Intended for healthcare professionals

Rapid response to:

Letters

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

Rapid Response:

Research Passports - the gateway to speedier entry for researchers to their projects?

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 [1] 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 [2] or unsafe research.

The onerous requirements in connection with honorary research
contracts that I described in my letter [3] 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 [4]: 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
research passports
(http://www.gmsha.nhs.uk/research/research_passport2005.pdf) for involved
patients and the public modelled on the one proposed in Greater Manchester
[5] would help smooth the path towards better research and more sensible
and workable processes for governance?

Hazel Thornton

Independent Advocate for Quality in Research and Healthcare.

[1] Mick E Bond. Research governance approval a response from an RM&G
Manager, BMJ, 1 Feb 2006

http://bmj.com/cgi/eletters/332/7535/238-b#127335

[2] 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.

[3] Hazel Thornton. Research governance – whose idea is it? BMJ 2006;
332:238

[4] 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

[5] Julia Miller, et al. Greater Manchester NHS Trusts. Honorary
Research Contracts for Researchers working in Greater Manchester. The
Research Passport. April 2005.
http://www.gmsha.nhs.uk/research/research_passport2005.pdf

Competing interests:
None declared

Competing interests: No competing interests

03 February 2006
Hazel Thornton
Independent Advocate for Quality in Research and Healthcare
"Saionara", 31 Regent Street, Rowhedge, Colchester, CO5 7EA