Objectives: 

To describe legal guardians’ understanding of key concepts in a research consent form presented within 24 hours of their child’s admission to the PICU and to explore legal guardians’ opinions of the format (language, length) of the consent form and the overall consent process.

Design: 

Single-center, exploratory pilot study.

Setting: 

PICU at a tertiary-care hospital in Canada.

Subjects: 

Forty-one English- and French-speaking legal guardians of children less than 18 years old, who had been admitted to the PICU within the past 24 hours and were expected to stay at least 48 hours, between October 2018 and February 2019.

Interventions: 

The consent form from a previous PICU trial was given and explained to legal guardians within 24 hours of their child’s admission to the PICU.

Measurements and Main Results: 

Legal guardians’ understanding of key concepts in the consent form was evaluated using a questionnaire the day after the form was explained, and opinions were collected verbally and using an additional survey. The median number of questions answered incorrectly was three of seven (interquartile range = 2–4). Participants best understood the topic of the study (5% incorrect), but 80% of participants were unable to recall a single risk. The median rating of the language in the form was five of five (very easy to understand; interquartile range = 4–5), and 88% of participants said it was a reasonable length.

Conclusions: 

Despite positive opinions of the consent form, most legal guardians did not understand all key components of the consent information provided to them orally and in writing within 24 hours of their child’s PICU admission. Future studies are required to determine barriers to understanding and explore alternative approaches to obtaining consent in this setting.

中文翻译：

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父母对PICU中研究同意书的理解：一项初步研究。

目标： 

在孩子入院后24小时内以研究同意书的形式描述法定监护人对关键概念的理解，并探讨法定监护人对同意书的格式（语言，长度）和总体同意过程的看法。

设计： 

单中心，探索性试点研究。

设置： 

PICU在加拿大的三级医院。

学科： 

在过去的24小时内被接纳为PICU的年龄在18岁以下的儿童的英语和法语的41名法律监护人，预计在2018年10月至2019年2月之间至少停留48小时。

干预措施： 

法定监护人会在孩子入院后的24小时内向PICU发出先前的PICU试验同意书，并向其解释。

测量和主要结果： 

在解释了同意书的第二天，使用问卷调查了法定监护人对同意书中关键概念的理解，并通过口头调查和其他调查收集了意见。错误回答的问题的中位数是七个中的三个（四分位间距= 2-4）。参与者最能理解研究的主题（错误的占5％），但80％的参与者无法回忆起单一风险。该语言的中位评分为五分之五（非常容易理解；四分位间距= 4-5），而88％的参与者表示这是一个合理的长度。

结论： 

尽管对同意书表示肯定，但大多数法定监护人仍未理解孩子入院后24小时内以口头和书面形式提供给他们的同意信息的所有关键组成部分。需要进一步的研究来确定理解的障碍，并探索在这种情况下获得同意的替代方法。