Grant: Project Grant

In pediatric research, permission for a child to participate is usually obtained from the child's legal guardian. When possible, the child also participates in the decision making and gets to voice whether or not they would like to be part of the study. This important process is referred to as "assent". Children in the Pediatric Intensive Care Unit (PICU) are suffering from critical illness, and often have high levels of distress. Most PICU studies require time-sensitive enrollment within the first 24-48 hours after the child has been admitted. As a result, obtaining assent for research in the PICU is very challenging, especially because there are no clear guidelines on the best assent processes to use in this unique population. Our long-term goal is to develop guidelines for assent in Canadian pediatric critical care research. However, it is very important that these guidelines are based on patient and family preferences. The goal of this proposal is to explore the perspectives of PICU patients and their parents/caregivers towards assent in the PICU, including how they would like the assent process to be carried out and their perceived barriers to the assent process in this environment. To do this, we will perform two studies, a survey study and an interview study, in four Canadian PICUs. Twenty PICU patients and 20 parents/caregivers of PICU patients will be invited to participate in the interview study, and 100 families will be invited to participate in the survey study. We will aim to recruit a diverse study cohort, with specific attention paid to underrepresented minorities. The results of these studies will represent the initial step towards creating guidelines for assent in Canadian PICU research. Clear guidance will address the challenges associated with obtaining assent for research in the PICU, and increase the frequency of involving PICU patients in the decision-making process around research participation.