance with a Non-Food Animal Blood Bank Authorisation (NFABBA) under the VMR, granted by the VMD. Advice on whether authorisation is required can be sought from the VMD by contacting [email protected]

25.25  Due to the additional risk of harm to the donor, it would generally not be considered routine veterinary practice for sedation to be used to enable the collection of blood from a donor animal. The exception to this general rule would apply in an emergency, where the donor and recipient animals are both known to the veterinary surgeon, who is therefore able to conduct a comprehensive harm-benefit analysis, including an assessment of whether the harm potentially arising from sedation of the donor animal is outweighed by the benefits. These may include the benefits of sedation for the donor and benefits of transfusion for the recipient.

25.26  Note that the collection of blood for the preparation of blood products on a larger commercial scale for general diagnostic or therapeutic use (in animals or humans) or other scientific use or experimental purposes requires licences under the ASPA. Advice on whether work needs to be regulated can be sought from ASRU by contacting [email protected]

Taking samples for official purposes

25.27  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.

25.28  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

25.29  Authorisation under ASPA must be sought before a veterinary surgeon carries out a procedure on a protected animal for experimental or scientific or educational purposes, which may have the effect of causing the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice. Advice on whether work needs to be regulated can be sought from ASRU by contacting [email protected]

25.30  Examples of procedures that may require an ASPA licence include:

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

25.31  The above is subject to the following exemptions:

1. Non-experimental agricultural practices;
2. Non-experimental clinical veterinary practices;
3. Practices undertaken for the purpose of recognised animal husbandry;
4. The administration of a medicine for research purposes in accordance with an Animal Test Certificate granted by the VMD; and
5. Certain procedures done for the purpose of identifying animals.

25.32  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 may 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.

25.33  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.

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

When an Animal Test Certificate is required

25.35  A clinical trial is a study, usually conducted in client-owned animals, that aims to examine, under field conditions, the safety and/or efficacy of a medicine under the normal conditions of animal husbandry or as part of normal veterinary practice. Veterinary clinical trials may be conducted to generate some of the data required for a marketing authorisation application of a veterinary medicinal product, as set out in the Veterinary Medicines Regulations, or for research purposes. An ‘Animal Test Certificate’ (ATC) is normally required to carry out these types of study in the UK.

25.36  An ATC is issued by the Veterinary Medicines Directorate, and permits:

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

25.37  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 a veterinary clinical trial will be consistent with routine veterinary practice (clinical veterinary research) or appropriately regulated (e.g. Home Office licences). For more information about ATCs, see the VMD’s website. 

25.38  There are three types of application to obtain an ATC: types A, B, and S.

1. Types A and B applications are required by pharmaceutical companies and veterinary researchers wanting to conduct veterinary clinical trials to generate data to support a marketing authorisation application. These types of application may also be required to obtain an ATC to conduct the non-commercial clinical trial of a product that does not meet the criteria for a type S application.
2. Type S applications are required for small-scale non-commercial trials, which investigate the safety and/or efficacy of a human or veterinary medicine.

The use of animals in clinical teaching

25.39  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.

25.40  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.

25.41  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.

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

25.43  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.

25.44  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.

25.45  Perfusion of living animals before death to obtain fixed anatomical specimens is not considered routine veterinary practice and can only be regulated under ASPA dependent on appropriate scientific justification and favourable harm-benefit analysis. Contact the ASRU for more information.

25.46  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

25.47  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.

25.48  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].

25.49  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

25.50  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 [email protected]. 

25.51  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

25.52  For further information or support regarding a future ATC application, or  to enquire whether an ATC is necessary for your veterinary clinical trial, refer to the VMD’s guidance on ATCs on their website.

25.53  Otherwise, for more information about ATCs contact the VMD by email at [email protected], including the words 'clinical trial' in the subject line.