Ethics of Research involving animals
The A(SP)A in practice
13.8 The A(SP)A requires that three separate licences, which are described in more detail below, must be obtained before any animal is used in a regulated procedure.
i) A personal licence authorises an individual to conduct specified regulated procedures on specified animal species, at a specified place or places. A personal licence by itself does not authorise a person to carry out any procedures. Rather, the authorisation may only be used in conjunction with two further licences (paragraphs 13.12–13.13).
ii) A project licence forms the centrepiece of the licensing process. This licence authorises individuals who hold a personal licence to conduct a particular programme of work, for specific purposes, at one or more specified designated establishments. It also describes the types of animals involved, the estimated numbers of animals that are intended to be used, the prospective severity banding of the project and individual severity limits for the protocols contained in it (paragraphs 13.14–13.18 and Box 13.3).
iii) A certificate of designation is issued to a person authorising a specified facility (called a ‘designated establishment’) to conduct animal procedures and/or breed or supply animals for use in regulated procedures (paragraph 13.19).
13.9 The Secretary of State may add conditions to any licences or certificates as considered reasonable and appropriate. A series of standard conditions are routinely added to every licence and certificate.10 The Home Office employs Inspectors who assess all applications for licences and certificates and visit designated establishments to verify that procedures are conducted in accordance with the licences (see paragraph 13.20).
13.10 The Home Office also issues a Code of practice on housing and care of animals used in scientific procedures (published in 1989). It is widely agreed that the code does not identify best practice. Rather, it sets out the minimum standards expected of designated establishments, including minimum cage sizes, environmental conditions, animal health and welfare, and special considerations for individual species. Compliance with the code of practice is required by making it a condition of granting the certificate of designation. There are separate codes and guidelines for housing and breeding, as well as for animal euthanasia and a number of specific procedures.11 As in the case of the Code of practice on housing and care of animals used in scientific procedures, these documents set out minimum standards.
13.11 The penalties for contravening the provisions of the A(SP)A, licences or certificates include formal admonitions, requirements for retraining, the placing of restrictions on licences, revocation of licences, fines and imprisonment.12 Normally, the most effective deterrent is the Home Office’s authority to revoke certificates or licences, which could have serious consequences for universities or pharmaceutical companies (in cases where certificates of designation are revoked), or individual scientists (where a project or personal licence is revoked, see Box 2.5).
Personal licences
13.12 Before a scientist or animal technician can be granted a personal licence, they must successfully complete a training course covering the legislation, ethical aspects of animal use, animal biology, husbandry, care and welfare and, where appropriate, surgery and anaesthesia. The licence is specific for the designated establishment(s) where research is to be conducted, and applicants must specify the animals for which they are seeking authority to use. The licence also lists the range of techniques to be used, such as giving injections, or carrying out specific types of surgery. The use of any other combination of species, technique or research location not specified in the licence is a legal offence. Personal licences are not time-limited but are required to be reviewed at no more than five year intervals. Species or techniques may be added or removed in the course of the review.
13.13 The personal licence holders are obliged to ensure that any pain, suffering or distress to the animals is minimised and they bear primary responsibility for the welfare of the animals they use. Proper records must be kept for each project showing the number of animals used and the procedures that have been carried out, and giving information about the supervision of animals.
Project licences and the cost-benefit assessment
13.14 Project licences can only be granted for the following permitted purposes:
- ‘the prevention (whether by the testing of any product or otherwise) or the diagnosis or treatment of disease, ill-health or abnormality, or their effects, in man, animals or plants;
- the assessment, detection, regulation or modification of physiological conditions in man, animals or plants;
- the protection of the natural environment in the interests of the health or welfare of man or animals;
- the advancement of knowledge in biological or behavioural sciences;
- education or training otherwise than that in primary or secondary schools;
- forensic enquiries;
- the breeding of animals for experimental or other scientific use’.13
13.15 The project licence has a number of functions, including:
- defining the objectives of the project;
- outlining the likely benefits of the project;
- describing the work to be conducted to achieve the objectives;
- listing the specific procedures to be used;
- identifying the likely adverse effects that may be experienced by the animals and how these will be avoided, recognised and alleviated; and
- placing an upper limit on the severity of the adverse effects to the animals (see Box 13.3 for how the severity of procedures is considered in the licensing process).14
| Box 13.3: How is the severity of procedures considered by the Home Office? Severity to the animals involved is assessed prospectively, before a licence is granted. There are two main types of assessment, supplied by the licence applicant and evaluated by the Home Office, as follows.* i) The overall severity band of a research project is intended to reflect the number of animals used on each protocol and the suffering likely to be caused as a result. It is based on the overall level of cumulative suffering expected to be experienced by each animal, rather than the single worst possible case. It takes into account the proportion of animals expected to reach the severity limit of the protocol and the duration of the exposure to that severity limit, the nature and intensity of the adverse effects, and the actions to be taken to relieve the suffering. It is therefore a qualitative and quantitative assessment of the anticipated average suffering experienced by all the animals used (see paragraph 15.27). In 2003, 39 percent of project licences were assigned the mild category, 56 percent to the moderate category, three percent to the substantial category and two percent were unclassified (see below). ii) The severity limit of individual protocols is determined by the maximum level of the expected adverse effects that may be experienced by an individual animal, taking into account the measures specified in the licence for avoiding and controlling adverse effects. It represents the worst possible outcome for any animal subjected to the protocol, even if it may only be experienced by a small proportion of the animals to be used. Substantial: includes procedures such as major surgery, toxicity testing leading to significant morbidity or death, and the use of some animals as disease models. Unclassified: includes protocols in which animals are anaesthetised before a procedure starts and are killed at the end of the procedure without recovering consciousness. The Guidance on the Operation of the A(SP)A 1986 advises that the assessments of severity should be reviewed and revised as necessary during the lifetime of a project. *See: Guidance on the Operation of the A(SP)A 1986, Chapter 5; Home Office (2005) A(SP)A 1986 Application for a Project Licence. † See Box 13.1. |
13.16 Section 5 (4) of the A(SP)A requires the Secretary of State to weigh the likely benefits from a project against the likely adverse effects on the animals.15 In practice, this process is carried out by Home Office Inspectors who advise officials who in turn make the decision on behalf of the Secretary of State. This provision is frequently referred to as the ‘cost-benefit assessment’ (although the term is not itself used in the A(SP)A) and is widely regarded as the cornerstone of the way animal research is regulated in the UK (see paragraphs 3.58–3.61). While the ultimate decision on whether or not to grant a licence is made by the Secretary of State and his advisors, various other people and processes contribute to the cost-benefit assessment. A recent report by the APC, which examined in great detail the ways in which the cost-benefit assessment is, and should be, carried out, emphasised that primary responsibility for carrying out the assessment was held by the project licence holders.16 The roles of other parties involved, such as the Home Office, the ERP and, where relevant, the APC, were described as ‘to evaluate, advise, and in some cases adjudicate the researchers’ own cost-benefit assessments’ (see Figure 13.1).17
Figure 13.1: Relationship between the different
13.17 A project licence is not granted unless the Secretary of State (as advised) is satisfied that:
- the purpose cannot be achieved by any other reasonable and practicable method which does not use regulated procedures on protected animals;
- the minimum number of animals will be used, with the lowest degree of neurophysiological sensitivity;
- the procedures to be used are those that will cause the minimum distress or suffering to the animals;
- procedures are conducted under anaesthetic wherever this can be used to reduce suffering, unless it would interfere with the objective of the experiment.18
Animals are not permitted to be used in more than one protocol except in those circumstances where it would result in less animal distress or suffering overall than starting a new protocol with a new animal, or when animals need to be used for a series of procedures for a particular purpose. Any reuse is subject to approval by the Secretary of State (as advised). Section 14 of the A(SP)A provides that no animal that has been involved in protocols that caused severe pain or distress may be reused. Similarly, animals that have undergone procedures under general anaesthesia cannot be reused unless the Secretary of State has given permission and certain specified conditions are met.
13.18 Project licences last for a maximum of five years. The holder of a licence is personally responsible for all procedures conducted on animals under that licence. Project licences only give authority to perform those procedures stated in the licence. Contract research organisations are granted somewhat broader licences for toxicity testing. These might permit the testing of defined classes of, for example, pharmaceuticals or other chemicals to assess their effects on specific organs of specified animals, or they may be licensed to undertake particular types of research, for example on embryo or fetal development. In quantitative terms, licences may permit the conduct of many individual techniques, ranging from a few to several hundred. To conduct any procedures that vary from the specifications of the licence constitutes a breach of the law or the terms and conditions of the licence, and renders the licence holder liable to disciplinary action (see Box 2.5 and paragraph 13.11).19 next page
Footnotes8 Such power may be exercised by the Secretary of State or by members of the Inspectorate acting on his or her behalf.
9 The use of great apes and the testing of cosmetics are not prohibited formally by law, but as a matter of policy. In principle, the policy could therefore be revoked at any time.
10 For example, since 1999, certificates have not been granted unless there is an ERP in place (see House of Commons (2002)
Guidance on the Operation of the A(SP)A 1986 (Norwich: Stationary Office)). Other standard conditions include the
requirement that the establishment should be appropriately staffed at all times to ensure well-being of the animals (see
Guidance on the Operation of the A(SP)A 1986).
11 See Code of practice for the housing of animals in designated breeding and supplying establishments (1995), Humane killing
of animals under Schedule 1 to the A(SP)A 1986 (1997) and Housing and care of pigs intended for use as xenotransplant
source animals (draft). See Home Office website UK and European legislation and guidance, available at:
http://www.homeoffice.gov.uk/comrace/animals/legislation.html. Accessed on: 1 Apr 2005.
12 The Home Office reports summary details of infringements to the APC, and information with respect to the cases reported are
set out in the APC’s Annual Reports. For example, in its Annual Report for 2002, the APC reported that the Home Office had
revealed that there had been 20 ‘Class Three’ (the most serious) infringements during the period November 2000–December
2001. The same report also specifically referred to research that had gone beyond licensed procedures and recorded: ‘One such serious infringement [that impacted negatively on animal welfare] was reported to the Committee… This involved [loud] music being played to over 200 mice dosed with methamphetamine. Some of the mice were said to have suffered ‘seizures’ and at least 19 of them died as a result of the procedures. The study arose from a larger programme of work conducted as part of a licensed project concerning Huntington’s disease, but it went beyond the procedures covered by the licence authorities. The infringement had come to light through the publication of a scientific paper on the work. …the project licensee had been admonished [by the Home Office] and required to undergo training; a personal licence holder had been admonished; and the certificate holder was asked to remedy defects in the record keeping systems in the department concerned.’ No prosecution was brought and the APC noted that it was ‘particularly concerned about this case’. In 2003, sanctions used by the Home Office were admonishment, ordering retraining and requiring reviews of operational procedures. Revocation of licences was recommended in two cases; both a licence and a certificate were voluntarily returned to the Home Office in advance of any formal action. Home Office (2004) Statistics of Scientific Procedures on Living Animals Great Britain 2003 (London: HMSO).
13 A(SP)A, Section 5 (3).
14 Guidance on the Operation of the A(SP)A 1986, Chapter 5, available at: http://www.archive.officialdocuments.
co.uk/document/hoc/321/321.htm. Accessed on: 4 May 2005.
15 ‘In determining whether and on what terms to grant a project licence the Secretary of State shall weigh the likely adverse
effects on the animals concerned against the benefit likely to accrue as a result of the programme to be specified in the licence.’ See also Guidance on the Operation of the A(SP)A 1986, Appendix I, available at: http://www.archive.officialdocuments.
co.uk/document/hoc/321/321-xi.htm. Accessed on: 6 May 2005.
16 See also Guidance on the Operation of the A(SP)A 1986, Appendix I, available at: http://www.archive.officialdocuments.
co.uk/document/hoc/321/321-xi.htm. Accessed on: 6 May 2005.
17 Animal Procedures Committee (2003) Review of the cost-benefit assessment in the use of animals in research (London: Home
Office), p77.
18 See A(SP)A, Section 5 (5); Guidance on the Operation of the A(SP)A 1986, Chapter 5, available at: http://www.archive.officialdocuments.
co.uk/document/hoc/321/321.htm. Accessed on: 4 May 2005.