FAQs – Routine veterinary practice and clinical veterinary research

If you are undertaking a procedure or technique that is likely to be of direct benefit to the individual animal that you are treating, then this is RVP.

For non-food producing animals the following would be considered RVP or CVR (NB this is not an exhaustive list):

1. Taking a series of biopsies for the purpose of diagnosis, or to monitor the efficacy of veterinary treatment (RVP)
2. Taking blood samples to assist in clinical management, e.g. diagnosis, metabolic profile, public health, legislative reasons, notifiable and other diseases (RVP).
3. Giving veterinary treatment to an experimental animal when treatment is for the animal’s benefit (RVP).
4. In the course of testing the safety and efficacy of an unauthorised vaccine in dogs, taking blood samples at the time of first vaccination, prior to second vaccination, post-vaccination course and at the time of the annual booster in order to test the vaccine’s success (CVR, NB - an ATC from the VMD is likely to be required).
5. Using clinical waste for research purposes, e.g. collecting a sample of synovial joint fluid at the time of surgery for routine investigation of a cranial cruciate ligament rupture in a dog, and using any of the excess fluid for a research study (CVR).

For food producing animals the following would be considered RVP or CVR (NB this is a not an exhaustive list):

1. Taking blood samples from an animal or animals within a defined group e.g. herd or flock, to assist in clinical management, e.g. diagnosis, metabolic profile (RVP).
2. Taking blood samples from an animal or animals within a defined group, e.g. herd or flock, to test the efficacy of veterinary treatment (CVR).

A note on blood transfusions

Note that 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.

Further, 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.

Procedures done in the ordinary course of clinical diagnosis or treatment of an animal/s are generally RVP.

If you are undertaking research, using routine veterinary practices, such as comparing two existing procedures or developing a new procedure, but always with the intention of benefitting the individual animal(s) that are used, then this is considered clinical veterinary research..

If you are undertaking the procedure or technique for scientific or experimental purposes, without benefit for the individual animal(s) used, then you are likely to require a licence from the Home Office under ASPA. See Chapter 25, paragraph 26 for information on exemptions to ASPA.

Veterinary medicines are licensed by the Veterinary Medicines Directorate (VMD) to make sure they are safe and effective for specific animals/species. If a veterinary medicine is currently licensed for use, it is known as an ‘authorised’ medicine. Whether a medicine is currently authorised, and in which jurisdiction it is authorised, can be checked on the VMD’s Products Information Database.

The use of an unauthorised medicine in accordance with the prescribing cascade for the benefit of the animal will be considered as routine veterinary practice.

In the first instance a veterinary surgeon should prescribe a medicine authorised in the jurisdiction where they are practising, for use in the target species, for the condition being treated, and used at the manufacturer's recommended dosage. Where there is no such medicine available, the veterinary surgeon responsible for treating the animal(s) may, in particular to avoid unacceptable suffering, treat the animal(s) in accordance with the Cascade. Details of the Cascade can be found in Chapter 4.

If a veterinary surgeon intends to randomise animals to receive one of a selection of authorised medicines, this is CVR but would also require an ATC.

If a veterinary surgeon intends to use a completely novel or experimental product, even if the intention is to improve the welfare of the animal, further licence may be needed – see FAQ 6 below.

A detailed recorded conversation should take place with the client about the expected benefits and harms to the animal’s welfare, as well as alternative treatments to the procedure including any unknowns/gaps in knowledge. The option of euthanasia should be discussed where appropriate to the case.

For clinical veterinary research, clients should be informed that they can opt-out at a later stage without any penalty in the care of their animal(s) or themselves.

Note that informed client consent is necessary, but not sufficient to automatically make a procedure routine veterinary practice.

As clinical data is not covered under the GDPR, clinical audit data can be used in epidemiological research without further consent from the client.

(For further information on informed consent, please see Chapter 11 of the supporting guidance to the Code of Professional Conduct, ‘communication and consent’)

Routine veterinary practice is the baseline of what is acceptable in practice, and is undertaken for the direct benefit of the animal/s. Where the procedure is being carried out for the primary purpose of developing new knowledge, or to compare results or research design, but is still necessary for an animal’s diagnosis or treatment and is being done to improve that diagnosis or treatment, it is considered clinical veterinary research.

It should be noted that even where non-invasive measurements are being taken from animals as part of a study (e.g. mouth swabs), that this is still clinical veterinary research and therefore precautions such as informed consent, ethics approval, and a rescue plan should be considered.

In the context of RVP, the terms ‘clinical veterinary research’ and ‘clinical veterinary studies’ are used interchangeably, although it is encouraged that the former terminology is used. Veterinary professionals should note that the guidance on RVP also applies to a ‘study’.

A veterinary surgeon undertaking clinical veterinary research should consider the following:

1. Has the procedure or technique been performed before? See FAQ 6.
2. Have they performed the procedure or technique before? See FAQ 7.
3. Has the research been peer-reviewed? See FAQ 8.
4. Has the research has been subject to ethics review? See FAQ 9.

The development of any new procedure or technique must reasonably be expected to result in a similar or better outcome than that following conventional treatment i.e. there is true equipoise. The veterinary surgeon must have sufficient background knowledge of the treatment and there must be a professional judgement with an evidential basis.

It would not be acceptable for a veterinary surgeon to use an animal in the development of a new or improved veterinary procedure or treatment where it has not previously been made available to the veterinary profession and there is no background evidence to predict a clinical application in the species or other veterinary benefit (parallel evidence in humans may be acceptable). This type of new or improved procedure may require a licence under ASPA.

It is advised that a thorough review of the available peer-reviewed literature be carried out, and the veterinary surgeon be able to demonstrate that this has been done. It would not be sufficient to base a judgement on an anecdotal report of one case. Examples of existing suitable literature which would support the development of a procedure or technique include studies in other species, clinico-pathological rationale, or in vitro research. Care must also be taken to ensure that the procedure has not been classified as unethical by the RCVS.

Where development of a new or improved procedure or treatment is proposed, a harm/benefit analysis should be undertaken, which should include consideration of whether:

1. the expected benefits to the animal/s outweigh the potential risks and harms;
2. the effectiveness of the procedure or treatment is at least equivalent to available alternative treatments and less likely to cause harm in the longer term;
3. the procedure is expected to improve the animal’s overall welfare;
4. a ‘rescue’ plan is in place in the event of the unexpected so as to minimise the risks involved with the procedure; and
5. the veterinary professional has the appropriate skills, competence, and facilities to carry out this work.

RVP is contextual. What is regarded as routine veterinary practice in relation to a specific veterinary professional, patient, species or condition at one point in time, may not be regarded as routine veterinary practice if carried out by a different veterinary professional in a different clinical setting, in relation to a different patient, species or condition, and/or at a different point in time.

It is also relevant to consider the clinical setting. For example, it may be RVP to carry out a complex new procedure in a large hospital with advanced diagnostic equipment and numerous experienced support staff available to assist if complications were to arise, but it may not be RVP for the same procedure to be carried out by a veterinary surgeon in a small practice with limited equipment and staff. Timing and planning are also important. For example, not undertaking surgery when the practice is about to close (please see Chapter 2 of the supporting guidance to the Code of Professional Conduct, paragraph 15).

Where you have not performed the procedure and technique before, you should consider the following:

1. Do you possess the required skills, qualifications, and competence to perform the procedure or technique?
   This refers to your relevant experience, training, and knowledge of the proposed procedure or treatment. Have you performed the procedure or applied the treatment before? Have you performed a similar procedure or administered a similar procedure before? Do you hold specialist or advanced practitioner status in the field?
2. Do you have access to the necessary facilities to perform the procedure or technique?
   This refers to the practice setting, e.g. clinical facilities, diagnostic equipment, surgical equipment, etc.
3. Is appropriate support available if complications were to arise?
   This refers to the available team support that may be required. Are appropriately qualified staff available and able to provide the assistance that may be required, if necessary, for example, to assist in responding to an emergency arising during the course of treatment, or to provide overnight nursing care if required?

All clinical veterinary research should be subject to ethics review. This includes, but is not limited to, 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’s clinical records.

In addition, veterinary surgeons might find it helpful to consult a peer or colleague who is not directly involved in the case, and who is preferably not an employee of the veterinary surgeon or the veterinary practice. A record of the consultation discussion should be made.

Veterinary surgeons in practice may find the BRAN framework useful when undertaking peer review:

• Benefits – what are the benefits of the procedure or treatment?
• Risk – what are the risks of this procedure or treatment?
• Alternatives – what are the alternative procedures or treatments?
• Nothing – what would happen if nothing was done?

Regarding collection of data in practice, the primary purpose for doing so is clinical, the secondary purpose is internal clinical audit, and the tertiary purpose is collating data from a number of practices for research. Note that ethics review is not required when undertaking internal clinical audits, such as quality improvement work, unless the intention is to publish the results.

Veterinary surgeons, registered veterinary nurses, and veterinary students conducting veterinary clinical 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. For further information about seeking ethics review from the RCVS ERP, please see the Ethics Review Panel page.

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].

For further information in relation to ethics review of proposed veterinary clinical research studies, please contact the Secretary to the Panel via [email protected] or visit the Ethics Review Panel page.