Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, MD, USA.
Family League of Baltimore, Baltimore, MD, USA.
Clin Trials. 2021 Aug;18(4):466-476. doi: 10.1177/17407745211009529. Epub 2021 Apr 23.
BACKGROUND/AIMS: Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies).
In collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the information shared in the consent form approved for each parent study. Participants were randomized to the standard consent process, or to one of the two interventions. Once exposed to the assigned consent mode, participants were asked to complete an assessment of understanding. The study was powered to determine whether those exposed to the fact sheet or video performed better on the consent assessment compared to those exposed to the standard consent. We also assessed participant satisfaction with the consent process.
A total of 284 participants were randomized to one of the three consent arms. Assessments of understanding were completed with a total of 273 participants from July 2017 to April 2019. Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process ( value = 0.020). Participants were more satisfied with the video when compared to the standard consent. Participants who received the fact sheet did not achieve higher overall understanding or satisfaction scores when compared to the standard consent process.
This randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposed to the standard consent.
背景/目的：许多研究人员已经测试了各种方法的干预措施，以提高研究参与者对知情同意过程中分享的信息的理解，结果喜忧参半。大多数同意研究的一个有效批评是，研究通常在模拟研究环境中进行，而不是在正在进行的临床研究中进行。本研究严格测试了两种向有资格参加六项实际临床试验（即六项母研究）的参与者呈现关键同意信息的简单且易于采用的策略。
与每项母研究的研究团队合作，我们开发了两种同意干预措施：情况说明书和访谈式视频。每种干预措施的内容均基于为每项母研究批准的同意书中所分享的信息。参与者被随机分配到标准同意程序，或两种干预措施之一。一旦接触到指定的同意模式，参与者就需要完成对理解程度的评估。该研究的目的是确定与接触情况说明书或视频的人相比，接触标准同意的人在同意评估中的表现是否更好。我们还评估了参与者对同意过程的满意度。
共有 284 名参与者被随机分配到三种同意方式之一。从 2017 年 7 月至 2019 年 4 月，共有 273 名参与者完成了对理解程度的评估。与接触标准同意表格过程的人相比，接触视频的人理解得分更高（value=0.020）。与标准同意相比，参与者对视频更满意。与标准同意程序相比，接受情况说明书的参与者在总体理解或满意度得分方面并未获得更高的分数。
在六个不同的临床试验中对两种新的同意干预措施进行的这项随机研究表明，与接触标准同意的人相比，接触视频干预的人在总得分方面的参与者理解存在统计学显著差异。
