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Background Informed consent (IC) is legally and ethically required for trial participation. Evidence suggests participants do not always fully understand information before consenting. Systematic reviews highlight benefits of discussion to enhance understanding and call for standardisation when evaluating IC. We describe the development and preliminary evaluation of a novel measure for application to audio-recordings of recruitment consultations that aims to evaluate recruiter information provision and patient understanding.

Evaluating informed consent during trial recruitment consultations: development and preliminary evaluation of a new method