The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials

[...]of the unique design of CRTs, the interpretation of existing research ethics guidelines is complicated. * The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials aims to provide researchers and research ethics committees (RECs) with detailed guidance on the ethical d...

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Bibliographic Details
Published in:PLoS medicine Vol. 9; no. 11; p. e1001346
Main Authors: Weijer, Charles, Grimshaw, Jeremy M., Eccles, Martin P., McRae, Andrew D., White, Angela, Brehaut, Jamie C., Taljaard, Monica
Format: Journal Article
Language:English
Published: United States Public Library of Science 01.11.2012
Public Library of Science (PLoS)
Subjects:
Cluster Analysis
Community
Epidemiologic Research Design
Ethical aspects
Guidelines and Guidance
Hospitals
Humans
Informed consent
Intervention
Medical ethics
Medical research
Medical tests
Medicine
Philosophy
Practice
Randomized Controlled Trials as Topic - ethics
Randomized Controlled Trials as Topic - methods
Science Policy
Studies
Canada
Epidemiologic Research Design
Humans
Cluster Analysis
Randomized Controlled Trials as Topic
ISSN:1549-1676, 1549-1277, 1549-1676
Online Access:Get full text
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Summary:[...]of the unique design of CRTs, the interpretation of existing research ethics guidelines is complicated. * The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials aims to provide researchers and research ethics committees (RECs) with detailed guidance on the ethical design, conduct, and review of CRTs. * A five-year mixed methods research project explored the ethical challenges of CRTs. [...]researchers and research ethics committees (RECs) currently lack specific guidelines to help them design, conduct, and review CRTs according to internationally accepted ethical standards.
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Provenance: Not commissioned; externally peer reviewed.
The Guidelines and Guidance section contains advice on conducting and reporting medical research.
Wrote the first draft of the manuscript: CW JMG MPE ADM AW JCB MT. Contributed to the writing of the manuscript: CW JMG MPE ADM AW JCB MT. ICMJE criteria for authorship read and met: CW JMG MPE ADM AW JCB MT. Agree with manuscript results and conclusions: CW JMG MPE ADM AW JCB MT. Contributed to the conception and design of the study and secured funding: CW JMG MPE ADM JCB MT. Conducted the ethical analysis: CW JMG MPE ADM AW JCB MT.
Membership of the Ottawa Ethics of Cluster Randomized Trials Consensus Group is provided in the Acknowledgments.
The authors have declared that no competing interests exist.
ISSN:1549-1676
1549-1277
1549-1676
DOI:10.1371/journal.pmed.1001346