There are three levels of licensing required before a procedure can take place in the UK. The project, the individual and the institution must all have licenses from the Home Office. This post aims to discuss the process of getting a personal licence in the UK and is written by Peter Wright a PhD student at the National Heart and Lung Institute, Imperial College London (He is also the founder of KeepResearchAfloat).
In the UK the ability to perform animal experiments is regulated by the Animals in Scientific Procedures Act 1986 (ASPA 1986) (1). ASPA has recently been revised to transpose European Directive 2010/63/EU (2) on the protection of animals used for scientific purposes into UK law. The revised legislation came into force on 1 January 2013. The basic relationship between these two pieces of legislation is that ASPA 1986 defines the regulations and 2013/63 provides harmonisation with other EU member states. The reality was that 2010/63 makes little noticeable difference to individual UK researchers save for tightening controls on aspects such as record keeping in areas like training and numbers of animals used. It is with no small amount of pride that I can point out that this means the UK was working under the modern standards of regulation for at least a quarter of a century. ASPA 1986 is enforced by the UK Home Office and the Secretary of State rather than the Department of Business, Innovation and Skills.
Who can do research using animals in the UK?
‘No person shall apply a regulated procedure to an animal unless…
a) He holds a personal licence qualifying him to apply a regulated procedure of that description to an animal of that description
b) the procedure is applied as part of a programme of work specified in a project licence authorising the application, as part of that programme, of a regulated procedure of that description to an animal of that description and
c) the place where the procedure is carried out is a place specified in the personal licence and the project licence.
So to do research using animals one must have; a personal licence (PIL:regulating the person) that can be used in conjunction with a project licence (PPL:regulating the experiment) at licenced establishment (regulating the place). Hierarchically then, the personal licence is subordinate to the project licence which in turn is subordinate to the licencing of premises. No procedure can be performed without any part of this chain missing.
The process of acquiring PPL (3) and establishment licences is outside of the scope of this piece. But briefly a PPL application will require the researcher to define the question of interest, provide evidence of scientific and ethical necessity for this research (in answering unanswered questions pertaining to human or animal health). They will then list the experiments required, the techniques and species that will be used and the reasons for this including whether they are the species of lowest neurophysiological sensitivity suitable for the experiment. Importantly the worker will then define how severe the procedures are going to be in terms of invasiveness and or pain with predefined limits as to when the experiment must be abandoned and the animal humanely euthanized. This entire application will then be assessed by a panel of scientific experts, veterinarians, animal care staff and lay people (often clergy interestingly?!).
So how does one obtain a PIL? (4) Usually, the candidate will be either working or undertaking studies at a licenced establishment. It is unusual for researchers of less than graduate level to be in possession of a PIL. Prospective PIL holders need to undertake a mandatory Home Office accredited PIL course. Given the symbiotic nature of the three licence types most institutions will provide their own programme. Training before application for a PIL is split into modules focusing on different elements essential to being a PIL holder. A PIL can be obtained after completing Modules 1-3 but this will inhibit the scope of what experiments can be done (i.e. this will not permit the PIL to perform recovery surgical procedures). The training process will usually require between 30- 40 hours of study including lectures, practical training and written examinations. The syllabus for candidates is loosely defined by the ‘Guidance on operation of ASPA 1986’ (5, 6- Table 1). All institutions will have slightly different focuses but the general frame work will be as follows.
This course will usually involve participation and lecturing by the institutions ‘named veterinary surgeon’ (NVS) and ‘named animal care and welfare officer’ (NACWO). Institutions are legally obliged to have a staff of fully licenced vets who are wholly detached and disinterested in the research program. The NVS is usually the chief vet and the NACWO a very senior animal technician, in most large institutions there will be staff of animal technicians (AT). The basic function of an AT is to care for the animals. Animal technicians assist with the monitoring of the maintenance of the facilities (e.g. strict environmental parameters) and surveillance of the animals and importantly the compliance of researchers.
Module 1 introduces how legislation came to be as it is and the place of animals in research. This includes the ethics of animal research and in my experience was quite in depth, exploring ideas of animal rights in culturally Christian societies, through Benthamite/Enlightenment thought and finally the arguments of Peter Singer. The law is then illustrated in depth as new PIL holders must accept the very strict regulations on what they will be doing. Consequently, there is a necessity for them to be able to define what is and isn’t allowed by law given their personal PPL/PIL situation.
It is instilled in tutees that if the animals are not treated well, they are stressed; treated carelessly or diseased the resulting physiologic alterations will obviate the collection of meaningful data.
Module 2 covers state of the art methods of interpreting pain in other species. History has meant that many of the animals we use for research are prey species. These species unlike modern humans do not modify their behaviour in extreme ways unless they are severely ill. To ensure that humane endpoints described in PPL’s are not being exceeded PIL holders must be able to interpret animal behaviour. There are practical sessions on animal handling which are not trivial as most rodent species are handled as little as possible in the research environment. This lack of intervention ensures that they are subjected to the least amount of stress. But this means that they will be keen to escape and so are aggressive in the case of mice and may even injure themselves in the case of rabbits. Quick and humane euthanasia is also demonstrated and practice may be done on cadavers if available. Physical and pharmacologic methods are used and many facilities will require people to demonstrate they can do this effectively on live animals, once they are PIL holders. Local procedures for ensuring good health and safety, housekeeping, infection control and security will be described to the candidates at this point to ensure the efficient running of the premises.
Module 3 is the most scientifically and technically challenging of the course as it requires people from disparate fields such as engineering and neuroscience to be brought to the same level. The biology and husbandry of animals teaches many aspects of caring for common research model species. Some of which is surprising, for example, did you know the average rectal temperature of a rabbit is a degree higher than that of a rat? There is also a great focus on environmental enrichment for different species, this is quite simple with small rodent species but obviously requires great deal more thought for larger mammals. Previous work on pain recognition is built on in tutorials on diseases, their prevention and detection. Animal facilities utilize sentinel animals and regularly send off biological samples to test for common pathogens. Most of these common diseases are not life threatening and will not cause obvious symptoms but will severely hamper research. For this reason many facilities will have rooms of differing health and hygiene statuses and these procedures are carefully outlined to tutees. As a PIL holder it is therefore your responsibility to obey local rules to protect the work of others as well as your own. Module Four represents a continuation of Module Three and as such builds upon skills and knowledge in areas of surgery, analgesia and anaesthesia. Module Four is very much more practically focused than the other modules. Finally, some basic anaesthetic techniques and some surgery and suturing on cadavers will be demonstrated and a hands on practical given
After the final assessment is completed and marked, as per the accredited training bodies requirements, notification of successful completion will be issued and a formal certificate of modular training issued. The opinion of the NVS, NACWO, animal technicians and other parties who have assisted in the course may also be sought on whether or not a candidate has satisfactorily demonstrated the appropriate attitude towards animal welfare and the use of animals for in vivo research during the course. If they have, an application is sent to the home office and a civil servant acting on behalf of the secretary of state will issue a defined PIL.
In much the same way as you only truly learn to drive after passing your driving test you only truly learn to do animal research after completing this course. ASPA 1986 does not permit using animals to teach techniques after all it is not morally acceptable, scientifically relevant or sadly as in many matters cost effective to treat one animal as the practice and another as the real. If we do a procedure on an animal it has to be as part of a scientific study. The process of training in animal research then becomes ‘on the job’ more often than not procedures will be demonstrated and supervised by more experienced PIL holders or PPL Holders as part of a team. In turn this is always with the support and supervision of NVS and animal facility staff. An obvious learning curve is therefore present and data from very preliminary studies by newer staff will therefore be treated with some scepticism initially. But with adequate supervision and controls this data should always be scientifically relevant.
National Heart and Lung Institute
Imperial College London