Ethical approval – too strict on methodological research?

This week in Trials McKenzie and colleagues present their experience of obtaining ethical approval for a methodological study that planned to compare ethics committee applications with the published results of randomized controlled trials.

Obstacles to researching the researchers: A case study
of the ethical challenges of undertaking methodological research investigating
the reporting of randomised controlled trials

Joanne E McKenzie, G PETER Herbsion, Paul Roth, Charlotte
Trials 2010, 11:28 (21 March 2010)

The authors aimed to assess the prevalence of selective outcome reporting – where significant results are more likely to be reported than those that are not significant – but approval was denied on the grounds that they did not plan to obtain informed consent from trialists to view their applications. The committee’s response is not an unusual one, but McKenzie et al consider it to be symptomatic of weaknesses in the system, including a failure to recognize the nature and importance of methodological research of this kind.

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