Intended for healthcare professionals

Rapid response to:

Analysis And Comment Confidentiality and consent in medical research

Overcoming barriers to recruitment in health research

BMJ 2006; 333 doi: https://doi.org/10.1136/bmj.333.7562.300 (Published 03 August 2006) Cite this as: BMJ 2006;333:300

Rapid Response:

Response from the Central Office for Research Ethics Committees

Dear Editor,

Hewison and Haines criticise Research Ethics Committees (RECs) for
insisting that patients should only be allowed to opt in as participants
in some types of studies rather than opting out*. They claim that this
compromises important research and that patients may be being over-
protected. While that may be legitimate, sweeping generalisations are
always dangerous. Embarrassing or stigmatising disease might not be a
good subject for opt-out methods, for example. So there is always a
judgement to be made. This is the right and proper role of RECs.

RECs are constituted as independent bodies and consequently it is
their decision whether to approve a study or not. We at the Central Office
for Research Ethics Committees (COREC) nevertheless have the reponsibility
for ensuring that, as far as possible, REC decisions are consistent,
proportionate appropriate and timely. We aim thus to enable good research
while protecting the safety, dignity, rights and well-being of those who
participate. We do not make ethical decisions but have a rolling programme
of work to improve REC performance through training exercises and an
accreditation scheme.

We also issue educational material and guidance to RECs on a number
of topics in the form of ‘issues and arguments’ papers, which capture the
need to maintain independence of decision making but which we hope will
also lead to greater consistency and the development of a decision making
framework. This would be the best route to generate a constructive debate
on the points raised by Hewison and Haines and to effect any agreed
change. We will explore it.

The matter is timely since other important organisational changes to
the NHS research ethics service following a ministerial review ** are
about to be implemented. Details are available on the COREC website
(www.corec.org.uk) after August 21 2006.

Dr Janet Wisely,
Operations Director

Dr Hugh Davies,
Ethics Adviser

Sir John Lilleyman,
Medical Director

COREC

* Hewison J, Haines, A. Confidentiality and consent in medical
research: Overcoming barriers to recruitment in health research BMJ 2006;
333: 300-2

** Report of the Ad Hoc Advisory Group on the Operation of NHS
Research Ethics Committees Department of Health (England) 268110 (May
2005)

Competing interests:
None declared

Competing interests: No competing interests

16 August 2006
Dr Janet Wisely
Operations Director
Dr Hugh Davies and Professor John Lilleyman
COREC, 2nd Floor, A Block, 50 Eastbourne Terrace, London, W2 6LX