Participation of children in clinical research: factors that influence a parent's decision to consent.

BACKGROUND

Given the initiatives of the National Institutes of Health and other agencies to include children in research, it is important to understand the factors that influence their participation. This study was designed to identify factors that influence parents' decisions to consent to their child's participation in clinical research.

METHODS

This survey study consisted of 505 parents who had been approached for permission to allow their child to participate in a clinical anesthesia or surgery study at a large tertiary care children's hospital. Regardless of whether the parents consented to (consenters, n = 411), or declined (nonconsenters, n = 94) their child's participation in a study, they were offered the opportunity to complete a questionnaire eliciting information regarding factors that had influenced their decision.

RESULTS

Consenters exhibited less uncertainty in their decision making, were more trusting of the medical system, had greater understanding of the research, and believed that the environment in which consent was sought was less pressured than nonconsenters. Predictors of consent included low perceived risk, degree to which the parent read the consent document, characteristics of the consent document, parental understanding, perceived importance of the study, and perceived benefits.

CONCLUSIONS

Identification of factors that influence parents' decisions to allow their child to participate in a clinical research study will be important by way of developing strategies to improve the manner in which study information is disclosed and to ensure that parents are truly informed.