Research bureaucracy in the United Kingdom: Seeking a balance: response from the Department of Health and COREC
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7466.622 (Published 09 September 2004) Cite this as: BMJ 2004;329:622
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EDITOR- There is a perceived need to obtain quicker approval for
research (1). Within the UK research involving NHS patients is subject to
ethical review by an appropriate Research Ethics Committee. In addition,
each NHS Trust (hospital) must ensure that the research is approved via
delegated responsibility from the chief executive officer. This is
because there are more than just ethical issues to consider before
allowing a research project to proceed.
At Mid Essex Hospital Services NHS Trust (MEHT), the R&D
Department audited the time taken for Trust approval for 121 projects
approved between 27 Sept 01 and 1 May 04. There were a number of possible
time-frames to consider but we chose two main start dates: a) date the
R&D Department receiving the request for project approval and b) the
date of local research ethics approval. Median durations were 50 and 30
calendar days respectively. The higher median for trust-approval may, in
part, be due to the wider range of issues that a trust has to consider,
but some researchers only recognise the need for trust approval when they
see it as a condition of ethical approval.
To reduce the time for approval, MEHT has developed research
governance pathways for five types of study: clinical trial of a medicinal
product; student research; Department of Health sponsored surveys (i.e.
staff and patient surveys), externally sponsored studies and those
sponsored by MEHT. It is anticipated that the explicit identification of
risk for each type of research will enable NHS organisations to improve
the time it takes to issue Trust Approval.
Competing interests:
PS is a member of the National NHS R&D Forum
Competing interests: No competing interests
EDITOR- There has been much discussion relating to research
governance and ethics (1. Much of this has considered the time taken to
gain ethical approval. There is, however, a more basic problem: some
researchers do not seem to know that if their research in the UK involves
access to the National Health Service (NHS) then they require ethical and
NHS Trust (hospital) approval. This is worrying.
In the UK all NHS Trusts are required to approve research before it
goes ahead. At Mid Essex Hospital Services NHS Trust (MEHT) this policy
is disseminated through a variety of means (via an R&D training day,
information sent direct to researchers and general information to the
entire organisation. The effectiveness of this communication was assessed
via a questionnaire sent to 369 staff. The response rate was 41%; 29 had
attended training, 46 were researchers and 79 were neither researchers nor
had received training. There was no statistical difference (P>0.05,
ANOVA) in Research Governance Awareness (as assessed by correct responses
to some of the questions) between the group that had been trained (mean
score 7.3, 95% cfl 6.5-8.2) and researchers (mean score 7.2, 95% cfl 6.3-
8.0), but both were significantly greater (P<0.001, Bonferroni post hoc
test) than those that had neither received training or were researchers
(mean score 4.7, 95% cfl 4.0-5.3). Of importance, 15% of researchers were
not aware of the Trust’s R&D policy, 28% did not know they needed
ethical approval and 28% did not know they needed Trust approval.
If the data obtained here are representative then this reinforces the
need for more effective communication. It also demonstrates that R&D
training can work.
1 Pattison J, Stacey, R Seeking a balance: response from the
Department of Health and COREC. BMJ 2004;329:622 (11 Sept.)
Competing interests:
PS is a member of the National NHS R&D Forum. In case you were wondering, the questionnaire described in this letter was reviewed by the South Essex Local Research Ethics Committee (Ref 03/67d) on 17 Dec 2003 and was given a favourable opinion on 18 Dec 2003. It was also Trust-approved.
Competing interests: No competing interests
EDITOR-The bureaucracy of research ethics application is a serious
problem that is obstructing clinical research in the United Kingdom. This
was the subject of my article and several others published in the 31 July
2004 edition of the BMJ. 1 The letters published in the 11 September issue
of the BMJ in response to these articles minimise the problem. They were
published without giving the authors of the original articles an explicit
opportunity to respond. Furthermore there was a lack of balance because
even though all but one of the 14 rapid responses to my article published
on bmj.com supported the view that the current research ethics application
procedure is unnecessarily bureaucratic and damaging to research, only
that one dissenting voice 2 was published in the printed version together
with five others that supported the current COREC (Central Office for
Research Ethics Committees) procedure and one that did not.
The published correspondence also included a number of incorrect
statements. Walsh and Hewitt’s assertion that “ethics committees are out
of control and discouraging research” misses the point that it is the
complexity of the process that is the problem and this has been thrust on
ethics committees as much as researchers. 3 Pattison and Stacey suggest
that “had I read the question specific guidance” on the COREC website I
would have saved myself a lot of time, effort and phone calls”, a comment
echoed in the letter by Reid. 2,4 However Pattison, Stacey and Reid all
fail to say that when I completed the new COREC application (March 2004)
the website was incomplete and did not provide the necessary information.
It may do so now but this avoids the central issue that much of what has
to be done is time-consuming and unnecessary.
A divide is emerging between researchers and research administrators
which is surely unhelpful and against the public interest. The processes
need substantial simplification if medical research in the UK is not to
suffer. I believe that this view is widely held by established
researchers. It is certainly often expressed.
David S Wald
Specialist Registrar and Clinical Research Fellow in Cardiology
Wolfson Institute of Preventive Medicine, Charterhouse Square, London EC1M
6BQ
1. Wald D.S. Bureaucracy of ethics applications. BMJ 2004;329:282-284
2. Reid C. M. Ask for help. BMJ 2004;329:624
3. Walsh D.A, Hewitt M. Ethics committees have important roles in
research. BMJ 2004;329:623
4. Pattison J, Stacey. T Seeking a balance: response from the Department
of Health and COREC. BMJ 2004;329:622
Competing interests:
None declared
Competing interests: No competing interests
A brief suggestion with regards to the letter Prof Pattison wrote
regarding the ethics form (1), which he praises highly (clearly, he has
not spent time filling it in).
His last two paragraphs hold out a ray of hope for those of us
struggling to put through ethics applications for small, non-commercial
studies in normal volunteers i.e. the core of clinical research in the
University/NHS sector, from which studies using patients then develop. The
form, as it stands, clearly does not meet this need, as it is structured
with the view that patients will be used in drug company studies.
Could there, therefore, be a shorter form specifically directed at
normal volunteer studies which are not investigating new drugs or devices?
These are usually very simple small studies which have only minor ethical
issues (which are the same for any normal volunteer study of this type),
as they usually do not involve any significant risk to the volunteers.
They were, in times past, done by students as part of their degree and the
ethics application, locally, came to <20 sides, all relevant and with
little extra paperwork needed. Now the ethics form is obese, mostly
irrelevant and requires so much additional paperwork as to make the small
studies uneconomic, from the researcher's point of view. This is because
these studies are normally conceived on the margins of what the researcher
involved is doing, so adding 2-3 days of full time effort to gather all
the details is too much and seems absurd.
To force researchers to become one of Prof Pattison's 'silent
majority' is all very well, but the form takes up a lot of time. The
oversight required for a multi-centre industry sponsored novel drug study
is surely not required for a small scale normal volunteer study?
Therefore I applaud Professor Pattison's foresight in noting that 'No
one pretends the current application form or the process is perfect'. I
look forward to his promised smaller form, though I do hope it will be
introduced quickly, to ensure that small studies continue to happen.
Competing interests:
I have completed ethics forms over the past 10 years. It took 2-3 days of full-time work to complete this one and the associated paperwork - a record for me. Over 80 pages of documentation for a study that previously only took <_20 pages.="pages." i="i" am="am" seriously="seriously" considering="considering" not="not" doing="doing" any="any" more="more" blue-sky="blue-sky" research="research" on="on" the="the" margins="margins" as="as" form="form" takes="takes" too="too" long.="long."/>
Competing interests: No competing interests
Developing the face of research governance
Editor- Recent BMJ articles and correspondence on NHS research ethics
and research governance have helpfully highlighted the apparent
polarisation of views between researchers working in the NHS, and the
governance requirements of research ethics and governance (1). The
written and email responses to the BMJ articles highlighting research
administration, to which the present authors contributed (2 & 3), made
for interesting reading. On one hand, many researchers and research-
interested clinicians, appear to consider that the administrative burden
is currently over bureaucratic. On the other, NHS R&D governance
managers, NHS research ethics Committees, and other regulatory bodies,
whilst in many cases recognising researchers’ grievances about
bureaucracy, consider that the arrangements under research governance and
ethics are necessary and designed to safeguard the public and NHS patients
(4). This polarisation of views can only contribute negatively to NHS
research.
Following our exchange of articles, we (the researcher and R&D
Director) met for a series of frank and open meetings to discuss our
experiences and the issues raised in the research ethics correspondence.
Care had to be taken, as these meetings had the possibility of generating
tensions. However, as a result of this in-depth dialogue there was
increased common understanding of the framework within which both
researchers and NHS R&D managers currently work. The researchers
stressed the difficulties of undertaking research within a demanding
clinical context and the rapidly changing demands of research governance.
The R&D Director highlighted that the Trust had to implement the
framework of research governance throughout the Trust, and be able to
demonstrate this to the Trust Board and the Department of Health. This
had entailed a steep learning curve for the NHS Trust, and the case
highlighted by Jones and Bamford (2) had been the Trust’s first formal
case of disagreement with researchers about the need for ethics review.
This improved understanding led both parties to have a greater
appreciation of the need for research governance and the role R&D
Departments can play in facilitating this process. Day to day practice in
carrying out current research has directly benefited from this increased
dialogue, for example with the researcher being willing to consult with
the R&D Office more readily on research issues that might require
ethics review. Likewise, the R&D Management has benefited improved
research governance training and information.
There was also an acknowledgement that debate and liaison was
required in the implementation of research governance. It was heartening
for the researcher to hear that attempts were being made to work on ways
that projects can be graded as to ethical risk, and that the new draft 2nd
edition of the Research Governance Framework (5) highlights the needs for
monitoring and management arrangements to be proportionate to risk.
Similarly, the current UK Ministerial review of research ethics
arrangements is very welcome (6). The review will examine the systems
that support NHS Research Ethics Committees in England, and make
recommendations for further steps to improve their operation, building on
changes already under way. The group first met in November and will report
to UK Health Ministers by the end of March 2005.
A number of important lessons emerged from these meetings: Firstly,
the difficulties that we have experienced are not an unusual occurrence.
We are aware that many R&D Departments and many clinicians attempting
to conduct research within NHS settings come into conflict regarding
issues of research governance and administration. The recent exchange of
articles in BMJ bears witness to this. We hope that through writing this
article we can help others facing similar difficulties.
Secondly it needs to be acknowledged that it is often difficult for
clinicians to be fully cognisant of all the necessities of the research
undertaking, and the rapid changes in governance and ethics. However,
many R&D management staff find it hard to imagine that researchers
have not kept up to date with these regulations. Therefore, at the
suggestion of clinician researchers, our NHS Trust R&D Department has
taken the initiative to provide a formal training to all clinicians in
receipt of grants. Whilst this may initially add to the clinician
researchers’ time needed for undertaking research, it will hopefully help
researchers to know what they need to know.
Thirdly, many of the restraints imposed on research by ethics
committees and NHS research offices are not generated directly by these
bodies, but are in reality requirements imposed by the Department of
Health or legislation. For example the highly topical issues surrounding
confidentiality and access to patients and their information by
researchers, as highlighted by Ward and colleagues (7).
Finally it should be stressed that ultimately both researchers and
NHS research managers are working towards the same goal, although it is
easy to lose sight of this. The goal is to facilitate high quality
research in the NHS. Perhaps researchers and manager have more in common
than differences.
References
1. Warlow C. Researchers Drowning Bureaucracy BMJ 2004; 329: 241-242.
2. Jones AM & Bamford B The other face of research governance.
BMJ 2004; 329: 280 – 281.
3. Soteriou T. View from the research and development office. BMJ
2004; 329: 281 - 282.
4. Pattison J. & Stacey T. Research bureaucracy in the United
Kingdom 2004 BMJ; 329: 622.
5. Department of Health. Draft document Research Governance Framework
for Health and Social Care. 2nd Edition. Department of Health, London
2003.
6. Department of Health. Ministerial Statement: Advisory group on the
on the operation of the NHS research ethics committee system. Department
of Health, London 2004.
7. Ward HJT., Cousens SN, Smith-Bathgate B, Leitch M, Everington D,
Will RG, Smith PJ. Obstacles to conducting epidemiological research in the
UK general population. BMJ 2004; 329: 277-279.
Competing interests:
None declared
Competing interests: No competing interests