在代表性不足的少数群体中评估知情同意与反馈和音频辅助以提高参与临床试验的意愿：一项随机试点试验。

IF 1.7 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics Pub Date : 2023-12-01 Epub Date: 2023-10-12 DOI:10.1177/15562646231207266

Brenda Jamerson, Barry Shuster

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引用次数: 0

摘要

知情同意书（ICF）旨在确保受试者参与研究是知情和自愿的。然而，有充分的证据表明，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与有或无反馈的音频辅助ICF进行了比较。我们发现，音频辅助ICFs显著提高了我们主要以非裔美国人为样本的参与者参与模拟临床试验的意愿。

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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. 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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来源期刊

Journal of Empirical Research on Human Research Ethics 医学-医学：伦理

CiteScore

3.50

自引率

7.70%

发文量

审稿时长

>12 weeks

期刊介绍： The Journal of Empirical Research on Human Research Ethics (JERHRE) is the only journal in the field of human research ethics dedicated exclusively to empirical research. Empirical knowledge translates ethical principles into procedures appropriate to specific cultures, contexts, and research topics. The journal''s distinguished editorial and advisory board brings a range of expertise and international perspective to provide high-quality double-blind peer-reviewed original articles.