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Should research ethics committees police reporting bias?

BMJ 2017; 356 doi: https://doi.org/10.1136/bmj.j1501 (Published 27 March 2017) Cite this as: BMJ 2017;356:j1501
  1. Simon E Kolstoe, senior lecturer and ethics adviser1,
  2. Daniel R Shanahan, publisher2,
  3. Janet Wisely, chief executive3
  1. 1Institute of Biomedical and Biomolecular Science, University of Portsmouth, Portsmouth, UK
  2. 2Health Sciences, BioMed Central, London, UK
  3. 3Health Research Authority, London, UK
  1. Janet.wisely{at}nhs.net
  2. Correspondence to: S E Kolstoe simon.kolstoe{at}port.ac.uk, Janet Wisely Janet.wisely{at}nhs.net

Ethics review bodies are well placed to check trial reporting, say Simon E Kolstoe and Daniel R Shanahan, but Janet Wisely worries about resourcing and the lack of sanctions available once approval has been granted

Yes—Simon E Kolstoe, Daniel R Shanahan

Progress through the application of science cannot be achieved if the results of scientific studies are not communicated appropriately. This is particularly relevant in medical research, where experiments are often conducted on human volunteers. Expensive new innovations cannot be produced without returns for investigators, but the distortion of the evidence base by long term withholding of data, either for financial gain or simply through negligence, can do real harm to patients.1

To tackle this problem the World Medical Association has set standards for the conduct and dissemination of research,2 but the sheer number of funders and researchers make it difficult even to identify trials that have been conducted, let alone to discover whether the results have been reported accurately.

Lack of coordination

This problem, called reporting bias, has become increasingly prominent both in the public’s consciousness3 and politically.4 Efforts to tackle the problem include trial registration,5 consensus based statements on how to report research,6 and audit attempts by funders,7 companies,8 and research organisations.9 However, these solutions lack coordination and examine only limited populations of researchers. What is needed is a larger and more systematic method for detecting this substantial ethical problem.

The Declaration of Helsinki states that “any experiment involving human beings must be submitted to an independent committee for review, comment, and guidance,”2 and these research ethics committees could hold the answer. …

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