Simplified consent in cluster randomised trials: the new EU Clinical Trials Regulation does not provide sufficient guidance

Key messagesThe new European Union Clinical Trials Regulation requires the use of “simplified consent” for all cluster randomised trials, but how to interpret this is unclearThe ambiguity of simplified consent can push ethics committees towards inappropriately promoting and approving opt-out consent approaches in cluster randomised trials evaluating medicinal products The criteria for an ethics committee to grant simplified consent must be clarified to ensure appropriate ethical protections are afforded to research participants in cluster randomised trialsThe new European Union (EU) Clinical Trials Regulation 536/2014 is designed to streamline and harmonise the submission and review process for clinical trials conducted in EU member states and countries in the European Economic Area.1 Since 31 January 2023, clinical trial applications in the EU must be submitted through the Clinical Trials Information System and must abide by the regulation.2This includes applications to conduct cluster randomised trials (CRTs), which are commonly used for the evaluation…
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