Consent (assent) for research with pediatric patients.
OBJECTIVE
To discuss the unique terms and conditions relative to the assent of children and the consent of their parents for research participation, to describe the capabilities of children as they influence understanding of and willingness to participate in research, and to discuss issues related to research participation.


METHODS
Research articles, review articles, clinical experience, and government policies.


CONCLUSIONS
The participation of children in research is complex. Developmental limitations, the imbalance of power between children and adults, and, in some cases, their compromised health status can influence the willingness of children to participate in clinical research.


CONCLUSIONS
Health care providers and researchers must be aware of the need of children to have full disclosure and clear descriptions about research in age-appropriate language. Obtaining a child's agreement to participate in research should be carefully planned and implemented.
Broome
M E
ME
University of Wisconsin-Milwaukee 53201, USA.
D000367:Age Factors; D002648:Child; D002657:Child Development; D032882:Comprehension; D032962:Consent Forms; D036262:Empirical Research; D006801:Humans; D007258:Informed Consent; D033281:Nontherapeutic Human Experimentation; D009859:Oncology Nursing; D010287:Parent-Child Relations; D033282:Parental Consent; D010349:Patient Compliance; D012106:Research / Q000592:standards*; D035842:Research Subjects; D036302:Therapeutic Human Experimentation; D014481:United States