The Ottawa statement on the ethical design and conduct of cluster randomized trials: A short report

TitleThe Ottawa statement on the ethical design and conduct of cluster randomized trials: A short report
Publication TypeJournal Article
Year of Publication2015
AuthorsWeijer, C, Taljaard, M, Grimshaw, JM, Edwards, SJL, Eccles, MP
JournalResearch Ethics
Volume11
Issue1
Pagination52-60
Date Published2015
Publication Languageeng
KeywordsClinical , cluster , design , ethics , Gatekeepers , guidelines , Informed , Institutional , research
AbstractOwing to unique features of their design, cluster randomized trials complicate the interpretation of standard ethics guidelines. The recently published Ottawa statement on the ethical design and conduct of cluster randomized trials provides researchers and research ethics committees with detailed guidance on the design, conduct, and review of cluster trials. The Ottawa statement sets out 15 recommendations, including guidance on the justification of study design, the need for research ethics committee review, the identification of research participants, obtaining informed consent, the role of gatekeepers in protecting cluster interests, the assessment of benefits and harms, and the protection of vulnerable participants.
NotesWeijer, Charles 1; Email Address: cweijer@uwo.ca Taljaard, Monica 2 Grimshaw, Jeremy M. 2 Edwards, Sarah J. L. 3 Eccles, Martin P. 4; Affiliation: 1: Western University, Canada 2: Ottawa Hospital Research Institute, Canada 3: University College London, UK 4: Newcastle University, UK; Source Info: Mar2015, Vol. 11 Issue 1, p52; Subject Term: CLINICAL trials -- Moral & ethical aspects; Subject Term: CLINICAL trials; Subject Term: ETHICS committees; Subject Term: INSTITUTIONAL review boards (Medicine); Subject Term: RESEARCH subjects (Persons); Subject Term: INFORMED consent (Medical law); Subject Term: GATEKEEPERS; Subject Term: DESIGN & construction; Author-Supplied Keyword: cluster randomized trial; Author-Supplied Keyword: ethics; Author-Supplied Keyword: guidelines; Author-Supplied Keyword: informed consent; Author-Supplied Keyword: research ethics committee; Number of Pages: 9p; Document Type: Article
URLhttp://dx.doi.org/10.1371/journal.pmed.1001346
DOI10.1371/journal.pmed.1001346

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