An international core outcome set for evaluating interventions to improve informed consent to clinical trials: the ELICIT Study

Informed consent is central to participation in clinical research. The requirement of informed consent for participation in randomised controlled trials (RCTs) was established to allow people to recognise and consider potential risks or benefits of participating, and to respect their autonomous choices [1]. The adequacy of these processes has, however, been called into question [2, 3]. Concern stems from evidence that trial participants often lack understanding (so cannot be considered ‘informed’) about the trial rationale and the risks of interventions [4].

Source: Journal of Clinical Epidemiology - February 26, 2021 Category: Epidemiology Authors: Katie Gillies, Paula R Williamson, Vikki A Entwistle, Heidi Gardner, Shaun Treweek, Marion K Campbell Source Type: research