Veterinary clinical research – legal, ethical and welfare considerations

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As veterinary surgeons we have a professional responsibility to make animal health and welfare a prime consideration when attending to the animals under our care. In order to do this we need to keep our knowledge up to date, critically appraise the evidence we use to make decisions and communicate this clearly to our clients so that they are able to participate in the decision making process.

However, in the veterinary profession we have to acknowledge that there are many areas where we do not have robust evidence on which to base our decisions. As a small profession with a broad area of knowledge, the production of evidence, through research, needs to become something that involves us all, whether we are contributing cases to epidemiological or clinical research projects, or carrying out, and publishing, our own research. Research essentially refers to the gathering and analysis of data in order to provide evidence which can further the advancement of knowledge. This can involve data collected on cases and procedures carried out in the course of normal veterinary practice as well as that specifically undertaken for research purposes.

Animal research in the UK is regulated under the Animals (Scientific Procedures) Act 1986 [A(SP)A], currently being updated to bring it into line with European Directive 2010/63/EU on the protection of animals used for scientific purposes. The purpose of this legislation is to ‘harmonise’ animal research legislation across EU countries, to strengthen the protection of animals used in scientific procedures and to promote the principles of replacement, reduction and refinement. In the UK this is being implemented through the A(SP)A Amendment Regulations 2012 (SI 2012/3039), made on 18 December 2012 (Home-Office 2012).There will be a period of consultation on the proposed changes with the new Act likely to come into force in spring 2013.

The updated A(SP)A defines both “a protected animal” (any living vertebrate other than man and any living cephalopod) and “a regulated procedure” (any procedure applied to a protected animal 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). Any regulated procedure must be licenced by the Home Office with the person, programme of work and the place where the scientific procedures are carried out all requiring separate licenses.

The current version of the A(SP)A states that the term “regulated procedure” does not apply to any recognised veterinary practice although the proposed wording in the updated version is “non-experimental clinical veterinary practices” (Home-Office 2012).

The Royal College of Veterinary Surgeons provides supporting guidance under its Code of Professional Conduct on both the role of the Named Veterinary Surgeon and on recognised veterinary practice (RCVS 2012). This advice will be reviewed once changes have been made to the A(SP)A.

The current advice seeks to clarify the interface between the Veterinary Surgeons Act 1966 and the Animals (Scientific Procedures) Act 1986 in relation to veterinary clinical research, and states that “In all circumstances, the individual has to consider the primary purpose and whether he or she is acting in a professional capacity as a veterinary surgeon or as a research scientist. Although the procedures and techniques may be identical, analysis of the purpose for which they are applied should help the veterinary surgeon to determine if the intervention is of direct benefit to the animal or its immediate group (i.e. others of the same species) and therefore recognised veterinary practice, or, if the intervention is for an experimental or other scientific purpose and controlled by the A(SP)A.” (RCVS 2012)

While there will always be issues of interpretation these can be particularly acute when considering research into novel therapies which have not yet become part of accepted veterinary practice. The paper carried in this edition of JSAP on Ethical and Evidential Considerations on the Use of Novel Therapies in Veterinary Practice (Yeates et al. 2013) seeks to clarify some of these issues. The paper developed out of discussions that took place between members of the BSAVA Scientific Committee and BSAVA Officers on the use of novel therapies and how they should be developed and communicated to the profession.

Novel therapies may be necessary both in the interests of the individual animal and in the advancement of veterinary science. However, as the paper indicates their use can raise particular issues, particularly relating to the discussion of treatment options in a way that will enable the animal's owner to be in a position to give fully informed consent.

While a novel procedure may initially only be carried out on an individual animal a successful outcome may mean that it is repeated on a number of cases. It is at this stage that serious consideration needs to be given as to how best to collect data on the cases in order to assess the safety and efficacy of the procedure, as well as comparing it with currently available procedures. The preferred methodology for comparing the benefits and harms of treatments is the Randomised Controlled Trial (RCT) (OCEBM 2011), however a RCT will almost certainly count as research requiring a licence under the A(SP)A.

Nevertheless where a veterinary surgeon carries out a series of procedures it is important that that information is made available to others through publication. In order to achieve the best chance of publication it is important that the work is carefully planned and carried out in accordance with legal and ethical requirements in relation to animal welfare. Many journals will expect that the work has been subject to ethical review and while this is normally fairly straightforward for those working in Universities or research institutions it can be more difficult for those working in private practice.

In 2012 the RCVS and BVA set up a working party, involving representatives of relevant bodies and experts, to look at the subject of ethical review for practice-based research. The draft report produced by the group defined practice-based research as “research involving client-owned animals and conducted by non-institutionally-based veterinary practitioners”. They listed several different types of practice-based research which might require ethical review including:

  • Novel uses of licensed medicines in prospective group or cohort studies, which would be subject to reference to the veterinary medicines cascade.
  • Novel surgical techniques, which while not regulated should be justified with reference to literature relating to ex vivo research, or translation of data from other species.
  • Any study where a diagnostic or therapeutic intervention is determined by the study design, rather than the attending veterinary surgeon.

The working party also pointed out that ethical approval is necessary for retrospective studies and studies involving questionnaires because patient and owner data will be collected. Therefore consideration needs to be given as to how the data will be collected, processed and stored in order to protect participant anonymity and confidentiality. They also point out that obtaining informed consent is a process that goes beyond obtaining a signature on a consent form, requiring that the owner has been in a position to give fully informed consent which will include an understanding of the nature of the research project, the options for treatment and their freedom to withdraw.

All of this may seem rather daunting to the inexperienced researcher, however it needn't be. The most important thing is to plan your research and consider the legal, ethical and welfare implications before you start. If you approach colleagues in academia you may find that you not only have someone to advise and help you through the planning of the research but also access to ethical review through their University/Institute and advice on writing up and getting published. There is also published advice available, for example The Handbook of Veterinary Clinical Research (Holmes and Cockcroft 2008), and pertinent guides published in this journal (Scott et al. 2012). Wiley also produce a guide to Writing for Publication in Veterinary Medicine (Wiley 2011).

Dr Sally Everitt qualified from Bristol in 1981 and spent most of her working life in companion animal practice. She undertook a Masters degree investigating Clinical Audit in the veterinary profession and a PhD in Clinical Decision Making at the University of Nottingham. She is currently Scientific Policy Officer at BSAVA.