Evaluation of Informed Consent with Teach-Back and Audio Assistance to Improve Willingness to Participate in a Clinical Trial Among Underrepresented Minorities: A Randomized Pilot Trial.

The informed consent form (ICF) is intended to assure that subject participation in research studies is informed and voluntary. Yet, there is ample evidence that many subjects do not adequately understand the concepts and language in a clinical trial ICF, which may undermine their willingness to participate in a clinical trial. In a randomized setting, we compared a standard read-only ICF to an audio-assisted ICF with or without teach-back.