Children are not small adults: documentation of assent for research involving children.
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.
Ungar
David
D
Division of Pediatric Hematology/Oncology, Penn State Children's Hospital, Hershey, PA 17033, USA. dungar@psu.edu
Joffe
Steven
S
Kodish
Eric
E
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