Challenges in the research ethics review of cluster randomized trials: International survey of investigators

Shazia H Chaudhry, Jamie C Brehaut, Jeremy M Grimshaw, Charles Weijer, Robert Boruch, Allan Donner, Martin P Eccles, Andrew D McRae, Raphael Saginur, Zoë C Skea, Merrick Zwarenstein, Monica Taljaard

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines for several reasons. For one, the units of allocation, intervention, and observation often may differ within a single trial. In the absence of tailored and internationally accepted ethics guidelines for CRTs, researchers and research ethics committees have no common standard by which to judge ethically appropriate practices in CRTs. Moreover, lack of familiarity with and consideration of the unique features of the CRT design by research ethics committees may cause difficulties in the research ethics review process, and amplify problems such as variability in the requirements and decisions reached by different research ethics committees.
Original languageEnglish
Pages (from-to)257-268
Number of pages12
JournalClinical Trials
Volume10
Issue number2
DOIs
Publication statusPublished - Apr 2013

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    Chaudhry, S. H., Brehaut, J. C., Grimshaw, J. M., Weijer, C., Boruch, R., Donner, A., Eccles, M. P., McRae, A. D., Saginur, R., Skea, Z. C., Zwarenstein, M., & Taljaard, M. (2013). Challenges in the research ethics review of cluster randomized trials: International survey of investigators. Clinical Trials, 10(2), 257-268. https://doi.org/10.1177/1740774513475530