Applying for ethical approval for research in the United KingdomBMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b4013 (Published 16 October 2009) Cite this as: BMJ 2009;339:b4013
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Applying for ethical approval for research in the United Kingdom … is getting more and more difficult.
We completely agree with the first sentence in Smajdor et al’s
article on the topic of obtaining ethical approval for research in the UK
(1), namely that “Applying for ethical review in the United Kingdom can be
time consuming and burdensome for researchers” but wished they had also
added “and the present system discourages many from carrying out clinical
research”. Although we have no hard data to support this except for
discussions with our colleagues, there seems little doubt our minds that
the enormous bureaucracy which surrounds the ethics application process is
so off putting that it arrests many studies dead in their tracks.
The current system makes no distinction between a multi-million
pound, multi-centre study funded by a large pharmaceutical company or a
major grant giving body such as the Medical Research Council, with the
inevitable infrastructure support, and the lone, busy clinician attempting
a small observational study in his or her spare time. Both have to go
through the same process, complete the same application forms and provide
virtually the same documentation, which as pointed out by Smajdor et al,
currently stands at up to 20 different documents. We have not formally
calculated the number of fields which have to be completed on the on-line
application form on www.myresearchproject.org.uk, but only because there
are too many to count; many of the fields are so similar as to be virtual
repetitions of each other. Added to all this are the voluminous
instructions which need to be read even before starting the application;
to give but one example, the guide on the preparation of a patient
information sheet and consent, just two of the components of the
application process, is itself 196 pages long (2). The application can
take longer than the research itself!
It seems to us that the process for obtaining ethical approval has
become an all consuming monster which threatens the long and illustrious
history of research from the United Kingdom. With every reform, the
process has become even more complex and time consuming. For the majority
of clinicians who merely want to combine their clinical work with some
local research, the process is often disproportionate to the magnitude of
the planned study, and it should not be surprising if many clinicians,
including ourselves, think twice before considering any small project.
Junior doctors interested in research during their residency are barely
able to obtain ethical approval before they have to move to a different
hospital, so long has the process become.
No scrupulous researcher will disagree that the ethics committee is
an important and integral control to any clinical research. However, the
system needs to encourage and not discourage research. It needs to become
more flexible, appropriate and proportionate to serve the best interests
of patients and clinicians alike. There should not be a “one fits all”
application process, but one which reflects the planned research in terms
of its complexity and risk. If we do not change, clinical research in the
UK will almost certainly lag behind other nations. No one wants that.
1. A Smajdor, M R Sydes, L Gelling, M Wilkinson. Applying for ethical
approval for research in the United Kingdom. BMJ 2009; 339: 968-971.
2. National Research Ethics Service. NRES guidance on information sheets
and consent forms v3.5 May 09.
Competing interests: No competing interests