Christian M Simon, Kai Wang, Laura A Shinkunas, Daniel T Stein, Paul Meissner, Maureen Smith, Rebecca Pentz, David W Klein
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引用次数: 0
摘要
一些人对知情同意(IC)信息的理解可能会随着电子文件的提供而得到改善,但另一些人可能会从面对面(F2F)中受益。这项随机、多地点研究探讨了来自不同背景的个人如何理解电子 IC 文件与面对面文件、他们对理解的信心以及研究注册情况。共有 501 名来自美国两个不同人群的生物库的患者参与了这项研究。对电子文件和面对面文件的理解总体上没有差异,但面对面文件会使理解和注册的信心更高。种族和教育水平越高,对电子同意书的理解和信心越高。研究结果表明,对于社会经济地位较高的非西班牙裔患者来说,电子同意书可能会让他们更好地理解。F2F流程可能会让西班牙裔和社会经济地位较低的患者更好地理解,注册率也会更高。研究人员应仔细考虑如何实施电子 IC 流程,以及是否保留 F2F 流程,以更好地满足某些人群的需求和局限性。
Communicating With Diverse Patients About Participating in a Biobank: A Randomized Multisite Study Comparing Electronic and Face-to-Face Informed Consent Processes.
Some individuals' understanding of informed consent (IC) information may improve with electronic delivery, but others may benefit from face-to-face (F2F). This randomized, multisite study explores how individuals from diverse backgrounds understand electronic IC documents versus F2F, their confidence in understanding, and enrollment in research. A total of 501 patients at two U.S. biobanks with diverse populations participated. There were no overall differences between electronic and F2F understanding, but F2F predicted higher confidence in understanding and enrollment. Ethnicity and a higher educational level predicted higher understanding and confidence. Study findings suggest that electronic consent may lead to better understanding for non-Hispanic patients of higher socioeconomic status. F2F processes may lead to better understanding and higher enrollment of patients from Hispanic and lower socioeconomic levels. Researchers should carefully consider how they implement electronic IC processes and whether to maintain an F2F process to better address the needs and limitations of some populations.
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.