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Evaluation of Informed Consent with Teach-Back and Audio Assistance to Improve Willingness to Participate in a
Brenda Jamerson1, Barry Shuster2
1Adjunct Assistant Professor in Psychiatry and Behavioral Sciences, Duke University Health System, Durham, NC, USA.
Abstract:
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. We found that audio-assisted ICFs significantly improved willingness to participate in a mock clinical trial among our sample of primarily African-American participants.
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