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:
"ERP has undoubtedly
brought benefits in ensuring high quality of training of scientists,
and of animal welfare, greater involvement of NACWOs and has probably
improved the quality and clarity of project licences overall".
Nonetheless, we consider that the ERP is often an
ineffective way of achieving these benefits.
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.
6.10 The Chief Inspector said that a move was
gradually being made towards making project licences give "performance
standards" rather than "engineering standards".
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.
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
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
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.
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.
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
Review, p. 13. Back
Huntingdon Life Sciences estimate the annual cost of running an
ERP to be £100,000 a year (p. 187). Back
The statement is contained in Appendix J to the Home Office Guidance
on the Operation of the Animals (Scientific Procedures) Act 1986. Back
Professor Nancy Rothwell (p. 278). Back
See para. 5.32. Back
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
Professor Rothwell (p. 184). Back
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
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.
For example, the Research Defence Society (Q. 934) and the MOD
(Q. 1624). Back