The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials
Authors
Weijer, CharlesGrimshaw, Jeremy M.
Eccles, Martin P.
McRae, Andrew D.
White, Angela
Brehaut, Jamie C.
Taljaard, Monica
Ottawa Ethics of Cluster Randomized Trials Consensus Group
Kiefe, Catarina I.
UMass Chan Affiliations
Department of Quantitative Health SciencesDocument Type
Journal ArticlePublication Date
2012-11-12Keywords
Cluster AnalysisEpidemiologic Research Design
Humans
Randomized Controlled Trials as Topic
UMCCTS funding
Bioethics and Medical Ethics
Epidemiology
Health Services Research
Metadata
Show full item recordAbstract
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.Source
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 websiteDOI
10.1371/journal.pmed.1001346Permanent Link to this Item
http://hdl.handle.net/20.500.14038/46647PubMed ID
23185138Notes
Catarina Kiefe is a member of the Ottawa Ethics of Cluster Randomized Trials Consensus Group.
Related Resources
Link to article in PubMedRights
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.
ae974a485f413a2113503eed53cd6c53
10.1371/journal.pmed.1001346