Memorandum by Dr Richard Nicholson—Bulletin
of Medical Ethics (PI 104)
The overall impression given by this section
is that research ethics committees (RECs) have been rather difficult,
but that the DoH through COREC has made lots of improvements and
now has a good system up and running. The reality is rather different.
For many years the DoH did nothing to support RECs and the 3,000+
members who volunteer to do the tough and rigorous analysis needed.
When DoH finally recognised that it could no longer get away with
doing nothing, it set up the Central Office for Research Ethics
Committees and gave its dictatorial director free rein to impose
whatever ideas he liked on RECs without any requirement for proper
consultation. The result has been hundreds of pages of rules and
regulations for RECs to follow, dozens of standard letters to
be used in every eventuality, and an attempt to impose so much
bureaucracy that RECs have no time left for the ethics review
and patient protection that are their proper functions.
3.1 RECs started work in 1967. The 1991
guidance from the DoH was brief and of little consequence because
it came with no instructions to health authorities to support
RECs and their administrators. DoH did not make any funds available
specifically for ethics review until COREC was set up.
3.2 Training for REC members has been available
since the late 1980s, well before 1997, but many RECs had no funding
from their health authorities to take it up. The DoH commissioned
its own report into the training needs of REC members in 1992,
but never acted on its recommendations. When COREC presented a
training strategy three years ago (without consulting any of the
training providers) it was clear that it did not know of the existence
of the earlier report. Both the 1992 report and one by Rabbi Julia
Neuberger for the King's Fund recommended that all REC members
should receive the Bulletin that I edit: both DoH and COREC have
refused even to discuss with me how that might be achieved.
There is no fundamental reason why every REC
should come to the same conclusion on a given protocol, and ask
for the same protocol amendments. Ethics review is not a mechanistic
process that must always produce the same answer. Inconsistency
between REC opinions often arises because the average protocol
has so many ethical problems. Different committees may choose
to emphasize different problems, thus requiring different changes
to the protocol.
3.3 There is little or no evidence that
RECs and their administrators are working any more effectively
or consistently under the various "national systems"
introduced without adequate consultation by COREC. They have added
to administrative burden and reduced morale. Although five possible,
commercially-available, software systems were already in use by
comparable committees in North America that could have greatly
eased the administrative burden, COREC did not look at any of
them, choosing instead to have a system created de novo with
all the inevitable delays and teething problems.
3.4 There may have been discussion of ethical
review in the PICTF clinical research working group, but little
evidence that it has made any difference. Given that a constant
moan of the pharmaceutical industry is that any delay to their
clinical trials may cost them millions of pounds per month, it
is extraordinary that most companies remain incapable of writing
adequate patient information sheets for clinical trials. My REC
still requires over 90% of the information sheets it sees to be
rewritten, resulting inevitably in at least one month's delay
in starting the clinical trial. I helped to produce guidelines
on writing information sheets six years ago, but my analyses show
that there has been no significant improvement since then. Only
one company, Novartis, has made a serious attempt to produce better
information sheets.
3.5 One should remember that there was no
consultation of RECs during development of the EU clinical trials
directive. In the UK the negotiations were left to the then Medicines
Control Agency: even though it had no knowledge of RECs or any
routine involvement with them, it did not find it necessary to
involve anyone with such knowledge in formulating its approach.
There is nothing in the directive to suggest that we have to have
an UKECA that is made up of ministers. It would still make much
more sense if it were to be reconstituted as a committee of experts.
3.6 This paragraph implies that the appeal
mechanism is required by the directive: it is not.
It also says that the Regulations reflect international
standards. In one important respect they do not. The current most
widely accepted ethical guidance on medical research is the version
of the Declaration of Helsinki agreed unanimously by the World
Medical Association in 2000. The Regulations require that UK clinical
trials be carried out according to an out-of-date version, almost
all of which was written in 1975. Were RECs allowed to work to
the 2000 version, they could for instance insist on publication
of trial results as a condition of ethics approval. But they cannot,
because that was not a requirement of the old version to which
we have to work.
3.7 UKECA may, in practice, choose not to
appoint or dismiss REC members. But the Regulations give it the
power to set up or abolish any committee and to appoint or dismiss
the members, the chairman or the vice-chairman of any NHS REC.
If that power is not to be used, why was it created earlier this
year? There is nothing in the Regulations to indicate that UKECA
is only the appointing authority for NHS RECs as a transitional
measure, as claimed here.
3.8/9 I doubt that COREC is anywhere near
being competent enough to qualify as an "expert unit".
The training provided by COREC is of very doubtful
quality. It has not engaged constructively with the eight or nine
providers of training to RECs, and has sought to limit their activities
by maintaining central control of the training budget.
While Ministers may wish to avoid excessive
bureaucracy and micromanagement, COREC certainly does not. COREC's
micromanagement extends to specifying how many spaces to leave
after a full stop in letters written by RECs. COREC has also been
responsible for many arbitrary decisions.
November 2004
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