Ethics in cluster randomised trials

Date: Monday 19th November

Time: 12.45 – 14.00

Location: LG7, Keppel Street

Speaker: Monica Taljaard and Charles Weijer

Cluster randomisation is an increasingly important research design in public health and medicine. In this presentation, a statistician and bioethicist will discuss key methodological and ethical considerations in the adoption of this design. While the importance of providing an appropriate justification for the choice of cluster randomisation is widely recognised, some reasons are more compelling than others. For example, the rationale for adopting the design is clear in the case of cluster-level and professional-level interventions, but less clear in the case of individual-level interventions, particularly when a waiver of consent is necessary for feasibility. In the first part of the session, various considerations in the adoption of cluster randomisation for evaluating individual-level therapeutic interventions will be presented together with results from a review of published trials. In the second part of this session, we discuss key ethical issues in three cluster randomised trials involving interventions at the level of the cluster, the health professional and the individual patient. While a waiver of informed consent is often appropriate for cluster-level interventions, the scope for its use is contested. We describe and critically evaluate several potential justifications for a broader application of waivers of consent in cluster trials.

Watch the presentation online and download Monica and Charles‘ slides.

Monica Taljaard, PhD is Senior Scientist in the Clinical Epidemiology Program at the Ottawa Hospital Research Institute and Associate Professor in the School of Epidemiology and Public Health at the University of Ottawa. Her main research interests are in the design, analysis and ethics of cluster randomized trials.

Charles Weijer MD, PhD is Professor and Canada Research Chair in Bioethics at the Rotman Institute of Philosophy at Western University in London, Canada. His research interests are in the ethics of randomized controlled trials, particularly innovative trial designs.