Inadequate reporting of research ethics review and informed consent in cluster randomized trials

review of random sample of published trials

Monica Taljaard, Andrew McRae, C Weijer, C Bennett, S Dixon, J Taleban, Zoe Christina Skea, J Brehaut, M Eccles, A Donner, R Saginur, J Grimshaw

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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.
Original languageEnglish
Article numberd2496
JournalBritish Medical Journal
Volume342
DOIs
Publication statusPublished - 2011

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Research Ethics
Informed Consent
Ethics
Information Storage and Retrieval
Helsinki Declaration
Journal Impact Factor
Manuscripts
Cluster Analysis
Publications
Language
Confidence Intervals
Health
Research

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Inadequate reporting of research ethics review and informed consent in cluster randomized trials : review of random sample of published trials. / Taljaard, Monica; McRae, Andrew; Weijer, C; Bennett, C; Dixon, S; Taleban, J; Skea, Zoe Christina; Brehaut, J; Eccles, M; Donner, A; Saginur, R; Grimshaw, J.

In: British Medical Journal, Vol. 342, d2496, 2011.

Research output: Contribution to journalArticle

Taljaard, M, McRae, A, Weijer, C, Bennett, C, Dixon, S, Taleban, J, Skea, ZC, Brehaut, J, Eccles, M, Donner, A, Saginur, R & Grimshaw, J 2011, 'Inadequate reporting of research ethics review and informed consent in cluster randomized trials: review of random sample of published trials', British Medical Journal, vol. 342, d2496. https://doi.org/10.1136/bmj.d2496
Taljaard, Monica ; McRae, Andrew ; Weijer, C ; Bennett, C ; Dixon, S ; Taleban, J ; Skea, Zoe Christina ; Brehaut, J ; Eccles, M ; Donner, A ; Saginur, R ; Grimshaw, J. / Inadequate reporting of research ethics review and informed consent in cluster randomized trials : review of random sample of published trials. In: British Medical Journal. 2011 ; Vol. 342.
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title = "Inadequate reporting of research ethics review and informed consent in cluster randomized trials: review of random sample of published trials",
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.",
author = "Monica Taljaard and Andrew McRae and C Weijer and C Bennett and S Dixon and J Taleban and Skea, {Zoe Christina} and J Brehaut and M Eccles and A Donner and R Saginur and J Grimshaw",
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T1 - Inadequate reporting of research ethics review and informed consent in cluster randomized trials

T2 - review of random sample of published trials

AU - Taljaard, Monica

AU - McRae, Andrew

AU - Weijer, C

AU - Bennett, C

AU - Dixon, S

AU - Taleban, J

AU - Skea, Zoe Christina

AU - Brehaut, J

AU - Eccles, M

AU - Donner, A

AU - Saginur, R

AU - Grimshaw, J

PY - 2011

Y1 - 2011

N2 - 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.

AB - 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.

U2 - 10.1136/bmj.d2496

DO - 10.1136/bmj.d2496

M3 - Article

VL - 342

JO - BMJ

JF - BMJ

SN - 0959-8146

M1 - d2496

ER -