Published in:
01-12-2015 | Poster presentation
Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): developing a core outcome set
Authors:
Katie Gillies, Cynthia Fraser, Vikki Entwistle, Shaun Treweek, Paula Williamson, Marion Campbell
Published in:
Trials
|
Special Issue 2/2015
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Excerpt
The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to recognise any potential risks, or benefits, associated with the research. A number of interventions have been put forward to improve this process. Outcomes reported in trials of interventions to improve the informed consent process for decisions about trial participation tend to focus on ‘understanding’ of trial information and recruitment to the parent study. Yet there is a lack of clarity regarding whether these are the ‘right’ outcomes to measure and which outcomes matter (to whom) and why. …
