Research governance: Whose idea is it?BMJ 2006; 332 doi: https://doi.org/10.1136/bmj.332.7535.238-b (Published 26 January 2006) Cite this as: BMJ 2006;332:238
All rapid responses
Both research governance and patient and public involvement in
research have an important part to play in improving the quality of
research. Together they might go some way to addressing the problem Bond
describes  about some particular commercial drug trials where his
network had “significant concerns either about the value of projects or
about aspects of safety”. Patient and public involvement in the whole
research process; registration of trials; and insistence by funders and
research ethics committees that systematic reviews are routinely
undertaken by research applicants would all begin to reduce the amount of
unnecessary  or unsafe research.
The onerous requirements in connection with honorary research
contracts that I described in my letter  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 by the University Research and
Commercial Division for two months and were then only resolved at the
insistence of the lead applicant and myself. Voluntary, independent,
patient-researchers like myself on trial management or steering committees
are in a different category from their professional colleagues: how and by
whom should they be indemnified?
One of my main concerns is that such an unreasonable demand to sign
an onerous, inappropriate contract is a deterrent to those patients and
members of the public invited to be active patient-researchers in
necessary research, such as the Department of Health project for a
systematic review in this case, in which I had been involved during the
whole application stage. Researchers are already thoroughly demoralised by
excessive demands and delays : this unreasonable hurdle for them or for
would-be patient researchers is a further impediment.
The NHS Research & Development Forum explored “The Realities of
Service User and Carer Involvement in Research” at a meeting 26th January
2006: delegates included the Director of INVOLVE and the Consumer Liaison
Lead of the UK Clinical Research Network. Workshops on `Payment for being
an involved service user/carer` and on `Research Governance` were
opportunities for exploring the complexities of these issues. Perhaps
(http://www.gmsha.nhs.uk/research/research_passport2005.pdf) for involved
patients and the public modelled on the one proposed in Greater Manchester
 would help smooth the path towards better research and more sensible
and workable processes for governance?
Independent Advocate for Quality in Research and Healthcare.
 Mick E Bond. Research governance approval a response from an RM&G
Manager, BMJ, 1 Feb 2006
 Imogen Evans, Hazel Thornton, Iain Chalmers. Testing treatments.
Better research for better healthcare. British Library. In Press 2006.
Chapter 5: Clinical research: the good, the bad, and the unnecessary.
 Hazel Thornton. Research governance – whose idea is it? BMJ 2006;
 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
 Julia Miller, et al. Greater Manchester NHS Trusts. Honorary
Research Contracts for Researchers working in Greater Manchester. The
Research Passport. April 2005.
Competing interests: No competing interests
I read with interest the letters in the latest edition of the BMJ
about the problems researchers are having with obtaining research
governance approval. I have experience of these issues from both sides
being a Primary Care Trust Research Management & Governance Manager
and an active researcher who has recently gained approval for a project
across the local Strategic Health Authority. My comments are as follows
1) I see no reason why trusts should be asking fellow NHS employees
for honorary contracts, all NHS organisations are signed up to research
governance and that should be sufficient proof of their status. This is
not a good use of researchers or research governance staff time.
2) If a researcher has an honorary contract with one NHS organisation the
facility exists to issue a letter of authorisation to accept this
elsewhere and unless there are compelling reasons not to do this i.e. no
contact with children or vulnerable adults in other sites then this is
surely the way forward.
3) Procedures are inconsistent across Trusts and one of the reasons for
this is the lack of nationally agreed procedures for which the Department
of Health bears a significant responsibility. One way forward would be
for them to endorse the Research & Development Forum’s toolkit or to
produce their own detailed guidance and standard forms. In the area of
honorary contracts I understand progress is being made by the R&D Forum
and the UK Clinical Research Collaboration on the introduction of a
research passport. There is a need for some kind of multi centre process
to give approval to large scale projects, allowing local Research
Management & Governance groups to concentrate on purely local issues.
I would hesitate to claim we have got it completely right locally
although we do try to be as prompt as we can. What needs to be borne in
mind is in this debate is that research governance is there for a purpose,
namely to provide local quality control on research projects and to
protect the interests of patients and staff. In most cases the projects
we have dealt with have been unproblematic. However there have been a few
cases, in particular commercial drug trials where we have had significant
concerns either about the value of projects or about aspects of patient
safety. It has not always proved easy to get information on why these
have been approved or to take up our concerns. I think this demonstrates
that research governance, though hopefully streamlined, still has an
important role to play.
North Derbyshire Public Health Network
My employers Chesterfield PCT have received RM&G funding from the Department of Health since 2002 to covre research governance activities in the three north Derbyshire PCTs
Competing interests: No competing interests