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Article
The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials
Quantitative Health Sciences Publications and Presentations
  • Charles Weijer, Western University
  • Jeremy M. Grimshaw, Western University
  • Martin P. Eccles, Newcastle University
  • Andrew D. McRae, Western University
  • Angela White, Western University
  • Jamie C. Brehaut, University of Ottawa
  • Monica Taljaard, Western University
  • Catarina I. Kiefe, University of Massachusetts Medical School
UMMS Affiliation
Department of Quantitative Health Sciences
Date
11-12-2012
Document Type
Article
Medical Subject Headings
Cluster Analysis; Epidemiologic Research Design; Humans; Randomized Controlled Trials as Topic
Abstract

Summary points:

  • In cluster randomized trials (CRTs), the units of allocation, intervention, and outcome measurement may differ within a single trial. As a result 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. Empirical studies documented the reporting of ethical issues in published CRTs, interviewed experienced trialists, and surveyed trialists and REC chairs. The ethical issues identified were explored in a series of background papers that provided detailed ethical analyses and policy options, and a panel of experts using a systematic process developed a consensus statement.
  • The Ottawa Statement sets out 15 recommendations for the ethical design and conduct of CRTs. The recommendations provide guidance on the justification of a cluster randomized design, the need for REC review, the identification of research participants, obtaining informed consent, the role of gatekeepers in protecting group interests, the assessment of benefits and harms, and the protection of vulnerable participants.

Comments

Citation: Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, et al. (2012) The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Med 9(11): e1001346. doi:10.1371/journal.pmed.1001346. Link to article on publisher's website

Copyright 2012 Weijer et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Catarina Kiefe is a member of the Ottawa Ethics of Cluster Randomized Trials Consensus Group.

Related Resources
Link to article in PubMed
Keywords
  • UMCCTS funding
PubMed ID
23185138
Citation Information
Charles Weijer, Jeremy M. Grimshaw, Martin P. Eccles, Andrew D. McRae, et al.. "The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials" Vol. 9 Iss. 11 (2012) ISSN: 1549-1676
Available at: http://works.bepress.com/catarina_kiefe/212/