Improving Informed Consent: Suggestions from Parents of Children with Leukemia

Objective: The objective of this study was to report suggestions for improving the informed consent process from the perspective of parents of children with leukemia.

Methods: Recommendations for improving informed consent were elicited from 140 parents of children who had been offered participation in a randomized clinical trial for the treatment of their acute leukemia. Four different methods and data collection time points were used with this group of parents, including open-ended, in-person interviews within 72 hours after the informed consent conference; follow-up telephone interviews 6 months after diagnosis; focus groups during year 3 of the project; and a parent advisory group on informed consent meeting in year 4.

Results: The most frequently cited suggestions for improving informed consent during the interviews and focus groups related to giving parents more time to make their decision, the amount and type of information provided, organization of the consent conference, communication style, and providing additional materials. During the parent advisory group on informed consent meeting, parents developed specific guidelines for organization of the information that is presented during the consent process that include 7 major components: timing, sequence, checklist, checking for understanding, anticipatory guidance, segue into randomized clinical trial discussion with historical perspective, and choice.

Conclusions: Through the incorporation of parental perspectives that provide an authentic stakeholder voice, our research represents a true partnership approach to improving the consent process. Parents provided practical advice for improving informed consent that can be applied to most adult and pediatric patient populations.