Ethics review roulette: what can we learn?

BMJ 2004; 328 doi: http://dx.doi.org/10.1136/bmj.328.7432.121 (Published 15 January 2004)
Cite this as: BMJ 2004;328:121

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  1. Paul Glasziou, reader (paul.glasziou@dphpc.ox.ac.uk)1,
  2. Iain Chalmers, editor2
  1. 1Department of Primary Health Care, Oxford University, Oxford OX3 7LF
  2. 2James Lind Library, James Lind Initiative, Oxford OX2 7LG

    That ethics review has costs and one size doesn't fit all

    Ethics review is an “intervention” in the system of health care that has been less evaluated than others. It aims to minimise risks to patients from inappropriate research or inadequate consent, but as a consequence it may delay or inhibit research beneficial to those same patients. The balance of risks and consequences will clearly be different for different types of research: some questionnaires, clinical audits, or comparisons of standard treatments are associated with low risks, while comparisons of known treatments against placebo and studies of new, potentially dangerous interventions carry higher risks.

    To what extent might studies of variations in the work of research ethics committees help investigate how this balance is managed? In this week's BMJ, Hearnshaw reports the latest of several investigations documenting variations in the work of research ethics committees.1 The principal messages from this body of evidence are that variations are often striking and the consequences can be substantial. In Hearnshaw's example, a trial of a leaflet intended to improve older patients' involvement in general practitioner consultations, was deemed not to require ethical review in Austria, France, Germany, and Switzerland. In the UK, Belgium, …

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