Survey of consent practices in cluster randomized trials: Improvements are needed in ethical conduct and reporting

Clin Trials: December 17, 2013

Background Informed consent procedures in cluster randomized trials (CRTs) are considerably more complicated than in individually randomized trials. In a CRT, the units of randomization, intervention, and observation may differ in a single trial; there can be multiple levels of participants (individual and cluster level); consent may be required separately for intervention and data collection; and there may be practical constraints to seeking informed consent, for example, due to cluster-level interventions or the sheer size of clusters. Read more