Education And Debate

Bureaucracy of ethics applications

BMJ 2004; 329 doi: http://dx.doi.org/10.1136/bmj.329.7460.282 (Published 29 July 2004) Cite this as: BMJ 2004;329:282
  1. David S Wald (d.s.wald@qmul.ac.uk), clinical research fellow1
  1. 1 Wolfson Institute of Preventive Medicine, London EC1M 6BQ
  • Accepted 28 June 2004

One research group decided to determine exactly how much effort is required to get ethical approval by recording the submission of its first application under the new UK system

Introduction

March 2004 heralded the introduction of the new Central Office for Research Ethics Committees (COREC) application form and a bad time for anyone aiming to conduct clinical research in the United Kingdom. Here I recount the experience of a clinical research group submitting the first application at their university hospital. We logged the time and activity required for the application process.

We designed a double blind randomised, placebo controlled, factorial study in 50 volunteers to determine whether the blood pressure lowering effects of a low dose α blocker and low dose angiotensin converting enzyme inhibitor are independent. We sought no external funding for the study and expected no ethical obstacles.



Embedded Image

Credit: TONWEN JONES

Application process

The application procedure began with a phone call to the local research ethics committee to find out the dates of the forthcoming committee meetings and submission deadlines. We received a list of dates and were advised that the local 10 page application form was no longer in use and that we should download the new four part, 68 page form from the COREC website (http://www.corec.org.uk/). Two files could be completed online; the first, COREC 2, was a 57 page form divided into three parts (A, B, and C) and was required by the local research ethics committee for a decision on whether the proposed research was ethical. The second “COREC application,” comprised part D and was an 11 page finance form for the research and development department.

COREC 2

Part A

Part A contained 68 questions on 26 pages. Most of these related to the scientific justification for the study and the proposed methods. Six questions related to issues of funding and …

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