Letters Problems with ethics approval

Authors’ reply to Beales

BMJ 2017; 356 doi: https://doi.org/10.1136/bmj.j1196 (Published 07 March 2017) Cite this as: BMJ 2017;356:j1196
  1. Ben Goldacre, senior clinical research fellow1,
  2. Samuel Whittle, consultant rheumatologist2,
  3. Edzard Ernst, emeritus professor3,
  4. Jonathan Mendel, lecturer in human geography4
  1. 1Centre for Evidence-Based Medicine, University of Oxford, Oxford OX2 6GG, UK
  2. 2Discipline of Medicine, University of Adelaide, Australia
  3. 3Peninsula Medical School, University of Exeter, UK
  4. 4Geography, School of Social Sciences, University of Dundee, Dundee DD1 4HN, UK
  1. ben.goldacre{at}phc.ox.ac.uk

Beales argues,1 in response to our paper,2 that trialists should bear responsibility for trials with inappropriate comparators. We agree that trialists should share this responsibility. But about half a million randomised trials have been conducted in medicine to date, involving millions of investigators. These researchers will undoubtedly have heterogeneous skills and conflicts of interest.

Some researchers may lack the key competences to be aware of their ethical breaches. For example, some investigators may be unaware of the need to conduct a systematic review before a trial starts or may regard it as a low priority or may conduct a poor …

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