The Boyd Group is a forum for open exchange of views on animal use in science.

The members and observers of the Group who contributed to these comments represent a range of different viewpoints, including:

• people involved in at least 22 different ethical review processes (ERPs), in industry, academia and research institutes. They include NACWO and NVS members (some of whom represent their respective professional bodies within the Boyd Group), project licence holders, who are members of ERPs and/or applicants to the process (some of whom represent scientific societies and professional bodies) and lay/external members of ERPs (including philosophers and representatives of animal welfare organisations);

• others with an interest - including anti-vivisectionists, representatives of animal welfare organisations, representatives of scientific societies and professional bodies that support scientists, and of funding bodies.

The majority of members of the Boyd Group believe that the introduction of ERPs has brought significant benefits in relation to each of the aims of the process set out in paragraph 3 of the Annex to PCD circular 3-4.98. The few members who feel that the benefits have been slight in relation to the effort put into ERPs nevertheless are agreed that ERPs might potentially bring more significant benefits.*

Examples of the benefits that members of the Group identified in relation to each of the three overlapping aims of the process are listed below.

ERPs have contributed to this aim by, for example,

• providing a clear forum within establishments for consideration of ethical aspects of animal use, including animal welfare issues;

• enabling review of ethical issues in light of local circumstances and procedures;

• potentially helping to improve the quality, and in some cases the speed, of project licence applications;

• involving a wider diversity of perspectives in ethical review of animal research, and, in particular:

• giving explicit voice to those who care for the animals (NVS, NACWOs, technicians), providing opportunities for their particular knowledge and expertise to be fed into the ethical review; and

• providing the opportunity to involve external/lay people as well as scientists from different disciplines, who can ask challenging questions and help to clarify thinking;

• helping to serve the public interest better, by including lay/ external / disinterested perspectives in the ethical review.

• involving NACWOs in the ERP has helped to raise their profile within establishments, encouraging wider understanding of their role and support for it; and this has helped to raise the status of animal technicians;

• the ERP allows people involved with care of animals (e.g. NVS, NACWO) to have inputs into the design and management of animal procedures at an early, project planning, stage, helping to avoid later problems and, thus, assisting the named people in their roles;

• involving both animal care staff and licensees in the ERP has helped to improve communication and trust between the different people involved in use of animals within establishments;

• local review facilitates on-going advice to licensees, particularly with respect to local circumstances and arrangements, and this can facilitate better implementation of the 3Rs.

The educational roles of ERPs are key in ensuring that the process fulfils the other two aims and adds value to other review processes, such as HO and funding body review. In particular, introduction of the ERP has

• helped to increased awareness of ethical and welfare issues amongst scientists, and this, along with the ERP's concern with other aspects such as managerial systems, staff training and competence, can help to promote a 'culture of care' within establishments;

• encouraged better dissemination of information (e.g. about the 3Rs) within establishments: for instance, some establishments have developed internal web-sites and/or programmes of seminars to assist in this;

• encouraged more consideration of opportunities to improve animal husbandry;

• provided a mechanism that can assist establishments in responding to external enquiries about the use of animals.

The experiences of members of the Group show that a wide range of benefits has already come from the implementation of the ERP. However, they also indicate variation in whether, and how far, these benefits have been achieved in particular establishments. Only one member of the Boyd Group suggests that the benefits are accompanied by no major difficulties. Others have encountered various difficulties that have limited the effectiveness of ERPs in certain circumstances. Many of these are related to a need for adequate resources to support the process.

The potential problems are summarised below:

• increased paperwork and administrative demands, without the resources to support these;

• increased time for approval of new project licences and amendments - though some members argue that this is not a problem, because the time and other resources needed to review projects are clearly justified by the benefits of the review (in terms of improved animal welfare, experimental design and speed of the overall review process, for example). Others argue that the ERP has added unjustified delay to the whole process of review and approval applications for licences and amendments;

• welfare-friendly and minor amendments can be subject to unnecessary delay;

• increased workload for already busy people (both applicants and members of ERP), and, in particular:

• ERP's demands on named peoples' time can divert attention from their clinical and animal care commitments;

• some scientists argue that the sometimes lengthy process of drafting and revising applications can take their time away from research and/or patients - and that, in some cases, this can lead to hostility towards the ERP.

• some ERPs place too much emphasis on project licence review, at the expense of consideration of wider issues impacting on animal use and welfare within establishments;

• there has been a steep learning curve for ERPs and there is still uncertainty about what the HO expects, and how it should be achieved - for example, some feel that the goals of project review by the ERP have not been sufficiently clearly defined;

• some members argue that people within the ERP operate outside their own area of expertise - and, in particular, some scientists suggest that ERPs lack the expertise to deal with 'quality of science issues', which are often already peer reviewed by funding bodies;

• there is potential for duplication of effort in project review between the ERP, HO, and the funding bodies;

• some scientists report that some HOIs make fewer visits to their establishments since the introduction of the ERP;

• the ERP can be chaired by the establishment's Certificate Holder who is usually a member of senior management, and this has in some instances provoked apparent conflicts of interest, particularly with respect to provision of resources;

• ERPs do not necessarily represent the whole spectrum of views on the use of laboratory animals, because, for example:

  • animal technicians are not involved in some places, and where they are involved may sometimes feel apprehensive about expressing concerns;

  • representatives from outside the establishment are not always included, and

  • people opposed to animal experiments are rarely involved.

In considering possible changes in the arrangements of ERPs, the Group's overall feeling is that care should be taken 'not to throw the baby out with the bath water'.

For example, although it is suggested that some difficulties can be associated with the ERP's role in project review, this aspect of the ERP's work is potentially very valuable in, for example:

• considering proposed and on-going work with respect to local factors (such as quality of facilities, local expertise, availability of resources, management structures etc);

• widening consultation to include specialist veterinary, animal husbandry and statistical inputs, as well as input from scientists not involved in the applicant's field of work, lay people, and people from outside the establishment. All of which can result in better application of the ethical weighing required under ASPA and improved implementation of the 3Rs;

• helping to identify wider issues arising in work within the establishment for the ERP to address.

There are therefore strong advantages in retaining the project review function of the ERP and working to find ways of overcoming any problems encountered in practice.

Members' suggestions for building on current good practice, and/or altering or refining the ERP's approach to both project review and wider issues include the following:

The following suggestions are based on observations of actual practice within ERPs. Widespread adoption of such approaches could help to ensure that the benefits of project review outweigh the time and other resources needed to carry it out:

• concentrate project review on the broad issues raised, and not the details of licence drafting; and develop SOPs that can be used for common techniques and procedures;

• allow prioritisation of some applications, depending on circumstances and defined by clear local criteria;

• 'fast-track' amendments where appropriate - particularly those that are minor and/or intended to improve or safeguard animal welfare;

• ensure that ERPs meet frequently enough to deal with applications efficiently, and/or set up e mail systems for review of routine applications.

In addition, members of the Group

• ask that feedback from the HO review of the ERP includes further clarification of the roles of ERPs, and in particular, the expected goals and outcomes of ERP review of new licences and amendments, as well retrospective (interim) review of on-going projects.

Two more radical suggestions relating to project review elicited particular discussion within the Group. These suggestions, made by one or two individuals but not more widely agreed, are that:

• ERPs should 'fast track' project licence applications relating to work funded by recognised agencies (such as the MRC and Wellcome Trust); and

• should not concern themselves with 'quality of science' issues.

The suggestions also relate to a more general concern that ERPs should not merely duplicate HO and/or funding body review of projects.

As already noted, ethical review by the ERP is different from HO and funding body review in that it is carried out with respect to local factors, and involves a wide diversity of perspectives on the issues. Furthermore, in relation to the other processes, ERPs have the potential more directly to influence their establishment's 'culture' regarding animal use.

Regarding quality of science issues, most members of the Group argue that consideration of these is an essential part of the cost-benefit assessment required under ASPA. They also suggest that ERP and HO review of quality of science is different from funding body review, in that the former processes should explicitly evaluate quality of science in relation to the harms likely to be caused to the animals, whereas funding body review does not usually involve such detailed consideration of the animal procedures.

Nevertheless, in practice, liaison between the HO, ERP and funding body review 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. Better co-ordination and communication 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 of review.

In light of this discussion, the following suggestions for avoiding duplication of effort in project review are offered by members of the Group (but not necessarily widely agreed within the Group):

• review by ERP and funding body should be synchronised wherever possible;

• better liaison should be established between the three processes of review (HO, ERP and funding body), so that each can benefit from the other's expertise and approach to the issues;

• some members feel that it would be helpful if all HOIs are more available at an early stage in licence preparation, and would routinely sit in on ERP discussions - they suggest that this could help to establish better dialogue between the ERP and HO, enabling them to work together to achieve common aims; and

• a more radical suggestion is that HO and ERP review of licence applications should take place in parallel.

(i) Although project licence review is very valuable, it is not the ERP's 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.

• ERPs, universally, should recognise the importance of their educational roles, ensuring that there is an appropriate balance between review of project licences and consideration of wider issues that impact on welfare and science within establishments; and

• some ERPs need to enhance communication with scientists, in order to facilitate both understanding of the process itself, and sharing of information concerning the 3Rs and other matters of 'best practice'. In-house web-sites are particularly successful in this regard - but considerable resources are required to set up and maintain them properly.

Training for all involved is also likely to be important in helping the ERP to fulfil its aims. Members of the Group suggest that

• there should be induction, and perhaps on-going, training for all ERP members; and

• licensee training should cover local processes and arrangements, so that licensees understand their establishment's own particular approach to the ERP and what is expected of them. Commercially available Module 1 and 5 courses, attended away from the licensees' own establishments, cannot cover such local issues.

In the educational context, too, the HOI continues to play a vital role in monitoring how animals are actually being used within establishments, ensuring constant consideration of the cost-benefit assessment and implementation of best practice. Some members of the Group believe that the frequency of visits by some HOIs to some establishments has decreased since the introduction of the ERP. Whether this perception is correct or not is unclear. Nevertheless, it is important that this role is not diminished - particularly since, in law, HOIs can impose best practice.

(ii) ERPs provide an important opportunity to widen consultation on ethical issues arising in laboratory animal use. Few, 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 unless and until their perspectives are included.

Whilst 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; and some committed anti-vivisectionists are likely to find it difficult to take part in the ERP on these terms. Nevertheless, inclusion of a wide ranger of perspectives should be encouraged.

To be effective, ERPs require adequate resources to support their work. Most of the ERP's activities require both financial and time commitments, and many of the above comments suggest needs for extra resources - for example:

• in order to manage the work of the ERP effectively, many establishments have needed to employ a dedicated ERP co-ordinator;

• proper dissemination of information, about the 3Rs for example, requires both financial and time resources (e.g. in setting up web-sites, circulating papers);

• the extra work that the ERP requires of NVS and NACWOs places considerable burdens on their time, can take them away from their clinical and animal care duties, and has required extra staffing in some establishments;

• in large establishments, with many licences, interim review of licences requires considerable additional resources.

Some establishments, especially some universities, are unable (or unwilling) to make these kinds of resources available to the ERP.

In order to ensure that the considerable benefits of ERPs are fully realised, means of meeting such resource needs should be actively sought.