Ethical issues in the design and conduct of cluster randomised controlled trials

Abstract

Need for cluster trials will increase with concern over health service evaluation, but issues of ethics and guardianship must be addressed. In some cluster trials the intervention can be targeted at individuals (individual-cluster); where this would be too difficult or expensive the intervention is targeted at the whole group (cluster-cluster). Autonomy is important in individual-cluster trials, while the utilitarian welfare of the cluster as a whole is of paramount importance in cluster-cluster trials. In individual-cluster trials the participants should give consent; cluster-cluster trials need procedural safeguards appropriate to the risks carried by the cluster intervention. Guardians should sign a consent form that sets out their duties before they volunteer a cluster for a trial.