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A Randomized Controlled Trial of an Electronic Informed Consent Process

机译：电子知情同意过程的随机对照试验

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摘要

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study.
机译：一项试点研究评估了一项随机对照试验（RCT）中的电子知情同意模型。随机选择参加RCT父项目的参与者，并随机分为电子同意组（n = 32）或简化纸质同意组（n = 30）。电子同意小组的结果表明，他们对研究的目的，参与的替代方法以及对研究有疑问或疑虑的联系人有了更高的了解。但是，纸质对照组的参与者在某些调查项目上的平均得分较高。这项研究表明，电子知情同意书可以提高参与者对研究研究某些方面的理解。

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