Bureaucracy of ethics applications
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7460.282 (Published 29 July 2004) Cite this as: BMJ 2004;329:282All rapid responses
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For anyone with experience of COREC’s new application form, David
Wald’s article and the responses and reflections it has generated will be,
to a greater or lesser extent, all too familiar. I am sure that the
research community will be nodding in collective agreement and it has come
as a welcome relief that ‘I am not alone’. However, rather than reflecting
on my negative experiences with the process, I would like to pick up on
Karen Spilsbury’s comments relating to Site Specific Assessments (SSAs)
and offer some advice on a potential route over this hurdle.
With MREC approval in place (and having failed in the ‘no local
researcher’ attempt), I set about completing Part C. Being unsure as to
what exactly a constituted a ‘site’ in a SSA, I took advice. Two calls
generated two different responses. The first response was that a PCT was a
site; the second was that a site was in fact an individual practice.
Naively, I thought that the PCT option would be better for me; after all I
would need to complete fewer SSAs. However, telephone calls to various
Trusts to discuss the possibility of ‘a member’ being our study Principal
Investigator (PI) proved fruitless. No takers.
Needing to recruit approximately sixty practices to the trial, I was faced
with convincing sixty GPs that not only did they want to take part in the
study, but that they wanted to be responsible for the day to day running
of the study in their ‘site’ and wanted to give me a copy of their current
CV (maximum of two pages) to accompany Part C.
To soften the blow (absorbing yet more tasks into the research
process), I set about designing an electronic CV template. We would
complete what we could, email it to PIs who would then fill in the blanks
and send it back to us. More work, but at least it was possible to
complete our SSAs.
A casual remark from a Local REC secretary, during another telephone
conversation, about two or more sites ‘working together’ opened up another
possibility. I could try and find out whether practices would collaborate
and therefore have one PI assuming responsibility for more than one site.
A GP colleague said that he would be willing to do this for all practices
in his PCT. Close scrutiny of the COREC Standard Operating Procedures
(paragraph 4.15) suggested that it was acceptable to have a research
consortium with one PI responsible for the research in that consortium.
We are fortunate in the North East to have an active Northern Primary
Care Research Network (NoReN) - with an equally active Director. With
support from the Director and the Network (and response from the Regional
OREC Manager to confirm acceptability) we have our consortium, we have our
PI and we have submitted our SSAs.
The key point for our research has been the reinterpretation of a 'site'.
I would encourage any other researchers engaged in multi-practice research
to ‘reinterpret’ and to work closely with your local (Primary Care)
Research Networks.
Competing interests:
None declared
Competing interests: No competing interests
Editor,
I read the article by Wald[1] with compassion, having recently taken
a similar length of time to complete a 60 page COREC form for a study
comparing two different approaches to the management of cancer pain.
However, I feel that at times he was unduly harsh on the process and
available support.
Perhaps I have been lucky, but I have had invaluable help from our
trust Research and Effectiveness Unit, based at the Bristol Royal
Infirmary. Involving them at the protocol development stage undoubtedly
facilitated this. I have also received useful (and money-saving) advice
from the Medicines and Healthcare Regulatory Agency (MHRA), and like Wald
was able to apply for a Doctors and Dentists Exemption (DDX) which was
rolled over to a Clinical Trials Authorisation on May 1st, thereby saving
approximately £2000. It was not a surprise that because other researchers
were doing likewise (the MHRA’s workload was quadrupled for that
period)[2], this resulted in some delay in issuing the certificates. The
COREC IT help-line staff have been both helpful and friendly, even on the
two occasions when it became clear that the technological problems I had
in completing the form were due to errors that I had made.
In his article, Wald refers to his difficulties with Part A of the
form, in particular the reference numbers requested. The COREC form
website has Frequently Asked Questions and Question Specific Advice
documents, both highlighted when logging-on to the system for the first
time. These state clearly the nature of the reference numbers requested
and what to do if they are not required or available for a study.
I wonder if “resorting” to phoning local research and development
offices and referring to available guidelines are the academic equivalent
of asking for directions when lost?
1. Wald DS. Bureaucracy of ethics applications. BMJ 2004; 329: 282-4
2. MHRA personal communication
Competing interests:
None declared
Competing interests: No competing interests
As the R&D Department at an acute NHS Trust, part of our role is
to assist researchers with applications to ethics committees. It is fair
to say that our jobs have become more challenging following the
introduction of the new electronic ethics form. Others have described the
difficulties but we decided it was important to be positive.
Whilst we emphasise with the difficulties faced by researchers we can
see the benefits of a form that addresses a wide range of potential issues
and feel that the process of completing the application may help
researchers to clarify project-related issues. We have even had some
positive feedback from one of our researchers about the process, although
admittedly this was after she had virtually completed the form and had had
time to reflect.
We have recently offered assistance to researchers completing the
form for their BSc projects. One of the researchers has obtained ethical
approval subject to minor amendments and the other is due to submit the
application in the near future. It has been as much a learning experience
for us as for them and we decided it might be helpful to share the
knowledge we have acquired. We have therefore compiled ten tips for the
ethics procedure. We have, in some places, used direct reference to the
COREC Form questions - for example A45 refers to question 45 in section A.
Please note that these tips may not be applicable to all
organisations. We cannot be held responsible for any incorrect
information researchers may submit to ethical committees on the basis of
this letter.
Ten Tops for the New Ethics Form
1. The form is available either on-line or by downloading form filler
at www.corec.org.uk. At our Trust there were many problems downloading a
compressed executable file and we found the online version easier to use.
With this you need to register with a user name and password. This can
take 10 minutes or so but allow longer. If you forget your password, there
is a facility for emailing COREC who will send you a reminder.
2. It is important to be clear whether your study should be submitted
to your local ethics committee or if you need to proceed via the central
allocation system. This will depend on the type of study and further
information can be obtained from the main COREC website. The form consists
of Parts A to C and where the various sections should be sent to depend on
whether the submission is to a local ethics committee or via the central
allocation system. Parts A and B are generic and Part C is a locality
assessment. Part D may be used by the hosting NHS Trust, but is not
required for review by the ethics committee. If you have to use it then
be careful - it is currently not on-line, has to be downloaded as a
compressed executable file and is not linked to Parts A to C. However,
text can be manually cut and pasted from parts A to C.
3. Various signatures are required on the COREC form. For example,
if you are carrying out a student project you will require your Academic
Supervisor’s signature. It is therefore important to take this into
account when planning time-scales for completion. August can be difficult
for locating academics!
4. You need to submit the checklist of information with your ethics
application. This is available on the COREC web-page. You will not
necessarily need to submit all the documents on the list but if a document
is not applicable to your study you should indicate this, otherwise it may
appear as if you application is incomplete. It is advisable to look at
the checklist before you start the application form as there may be some
documents, for example the letter from Sponsor, that take a while to
obtain.
5. All research now requires an identified Sponsor according to
guidelines from the Department of Health. Question A59 (P21) of the COREC
forms refers to whether the funder of the research has agreed to act as
Sponsor as set out in the Research Governance Framework and you also need
to submit a declaration from an organisation stating they will act as
Sponsor, which should be signed by the Chief Executive of the organisation
or somebody who authority has been delegated to. It is important to
clarify who will act as Sponsor at an early stage but the general guide we
use is as follows:
· For student projects, the university should act as Sponsor as
suggested by the Department of Health.
· For single site studies funded by and taking place at an NHS Trust
the Trust may act as Sponsor.
· For non-commercial externally funded research the external funder
would usually act as Sponsor but in exceptional circumstances, the Trust
may act as Sponsor.
· For commercial externally funded research the external funder
should act as Sponsor.
6. As the form is intended for all types of projects, not all
questions may be applicable to a given study. It is not necessary to have
addressed all the issues raised in the questions for all projects, as the
requirements of a multi centre clinical trial differ greatly from those of
a single-site research project such as a questionnaire. If a question is
not applicable you should state this and provide justification if
necessary. For example, useful reference numbers are asked for in A65
(P23) but not all projects will have all of these. Similarly, in some
cases it may not be necessary for student projects to have an external
peer review (A45, P17) as they should be reviewed by the Academic
Supervisor.
7. We were originally slightly confused by Question A31 (P13)
relating to whether the study has, or requires approval of PIAG (Patient
Information Advisory Group) or other bodies with a similar remit. As our
Trust has a patient representative group with a similar name we initially
wondered whether this question referred to this group. However, we
clarified this issue with the Department of Health and the question refers
specifically to
Section 60 of the Health and Social Care Act with respect to the use of
personally identifiable information without anonymising the data or
without obtaining consent. Further information on PIAG can be obtained
from the Department of Health website http://www.dh.gov.uk.
8. Questions A35 and A36 (P14) relate to indemnity and some general
guidelines are as follows.
· The Sponsor is generally required to take on the responsibility of
non-negligent harm.
· For research sponsored by the NHS normal NHS indemnity will usually
apply.
· With respect to research sponsored by a commercial company or other
organisation, they should provide indemnity for non-negligent harm.
· For negligent harm, the NHS is responsible for NHS employees, even
when sponsored by another organisation. The above information should be
made explicit on the patient information sheet.
9. Once you have completed the form you need to lock it before
printing it out. This is to prevent the form being changed after
signatures have been obtained. Before locking the form you need to
telephone either the central allocation system or the ethics committee
(depending on which of these you have to submit to) for a project number.
You will also require an R&D number from the host organisation before
you lock the form - so request this number early on.
10. The ethics committee will only accept a complete and valid
submission. Version number and dates need to be on all relevant documents
and you need to ensure you have included all applicable documents.
Further information
We hope you have find the above helpful. The R&D Department at
Mid Essex Hospital Services NHS Trust have compiled a document on
completing the new ethics form, which has been given positive feedback by
COREC. If you would like a copy of this document please contact Julie
Scott on email address Julie.Scott@meht.nhs.uk or telephone number 01245
514891. The above tips are intended as a summary only and detailed
instructions can be found on the website at www.corec.org.uk.
End note
Although we recognise that there are difficulties with the new
ethical procedure we feel these will become easier over time once people
have gained familiarity with the form, although we do not underestimate
the problems it will create for first-time researchers. However, the
system is now in place and we feel it is more beneficial to try and work
with it rather than against it.
Above all please remember, keep smiling, consider NHS R&D Teams
as helpful and communicate with COREC.
Competing interests:
Phillip Smith is a member of the National NHS Research and Development Forum's Research Governance working group and is a Visiting Fellow to Anglia Polytechnic University.
Competing interests: No competing interests
My heartfelt thanks to the BMJ and to all the authors with the
courage to criticize the ethical red tape! Although I have never had the
misfortune to encounter a COREC form, the system is almost exactly the
same in little Switzerland. Or at least it was when I still had any
academic ambitions. In the late nineties, my boss wanted to find out
whether asymptomatic swelling of the optic discs occurs in patients on
minocycline, the background being that "idiopathic" intracranial
hypertension is a rare but well-known side-effect of this drug. We were
submitted to a one-fits-all procedure that would have been the same had we
proposed experimental brain surgery. How dangerous is an ophthalmoscope,
expletive deleted? We ended up not doing the study. Among other things,
the ethics committee asked us to explain what we meant by idiopathic
intracranial hypertension... I have a hard time remaining polite when the
subject comes up, and I am grateful to all of you for pointing out the
problem. Keep up the good work!
Competing interests:
None declared
Competing interests: No competing interests
As an aspiring part-time researcher myself, I share the frustration
and disillusionment of many of my colleagues at the recent changes in the
REC application and approval process. However dispassionate, one cannot
but agree that the new process is cumbersome and cost-ineffective. It also
leads one to suspect if the bodies (? DOH) that implement or oversee these
changes have a hidden agenda – i.e. to dissuade clinicians who are engaged
in part-time research, from doing research and thereby get them to spend
more time on clinical work. The significance of this, in the form of
shorter waiting lists, meeting more of the government targets etc, to
politicians is immense and for them is of more direct and personal
benefit, than doctors doing part-time research. Extrapolating my
‘conspiracy theory’ further, maybe the so-called ‘academic elite’, who are
already an exclusive club, also play a role in determining such policy. By
increasing such bureaucratic and administrative obstacles, it becomes very
difficult for ‘small-scale’ researchers to conduct any meaningful
research. Thus research, grants, publication and any other positive
outcome that follows, will become the exclusive ‘property’ of those
academics in the ‘powerful’ centres around the UK.
Having stated my ‘conspiracy theory’, I will briefly discuss my
experience of sitting in as an observer at one of the LREC meetings and
the lessons I learnt. The committee discussed 10 applications and there
was also an opportunity for researchers (pre-arranged) to clarify certain
aspects of their protocol. The committee members were very well prepared,
had a good skill mix and an excellent understanding of the basic research
principles. Most of the suggestions given were sensible, practical and
easy to implement. Some recommendations like ‘piloting the questionnaire’,
‘seeking expert advice for qualitative analysis’, ‘ having to do a sample
size calculation’, etc would have improved the methodological rigour of
the respective projects. No proposal was needlessly or merely for
administrative reasons rejected or send for amendments. I learned some
important lessons on how not to fill a REC application form. I would urge
any junior researcher (like myself) to attend at least one LREC meeting,
for it’s definitely a fruitful exercise. The inferences that can be drawn
from my experience of observing one meeting are limited. However, it
suggests that RECs are not to be blamed for all research applications
being unduly delayed and maybe the research governance framework and other
wider policies and policy makers need to share the blame.
Upholding the principle that even if few ethically – ‘correct’
applications are wrongly delayed (though not by much!), if one ethically
‘wrong’ application can be rightly prevented from going through (which
could potentially harm research subjects), I feel that ultimately it is
all well worth it. For we all know the direction research could take in
the absence of regulatory bodies!
Competing interests:
None declared
Competing interests: No competing interests
Ethical approval is only part of the tortuous path of clinical
research. Bureaucracy associated with research governance wastes
resources, delays and sometimes undermines research itself. We are
currently seeking approval within numerous primary and secondary care
Trusts around England. Finding the right research governance contact can
be difficult, confounded by some Trusts not understanding their
responsibilities. Trusts request numerous forms in different formats. For
one project it was necessary to send 44 documents to each PCT, almost all
duplicating material already considered by the ethics committee.
Misunderstandings about data protection requirements are common. Despite
guidance to the contrary, some Trusts will not consider research
governance applications until ethical approval is obtained, and insist on
researchers applying for multiple honorary contracts from different
Trusts.
We fully support the need for quality and accountability in research,
but feel that the responsibilities of the various participants set out in
the Research Governance Framework1 are not reflected in the approvals
process. We would suggest the following changes. Since sponsors approve
the quality of research and ethics committees appraise ethical issues,
Trusts only need to consider the financial, workload, indemnity and
operational aspects of the project. These are all covered by Form D of the
ethics application, so Trusts should only request this standard form, the
protocol and approvals from the ethics committee and sponsor. Ethics
approval should include consideration of data protection issues so that
this does not have to be reconsidered at every local site. There should be
a database on the COREC website of the research governance contact details
for every Trust in England. Research governance approval should be subject
to the same 60 day deadline as for MREC applications, and should run in
parallel. A standard honorary contract for each researcher should be
administered by one NHS organisation and be accepted by all others. Until
these problems are resolved patients will continue to receive treatment
that is pointless or harmful because it is not evidence-based. The
benefits to be gained from research governance must be weighed against the
harm of obstructing research.
1 Department of Health. Research Governance Framework for Health and
Social Care. London: Department of Health, (2001).
Competing interests:
None declared
Competing interests: No competing interests
Editor,
Wald’s closing paragraph is all to familiar: “COREC and the European
directive claim to support research, but their ethics forms serve more to
obstruct research than protect patients. The current COREC requirements
add to a level of regulation that is making it increasingly difficult for
practising clinicians to conduct small-scale clinical research. Action is
urgently needed to reduce a research bureaucracy that has largely lost
sight of the patient, advancing medical knowledge, and improving medical
care” (2004:284).
We have recently been commissioned by the Department of Health’s
Patient Safety Research Programme to undertake an investigation of the re-
use of medical consumables designated as single use. The commissioners
requested a national census of re-use in all NHS anaesthetic and theatre
departments in England, in addition to a follow-up interview study, all to
be completed within 18 months. We are now 2 months into this schedule and
have discovered that it has now become practically impossible to carry out
a national survey of anything in the NHS.
In addition to MREC approval (and SSA approval for the interview
phase of the study), we will need honorary contracts and R&D approval
from each trust, resulting in yet more forms requiring completion, cost
assessments (even though there are no costs incurred by the NHS) and
signatures from various members of trust staff. We have been warned that
the R&D process is inconsistent, with many trusts refusing to accept
COREC part D in favour of their own form. The Guardian (30 July 2004)
recently reported a survey of all NHS Hospital Trusts about junior
doctors’ working hours, to which 75/173 replied, despite the work
involved, in the depths of the summer. When journalists do this, there is
no regulation: when social scientists commissioned by the Department of
Health itself undertake an identical exercise, the result is 350 honorary
contracts, 350 R&D forms, 350 sets of costings and 1400 signatures
before the research can even start. Moreover, we have recently learnt
that our questionnaire also has to be assessed by the Gateway team in
Leeds, who will examine this, Department of Health-commissioned study to
determine whether it will be too burdensome or similar to NHS data already
being collected, and can refuse access. Lastly, we have learnt that,
unlike journalists, we must not approach our sample directly, but will
have to rely upon clinical directors inviting their staff to participate
in the research – surely a process which will have a greater negative
resource impact upon NHS than the supposed ‘harm’ that us directly
approaching public employees identified by job title might have.
Although it is of some comfort to know that we are not alone in the
struggle we face, it remains that the Research Governance Framework and
the ICH Good Clinical Practice guidelines, whilst introduced with very
good intentions, have in practice, severely hindered the capacity to carry
out large scale survey research in the NHS.
References:
Wald, D.S. (2004) Bureaucracy of Ethics Applications British Medical
Journal 329: pp 282-284.
Carvel, J. (2004) NHS hit by crisis over doctors' hours The Guardian
Online
(http://society.guardian.co.uk/NHSstaff/story/0,7991,1272457,00.html)
Competing interests:
None declared
Competing interests: No competing interests
I have read the articles on research ethics approval in this week's
BMJ with interest, having had to submit an application to COREC in March
this year.
My project involved qualitative interviews with a handful of NHS
staff involved in the care of pregnant women and new babies in London. The
staff I wished to interview included community and Health Protection
Agency (HPA) Staff, as well as those in the acute sector. I was also
particularly keen to interview at least one member of staff working with
women who were, or had been, intravenous drug users. These services were
the remit of the local mental health trust.
Going through the COREC and local Research Governance approval
process to interview seven people working in the NHS and HPA, but across
different employing organisations, albeit in the same part of London, was
long winded and painful. I had to complete 54 pages of the COREC form as
well as making a further application to two acute NHS Trust ethics
committees for site specific approval. I also had to fill in the forms
required by the Local Research Governance Support Unit. And then wait for
the outcome.
Because of a computer "glitch" on the COREC form, which the COREC
office acknowledged they were aware of, the electronic form inadvertently
recorded that I wished to interview "vulnerable adults" and asked
questions about whether I intended to contact my interviewee's GPs for
information. I was not sure that the local NHS Consultants I wanted to
approach would even tell me who their GPs were, let alone consent to them
being approached! However it was impossible to complete this form without
answering this question.
Further, there was a lack of clarity about who to approach for
permission to interview staff in the Primary Care Trusts, and the HPA. And
I have been waiting since April for Site Specific Approval from the Mental
Health Trust.
In all, I probably spent about three or four days going through the
process of gaining ethics approval. All this for one small MSc
dissertation, involving only NHS and HPA staff!
I fully support the most stringent and rigorous checks on research
where patients or healthy volunteers are involved, particularly if the
research involves new drugs or treatments. But the COREC process which was
established in March this year had shown that a "one size fits all"
approach is the wrong approach.
Competing interests:
MSc Student
Competing interests: No competing interests
Editor- I congratulate the BMJ on highlighting the plight of British
researchers as they attempt to perform world class research while having
their efforts thwarted with unnecessary bureaucracy. When I worked in the
United States I had to submit my research applications to one committee -
the local Institutional Review Board. This compares to the situation in
the United Kingdom where five unrelated committees need to be informed of
my applications. These are a peer review group in my clinical directorate,
the research and developmental office and the data protection office of my
hospital trust, my University research office and of course the local
research ethics committee. The massive administration required to satisfy
these five committees (all asking for similar information in slightly
different ways and on different forms) necessitates employing additional
staff at great cost to the NHS and significantly delays research projects.
It also prevents junior doctors accomplishing any useful research in 6
month attachments as the forms are rarely finished prior to them leaving
their posts. This is utter maddness. Could government please listen, take
control of this mess and reduce these five committees to one. Otherwise
clinical research in the United Kingdom will die.
Competing interests:
None declared
Competing interests: No competing interests
Questionnaire Quibbles
EDITOR-We have great sympathy with David Wald and colleagues in their
fight against the bureaucracy of ethics applications and would like to
contribute our own experience. We too clocked up about the same number of
hours completing and submitting the 68 page COREC form, and would have
incurred the same expenses had our staff been salaried. Our study, though,
constituted a simple 10-point questionnaire survey relating to
complementary medicine usage, on one sheet of A4 paper, to be administered
within our own chest clinic. Due to huge problems related to the on-line
application and difficulties with downloading our completed form etc, we
nearly gave up altogether.
Whilst it may just be possible to understand the need for a lengthy
ethics form in relation to a randomised controlled trial involving drugs,
what about for a small questionnaire study such as ours? Such surveys used
to be passed on a sensible ethics committee chairperson's approval, having
been sent the protocol, questionnaire and patient information sheet. The
submission process is now incredibly laborious and out of all proportion
to the size and nature of the study. We suggest that those responsible
conceive alternative more simple means of obtaining ethical approval for
questionnaire surveys and similar small research projects.
Competing interests:
None declared
Competing interests: No competing interests