Select Committee on Animals In Scientific Procedures Report


CHAPTER 6: THE ETHICAL REVIEW PROCESS

6.1  From 1st April 1999, all certificate holders in licensed establishments have been required to have in place an Ethical Review Process (ERP). The aims of the process are:

    (i)  to provide independent advice to the certificate holder, particularly with respect to project licence applications and standards of animal care and welfare;

    (ii)  to provide support to the Named Veterinary Surgeon (NVS) and the Named Animal Care and Welfare Officer (NACWO), and advice to licensees regarding animal welfare and ethical issues arising from their work;

    (iii)  to promote the use of ethical analysis to increase awareness of animal welfare issues and develop initiatives leading to the widest possible application of the Three Rs.[156]

6.2  The process has had many benefits. The ERP has enhanced the status of Named Veterinary Surgeons and Named Animal Care and Welfare Officers, and given them a platform to express their views. It has brought together expertise from across institutions to give advice on experimental design and the writing of project licences. ERPs are also encouraged, but are not required, to involve lay members.

6.3  The Home Office review of the ERP, published in November 2001, concludes that:

"There is no doubt that the ERP has made a positive contribution to the production, care and use of animals for experimental and other scientific purposes".[157]

6.4  These benefits, however, come at a cost, and one which has not been fully recognised by the Inspectorate. In its review of the ERP prepared by the Inspectorate, the time taken to operate the ERP was dealt with in only the most cursory manner, and no attempt to quantify the opportunity and monetary costs was made.[158]

6.5  Moreover, in their review the Inspectorate take a somewhat Panglossian view — that all is for the best in this best of all possible worlds. They recommend that the ethical review process statement issued by the Home Office should remain unchanged.[159] They say that flaws with the ERP are solely the fault of inadequate implementation by individual institutions, and they fail to acknowledge the complaints of scientists that "the Home Office provided little or no guidance on how ERP should be established".[160]

  

ROLE OF THE ERP

6.6  These early problems with the ERP are now beginning to be solved. Even those who remain sceptical about the overall value of the ERP acknowledge that:

6.7  At the moment, we consider that the ERP duplicates much of the work of the Inspectorate. This seems to be partly the fault of the scientists who use animals in research (as the Home Office suggests), and partly the fault of the Home Office (as many scientists suggest). Licensed establishments are required to have an ERP, a body of expertise to scrutinise project licences, but their remit is limited to amending and improving the licence application before it is submitted to the Inspector. The Inspector then carries out the cost/benefit assessment in exactly the same way as occurred before the introduction of the ERP.

6.8  We consider that better use could be made of the work already done by the ERP. At present, both new project licences and minor amendments are scrutinised by the ERP, who may require changes, scrutinised again by the Inspectorate, who may also require changes, and passed to the Home Office. Some controversial licences are then passed to the Animal Procedures Committee, other even more controversial licences are passed to Ministers, and advice may be sought from independent assessors. Under the Act, all decisions on project licences have to be taken by the Secretary of State. In practice, these decisions are delegated to the Animal Procedures and Coroners Unit (APCU) in the Home Office (Q. 1963).

6.9  Project licences last for up to five years. This elaborate process of scrutiny may be appropriate for licences which last the full five years, and scientists are mostly content with the agreed processing time of 35 clock days. For routine or minor amendments, however, the processing time of 35 clock days, in addition to the time spent by the ERP, is considerable. This is not only frustrating for scientists, but has adverse consequences for animal welfare.[162]

6.10  The Chief Inspector said that a move was gradually being made towards making project licences give "performance standards" rather than "engineering standards".[163] Where licences are written to "performance standards", the ERP examines each case to ensure that the standards are adhered to. We are in favour of moving towards this system, but the Home Office and Inspectorate need to issue guidelines on, and examples of, exactly what is required.[164] This may be an effective long-term strategy, but it seems unlikely that licences, however well drafted initially, will be flexible enough to incorporate all the advances and technological changes which may occur during the maximum five year duration of the licence. There is always likely to be a need for routine or minor amendments. The long term strategy also does not address the immediate concerns of processing amendments.

6.11  We recommend that the Home Office should delegate interim authority to the local Ethical Review Process to approve routine or minor amendments.

6.12  Under such a system, once the ERP had approved an amendment, it could immediately be implemented. Within a week, a retrospective notification would be given to the Home Office. The Inspectorate would monitor the performance and effectiveness of ERPs, as they do at the moment. Any ERP found to be operating unsatisfactorily could have its delegated interim authority to approve amendments suspended or withdrawn.

6.13  We envisage that the Inspectorate should draw up guidance on which amendments should be considered "routine or minor". Such amendments might include: the use of a different strain (though not a different species), provided there was no significant additional detriment to animal welfare; improvements to animal welfare, such as environmental enrichment or the use of better anaesthetics; small changes in the number of animals used (for example up to 10%); and small changes to the procedures used to obtain samples or administer test substances.

6.14  The Chief Inspector said that empowering ERPs to make licensing decisions would require primary legislation (Q. 1910). We do not believe this to be true — in most instances decisions are already delegated from the Secretary of State to the Home Office. Moreover, we have heard that there is already scope for the granting of interim authorities to make changes to protocols.[165] Our proposal would simply extend this principle. We consider that this problem can be overcome if there is the political will to do so, especially as this recommendation, to slim down bureaucracy and stimulate research, is in keeping with recent policy statements by Government.

6.15  We consider that the rapid processing of routine or minor amendments has clear benefits, both in terms of improving animal welfare and in terms of reducing the burden of bureaucracy. We also consider that it will reduce the burden of trivial work on Inspectors. Lord Sainsbury noted the problem of excessive paperwork, which "was distracting the Inspectors from getting on and considering the animal welfare because people were spending a lot of time just processing the paper and ticking boxes" (Q. 1667). Animal welfare will be improved if Inspectors are given more time to make full use of their extensive expertise.

6.16  With this recommendation our intention is clear — to reduce the burden of unnecessary bureaucracy and associated costs and delays. We consider that this proposal will also have a beneficial effect on animal welfare, both by speeding up the implementation of amendments which improve animal welfare, and by preventing unnecessary animal use. We have no wish to impose further burdens on ERPs, the Inspectorate, or the Home Office. We emphasise that these suggestions rely on a reasonable interpretation being made of "routine or minor" amendments. We do not intend to compromise animal welfare, but equally these recommendations will have no effect if the Home Office defines "routine or minor" amendments to include only the most trivial of changes. It may well be that any changes are best made by operating pilot schemes, or by gradually extending the definition of "routine or minor". We have made what we consider to be realistic and practical suggestions for dealing with a problem presented to us by many witnesses. It is up to the Home Office to consider these recommendations in the spirit in which they are made, and make a clear commitment to operating the Act as effectively and efficiently as possible.

  

MEMBERSHIP OF THE ERP

6.17  In order to ensure that ERPs are of sufficiently high standard, and to maintain public confidence in the regulatory system, we consider that ERPs should be strengthened.

6.18  Each ERP should include at least one lay member who should be totally external to the institution. The advantages of lay membership are clear. Lay members, as outsiders to the scientific community, can ask fundamental questions about justification which scientists might pass over as being seemingly too obvious to need justification. They can represent ethical viewpoints which those who are immersed in science might not normally consider. Lay membership allows a form of public scrutiny which should contribute to greater openness and a more rounded assessment of animal research.[166]

6.19  Many ERPs currently have lay membership, but such members are frequently non-scientific employees in the same institution. If lay members are to be effective in their role of scrutinising project licences, then they need to be able to express freely opinions which scientists may find uncomfortable. A lay member employed by an institution may not be in a position to criticise colleagues as rigorously as might be desirable. This is not to suggest that any conscious pressure has ever been brought to bear on any individual; it is however undesirable that a lay member should be under even sub-conscious pressure not to be as frank as possible and for self-censorship to operate.

6.20  Most of our witnesses were in favour of lay membership in principle, though a number said that lay members were difficult to find in practice.[167] We recognise that finding such lay members is not always easy. Nonetheless, lay membership of Institutional Animal Care and Use Committees is already obligatory in the US (where many lay members are lawyers or ministers of religion) and there seems to be no good reason why it should not also be possible in the UK. We note that many UK establishments already have external lay members on their ERP. This good practice has been encouraged by the Home Office for some time. We consider that encouragement alone has not been effective.

6.21  We recommend that each Ethical Review Process should be required to have an external, lay member, whose term of office should be time-limited.



156   These aims are set out in paragraph 3 of the Annex to the PCD Circular 3-4.98. Back

157   Review, p. 13. Back

158   Huntingdon Life Sciences estimate the annual cost of running an ERP to be £100,000 a year (p. 187). Back

159   The statement is contained in Appendix J to the Home Office Guidance on the Operation of the Animals (Scientific Procedures) Act 1986. Back

160   Professor Nancy Rothwell (p. 278). Back

161   Ibid. Back

162   See para. 5.32. Back

163   Q. 1911. This distinguishes between specifying on the licence a quality standard to which all work will be done ("performance standard"), and specifying the exact procedures to be carried out ("engineering standard"). Back

164   Professor Rothwell (p. 184). Back

165   David Robb from Inveresk Research said, "I have been aware in the past of receiving verbal authority from an inspector to waive conditions on a project licence where the waiver was going to avoid the increased use of animals as long as that waiver was followed by a formal approach to amend the licence within a short period" (Q. 362). Back

166   The advantages of lay membership are recognised by many witnesses, including the Boyd Group (p. 45); GlaxoSmithKline (p. 156); the Royal College of Obstetricians and Gynaecologists (p. 280); the University of Birmingham (p. 338); and the Wellcome Trust (p. 354). Back

167   For example, the Research Defence Society (Q. 934) and the MOD (Q. 1624). Back


 
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