Inadequate reporting of research ethics review and informed
consent in cluster randomised trials: review of random
sample of published trials
http://www.bmj.com/content/342/bmj.d2496.abstract
Monica Taljaard, scientist,1 Andrew D McRae, research director,2 Charles Weijer, professor,3 Carol Bennett,
research coordinator,1 Stephanie Dixon, postdoctoral fellow,4 Julia Taleban, PhD candidate,4 Zoe Skea,
research fellow,5 Martin P Eccles, professor,6 Jamie C Brehaut, scientist,1 Allan Donner, professor,4 Raphael
Saginur, professor,7 Robert F Boruch, professor,8 Jeremy M Grimshaw, senior scientist1
ABSTRACT
Objectives To investigate the extent to which authors of
cluster randomised trials adhered to two basic
requirements of the World Medical Association’s
Declaration of Helsinki and the International Committee
of Medical Journal Editors’ uniform requirements for
manuscripts (namely, reporting of research ethics review
and informed consent), to determine whether the
adequacy of reporting has improved over time, and to
identify characteristics of cluster randomised trials
associated with reporting of ethics practices.
Design Review of a random sample of published cluster
randomised trials from an electronic search in Medline.
Setting Cluster randomised trials in health research
published in English language journals from 2000 to
2008.
Study sample 300 cluster randomised trials published in
150 journals.
Results 77 (26%, 95% confidence interval 21% to 31%)
trials failed to report ethics review. The proportion
reporting ethics review increased significantly over time
(P<0.001). Trials with data collection interventions at the
individual level were more likely to report ethics review
than were trials that used routine data sources only (79%
(n=151) v 55% (23); P=0.008). Trials that accounted for
clustering in the design and analysis were more likely to
report ethics review. The median impact factor of the
journal of publication was higher for trials that reported
ethics review (3.4 v 2.3; P<0.001). 93 (31%, 26% to 36%)
trials failed to report consent. Reporting of consent
increased significantly over time (P<0.001). Trials with
interventions targeting participants at the individual level
were more likely to report consent than were trials with
interventions targeting the cluster level (87% (90) v 48%
(41); P<0.001). Trials with data collection interventions at
the individual level were more likely to report consent
than were those that used routine data sources only (78%
(146) v 29% (11); P<0.001).
Conclusions Reporting of research ethics protections in
cluster randomised trials is inadequate. In addition to
research ethics approval, authors should report whether
informed consent was sought, from whom consent was
sought, and what consent was for.
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