Challenges in the Ethical Conduct and Ethics Review of Cluster Randomized Trials: A Survey of Cluster Randomization Trialists

Abstract

Unique characteristics of cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines. Variable interpretation by research ethics committees may further complicate review and conduct. An international web-based survey was administered to corresponding authors of 300 randomly sampled CRT publications. We investigated ethics review and consent practices, investigator experiences with ethics review, and the perceived need for CRT-specific ethics guidelines. The response rate was 64%. Ethics review and consent were under-reported in publications. Ethics approval was obtained in 91%, and consent from individual and cluster level participants in 79% and 82% of trials. Consent varied by level of experimental intervention, data collection, and cluster size. Respondents cited variability among ethics committees (46%), and negative impacts of ethics review on their studies (38%). The majority perceived a need for ethics guidelines (73%), and guidance for ethics committees (70%). CRT-specific ethics guidelines are required to ensure practices meet ethical standards.