Ethics and research governance in a multicentre study: add 150 days to your study protocol
BMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7495.847 (Published 07 April 2005) Cite this as: BMJ 2005;330:847
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Having seen the Rapid response post from Niall Galbraith et al. of 17
January I am concerned that R&D Offices are rapidly portrayed as a block
to research, when the prime function of an R&D Office is just the converse
of this. Within an R&D Office it is essential to apply the Research
Governance Framework in a sensible, practical manner to allow swift
approvals and comply with guidance. The aim is to facilitate good quality
research within the NHS, whilst also safeguarding patients. Often
problems can occur as Researchers do not seem to be aware of the need for
R&D notification and approval despite this being outlined within MREC/LREC
approval letters, and being flagged up to researchers when completing the
COREC form where there is an option/offer to prepare an accompanying R&D
form related to each COREC submission. A result of this is that studies
are commencing within NHS organisations without any notification or
attempt to seek approval for research. One particular concern outlined
here relates to Honorary Contracts and CRB checks. When studies are
submitted to us, as this one involving Niall Galbraith, and we are aware
it does involve contact with patients by non-NHS staff which could have a
potential impact on the quality of their care (in this instance
unstructured face to face interviews with patients) we of course must seek
CRB checks as part of the Honorary Contract process. This is standard
practice to do so. In the current climate not doing so would suggest
negligence on our part, and certainly not allow us to demonstrate to our
users – our patients, that duty of care to them was being upheld. CRB
checks do incur a cost, and although this cost should be borne by the
researchers, rather than the NHS, in this instance as the study involved
our local University, to which we have always had good links, we offered
to absorb these costs as a gesture of goodwill. Had CRB checks been
carried out by the Researchers prior to the R&D Approval process, time
delays could have been reduced, as CRB timelines are outside of the
control of PCTs.
The system of NHS R&D Approval is not a duplication of the role of an
Ethics Committee, but an essential step with a variety of functions, not
least to protect researchers/investigators by providing a clear framework
to work within; to monitor practice and performance; to minimise risk,
uphold the Trust’s duty of care to patients; to enhance ethical and
scientific quality, promote good practice and ensure lessons are learned
continuously improve research quality. R&D Offices across the country are
working hard to follow the most up to date Research Governance Framework
and guidance produced from the R&D Forum. Much work is also being done at
a national level to streamline processes wherever possible. At a local
level work is being undertaken to raise awareness of the R&D approval
process, with most R&D Offices, including our own, keen to discuss the
process of R&D approval with researchers and assist in making
applications. Indeed our office has received a large amount of good
feedback over the past 12 months as to the helpfulness our staff, and how
supportive the department is of local research. We work very closely with
our academic partners, such as the University of Warwick, and wish for
this to continue. Should Niall or his colleagues wish to contact me to
discuss the current position with respect to R&D approval and the various
processes we employ as part of compliance with the RGF he is most welcome.
Elizabeth Kettle
R&D Manager
West Midlands South Joint PCT RM&G
Competing interests:
None declared
Competing interests: No competing interests
Neil Galbraith, in responding to Elwyn et al`s letter that described
the problems and delays caused by “research governance” procedures, [1]
identifies a further major obstacle and hindrance – the procedures for
gaining honorary contracts required by all those conducting research
within the NHS. [2] Galbraith expresses his justified astonishment at what
this can actually demand in practice when he encountered the variability
of Trusts` requirements, detailing the time and effort required to
surmount all these hurdles. He reports that Government Funders were
incredulous at the resulting delay to undertaking the research caused by
idiosyncratic R&D Departments.
As a voluntary, independent, `self-employed` individual
`patient/researcher`, I have been involved as a steering group `patient`
member in various research projects at different institutions since 1995.
In November 2005 I received from a University Research and Commercial
Division `duplicate originals` of a formal agreement for signature for
participation as a steering group member in a Department of Health funded
project to undertake a systematic review. To say that the requirements
were onerous understates the case. It included, for example, that I (“the
Consultant”) should: “obtain adequate professional indemnity cover for all
work done by the Consultant under this Agreement, and will provide the
University with a copy of the policy on request.” Immediate requests for
explanations remained un-clarified: current challenges to this contract
remain unresolved.
Public involvement in research is encouraged, indeed stipulated by
the Department of Health and related research commissioning bodies (MRC,
HTA, SDO, etc.). The National Cancer Research Institute/National Cancer
Research Network has devoted time and energy to defining the
practicalities of involving members of their Consumer Liaison Group in
research. This includes setting out in detail, for example, how honoraria
and other payments for attendance at meetings on behalf of these
institutions, or for attendance by invitation to sub-groups or working
groups, or other meetings elsewhere should be made.
The Research Governance approval system unnecessarily obstructs and
delays research: this is unethical and ultimately reduces patients` length
and quality of life. Huge amounts of time, energy and resources are being
wasted on this bureaucratic nightmare. The `new professionalism` being
encouraged in the Royal College of Physicians` Report [3] calls for a
“responsible engagement that draws in a well informed public alongside the
medical profession, together with national agencies that have an essential
part to play in influencing the steps we believe are necessary.” Where
better than to start here? Testing treatments [4] should be “everyone`s
business”. [5]
Hazel Thornton (Mrs.)
Independent Advocate for Quality in Research and Healthcare.
[1] Elwyn G, Seagrove A, Thorne K, Cheung WY. Ethics and research
governance in a multicentre study: add 150 days to your study protocol.
BMJ 2005; 330: 847
[2] Galbraith, NG. Research governance approval is putting people off
research. Rapid response on bmj.com 17th January 2006, accessed 18th
January 2006.
[3] Report of a Working Party, December 2005, for the Royal College
of Physicians. Doctors in society. Medical professionalism in a changing
world.
[4] Imogen Evans, Hazel Thornton, Iain Chalmers. Testing treatments.
Better research for better healthcare. The British Library, 2006. In
press.
[5] Chalmers I. Silverman WA, Professional and public double standard
on clinical experimentation. Control. Clin. Trials. 1987; 8; 388-91
Competing interests:
None declared
Competing interests: No competing interests
Last year the BMJ highlighted the bureaucratic burden placed on
health researchers by the Research Governance approval process 1 (see also
2 ). In contrast to Elwyn et al. our own study sought only to interview
health professionals in 12 Trusts about advice-giving, with a small number
of patient telephone interviews. However, the process of seeking approval
from one R&D consortium delayed our project by 11 weeks. If this sort of
Research Governance approval process does not put researchers off, then
the procedure for gaining honorary contracts surely will. These contracts
are apparently a necessary requirement for all those conducting research
within the NHS – even NHS staff if they are collecting data from NHS
Trusts other than the one which employs them.
Unbelievably, even when one
of the authors already held an NHS honorary contract with one Trust
another honorary contract had to be issued by the same Trust (with
accompanying delays) because the previous one was linked to a different
project. Many Trusts also require an occupational health check and proof
of immunisation to various diseases – even for researchers who will have
no patient contact. This further administrative hurdle can take months to
overcome, unfortunately however, it is not the last. Many Trusts now even
insist that honorary contracts are accompanied by a Criminal Records
Bureau (CRB) check, which can take several months. We protested that CRB
checks aimed to protect vulnerable adults were unnecessary. But,
astonishingly, even our simple interviews with health professionals were
forbidden until after CRB checks and honorary contracts were issued -
another two month delay. To make matters worse, one R&D department failed
to initiate the CRB process for at least two weeks, and only realised
their mistake after yet another enquiring phone call from us. Eventually,
after even more protesting e-mails and phone calls (including one from our
Government Funders who were incredulous at the delay), we were given the
go-ahead to speak to health professionals, without needing honorary
contracts – but not before R&D approval had been formally agreed.
Research Governance approval is redundant, providing little benefit
to research but instead offering a great deal of hindrance 3. It is a
system for ensuring optimum scientific and ethical standards in research
4, but ethics committees do this already, there is no need for R&D
departments to do it all over again. Indeed, one R&D department blocked
our research until we addressed their query on an ethical issue that had
already been allowed by the MREC months before. The advantage of the
centralised COREC ethical review system is that it avoids the old problem
of ethics committee inconsistency between sites. However, the new problem
is idiosyncratic R&D departments. The Research Governance approval system
should be revised before more health researchers change careers.
Niall Galbraith, Research Fellow, Carol Hawley, Principal Research
Fellow, Valerie De-Souza, Research Fellow.
Division of Health in the
Community, Warwick Medical School, University of Warwick, Coventry CV4
7AL.
References
1. Elwyn G, Seagrove A, Thorne K, Cheung W Y. Ethics and research
governance in a multicentre study: add 150 days to your study protocol.
BMJ 2005; 330: 847.
2. Warlow C. Clinical research under the cosh again. BMJ 2004 329:
241-242
3. Jones A M, Bamford B. The other face of research governance. BMJ
2004 329: 280-281.
4. Medical Research Council. Policy and procedure for inquiring into
allegations of scientific misconduct. London: MRC, 1997.
Competing interests:
None declared
Competing interests: No competing interests
The Research Governance Framework (RGF) protects NHS staff,
facilities and patients from poor research by ensuring it is carried out
according to agreed guidelines [1,2]. Implementation of the RGF lacks
standardisation across NHS sites with substantial variations in approval
procedures and the time taken to assess potential projects [3,4]. The
importance of the RGF is acknowledged [5,6,7] but concerns have been
raised that the administrative burden of obtaining Research &
Development (R&D) approval may be a barrier to timely research. The
level of administration may seem particularly inappropriate in the case of
studies that carry minimal hazards or costs and are carried out at
multiple sites.
We describe our experience of obtaining NHS Trust R&D approval to
conduct a survey of NHS Consultants that forms part of a prospective,
randomised, controlled trial, aimed at assessing the clinical and cost-
effectiveness of thiopurine methyltransferase (TPMT) genotyping to guide
azathioprine prescribing (The TARGET study). The postal survey aims to
determine current azathioprine prescribing practices in the management of
inflammatory conditions and the implementation of current monitoring
guidelines. One randomly selected Consultant in Rheumatology, Dermatology
and Gastroenterology at each NHS Trust in England and Wales, identified
using the Dr Foster’s website, will be sent a questionnaire. The survey
results will inform the design of the standard care arm of the TARGET
study and confirm its relevance to national practice.
MREC approval for the survey was granted and designated ‘No local
investigator’ status, requiring no site-specific approval. In the absence
of any mechanism to obtain global R&D approval and because this study
design was perceived to fall into a ‘grey area’, our local R&D office
were unsure whether we should apply for separate approval from all 178 NHS
Trusts. This seemed an inappropriate level of administrative burden for a
simple survey and it was suggested that we should seek advice from the NHS
R & D Forum, who categorised this study as ‘clinical audit’ [8]. Our
local R&D Office was initially satisfied with this, and we posted a
pilot survey to 15 North West based NHS Hospital Trusts. However, after
reflection, and some consultation with the local clinical audit
department, our local R&D office advised that we should seek
permission from the remaining 163 NHS Trusts. The R&D office
suggested that, to reduce the administrative time and costs, we contact
the R&D offices by e-mail explaining the survey sending copies of the
MREC approval letters, the survey and the National R&D form. The e-
mail stated that if further information was required, or that if there was
any objection to sending the survey, then they should contact the named
study co-ordinator. We stated that if we did not hear a reply by two weeks
from the email, we would assume that the office had no objections to the
survey being sent.
The first problem encountered was that the contact list, supplied by
the NHS R & D Forum, was incomplete and inaccurate and ten e-mails
were returned undelivered and we had to telephone the relevant sites to
collate the missing information. Responses to the e-mail were varied and
73 (45%) of the 163 R&D offices contacted responded. Eleven centres
required full applications and a decision was made to exclude these sites
because this would incur disproportionate amounts of cost and time.
Twenty sites granted approval immediately and further information was
requested from 30 sites who subsequently granted approval. Nine sites
recommended our study for consideration by their committee or for chair's
action. Two sites refined our sampling frame as there were no relevant
Consultants at their hospitals.
Six centres requested that the National R & D Form be signed by
the Chief Investigator and two centres asked for the signature of the NHS
Trust Medical Director, since there were no local investigators. This
disparity may reflect the ambiguity of the guidance provided, which
indicates that it is necessary to identify a ‘local collaborator’. All NHS
Trusts accepted the ‘national’ form, but eleven also required further
local forms to be completed. Five centres asked the researcher to
complete the form so that the Trust could register their participation on
the National Research register.
This shortened version of the R&D notification process took two
researchers six weeks and 261 e-mails to achieve 105 R&D approvals
granted either by Chairman’s action or a committee’s decision. It is
clear that the R&D approval process would benefit from standardisation
and, the NHS R&D forum is working to achieve this. Our experience
highlights that there is still a considerable way to go towards achieving
standardisation and identifies a need for researchers to be able to obtain
‘global’ R & D approval, or exemption, for national surveys, to equate
with the COREC system.
References
1. Department of Health. Research governance framework for health and
social care. London: DoH, 2001
2. Kerrison S, McNally N & Pollock AM. United Kingdom research
governance strategy. BMJ 2003; 327: 553-556
3. Elwyn G, Seagrove A, Thorne K & Cheung WY. Ethics and research
governance in a multicentre study: add 150 days to your study protocol.
BMJ 2005; 330: 847
4. Torgerson DJ & Dumville JC. Research governance also delays
research. BMJ 2004; 328: 710
5. Denholm JT. Research governance is about protection, not
convenience. BMJ 2004; 329: 623
6. Jones AM & Bamford B. The other face of research governance.
BMJ 2004; 329: 280-281
7. Soteriou T. Commentary: View from the research and development
office. BMJ 2004; 281-282
8. ‘Guidance on developing procedures within NHS organisations for
appropriate authorisation and management of research and related
projects.’ http://www.rdforum.nhs.uk/
Competing interests:
None declared
Competing interests: No competing interests
Editor- Elwyn et al bring to attention the long lag times now
inherent in research. However 150 days may be an underestimate and this
lag time can often be considerably longer. This is especially true of
multi-centre research in primary care. Each Primary Care Trust (PCTs)
often has its own research governance procedures that take varying lengths
of time but which usually stretch into months. PCTs will often require
their own Criminal Records check before issuing honorary contracts. These
too can take months to be processed by the Criminal Records Bureau. Each
PCT also requires its own honorary contract with the associated
application procedures and time taken for these to be processed.
A lead in time of nine months to one year should be added to
protocols for multicentre primary care research until research governance
procedures can be ratified across PCTs.
Competing interests:
None declared
Competing interests: No competing interests
Research governance or research hindrance?
Dear Editor,
There are growing concerns about the effect of UK Research Governance
arrangements on health service research (1-3).We describe the difficulties
faced in obtaining research governance approval and the impact this has
had for our project after multi-centre research ethics (MREC) approval for
what was deemed a ‘no local investigator study’.
The study consisted of a postally administered questionnaire looking
at health and social costs and quality of life in patients with Multiple
Sclerosis(MS) participating in the UK MS risk-sharing scheme. The
questionnaire comprises two validated quality of life instruments and a
resource use questionnaire.
We wrote to research governance departments in 58 centres
participating in the risk-sharing scheme where governance approval has
already been obtained for the core study. Each centre received a letter
explaining the nature of the study and its relationship to ongoing
research within the trust in addition to a copy of the study protocol and
MREC approval.
We received a prompt reply from 15 centres of which 6 trusts granted
immediate permission to proceed with the study. The remaining 9 centres
who replied required a completed R&D application form, sponsorship letter
and data protection forms.
The remaining 43 centres did not respond to our initial
correspondence and were written to again and contacted directly. Some
claimed they had not received our initial letters while others had
received our correspondence but needed further information, yet had not
replied.
What followed was – and continues to be – a frustrating signature and
paper chase exercise with individual departments requiring a whole range
of trust specific documentation. This has included proof of indemnity,
submission of ICH-GCP forms for individuals involved in the study, ‘no
local investigator forms’ (despite the MREC designation), confirmation of
consent arrangements, honorary contract applications, individual criminal
record bureau checks and fire training! On several occasions the re-
deployment of temporary staff in departments led to failure to progress
the application. The requirement – often falling to investigators – to
obtain signatures from two or three senior trust staff again led to
substantial delays.
We have eventually received approval from 30 trusts and have been
able to undertake the study in 28 of these, enrolling approximately 1400
of a potential population of 5000 patients. The median time to receive
approval was 70 days, maximum 200 days (though final approval was not
obtained in the remaining centres). These figures do not include the
additional 4-6 weeks often required to obtain honorary contracts. In the
remaining centres we have been unable to undertake this study in a time
frame which allows data analysis during what is inevitably a time limited
research period.
Investigators undertaking UK based multi centre research of any
nature – this was not a complex or costly study – need to be aware of the
difficulties they are likely to face with the current research governance
procedures. Centralisation of governance and contractual arrangements are
needed urgently to prevent studies such as this drowning in a sea of
paper.
Dr Shagufay Rashid, Research Fellow,
Dr Mike Boggild, Consultant Neurologist.
Walton Centre for Neurology and Neurosurgery, Lower Lane, Liverpool,
L9 7LJ.
References
1.Hearnshaw H. Comparison of requirements of research ethics committees in
11 European countries for a non-invasive interventional study. BMJ
2004;328: 140-1. (17 January.)
2.Glyn Elwyn, Anne Seagrove, Kym Thorne, and Wai Yee Cheung. M Ethics and
research governance in a multicentre study: add 150 days to your study
protocol BMJ 2005 330: 847.
3.Dumville JC, Watson J, Raynor P, Torgerson DJ. Research governance: a
barrier to ethical research. Q JMed 2004 Mar; 97(3):113-4
Competing interests:
None declared
Competing interests: No competing interests