ILAR Journal Online, Volume 37(2) 1995: Laboratory Animal Care Policies and Regulations

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ILAR Journal V37(2) 1995
Laboratory Animal Care Policies and Regulations

United Kingdom
Paul Townsend and David B. Morton

Paul Townsend, B. VetMed, Cert LAS, MRCVS, is deputy director of the Biomedical Services Unit, The University of Birmingham. David B. Morton, BVSc, Ph.D., MRCVS, is head of the Department of Biomedical Science and Ethics, and director of the Biomedical Services Unit, the University of Birmingham.

OVERSIGHT

The United Kingdom enacted a national law in 1986, the Animals (Scientific Procedures) Act (A(SP)A), which put into legislation the European Directive 86/609/EEC. The 1986 Act replaced the earlier Cruelty to Animals Act, which had been in place since 1876. There are no derogations for government or industry except for the very small number of veterinary field trials conducted under an Animal Test Certificate authorized by the Medicines Act, 1968. Anyone carrying out animal research outside the 1986 Act may be prosecuted under other animal protection legislation (such as for causing unnecessary suffering under the Protection of Animals Act 1911 [1912, Scotland]). There is no other state or local legislation pertaining directly to animal research. The Home Office is the ministry responsible for this Act and more generally for law and order issues nationally. It equates broadly to the U.S. Department of Justice or to the Ministry of the Interior in other countries.

The scope of the Act is broad. It protects all living vertebrates, including their free-living immature forms and embryos more than 50 percent of the way through gestation, when used for scientific purposes that may cause the animal pain, distress, suffering, or lasting harm. The Act has recently been extended to cover Octopus vulgaris. Perhaps of particular note, it protects genetic mutants that have defects that may potentially compromise their welfare and all transgenic animals until two successive generations have shown the transgene to have no significant detrimental effect.

The Act controls animal research in four main ways (1) by a system of certification and licensing, (2) at the institutional level, (3) by a group of national inspectors, and (4) by a national committee. Each of these is described in more detail below.

Certification and Licensing

A Certificate of Designation applies to premises (including animal facilities and animal laboratories) deemed to be suitable either for the performance of scientific procedures (such as surgical procedures and the breeding of mutants), or for the breeding and supply of animals for research, or a combination of these. It is granted by the Secretary of State at the Home Office. The certificate is granted in the name of a senior individual at the institution (such as the vice-chancellor, secretary to the university, managing director of a company, or a board member).

A project license is given for a program of research to a named individual, normally a senior researcher, by the Secretary of State. A project license may consist of several "protocols," which are called "procedures" in U.K. jargon. Each procedure forms part of the overall experimental plan (the project) and may consist of a number of different "techniques'' applied to the animals, such as anesthesia, blood sampling, and dosing. Different procedures within a project license are usually aimed at investigating different parts of the overall question for which the project license has been granted. Procedures are also classified by the degree of suffering incurred by animals undergoing them. A procedure may be given a severity limit of "mild," "moderate," or substantial." The endpoints for each procedure are dependent on the severity limit; the more severe a procedure the greater the degree of morbidity allowed. Thus within a project there may be procedures of all three severities. Animals must not exceed the severity limit for the procedure in which they are being used and it is the responsibility of the personal and project license holders to prevent this from occurring. In addition the project as a whole receives an overall severity band which is assessed from the severity limits of the procedures and the number of animals likely to reach the limit in each procedure. In the application, it has to be shown that the harms done to the animals are, in the opinion of the Secretary of State, balanced by the potential benefits of the research (that is a harm-benefit analysis is considered) and consequently, the license is limited to that scientific purpose and specifies fairly precisely what can be carried out.
Finally, there is the personal license, which aims to ensure adequate education and training of the investigator, and, through supervision, eventual competence in specific techniques. The actual license tightly defines the scientific techniques the investigator is authorized to perform, which are delineated by species and by the use (or not) of anesthesia. The personal licensee is ultimately responsible for the animals he or she is using and can never work without the authority of a project license.

The Institutional Level

The individual who holds the Certificate of Designation (the Certificate Holder) is responsible for ensuring compliance and facilitating implementation of the requirements of the 1986 Act. The Certificate Holder must appoint a Named Veterinary Surgeon (NVS) and a Named Day-to-Day Care Person (NDDCP) to help ensure the well-being of protected animals at the institution (there may be more than one NDDCP according to the size and layout of the institution). The NVS should provide advice on animal health and welfare. The NDDCP (who is normally a senior animal technician or caretaker) is responsible for the husbandry and care during experimental procedures of all protected animals on the premises. In essence, both the NVS and NDDCP act as advocates for the animals.

National Inspectorate

A cadre of Home Office inspectors, who must hold either medical or veterinary qualifications, provide a third level of control. They are appointed by the Secretary of State, and at the end of 1994 there were 20 such inspectors. Their number is determined by the government and is set by the U.K. Treasury in negotiation with the Home Office. Remuneration of the inspectors is based on national pay scales for government employees. There are two women and all inspectors are white apart from one Asian male. The role of the inspector was described in the Report of the Animal Procedures Committee for 1992 (HMSO, 1993). It has three major components and each is reviewed below.

1. "To consider in detail applications for licenses and advise the Home Secretary how to ensure that only properly justified work is carried out." In U.S. terms, this means that the inspector is a one-person institutional animal care and use committee (IACUC). The project license application form is similar in many respects to the typical protocol review form in use in many institutions in the United States. The U.K. Act requires the inspector to make the "ethical" harm-benefit analysis on the project and to review (and suggest modifications where appropriate) both the severity limits for individual scientific procedures within the research program specified in the project, and also the severity band of the project as a whole. A project license can be granted for a maximum of 5 years and is not normally subject to further review over that time, unless new cause for concern arises. However when any interim changes are sought, these must be assessed and formally approved by the Home Office. Note that unlike the United States and Canada, protocols do not normally have to be assessed and licensed by the Home Office before applying for funding.

2. "To carry out visits...to establishments designated under the Act to ensure that its controls and the terms and conditions of licenses issued under it are being observed." In 1993, inspectors were responsible for 345 designated establishments, at which there were 5,570 project licenses and about 16,800 personal licensees. In that year they made 2,507 visits for the purpose of inspection or assessment of research projects, or an average of just over seven visits per establishment (down from an average of eight in 1992). This is "oversight" in the literal sense, ensuring that license holders are complying with the specifics of both project and personal licenses and meeting their other responsibilities under the 1986 Act, such as keeping records and purchasing animals only from designated suppliers. As the Home Office also issues the Certificate of Designation for the establishment and has produced a "Code of Practice for the Housing and Care of Animals Used in Scientific Procedures" (the equivalent of the Guide for the Care and Use of Laboratory Animals (NRC, 1985), the inspectors are also responsible for approving the suitability of the facilities for their required purpose.

3. "... to give advice and assistance to licensees and other personnel." As the interpreters of the legislation and associated guidelines and codes, the inspector is required to give his or her opinion and approval in various circumstances regarding the A(SP)A.

National Committee

The fourth level of oversight is the Animal Procedures Committee, a statutory body that passes broad judgements on matters referred to it by the Secretary of State. It can also initiate its own enquiries and pass comments back to the Secretary of State. It has a small fund to support research related to the three Rs (reduction, refinement, and replacement of the use of animals in research) (Russell and Burch, 1959). At least two-thirds of the committee must be scientists, veterinarians, or medical doctors, and at least one member must have legal training. At least half the committee is required to be made up of people who have not been actively involved in scientific procedures using animals in the previous 6 years (that is, they cannot have held a license under the 1876 or 1986 Acts). The Act further states that "the Secretary of State shall have regard to the desirability of ensuring that the interests of animal welfare are adequately represented'' but does not spell out further details such as the number of such persons, the overall proportion on the committee, or their background.

FUNDING

All the costs arising from the central administration of the A(SP)A are funded through the central government (through public taxation). However, the charge for certificates and licenses covers some of the administration costs including salaries and the research budget of the Animal Procedures Committee. At present the annual cost of designation for a scientific procedure establishment is £200 ($318), for a breeding and supplying establishment £400 ($636), and for a personal license £ 110 ($175). There is no charge for a project license.

ENFORCEMENT

Home Office inspectors periodically make unannounced visits to look for breaches of the Act; inspect records (records are required of numbers of animals used, adverse effects incurred during the research, and health of the animal colonies including any screening results and veterinary visits); make suggestions on the husbandry, care, and use of animals; carry out audits of particular procedures (such as those with high severity limits); and discuss the work and give advice to the personal licensees and project license holders.

Depending on their nature, breaches of the terms and conditions attached to a personal or project license can result in criminal penalties (imprisonment for not more than 2 years, a fine, or both) or in a wide range of administrative sanctions, which range from revocation of a license to letters of admonishment. Breaches are not reported in detail (we have no Freedom of Information Act as in the United States) but are summarized annually in the Report of the Animal Procedures Committee. Although 10 to 20 infringements are investigated by the Home Office annually, only one case has been prosecuted since 1987 (of an unauthorized rabbit dealer). It is likely that other "technical breaches" are noted and resolved by the institution and sometimes by individual inspectors without warranting a formal investigation. In such cases, the personal licensee and the project license holder would normally be disciplined; in extreme circumstances (one or two cases each year) licenses are revoked. While Certificate Holders may be indirectly responsible for such offenses on the basis of poor management, the Home Office has only admonished them so far and not yet removed one from office. Unlike personal and project licenses, breaches of the conditions attached to a Certificate of Designation are not criminal offenses.

There are no direct sanctions in regard to research funding for a breach of the Act as in other countries, although funding may be contingent on persons being licensed to carry out the work. If an investigator's license has been revoked then he or she will not be able to do the work, and the granting bodies may decide not to make an award. So far as we are aware this question is not directly addressed by the granting bodies. They are, of course, interested in whether there are already licenses in place to permit the work.

APPLICABILITY

The law applies to individuals within the institution with responsibilities under the Act, such as the Certificate Holder, project license holders, personal licensees, NDDCP, and NVS. The Home Office has refused Certificates of Designation on several occasions to institutions with facilities that did not meet the standards laid out in the Code of Practice (HMSO, 1989). On other occasions, it has prescribed a strict program for upgrading. In all cases Home Office approval is required for the proposed NVS and NDDCP in the application for a certificate.

The Certificate Holder is often a senior executive of the institution and is responsible for many aspects of implementing the Act, including those outlined above, and for compliance with the law (such as keeping species of animals in designated rooms; recording sources of animals; and identifying primates, dogs, and cats). The Certificate Holder must, among other requirements, ensure appropriate staffing, adequate care and accommodation as outlined in the relevant Code of Practice, adequate security (that is, preventing unwanted intrusion and animal escape), competence in killing animals according to a schedule of approved methods, and adequate training for researchers.

A project license is granted for a specific program of research work and is normally explicit in the numbers of animals and scientific procedures to be used. The applicant has to show that the experimental design is sound and the source of animals has to be approved (pound animals cannot be used). Because of the harm-benefit analysis, the license is restricted to its specified purpose; even if the procedures described could be used for another scientific purpose, that purpose would have to be approved in a separate license. Furthermore, the applicant must show that the 3 Rs (replacement, refinement, and reduction) have been addressed, by showing that there are no replacement alternatives, that the number of animals used has been reduced to the minimum, and that the scientific procedures have been refined so as to cause the least amount of suffering. Specific sections of the license deal with the potential benefits of the project as well the adverse effects, their recognition, alleviation, avoidance, and control (including endpoints). Each scientific procedure, which in some circumstances can be interpreted as each animal model, has an upper severity limit and action has to be taken if any animal exceeds that limit. In the U.K. there is a maximum limit to the suffering regardless of whether the scientific objective has been achieved such that any animal in severe pain or severe distress that cannot be alleviated must be killed. Some work may not be authorized on that basis regardless of the predicted benefit.

The Home Office has issued guidance on the conduct of specific procedures and techniques, such as the Draize test and the use of adjuvants, which must be adhered to by project license holders unless they make a scientific case for not doing so. Standard methods of humane killing are listed in Schedule 1 of the Act. If the only "technique" applied to a protected animal is killing it by one of the methods listed in Schedule 1, then such use is outside the scope of the Act and does not require project license authorization by the Home Office (that is, it does not require protocol review). If animals used in experiments covered by the A(SP)A are to be killed by a method not on Schedule 1, such as by decapitation, then authority to use an alternative method must be sought and approved through a project license.

A second schedule to the 1986 Act lists species of animals that must be specifically bred for research; exceptions can be made but are not common. Animals that must be purpose-bred are rats, mice, hamsters (Golden), rabbits, guinea pigs, dogs, cats, primates, and quail (Coturnix coturnix). No restriction is placed on the source of other species.

It is a criminal offense for a project license holder to procure or knowingly permit anybody under his control to carry out a regulated procedure either not authorized by the project license or outside the authority of that individual's personal license. Other examples of more serious offenses with respect to project licenses include carrying out procedures in a non-designated place and using a neuromuscular blocking agent without authority. While it is not a criminal offense for a project license holder to procure or knowingly permit a person under his control to perform experiments carelessly or incompetently or to allow an animal to exceed the severity limit for a particular procedure and take no action, it would be an administrative breach.

For a personal licensee, criminal offenses include performing techniques not authorized by a project license, carrying out a technique not authorized on the personal license, using a species not covered in the license, unauthorized use of neuromuscular blocking agents (for example, in place of an anesthetic), public exhibition of animal research, working in a non-designated place, unauthorized re-use of an animal, or allowing an animal to suffer after the scientific objective has been achieved. Failing to comply with a Home Office requirement to immediately kill an animal that the inspector considers is undergoing excessive suffering would be a breach of the conditions of the personal license but not an offense.

The Named Persons (the NVS and NDDCP), while having broad-ranging responsibilities and a statutory duty to act if an animal gives rise to concern, have no statutory authority in what is really muddy water in terms of the definition of "concern." When a stock animal is suffering and is not the responsibility of any one individual, the Named Persons are free to act in the animal's best interests. But when an experimental animal gives rise to concern because of the techniques being used, the competence of the researcher, or the interpretation of the severity limit, difficulties can arise. Authority can be delegated at a local level by the Certificate Holder to stop an experiment or to kill an animal, but the Certificate Holder has no statutory authority, only that which stems from the management structure within the institution. Only the Home Office inspector has explicit statutory authority to require an animal to be killed.

The NVS has a statutory duty to provide advice on animal health and welfare. The Guidance (HMSO, 1990) delineates further duties, which include making visits to assess health and keep records; maintaining regular contact with the Certificate Holder; having a thorough knowledge of laboratory animal science (in the future it may be that only those veterinarians with appropriate qualifications will be acceptable to the Home Office for approval as an NVS); providing a comprehensive service (such as being on-call 24 hours a day); being familiar with the project licenses and their severity limits including adverse effects and endpoints; and providing advice on anesthesia, analgesia, euthanasia, surgical technique, and the recognition of adverse effects.

The NDDCP is required to help ensure the well-being of the animals along with the NVS. They have a duty to take action when any animal gives rise to concern, even independently of the scientist (for example, if the severity limit has been exceeded and the personal licensee is unavailable). They must also be familiar with and take steps to implement the standards set out in the Code of Practice; keep health records with the NVS as well as records of the environment, of animals coming into the establishment, and of disposal of animals; with their staff, check all animals daily; familiarize themselves with project licenses including severity limits, adverse effects, and humane endpoints; be able to contact personal licensees, the NVS, and the Certificate Holder; and implement the schedule of killing methods to ensure competent destruction of animals.

ADMINISTRATIVE METHODS AND THEIR COSTS

All costs of institutional administration are borne by the institution. How this is paid for depends very much on the establishment concerned, but U.K. universities are working towards devolving real costs down to users. Consequently, there are now moves to recover the costs of licensing and new equipment to meet the code of practice or best experimental standards, from grant-awarding bodies. The national research councils will pay most of the costs apart from premises but research charities are reluctant to do so; commissioned commercial research is usually on a real-cost basis. There are also significant costs to the institution in meeting the mandatory requirements for the training of personnel under the Act.

STRENGTHS AND WEAKNESSES

The U.K. law has created one of the world's strictest environments in which to carry out animal research, in practice as well as in theory. There are many safeguards for animals, and the system contains several checks and balances such as interdependent licensing of research programs and technical implementation; stringent conditions attached to the licenses and certificates; appointment of animals' advocates; assignment of managerial responsibility; requirement of inspection, monitoring, and record-keeping; restrictions relating to animal supply; and provision of specific guidance and codes of practice.

There is also considerable emphasis on training and competence of those carrying out the research both in manual skills and in implementation of the 3Rs of reduction, refinement, and replacement. For example, there is a mandatory requirement for training for all project and personal license holders.

The Home Office also issues occasional and useful guidance on what constitutes best practice for techniques such as raising antisera, the use of neuromuscular blocking agents, and Draize tests. It has limited funds to support research into refinement. The Home Office issues statistics on various aspects of animal research including the numbers used in research and the reasons for their use, which allows for informed debate.

Assessment of Harm

A further strength of the U.K. system is that it accepts that the use of animals in science does not occur in a moral vacuum, that there is considerable and justified public concern over the performance of procedures that cause animals to suffer in the name of science, and that there are limits to what scientists should be allowed to do to animals. For example, severe pain or severe distress (the upper severity band) is not permitted. This is really an extension of harm-benefit analysis, which concludes that no justification can be made to cause severe pain or distress.

However, for a harm-benefit analysis to be carried out, assessment of the degree of harm is critical, and it is only after 7 years of working with this system that serious questions are being asked about what is meant by the "mild", "moderate," and "substantial" bands referred to as the severity limits in the A(SP)A. Little work on the assessment of these states has been carried out. It is quite reasonable to state that this concept has been used without any reasonable basis in objective fact. How do we know when a mouse, rat, or Xenopus laevis is suffering moderately, and do we have the scientific knowledge to make such a judgement? The degree of suffering is dependent upon many things, including the species, investigator competence, standard of care, and how a person's responsibilities are discharged in practice.

At a practical level a harm-benefit analysis also means that there are some things that we may wish to do to animals for scientific reasons that may not be justified, not because they are not scientifically valid questions but because the suffering caused is not outweighed by the value of the benefits gained (Bateson, 1986; Smith and Boyd, 1991). Thus a Home Office inspector is free to advise refusal of an application on the basis of it being ethically unacceptable, regardless of the degree of refinement that may have been applied to it. The "final" ethical decision does not simply reside in minimizing harms and maximizing benefits but in balancing the two parts. In practice this is very difficult to do.

Decision-making

The question also arises as to who should be involved in making the final ethical decision. The Home Office inspectors all have a scientific background but no formal training in making ethical decisions. In other countries, ethics committees make such decisions, and while their members may also not be trained, their consultation base is broader and may be more likely to represent public concern. Furthermore, such committees can be constituted to include members with training and experience in making ethical decisions. Decisions made by a single person may make the inspector a scapegoat for anything that goes wrong or can be contested, particularly considering the history of antivivisection movements in the U.K. Ethics committees, on the other hand, can provide a forum to debate these issues, raise awareness on both sides, and perhaps defuse tensions and lead to a greater mutual understanding (Boyd, 1995). This in turn may reduce violence of the animal campaigners towards the scientists and veterinarians involved in research.

Ironically, despite high standards employed in animal research in the U.K., the top-down approach of the legislation, because it specifically excludes those who have a serious interest in the debate, leads to discontent. Little opportunity arises for mutual education, unlike in countries where ethics committees have an active role to play. This exclusion makes genuine animal welfarists more skeptical about what goes on under the 1986 Act and gives them little option to make their voices heard other than through acts of protestation, and regrettably, sometimes violence.

The poor representation of community members, professional animal welfarists and Named Persons on the national Animal Procedures Committee contrasts strongly with ethics committees controlling animal research elsewhere in the world. The system of control of the Animals Procedures Committee and the Home Office inspectors gives an overwhelming scientific bias to the implementation of the 1986 Act.

Diffuse Responsibilities

The U.K. system is very dependent on the inspectors for formal oversight. The job of this small group is considerable and in addition to those duties described above they are

"...increasingly...being called upon to mount detailed retrospective investigations into allegations made by anti-vivisectionist organizations concerning animal handling or facilities at designated places, or the justification for animal work presented in published research papers" (HMSO, 1994).
The U.K. system, in our opinion, places much of the responsibility for overseeing animal research on a small group of civil servants. Because the inspectors are seen to be the ultimate arbiters of the performance of a particular research project and the level of animal suffering it causes, they are the focus of attention when it comes to defending and justifying such research, even though the U.K. system has multiple individuals with formal responsibility for the use of animals.

Although in theory, the Personal Licensee has ultimate responsibility for an animal, the various responsibilities for animal care and use and ensuring best practice and compliance are spread among the Personal Licensee, Project License holder, NDDCP, NVS, Certificate Holder and Home Office inspector. Perhaps responsibility is spread too widely for tight control. However, only the Project License holder and Personal Licensee can commit criminal offenses through neglecting their responsibilities, the others simply breach conditions attached to their license or do not follow the guidelines set out in the Home Office Guidance on the A(SP)A.

There is also much criticism from the public that the Director of Public Prosecutions, who handles all cases reported by the Home Office, seems remarkably reluctant to prosecute apparent criminal offenses under the Act (similar criticism surrounded the 1876 Act). They may fear a failure will reflect badly on the inspectorate, reveal significant flaws in the wording and application of the Act, and generally encourage further questioning of a system that is largely based on the inspector offering advice and the scientific community accepting and abiding by it.

Within an institution, the responsibility for compliance with the Act rests largely with the Certificate Holder, and the Home Office inspector monitors its effectiveness through regular visits and inspections (sometimes even monthly depending on the type and amount of work being carried out). While this is a strength of the system, the Certificate Holder is normally a very senior administrator responsible for fairly detailed matters and issues, many outside his or her area of expertise, and must delegate responsibility. It is important, therefore, that an effective management system be put in place that includes protecting the important roles and functions of the Named Persons as animal advocates. Apart from any other function, the Named Persons are responsible for ensuring that no animal suffers unnecessarily, from the stock animal not the responsibility of a licensee, to the animal that has exceeded the severity limit when the licensee cannot be contacted.

The Home Office inspector communicates with the individual licensees about their research protocols. While the Certificate Holder (or his deputy) must sign the application before it is submitted to the Home Office, there is no formal requirement for any wider review within the institution. The NDDCP and the NVS are required to be familiar with project licenses, but there is no formal requirement that either be consulted about any aspect of the protocol. It is up to the institution (or the Certificate Holder) to set up a management system that allows this to occur, and many do not appear to have such an infrastructure.

Re-use of Animals

There are also strict controls on the re-use of animals, which in our opinion, are based on the misguided criteria of whether an animal has had an anesthetic during the first protocol, rather than on the amount of suffering an animal might have experienced in total. Thus, an animal that has not had an anesthetic may be re-used in one or more unrelated projects if that is accepted in the project license application. However, an animal that has had an anesthetic cannot be re-used in an unrelated project except under terminal anesthesia. Exceptions are made if the first procedure using anesthesia was essential for the research project, such as surgical preparation of an animal or if the anesthetic was used solely to immobilize an animal. These regulations on re-use are likely to cause an unnecessary increase in the number of animals used (particularly those that cause most public concern such as dogs and primates) without any additional protection for the animals' welfare. In our opinion the harms involved in using a "new" animal are likely greater than the harms involving the re-use of an existing acclimatized animal. It also infers that animals that have had a general anesthetic for what may have been a relatively minor scientific procedure have suffered a significant harm.

Schedule 2 of the Act lists those animals that must be purpose-bred, which provides some reassurance to the public that pets (stray cats and dogs) will not end up in research laboratories. However, no such safeguard is in place for horses.

Animal Source and Disposal

Interestingly, killing animals for tissue using an approved humane method listed in Schedule 1 of the Act, is not classed as a procedure presumably because this type of use is of no ethical concern. Thus no statistics are kept on such use, which would give an idea of the use of animals in "replacement ex vivo" alternative methods. Animals lives could be wasted in this regard. Furthermore, there are fewer checks and balances on the competence with which killing is carried out compared with the same technical process for a scientific purpose (such as intravenous injection for an overdose of anesthetic, saline, or drug).

Conclusion

The implementation of the Act relies at the crucial level of protocol review on a small, overworked group of inspectors who have a scientific background and so may be more benevolent towards science when asking questions and making decisions about projects. However, the inspectors as a group have amassed a good deal of skill at encouraging best practice, refining animal experiments, and reducing animal waste. The legislation quite correctly emphasizes numerous personal responsibilities in the performance of animal research. However, it may not, in our opinion, have produced an effective practical system, readily applicable across a wide range of institutions, which allows responsibility to be taken by the entire biomedical research community within that institution, and which integrates public involvement and accountability. In fact it may, inadvertently, have had the opposite effect.

THE FUTURE

In the foreseeable future, the use of animals in science is likely to come under even closer scrutiny from the general public and anti-vivisectionist movement. Because of the U.K.'s centrally administered system of oversight and, as noted by the Animal Procedures Committee in its 1993 report, the increasing resort by anti-vivisection groups to require retrospective analysis of projects, the work load on the inspectorate will also increase. However, it is likely that the resources allocated to the inspectors by the government will fall in real terms (it is projected that the number of field inspectors will be decreased in the near future). The obvious criticism that can then be voiced is that the inspectors are even less likely to perform their functions effectively.

In order to deal with this problem, there is pressure from some quarters for the U.K. to introduce local ethics committees (similar to IACUCs) that would review protocols and help make the harm-benefit analysis currently required by the A(SP)A (Boyd, 1995). The Home Office is reluctant to see itself at the whim of institutional committees and lose some of its influence. Currently the only person who can authorize a program of animal research is the Secretary of State, advised by a Home Office inspector. A change to the present system would raise questions about authorization of projects, of consistency between IACUCs (although this criticism exists now with the national inspector), training of IACUC personnel, committee structure, and other questions similar to those raised in the United States. However, the Home Office inspector would be placed in a much stronger position to truly "oversee" the activities of IACUCs (much like the Canadian and the projected Australian and New Zealand systems) and "audit" the work of investigators. If the IACUC was also to include members of the local community and an animal welfare organization representative, then it would be less likely to be criticized for being an instrument of the scientific community. An argument for the establishment of IACUCs in the United Kingdom has been given by Jennings (1994) and a discussion of their possible role is addressed in LASA (1994).

While the U.K.'s legislation was internally driven, it was also a response to a European Community Directive 86/609/ EEC, which outlined a basis for animal research legislation for European Community countries. This Directive has now been ratified by some countries, but there is still pressure on the others to implement it. Therefore it is unlikely that further legislation arising from the European Community will have a major impact on the oversight of animal use in science in the United Kingdom during the next 10 years.

REFERENCES

Bateson, P. 1986. When to experiment on animals. New Scientists 109:30-32.

Boyd, K. 1995. Ethical Review of Research Involving Animals. A Role for Institutional Ethical Committees? Edinburgh, Scotland: The Boyd Group.

Russell, W. M. S., and R. L. Burch. 1959. The Principles of Humane Experimental Technique (Special Edition). Hefts, England: Universities Federation of Animal Welfare.

HMSO. 1989. Code of Practice for the Housing and Care of Animals Used in Scientific Procedures. London: HMSO.

HMSO. 1990. Guidance on the Operation of the Animals (Scientific Procedures) Act, 1986. London: HMSO.

HMSO. 1993. Report of the Animal Procedures Committee for 1992. London: HMSO.

HMSO. 1994. Report of the Animal Procedures Committee for 1993. London: HMSO.

Jennings, M. 1994. Ethics committees for laboratory animals: A basis for their composition and function. Horsham: Royal Society for the Prevention of Cruelty to Animals.

LASA. 1994. The Ethical Review Process--Report of the LASA Seminar. Tamworth: LASA.

National Research Council (NRC). 1985. Guide for the Care and Use of Laboratory Animals. Washington, D.C.: U.S. Department of Health and Human Services. NIH Pub. No. 86-23. (Available from Office for Protection from Research Risks National Institutes of Health, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20892-751)7. Tel: 3//1-496-7163)

Smith, J. A., and Boyd, K., eds. 1991. Lives in the Balance: Thc Ethics of Using Animals in Biomedical Research. Oxford: Oxford University Press.