title: Regulatory and ethical issues in the conduct of clinical research involving children.
abstract: Children are a uniquely vulnerable population, yet there is an overwhelming need to test safety and efficacy of therapies and preventions in the pediatric population. Results from studies in adults do not provide sufficient or accurate information. Recently, the need for research involving children has been recognized and action has been taken at the federal level to address both the need for pediatric research and the protection of the welfare and rights of children as research subjects. Other ethical and legal issues such as privacy and confidentiality of information are being addressed as well.
authors.affiliation: National Institud of Neurological Disorders and Stroke National Institutes of Health, Bethesda, Maryland 20892, USA. dh83f@nih.gov
authors.forename: Deborah G
authors.initials: DG
authors.lastname: Hirtz
authors.forename: Lorraine G
authors.initials: LG
authors.lastname: Fitzsimmons
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D003219:Confidentiality; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D010372:Pediatrics / Q000592:standards*; D012307:Risk Factors