Abstract

While cluster randomized trials (CRTs) have unique features that differentiate them from conventional (individually) randomized trials, standard research ethics guidelines by and large assume individual randomization. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials provides recommendations specific to CRTs to assist researchers and research ethics committees in the ethical design, conduct, and review of CRTs. In this article we describe the unique characteristics of CRTs, identify the main ethical issues raised, and discuss the application of the Ottawa Statement to CRTs in health, social, and behavioral research using a series of examples.

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