What question did this study set out to answer?

The study aims to evaluate how well authors of cluster randomised trials reported ethics review and informed consent, and to assess trends over time.

May 11, 2011BMJOpen Access

Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials

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Review identifies gaps in ethics reporting in cluster randomised trials, suggesting significant improvements needed.

The study aims to evaluate how well authors of cluster randomised trials reported ethics review and informed consent, and to assess trends over time.
Review of a random sample of 300 cluster randomised trials published between 2000 and 2008
Assessment based on adherence to ethics reporting standards set by the World Medical Association's Declaration of Helsinki
Analysis of variations in reporting practices based on trial characteristics and journal impact factors.
26% of trials failed to report ethics review, but reporting significantly increased over time (P<0.001)
Trials with individual-level data collection reported ethics review more frequently (79% vs 55%, P=0.008)
31% of trials failed to report informed consent, with significant improvements observed over time (P<0.001).

Taljaard et al. (2011) studied this question.

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