{"title":"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。","authors":"Brenda Jamerson, Barry Shuster","doi":"10.1177/15562646231207266","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7000,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Brenda Jamerson, Barry Shuster\",\"doi\":\"10.1177/15562646231207266\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":50211,\"journal\":{\"name\":\"Journal of Empirical Research on Human Research Ethics\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2023-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Empirical Research on Human Research Ethics\",\"FirstCategoryId\":\"98\",\"ListUrlMain\":\"https://doi.org/10.1177/15562646231207266\",\"RegionNum\":4,\"RegionCategory\":\"哲学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/10/12 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"ETHICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Empirical Research on Human Research Ethics","FirstCategoryId":"98","ListUrlMain":"https://doi.org/10.1177/15562646231207266","RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/10/12 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ETHICS","Score":null,"Total":0}
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.
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.
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