title: Ethical issues in neonatal and pediatric clinical trials.
abstract: Children have been identified as uniquely vulnerable clinical research subjects since the early 1970s. This article reviews the historical underpinnings of this designation, the current regulatory framework for pediatric and neonatal research, and common problems in pediatric research oversight. It also presents 3 areas of pediatric and neonatal research (genomic screening, healthy children donating stem cells, and therapeutic hypothermia for neonates with hypoxic-ischemic encephalopathy) that highlight contemporary challenges in pediatric research ethics, including balancing risk and benefit, informed consent and assent, and clinical equipoise.
authors.affiliation: Division of Neonatal-Perinatal Medicine, Department of Pediatrics and Communicable Diseases, University of Michigan School of Medicine, 8-621 C&W Mott Hospital, 1540 East Hospital Drive, SPC 4254, Ann Arbor, MI 48109-4254, USA. naomilav@med.umich.edu
authors.forename: Naomi
authors.initials: N
authors.lastname: Laventhal
authors.forename: Beth A
authors.initials: BA
authors.lastname: Tarini
authors.forename: John
authors.initials: J
authors.lastname: Lantos
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards; D004992:Ethics, Medical; D035082:Federal Government; D017408:Guidelines as Topic; D006801:Humans; D007231:Infant, Newborn; D007258:Informed Consent; D010372:Pediatrics / Q000941:ethics*; D018570:Risk Assessment; D014481:United States