Adjunct Assistant Professor in Psychiatry and Behavioral Sciences, Duke University Health System, Durham, NC, USA.
Clinical Associate Professor in Law and Ethics, North Carolina Central University School of Business, Durham, NC, USA.
J Empir Res Hum Res Ethics. 2023 Dec;18(5):372-379. doi: 10.1177/15562646231207266. Epub 2023 Oct 12.
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.
知情同意书（ICF）旨在确保研究对象参与研究是知情和自愿的。然而，有充分的证据表明，许多研究对象并不能充分理解临床试验 ICF 中的概念和语言，这可能会影响他们参与临床试验的意愿。在随机环境下，我们比较了标准的只读 ICF 与带或不带回述的音频辅助 ICF。我们发现，音频辅助 ICF 显著提高了我们的主要由非裔美国人组成的样本对模拟临床试验的参与意愿。
