Education And Debate

Research ethics paperwork: what is the plot we seem to have lost?

BMJ 2004; 329 doi: http://dx.doi.org/10.1136/bmj.329.7460.286 (Published 29 July 2004) Cite this as: BMJ 2004;329:286
  1. Konrad Jamrozik (jamrozik@imperial.ac.uk), professor1
  1. 1 Department of Primary Care and Social Medicine, Imperial College, London W6 8RP
  • Accepted 8 June 2004

The standardisation of applications to local research ethics committees seems likely to make ethical approval less efficient and more time consuming for everyone

Introduction

Researchers in the United Kingdom now have to submit their study proposals to local research ethics committees using a nationally standardised form. The form overcomes the problem of inconsistencies in the paperwork required by different committees.1 2 It is incredibly long, however, and threatens to overwhelm both committees and investigators with paperwork.24 The administrative burden is likely to be increased by the advent of a research management and governance framework for health and social care5 and the requirement for ethical clearance for all research by students on humans, including their tissues or data.6 Current trends are not sustainable in terms of time, money, or their impact on the environment, and it seems we have lost the plot. In this article, I examine how we can streamline the process.

Basics of ethical review

The first step is to determine the essential information required for ethical approval. Based on my experience as a member of three ethics committees in two countries, I think that members ask themselves four basic questions:

  • What hazards are raised by the research protocol?

  • Can the protocol be redesigned to reduce these hazards without compromising its ability to answer the research question?

  • Have the investigators taken reasonable steps to minimise …

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