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

Lookup NU author(s): Professor Jeremy Grimshaw, Professor Martin Eccles

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Abstract

© 2014, © The Author(s) 2014. Owing 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.


Publication metadata

Author(s): Weijer C, Taljaard M, Grimshaw JM, Edwards SJL, Eccles MP

Publication type: Article

Publication status: Published

Journal: Research Ethics

Year: 2015

Volume: 11

Issue: 1

Pages: 52-60

Print publication date: 01/03/2015

Online publication date: 09/07/2014

Acceptance date: 01/01/1900

ISSN (print): 1747-0161

ISSN (electronic): 2047-6094

Publisher: SAGE Publications Ltd

URL: https://doi.org/10.1177/1747016114531980

DOI: 10.1177/1747016114531980


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