How can research ethics committees protect patients better?
BMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7400.1199 (Published 29 May 2003) Cite this as: BMJ 2003;326:1199
All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
EDITOR- The paper by Garattini et al “How can ethics committees
protect patients better?” raises the important point that research ethics
committees are an essential component of a system that should protect
individual patients, but should concentrate on key aspects that make a
study ethically and scientifically justifiable (1).
My colleague and I are concerned about the unnecessary hurdles placed
by ethics committees, in the way of doctors wishing to perform simple
research and audit within the hospital setting. Our department decided to
look at the effectiveness of embolisation for testicular pain secondary to
varicoceles. We decided we should send a simple retrospective pain
questionnaire to the 105 patients who had undergone this procedure.
We are still awaiting final ethics committee approval, having filled
in 26 pages of forms and obtained 8 different signatures from 7
departments and having had the proposal was rejected twice. The reasons
for these rejections were the use of the word “groin”, which was felt to
be a medical term, and “important study” which was felt would put undue
pressure on patients to take part.
Most doctors agree that patients need representation when taking part
in research, and that research should be appropriately governed. However
in today’s culture of appraisal and revalidation it is increasingly
important for us to show that our practice is effective and evidence
based, and we need to reduce unnecessary barriers that stop us from
achieving this aim.
Surely most patients would be willing to offer some feed back into
the quality of their care. Those patients not wishing to participate will
simply not respond. Is all this bureaucracy really representing the views
of our patients or is it merely dissuading doctors from participating in
any form of research?
1) Garattini S, Bertele V, Li Bassi L. How can research ethics
committees protect patients better? BMJ 2003; 326:1199-1201. (31 May.)
Competing interests:
None declared
Competing interests: No competing interests
Sir,
Garattini et al1 deserve to be complimented on their paper; however, we
think that some points deserve further consideration.
According to the Declaration of Helsinki2, the primary purpose of medical
research is to improve procedures for patients, and so equivalence or non-
inferiority trials not aimed at “improvements” should not be carried out.
But the authors state that equivalence or non-inferiority trials are
“appropriate and without ethical problems” on the grounds of ease of
administration (focus on the patient) or lower cost (focus on the public
health), and it can also be added that physicians need at least equivalent
therapeutic alternatives for patients who do not respond to standard drugs
or who cannot be treated with them because of experienced adverse events
such as allergic reactions. It therefore seems that there at least two
(individual and collective) “aspects of ethics” in clinical research that
are at least partially conflicting.
The plain fact is that physicians can ethically perform controlled
clinical trials only if they are in the equipoise situation (the drugs are
equivalent), but are confident that the experimental drug will turn out to
be better than the current standard and this still has to be proved
scientifically (the controlled clinical trial model). It is difficult to
establish the extent to which physicians are confident about this
superiority or conservatively accept that the difference will be around
zero but within the limits of clinical equivalence (appropriately fixed by
panel expert committees, regulatory organisms, etc., rather than the
pharmaceutical industry).
We agree with Garattini et al.1 that medical research has to be carried
out “if the research question reflects a real need”, but this applies to
any model of clinical trials, not only to equivalence or non-inferiority
trials.
In addition, we would like to comment on a very important issue. If a
superiority study is negative (i.e. without a statistically significant
result), the tendency is to conclude equivalence between the new and
standard drug as reported for instance in the Gusto III trial3:
“…reteplase is not superior to alteplase for the treatment of acute
myocardial infarction. However, in terms of 30-day mortality, … the
results of reteplase therapy were similar to those of alteplase therapy.
Furthermore, because the long half-life of reteplase allows for bolus
therapy, it is easier to administer”. Apart from the fact that this
conclusion comes from mistakenly considering that a failure to disprove a
null hypothesis means its acceptance, this approach is potentially flawed
as a study may have insufficient power to demonstrate a difference that
has to be considered greater than the clinically acceptable threshold for
equivalence.
Equivalence or non-inferiority trials ending with a result that is not
statistical significant therefore allow a definite conclusion of
inferiority, unlike superiority trials that may be incorrectly and
unethically read as supporting non-inferiority.
In conclusion, a result of “equivalence” coming from an appropriately
designed, powered and conducted equivalence study can be considered
ethically and scientifically sounder than a conclusion of “equivalence”
coming from a negative superiority study.
References:
1 Garattini S, Bertele V, Li Bassi L. How can research ethics committees
protect patients better ?. BMJ 2003; 236: 1199-01.
2 World Medical Association. The Declaration of Helsinki (2000) (accessed
May 2003).
3 A comparison of Reteplase with Alteplase for acute myocardial
infarction. N Engl J Med 1997; 337: 1118-23.
Competing interests:
None declared
Competing interests: No competing interests
I did not find Garattini and Bertele's article useful, mainly because
it was far too technical for ethics committees to read. Some ethics
committee members are clinically qualified; the remainer hail from a
varied background, professional and non-professional. Committee members
evaluate research from their own framework of knowledge, but are not
expected to possess deep scientific knowlege of pharmaceuticals. It is
for the research physician to verify that his research proposal has passed
some form of peer review. The ethics committee would not necessarily know
what reaction a certain drug had in comparison to another, the outcome of
original trials (as opposed to comparitive trials), nor would members take
into account expected side effects of a drug in comparison to the
"established" treatment. That is all peer review material.
Competing interests:
None declared
Competing interests: No competing interests
Firstly we need to look at who sits on Ethics Committees in order to
decide how impartial or truly independant they can be in protecting the
interests of research 'participants'and the quality of research. The Chair
of the Ethics Committee of St Georges Trust was informed that there had
been a breach of DPA by a member of the psychology department. After the
most apalling run about by St Georges, including the Dean of the Medical
School, the Chief Executive and Caldicott Manager, the Chair of the LREC
concurred with them that there was no problem. The matter was then passed
to the Information Commissioner who wrote to St Georges advising them that
there was indeeed a problem, and highlighted their their duty to comply
with the law with respect to the rights of people under the Data
Protection Act.
The Chair did at no time declare that he had in fact
contributed to a book which included material written by members of the
psychology department. He did agree to forward a copy of the next LREC
Annual Report. After much delay and failure to return calls it transpires
that no LREC Report has been produced by the Ethics Committee at St
Georges. The Chief Executive and other managers seem unconcerned, COREC's
response was 'what do you expect us do do about it?
2
Recently a group of doctors who are promoting the expansion f
psychoanalytic practice in primary care have been publishing personal
information without consent, again at the Tavistock.The Research was
described as taking place at the Tavistock and elsewhere. The Chief
Executive and the Chair of the LREC were unhelpful to say the least. No
approval had been requested from a research ethics committee and no
willingness to take action was demonstrated. The case was referred to the
GMC which found a GP in breach of GMC guidelines.
The Tavistock LREC is
administered by the Secretary to the Dean. When a request for a copy of
the Anual Report was made an attempt to withhold it as
being'confidential' was made, then only part was forwarded until the Chair
intervened and sent the whole document.Their was a clear conflict of role
s demonstrated by the LREC. The actual report was one of the flimsiest any
Trust has produced.
The Chair is an ex Executive member of th Trust who
was asked in a rather informal manner to take the Chair after resigning
his Executive post. He is hardly demnstrating independance. The other
committeee members (except lay members who have not declared any
interests)are all involved with with the same work at the Tavistock and
similar projects as their colleagues ,who request approval from them, for
their studies. None have declared their self interests.
Practitioners
involved with the TAvistock have had several successful complaints upheld
against them by the Information Commissioner, the GMC and other bodies.
When the issue was referred to COREC they took no action and Terry Stacey
advised it is the resposiblity of the Strategic Health Authority to
investigate.
The MAnager of the S.H.A has advised that guidelines
concerning the composition of LRECs comittees will change when European
directives come in. They cannot be soon enough and hopefully will also be
monitoring COREC' role too.
Competing interests:
None declared
Competing interests: No competing interests
Who monitors Ethics Committees
I would like to correct an error in my initial response to this
article.
The Chair of the LREC of the Tavistock was still in post as a non-
executive (paid) member of the Executive according to the Annual Report
2001. (ie not 'recently resigned' as I initially described), when he was
asked to take over the Chair of the Tavistock LREC. I do not know who
made the request. He also in his non-executive role assisted in drawing up
the Annual Report and the Audit.Perhaps this is not unusual but perhaps
there should be a clear separation.There was no mention in that Report of
the activities of a private therapy organisation with which the Tavistock
is heavily involved and which bases some of it's work there. Obviously
with the agreement of the Tavistock some of whom are members of this
organisation - it could hardly use the resources there otherwise, although
there are descriptions of other activities by other groups.Some of the
work of the LREC was carried out by the Chair from his home address rather
than through the administrator at the Tavistock. This address is given by
a person with the same surname who practices as a therapist in an
organisation with ties to the Tavistock.
Nevertheless the Chair has not only stated in the LREC Annual Reposrt that
none of the members of the Committee had anything to declare but he has
totally failed to declare any of his own self interests.
Perhaps the new person from OREC who takes over in September should look
through the proposals submitted to this committee to see how far they
complied with ethical standards.None of those involved with this LREC took
any steps to ensure what even commonsense would tell most people - that
such a committee could not possibly function as a realistic Ethics
Committee.
Competing interests:
None declared
Competing interests: No competing interests