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.

中文翻译：

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通过回授和音频辅助评估知情同意，以提高代表性不足的少数群体参与临床试验的意愿：随机试点试验。

知情同意书 (ICF) 旨在确保受试者在知情且自愿的情况下参与研究。然而，有充分证据表明，许多受试者没有充分理解临床试验 ICF 中的概念和语言，这可能会削弱他们参与临床试验的意愿。在随机设置中，我们将标准只读 ICF 与带或不带示教的音频辅助 ICF 进行了比较。我们发现，音频辅助 ICF 显着提高了我们的样本（主要是非裔美国参与者）参与模拟临床试验的意愿。