The other face of research governance
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7460.280 (Published 29 July 2004) Cite this as: BMJ 2004;329:280All rapid responses
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Jones and Bamford (BMJ 2004;329:280-1) explain the loss of useful
research due to ethical committee action. These committees seem to act
without realising that scientific facts are there anyway, whether we
discover them or not and it now seems that researchers are no longer
trusted to be responsible for their action by making reasonable decisions
with sensible advice. This must be realised when an Ethics Committee or
any other takes control of what should proceed.
DGH research seems to have been damaged for many governance reasons.
Even minor research projects e.g. a decision to compare 2 different test
procedures in the laboratory, now require permission from a series of
officials and committees. What this leads to generally is that studies
now do not take place.
The application for a scientific project in the DGH goes through the
Scientific Steering Committee (SSC), the Financial department, the
Statistics group, the permission of the hospital department where it is
taking place, the ethics committee, the Chief Executive for the Trust, and
via the creation (and official acceptance) of standard items (e.g. forms).
Why for minor bacteriological projects do I ask a SSC for permission to go
ahead when their opinion adds little to peer discussion? Indeed ethical
aspects could commonly be made plain and advice given easily without a
committee.
Due to the simple excess of opportunities to trip up even minimal
projects, and almost impossibility of fast tracking preliminary studies,
we are watching as UK clinical research collapses e.g. the 80% drop in
clinical research since 1999. Because of the beurocratic difficulty the
number of applications to our local research ethical committee (LREC) in
Lancaster, has decreased until now it has been disbanded.
I would expect that it takes around 6 months to organise a project
now – far longer than acceptable in a fast racing scientific world- and
competitors around the scientist’s world may have trumped the work.
Scientists in a DGH know that to make a significant advance and be looked
on by peers as a success they must jump over an unclear path. Generally
only the work that commences uncertain, and may find no data whatever,
that is likely to create advance. Unfortunately the researchers that aim
down this road are not the ones that will wait 6 months while a series of
committees decide the project’s fate.
Imaginative scientists do not live a life of governance forms, of 69
page ethics applications, or the justifying of their work to the Chief
Exec. Ideas tend to appear to the luck of the individual and must be
fulfilled rapidly or never will. Six months tied up, even for the
simplest project is so long as to poison almost any stallion.
To some degree, in order to progress we must assume an element of
trust in medical researchers and give them responsibility for them
actions. If we don’t we will just see clinical research in the UK stop in
one DGH after another. The scientific facts are there but currently we
are hardly allowed to look.
Competing interests:
None declared
Competing interests: No competing interests
Our experience of research governance mirrors that of Jones and
Bamford(1). We conducted a Department of Health funded evaluation which
included a national postal survey, sending a questionnaire about the
primary care cancer lead (PCCL) role to every PCCL and PCT chief executive
in England; two per PCT. The most serious problem encountered was the wide
variation in research governance requirements. We sought approval from
each of the 59 Research Management and Governance Organisations
(RM&Gs), and from those PCTs not part of an RM&G. We sent an email
detailing our study to each RM&G and the subsequent process of
approval took 5 months. It required the input of a half time researcher,
significantly adding to the costs of the study.
We received 25 forms, all differing in content and layout. Despite
clear guidance to RM&Gs as to the information required to approve a
project, each imposed very different requirements (2,3) Some simply said
go ahead, whereas others required details of indemnity, financial probity,
the resource implications for PCTs, and the study’s independent reviews.
One RM&G conducted their own independent review of our study and
suggested changes. Such variations reflected considerable confusion about
what is required of externally funded and managed multi-centre projects,
as opposed to single site local projects. Most made no distinction between
studies involving patients in medical procedures and studies such as ours
where there was no possibility of harm. Lack of staff with research
experience was a major problem. Our most sympathetic responses were from
those RM&Gs with researchers in post. In several instances, staff left
and were not replaced and the whole process of approval ceased. Although
we have no problem with the concept of research governance, it is
essential that the process is streamlined, particularly for national
surveys, otherwise such research will no longer be viable.
1. Jones A, Bamford B. The other face of research governance. British
Medical Journal 2004; 329: 280-2.
2. Department of Health. Research governance framework for health and
social care. (Second draft). London: Department of Health, 2003.
3. Department of Health. Development of research management and
governance in primary and community care. Information for primary care
trusts. London: Department of Health, 2002.
Competing interests:
None declared
Competing interests: No competing interests
Jones and Bamford express surprise and frustration that their study
was temporarily halted after they introduced an interview to the existing
protocol without research ethics committee approval. They do not seem to
have recognised the fact that introducing a completely new aspect to their
project may bring with it both additional ethical considerations and
problems for their existing research aims. As they state in their article,
they did not mention this interview in the patient information sheets or
consent forms, and they appear to have introduced it after data collection
had already begun. It is unclear whether the interview itself had
significant ethical problems that required consideration; that, however,
is why ethics committee approval is required before beginning a research
project. In addition, it is entirely possible that their interview,
however well meant, may have asked sensitive or inappropriate questions
which might impact on the validity of the data they were collecting.
This is not an issue of researchers accidentally filling in the wrong
form or some other minor deviation. Jones and Bamford began what is in
effect a new study without approval from the research ethics committee.
Their intentions were no doubt good, and no harm may have ultimately
resulted, but the ethics committee has a responsibility to assess research
on ethical grounds before allowing it to proceed.
What this article has demonstrated is that research governance is, in
fact, working well. Far from being an “over-reaction” that destroyed “the
quality of the research”, a potential breach of care for research subjects
was identified and needed to be considered, just as a new project must be.
There may well be more efficient and satisfying ways to resolve research
governance issues, however, the primary concern of the research ethics
committee must be to protect research participants. Any ethical
implications related to loss of time and money to the researchers,
although clearly frustrating, are secondary and should not cloud the
issues.
Competing interests:
None declared
Competing interests: No competing interests
Transparent ethical scrutiny should come early in the 'life' of a
research project, preferably at a sufficiently early stage that management
of any risks to the public can be readily build into the design. A
feeding frenzy for funding opportunities can make it difficult to organize
scrutiny at such an early stage of developing ideas, although real
involvement 'ab initio' of patients and patient groups in research can
provide a good framework for subsequent ethical judgements. The BMJ's 31
July issue abounds with examples of a new problem: the paralysis of
research by bureaucracy associated with ethics committees [1]. Even the
committee members seem helplessly entangled in the new national procedures
[2]. Hopefully these BMJ voices will help to loose the Gordian Knot
created by the central 'COREC' procedures.
However, the essence of Research Governance goes far beyond the
inefficiency of a particular committee and is unfairly caricatured by the
'face' published here [3]. At the heart of governance in health and
social care research is accountability [4]. The scientific community owes
this accountability to the patients and wider public who support research
activities. Without their trust and goodwill, academic medical research
would die - or else, possibly, degenerate into the coercive horror of the
Nazi doctors' 'research' detailed at Nuremburg. At all stages of
planning, implementing and reporting health research we have a duty to
consider: the safety and dignity of the participants; the relevance of
research findings to both clinical and public health improvements; our
openness to critical reflection and refinement of our work. Mea culpa: I
dread criticism of my cherished ideas- but that sharing is how science and
practice flourish. Both academic and professional peers deserve to know
what is going on, in areas that affect them. If a patient (say the
reader's grandmother or son) puts their trust in the benevolence of a
health service, then that service needs to accept responsibility for
overseeing the clinical research that it 'hosts'.
It is only four years since the UK policy 'Research and Development
for a First Class Service' sketched out a need to improve research
governance. Even modest improvements in the quality of projects have
required much hard work, across the health service. Some efforts have
gone into dead ends: conflating the quality of management, ethics and
science into one formula is clearly one such failure! But learning to
improve our governance of research is a vital step to better research and
wiser researchers. Professional bodies have an important role in
promoting learning in a Real World context [5]. What is the BMA doing to
develop good governance?
1 Wald DS. Bureaucracy of ethics applications. BMJ 2004; 329: 282-5.
2 Goodman NW. We have no control. BMJ eletter 30 July 2004.
3 Jones AM, Bamford B. The other face of research governance. BMJ
2004; 329: 280-281.
4 Caan W. Accountability a must. Times Higher 2004; 5 March: 19.
5 Appleton J, Caan W. Guidance on research governance. Community
Practitioner 2004; 77: 303-305.
Competing interests:
a) Involved in a number of research governance initiatives, beginning with facilitating a workshop on Health & Safety issues for NHS R&D at the first Research Governance Conference (London, 29 May 2001).
b) Our latest application to an NHS Ethics Committee, for an unfunded student project, has just been bounced back requiring a list of 20 changes (of which perhaps one is something to do with Ethics).
Competing interests: No competing interests
I read this article with some interest and find it quite worrying
that researchers genuinely feel that having gained research ethics and
trust approvals for their work they are then free to change the protocol
and the conduct of the study in whatever manner they choose, to fit with
any further hypotheses that come along as the research progresses.
Having recognised that the original proposal required these approvals
before the research commenced, it should be quite clear that asking
patients personal questions about social contacts, relationships, family
and employment may be emotive and judgements about whether these questions
are acceptable in the context of the research should surely be left to the
ethics committees, not to individual researchers, to decide. It is
essential that other bodies, such as ethics and the governance team on
behalf of the trust, are aware of the exact nature of the intervention
being applied to the participants, whether in the form of a questionnaire
or a new drug.
This article asserts that the actions of the trust’s research office
had a major effect on the study, when in fact it could equally be stated
that these effects were as a result of the researchers not going through
the correct procedures for protocol amendment. Research Governance was
introduced to protect patients and ensures the transparent, safe and fair
conduct of research. We must acknowledge that these procedures are now a
compulsory part of the research process and instead of arguing about their
relevance, researchers and governance teams need work together to ensure
their smooth integration.
Competing interests:
None declared
Competing interests: No competing interests
As has been stated, research governance procedures have burgeoned
particularly since March 2004 with the introduction of new research ethics
approval procedures 1,2. I have no doubt that these have been designed out
of the best motives, yet something vitally important has been forgotten
along the way. As I battle through the bureaucracy, I find my enthusiasm
for what was a very exciting research idea steadily waning. Let us not
forget that the researcher's own enthusiasm is after all the most
important ingredient for research. We erode it at our peril. I would also
point out that those of us who are joint appointees between the NHS and
University Departments are required to apply to University Ethics
Committees as well as to a Local Research Ethics Committee (LREC) when we
wish to carry out cross-site research. Is one 57 page form not enough?
1. Jones AM, Bamford B. The other face of research governance. Brit
Med J 2004; 329: 280-281
2. Wald DS. Bureaucracy of ethics applications. Brit Med J 2004; 329:
282-284
Competing interests:
None declared
Competing interests: No competing interests
Letter to researchers
As Chairman of the Bath Research Ethics Committee that approved the
study that gave rise to Alyson M Jones’ and Bryony Bamford’s article ‘The
other face of research governance’, I would like to respond to a crucial
point in their argument.
They say that they were unaware of the requirement to submit protocol
changes for approval. The original ethics approval letter was clear in
this regard and stated ‘Any changes or extensions to the protocol, or
additional investigators should be notified to the Committee for
approval’. When the amended protocol was submitted, we acted promptly
and an executive sub-committee reviewed and approved the changes.
Competing interests:
None declared
Competing interests: No competing interests