Bureaucracy of ethics applications

doi:10.1136/bmj.329.7460.282

BMJ 2004;329:282-284 (31 July), doi:10.1136/bmj.329.7460.282

Education and debate

Bureaucracy of ethics applications

David S Wald, clinical research fellow¹

¹ Wolfson Institute of Preventive Medicine, London EC1M 6BQ d.s.wald@qmul.ac.uk

One research group decided to determine exactly how much effortis required to get ethical approval by recording the submissionof its first application under the new UK system

The first 150 words of the full text of this article appear below.

Introduction

March 2004 heralded the introduction of the new Central Officefor Research Ethics Committees (COREC) application form anda bad time for anyone aiming to conduct clinical research inthe United Kingdom. Here I recount the experience of a clinicalresearch group submitting the first application at their universityhospital. We logged the time and activity required for the applicationprocess.

We designed a double blind randomised, placebo controlled, factorialstudy in 50 volunteers to determine whether the blood pressurelowering effects of a low dose ${beta}$ blocker and low dose angiotensinconverting enzyme inhibitor are independent. We sought no externalfunding for the study and expected no ethical obstacles.

Credit: TONWEN JONES

Application process

The application procedure began with a phone call to the localresearch ethics committee to find out the dates of the forthcomingcommittee meetings and submission deadlines. We received a listof dates and were advised that the . . . [Full text of this article]

COREC 2

COREC application

Discussion

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