Parental Understanding of Research Consent Forms in the PICU: A Pilot Study.

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.