Ethics of Research involving animals
The A(SP)A in practice - continuation I
Certificates of designation
13.19 The holder of the certificate of designation is normally expected to be a senior manager or official in the establishment. This individual is personally responsible for ensuring that the establishment complies with the conditions of the certificate. The certificate holder is also required to nominate at least one person who has day-to-day responsibility for the health and welfare of all the animals in their charge, called the named animal care and welfare officer (NACWO). A named veterinary surgeon (NVS) to advise the certificate holder, licence holders, NACWOs and others about the health and welfare of the animals must also be nominated. As part of the conditions of the certificate, the holder is responsible for ensuring that the establishment complies with the appropriate Codes of Practice (see paragraph 13.10). They must ensure that proper records are kept about the source, use and eventual disposal of all animals.
The Home Office Inspectorate
13.20 The workings of the A(SP)A and the granting of the three types of licence described above is currently administered by the Home Office, rather than by other Government departments, to avoid possible conflicts of interest. Many other departments with responsibility for areas such as human health or the environment may be directly involved in animal research, for example by commissioning or funding research. The Home Office, by contrast, has no such involvement and has therefore been given the task of issuing licences. Its Inspectors are required to have medical or veterinary qualifications and are expected to have experience in scientific research. In 2004, there were 30 Inspectors who assisted in advising the Secretary of State in granting licences and any conditions that should be set. They also provide advice to certificate holders and others with a role under the Act on best practice in laboratory animal welfare. Inspectors make visits to research facilities to ascertain that licence authorities and conditions are being met. They have the right of access to any designated establishment to monitor compliance. At the end of 2003, there were 232 designated establishments in Great Britain. During 2003, the Inspectorate made 3703 visits to departments within establishments in addition to other visits for formal meetings. Over 50 percent of these visits were unannounced.20
Ethical Review Process
13.21 Since 1999, each establishment is required to have in place an ERP as a standard condition on all certificates of designation.21 The purpose of this process is to establish a local framework to ensure that all uses of animals are carefully considered and justified. An ethical review committee should provide independent advice to certificate holders and support to other staff with responsibility for animal welfare.
13.22 The provisions in the Guidance on the Operation of the A(SP)A 1986 require that the review process includes:
- a named veterinary surgeon;
- representative(s) from among the named animal care and welfare officers;
- representative(s) of the project licence holder(s); and
- representative(s) of the personal licence holder(s).
Facilities are also encouraged, but not required, to involve people who do not use animals, including one or more lay members from outside the institution.
13.23 Functions of the ERP include (where appropriate):
- promoting the development and uptake of Reduction, Replacement and Refinement alternatives to animal use in procedures at the establishment;
- examining the likely costs and benefits of each licence application;
- providing a forum for discussion of issues relating to animal research, and consider how staff could be updated on relevant ethical advice, best practice and relevant legislation;
- undertaking retrospective reviews of licensed projects;
- considering the care and accommodation of animals at the establishment and the humane killing of protected animals;
- reviewing the establishment’s managerial systems with respect to animal use;
- advising on staff training and ensuring competence.22
The order of this list is often understood to express a hierarchy of importance, and hence the two most important functions of the ERP are considered to be the promotion of the Three Rs and the review of the costs and benefits of research. However, depending on the type of research carried out at specific research facilities, those involved in the ERP may spend more time on other activities. In practice the review of protocols is often the primary focus.
Other aspects of the A(SP)A
Obtaining animals
13.24 Rats, mice and other commonly used laboratory animal species must be obtained from suppliers or breeders that have a certificate of designation and are subject to the same system of controls and inspection as establishments using animals in experiments.
Genetically modified animals and harmful mutations
13.25 The breeding of animals that are intended for use as disease models, and the breeding of animals for other purposes which are known to cause pain, suffering or distress are classified as scientific procedures. Similarly, the breeding of any GM animal is currently classified as a scientific procedure, because of possible adverse implications for welfare.23 In 2003, 27 percent of all animal procedures (764,000 in total) involved GM animals, more than treble that of 1995. Two thirds of these were used solely for the purpose of breeding, in order to develop and maintain ‘GM lines’; they were not involved in any other procedure or experiment, although some of these animals, once killed, may also have been used to provide tissue for research purposes. The breeding of phenotypically normal animals (i.e. animals that are said to be as ‘healthy’ as the average wild type of the animal) does not count as a scientific procedure.24
Killing of animals
13.26 Animals that are not used in regulated procedures but killed in designated establishments to obtain tissue samples or because they are surplus to requirements are excluded from the controls of the A(SP)A if they are killed by one of the methods of humane euthanasia listed in Schedule 1 of the Act.25 Certificate holders must ensure that humane killing is performed by a person who has been trained to use these methods competently.
Statistics about animal use and information about licences granted
13.27 The Home Office publishes detailed Annual Statistics on the numbers and species of animals used in scientific procedures in Great Britain, (see Appendix 2).26 For reasons related to the licensing process and European reporting requirements, the Statistics focus on details about the annual number of procedures started and numbers of animals used for the first time in procedures started that year. Animals used in more than one series of procedures are only counted once (see paragraph 13.17). The Statistics do not give any information about the degree of pain and suffering that is actually experienced by animals involved in procedures.
This is because the severity banding of procedures, protocols and projects is based on prospective assessments, and because information about severity bands assigned to particular projects relates to the estimated average suffering of all the animals involved (see Box 13.3 and paragraphs 15.25–15.34).
13.28 Section 24 of the A(SP)A makes it an offence for individuals with a function under the Act (i.e. the Minister, his officials and the APC) to disclose any information that they have received in carrying out that function and which they believe to be confidential.27 Until 2005, practical application of this clause meant that very little information about animal research has been made public. Those wishing for more access argue that the recently implemented provisions of the Freedom of Information Act 2000 (FoI, see Box 13.4) imply that there ought to be more openness.
| Box 13.4: The Freedom of Information Act 2000 and its bearing on information about animal research In 1997, the Government issued the White Paper Your Right to Know which led to the Freedom of Information Act 2000 (FoI Act). The FoI Act creates a statutory right of access to information held by public bodies (a definition that includes the Home Office, universities and publicly funded research institutes), provides for a more extensive scheme for making information publicly available and covers a much wider range of public authorities than previous legislation, including: local government, NHS bodies, schools and colleges, universities, the police and other public bodies and offices.* The Act enshrines in law the general right of access to (non-classified) information held by public authorities.† From 1 January 2005 information must be disclosed in response to any such requests made under the FoI Act. There are also a number of exemptions from the requirement of disclosure, the most relevant ones being for vexatious or repeated requests, where the cost of providing the information would be excessive, information provided in confidence, information relating to the development of government policy, information which, if disclosed, might endanger the health or safety of any individual, information that constitutes personal data under the Data Protection Act and information that, if disclosed, might prejudice commercial interests. These exemptions are disputed by those who argue that they prevent them finding out sufficient information about licence applications and the results of cost-benefit assessments. The implementation of the new Act with regard to animal research may not be straightforward. Reasons cited by stakeholders include:†‡
* The FoI Act applies to all recorded information held by public authorities in England, Wales and Northern Ireland and cross-border public authorities. Scotland is covered by a separate act (Freedom of Information (Scotland) Act 2002). † HMSO (2000) Explanatory Notes to Freedom of Information Act 2000, available at: http:// www.hmso.gov.uk/acts/en2000/2000en36.htm. Accessed on: 4 May 2005; Freedom of Information Act 2000 available at: http://www.hmso.gov.uk/acts/acts2000/20000036.htm. Accessed on: 4 May 2005. ‡ LASA (2004) Freedom of Information The Forum 1(3). ∫ Festing S (2004) Freedom of Information Act deadline looms RDS News Autumn 2004. ** Home Office (2005) Animal Procedures: Licence abstracts, available at: http:// www.homeoffice.gov.uk/comrace/animals/abstracts.html. Accessed on: 4 May 2005. |
Developments in policy
13.29 Since the full implementation of the A(SP)A, a number of changes in the regulatory system have been introduced as a matter of government policy. In the early 1990s, training requirements for all new applicants for personal and project licences were instituted. The Home Office issued a policy statement to make clear that the successful completion of training modules was viewed as necessary in order to meet the requirement in the A(SP)A that licence holders have ‘appropriate education and training’.
13.30 In 1997, the Home Office effectively ruled out certain types of animal research: the toxicity testing of cosmetics and (in 1998) their ingredients, alcohol products or tobacco products.28 It issued a policy statement to the effect that, in making the cost-benefit assessment, these tests were no longer considered a sufficient benefit to justify any use of animals. In addition, it was announced that, other than in very exceptional circumstances, the use of the great apes would be considered too great a cost to be justified by any possible benefit.29
13.31 There have also been other policy developments, concerning controls on the importation of primates,30 the use of the ascites method to produce monoclonal antibodies (see paragraphs 5.26 and 11.10), the use of certain toxicology procedures (Box 11.2) and the housing and husbandry of certain laboratory species, which have also been introduced by policy statements or the publication of supplementary codes of practice.31
Footnotes19 See also footnote 10.
20 Home Office (2004) Statistics of Scientific Procedures on Living Animals Great Britain 2003 (London: HMSO).
21 See Guidance on the Operation of the A(SP)A 1986, Appendix J, available at: http://www.archive.officialdocuments.
co.uk/document/hoc/321/321.htm. Accessed on: 4 May 2005.
22 Guidance on the Operation of the A(SP)A 1986, Appendix J, available at: http://www.archive.officialdocuments.
co.uk/document/hoc/321/321.htm. Accessed on: 4 May 2005.
23 See paragraph 4.57.
24 However, breeding facilities must have a certificate of designation.
25 Schedule 1 of the A(SP)A sets out ‘Appropriate methods of humane killing’. For example, all protected animals may be killed by an overdose of an anaesthetic, using a route and an anaesthetic agent appropriate for the size and species of animal. Dislocation of the neck is permissible for rodents up to 500g, rabbits up to 1kg, and birds up to 3kg.
26 Statistics for Northern Ireland are published separately and not included in the Home Office Statistics for Great Britain. In
2000, 14,124 animals were used in Northern Ireland. See House of Lords Select Committee on Animals in Scientific Procedures (2002) Animals in Scientific Procedures (Norwich: HMSO), Chapter 1.
27 See also: Ministerial Statement announcing the outcome of the review of section 24 of the Animals (scientific Procedures Act 1986, 1 July 2004, available at: http://www.homeoffice.gov.uk/docs3/animalproc_wms_section24_040701.pdf. Accessed on: 4 April 2005.
28 House of Lords Select Committee on Animals in Scientific Procedures (2002) Animals in Scientific Procedures, Chapter 1;
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.