The Boyd Group tries to involve in its discussions a wide diversity of perspectives on laboratory animal use, in order to clarify issues of concern; seek points of consensus on these issues; explore points of disagreement and the reasons for them; and wherever possible, make recommendations on aspects of common concern within the Group.

Given the membership, aims and philosophy of the Group, it seemed most appropriate that this response should focus on one aspect of the last question in the consultation paper - the procedures by which judgements on costs and benefits are made in practice, and possible means of enhancing trust and confidence in those judgements. Some of the points made in the response also relate to other questions in the consultation paper, but these questions are not explicitly addressed.

1.1 The Chief Home Office Inspector's paper in the 1997 APC report, along with other publications (such as that of a Working Party of the Institute of Medical Ethics, 1991), provide helpful guidelines on approaching the assessment and weighing of costs and benefits, required under ASPA. It should be recognised, however, that such advice can never be more than guidance on the issues at stake, and cost-benefit assessment will always remain a matter of moral judgement.

1.2 Use of the term 'cost-benefit' assessment (which is not the phrase used in the Act itself) tends to perpetuate a feeling that the process could be quantifiable, and that there might be some universal formula that could be applied - if only someone were clever enough to discover it (or the Home Office would divulge it!). However, because the process involves judgements, there can be no such 'magic formula'. Moreover, attempts to spell out detailed procedures for approaching cost-benefit assessment run the risk of bureaucratising the process - suggesting that it could be carried out using check-lists, or by 'box-ticking', for example, rather than through thoughtful deliberation and discussion, leading to informed and sensitive consensus judgements.

1.3 A particular problem is related to the notion of 'weighing', which implies that, no matter how great the harms to animals, a sufficiently serious benefit could 'outweigh' those harms. It is important that the cost-benefit assessment should not be viewed in such exclusively utilitarian terms. As suggested in the consultation document, there will at times be needs for absolute rules - setting limits, for example, on the harms that can be caused to animals, no matter what the benefits might be. For instance, it is possible that transgenic animals could be created that would suffer so much that their use could never be justified, however great the benefits might be. Similar arguments have been used to ban the use of Great apes in Britain; and some, but not all, members of the Boyd Group, would put the use of other non-human primates into the same category.

1.4 Beyond such absolute rules, decisions on whether, and if so how, animals ought and ought not to be used in research and testing are matters of judgement which, by their very nature, depend on the particular circumstances involved. Confidence in such judgements depends on whether and how far the people who make them are trusted to come to balanced, informed decisions, that take into account all reasonable perspectives on the issues.

Against this background, we wish to offer the following observations and practical suggestions on how trust in the application of the cost-benefit assessment might be enhanced:

2.1 Understanding the Home Office's approach

In law, the Home Secretary decides whether or not scientific work involving animals can be licensed (and some particular categories of work also require the approval of the APC). Thus, in practice, the Home Office Inspectorate, acting on behalf of the Home Secretary, takes responsibility for the application of the cost-benefit assessment under ASPA. Whatever inputs other review processes might have (such as the ERP), the final judgement is made by the Home Office.

Whilst the Chief Home Office Inspector's paper in the 1997 APC report is helpful in setting out factors that should be taken into account in the cost-benefit assessment, it does not explain how the HOI carries out the assessment and arrives at judgements in practice. For example:

• what weight is given to the standing and experience of the research team involved and their source of funding?

• how are 'quality of science' issues addressed, and how does the HOI obtain the necessary expertise to question such aspects?

• how far is the lifetime experience of the animals considered (for example, what weight is given to adverse effects due to the supply and husbandry of animals)?

• how is the value of different kinds of potential benefit distinguished, including scientific knowledge?

• are costs outside the scope of the project licence, but that may be incurred in carrying out the licensed work, taken into account (e.g. the killing of large numbers of animals under Schedule 1, in order to obtain biological reagents, tissues or organs that are used in licensed procedures)? and

• how are the different considerations brought together in arriving at the decision whether or not to licence the project?

For the reasons given in 1 above, it would be difficult to give further general explanation of the HOI's approach to such questions in practice, but case studies to illustrate how the cost-benefit assessment is carried out in particular circumstances would be very helpful.

Such illustration and clarification of the HOI's approach to cost-benefit judgements in practice

• would help to inform debate on how the cost-benefit assessment is actually applied;

• could assist others, such as members of ERPs, in carrying out their reviews; and

• might help to enhance wider confidence in the judgements that are made under ASPA.

2.2 On-going application of the cost-benefit assessment

Under ASPA, the cost-benefit assessment should be applied not only at the licensing stage, but also throughout the life of any project involving animals, and Home Office guidance emphasises that ethical review should be a "process, not an event". On-going ethical consideration of how animals are actually used under the terms of licences (whether best practice is applied and whether new information that could affect the cost-benefit assessment is taken into account for example) is a crucial part of regulation under the Act.

The introduction of the Ethical Review Process can help to ensure constant application of the cost-benefit assessment within establishments, provided that individual ERPs do not regard review of new project licences and amendments as their sole, or main, raison d'etre. ERPs have important wider, educational roles within establishments, that should help to create, or enhance, cultures in which continual, critical evaluation of costs and benefits, and implementation of best practice, are 'second nature' to everyone involved in animal use.

On-going consideration of the cost-benefit assessment by the HOI is also extremely important, and should not be devolved to local ERPs. Some scientists report that, since the introduction of the ERP, visits by HOIs to some establishments have been less frequent. Regular visits and inspections by HOIs (who in law can impose best practice) are vital in monitoring how animals are actually being used within establishments, ensuring constant consideration of the cost-benefit assessment, and implementation of best practice. This role should be enhanced and not diminished. Over the years, the variety of demands on inspectors' time has greatly expanded, but the number of inspectors has not increased proportionally. In our view, increasing the number of inspectors, to allow more frequent visits to establishments, would be welcomed not only by those opposed to, or critical of, animal experiments, but also by those who use animals, and others who are directly or indirectly involved (such as the Named Persons, other members of ERPs, and those who fund research).

2.3 Widening consultation on the cost-benefit assessment

Because cost-benefit assessment involves moral judgements, which, by their nature, can be contested, it is important that as wide a diversity of perspectives as possible is taken into account.

Again, ERPs provide an important opportunity to widen consultation on application of the cost-benefit assessment - in particular, because they

• give explicit voice to those who care for the animals (NVS, NACWOs, technicians), and provide opportunities for their particular knowledge and expertise to be fed into the assessments;

• should involve external/lay people as well as scientists who are not involved in the particular use of animals under consideration, who can ask particularly challenging questions.

Few ERPs, however, appear to involve people opposed to animal use.

Anti-vivisectionist members of the Boyd Group argue that the public will have little faith in ERPs, and by implication in proper application of the cost-benefit assessment, unless and until their perspectives are included. Whilst some reluctance on the part of ERPs is understandable, it should be possible to widen membership to include informed representatives of responsible organisations opposed to animal use. Like other members of ERPs, such people would also have to respect the confidentiality of matters discussed within the ERP and not seek to disrupt research.

Inclusion of such perspectives within the ERP might seem more feasible when the role of the ERP is seen as educational, rather than semi-judicial, and should be given serious consideration.

2.4 Enhancing dialogue on the issues raised in cost-benefit assessment

Cost-benefit assessments of the kind required under ASPA are carried out in a variety of different contexts - most notably by funding bodies, ERPs and the HO. In practice, communication between these different processes can be limited, raising the possibility of duplication of effort, and restricting opportunities for the individual processes to support and learn from the other.

For example:

• formal communication between an ERP and the Home Office is limited to the Certificate Holder's signature on applications that have been reviewed by the ERP, and ERPs usually do not communicate the nuances of their discussions directly to the HOI who makes the licensing decision;

• there is considerable variation in HOI involvement in ERPs - some sit in on discussions regularly or occasionally, and may be regarded as participants or observers;

• funding body review of animal work is often 'out of synch' with ERP and HO review of the relevant licence application, and issues arising in the funding body review are not usually communicated to either of the other processes.

Better dialogue between the different processes could help to inform the procedures used in each cost-benefit assessment, and to ensure that each 'adds value' to the overall process.

In our view, wherever possible, funding body review should be synchronised with licence review by the ERP and HO, and there should be communication between all three processes - so that each can benefit from the other's expertise and approach to the issues. Some members of the Boyd Group feel that it would be helpful if all HOIs were more available at an early stage in licence preparation, and would routinely sit in on ERP discussions. This could help to establish better dialogue between ERP and HO, enabling them to work together to achieve common aims, and helping to minimise unnecessary duplication of effort in the cost-benefit assessment.