Informed consent in pediatric clinical trials

Clinical research in children is increasing. Concerns have been raised about both the inclusion and the exclusion of children in such research. Corresponding to these concerns, issues in informed consent for pediatric trials have become more pressing. This review discusses informed consent in pediatric trials and characterizes the latest literature. Research into the consent process has shown that central concepts in pediatric research such as randomization and the distinctions between phases of clinical trials are not uniformly understood by parents or older pediatric patients. Newer approaches that are being developed to help remedy these deficits include the use of staged informed consent, the incorporation of interactive computer technologies to convey complex ideas, and variations in approaches to assent of the child based on multifactorial assessments of competence. Other variables in the consent process that are being studied for their impact on the process include individual life experiences and cultural background. Gaps in federal regulation and oversight of "informed consent" are emerging as new cases test established assumptions. Lessons learned from recent studies regarding oversight of the consent process in pediatric clinical trials, the complex nature of assent, the impact of cultural variables, and more effective means of communicating what is involved in a clinical trial will shape future studies in consent and help to improve the process.