The new system of review by multicentre research ethics committees: prospective study

doi:10.1136/bmj.320.7243.1179

BMJ 2000;320:1179-1182 ( 29 April )

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The new system of review by multicentre research ethics committees: prospective study

Editorial by Alberti, pp 1182 , 1217

Joanna Tully, clinical research fellow, ^a Nelly Ninis, clinical research fellow, ^c Robert Booy, professor, ^b Russell Viner, consultant in adolescent medicine. ^d

^a Department of Epidemiology, Institute of Child Health, London WC1N 1EH, ^b Department of Child Health, Royal London Hospital, London E1 1BB, ^c Royal College of Paediatrics and Child Health, London W1N 6DE, ^d Middlesex Adolescent Unit, Middlesex Hospital, London W1N 8AA

Correspondence to: J Tully j.tully{at}ich.ucl.ac.uk

Objective: To assess the function of the new system ofreview by multicentre research ethics committees and to highlightareas where improvement is stillneeded.
Design: Prospectively collected data from a multicentrestudy was examined with respect to the ethics review process.Administrative, financial, and time elements of the review processwereaudited.
Setting: A single multicentre research ethics committeeand 125 local ethics committees from six regions ofEngland.
Main outcome measures: Time to reply, time to approval, and numberof non-local changes to the applicationrequested.
Results: Only 40% of local ethics committees consideredour study in the manner specified in the 1998 directive. Lessthan a third of committees replied within the 21 day period stipulated,although committees acting by executive subcommittee replied morequickly than those not acting by executive subcommittee. Therewas a tendency for executive subcommittees to approve studiesin a shorter time. Local ethics committees asked for a large numberof non-local changes to the application. The financial cost ofapplying to multiple ethics committees remains high, mainly becausemultiple copies of research applications are beingrequested.
Conclusions: The new system of approval by multicentreresearch ethics committee for multicentre studies was introducedto reduce administrative costs, speed up the process of reviewsby multiple research ethics committees, and standardise the conclusionsof the local research ethics committees. Since its introductionan improvement has been seen, but the system is not yet universallyfunctioning as intended. Ethics review still remains a hindranceto the financial resources and commencement of national studies.We strongly support the structure of review by multicentre researchethics committees but suggest that the system has yet to achieveitsaims.

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