title: Children are not small adults: documentation of assent for research involving children.
abstract: Obtaining assent is an important part of research involving children, both from an ethical and regulatory perspective. Current practice for documenting assent is derived largely from documentation of informed consent for adults as there is little guidance in federal regulations. We propose a new approach to documenting assent.
authors.affiliation: Division of Pediatric Hematology/Oncology, Penn State Children's Hospital, Hershey, PA 17033, USA. dungar@psu.edu
authors.forename: David
authors.initials: D
authors.lastname: Ungar
authors.forename: Steven
authors.initials: S
authors.lastname: Joffe
authors.forename: Eric
authors.initials: E
authors.lastname: Kodish
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics; D003657:Decision Making / Q000941:ethics; D004282:Documentation; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D010372:Pediatrics / Q000941:ethics; D035842:Research Subjects