title: Ethical issues in neonatal research involving human subjects.
abstract: Research involving critically ill neonates creates many ethical challenges. Neonatal clinical research has always been hard to perform, is very expensive, and may generate some unique ethical concerns. This article describes some examples of historical and modern controversies in neonatal research, discusses the justification for research involving such vulnerable and fragile patients, clarifies current federal regulations that govern research involving neonates, and suggests ways that clinical investigators can develop and implement ethically grounded human subjects research.
authors.affiliation: Albert Einstein College of Medicine, Bronx, NY; Department of Pediatrics, Division of Neonatology, Children's Hospital at Montefiore, Bronx, NY. Electronic address: arf@fleischman.net.
authors.forename: Alan R
authors.initials: AR
authors.lastname: Fleischman
mesh_terms: D035843:Biomedical Research / Q000941:ethics; D002986:Clinical Trials as Topic; D016638:Critical Illness; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D015199:Extracorporeal Membrane Oxygenation / Q000941:ethics; D035082:Federal Government; D017408:Guidelines as Topic; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000628:therapy*; D007258:Informed Consent / Q000941:ethics*; D009359:Neonatology / Q000941:ethics / Q000639:trends; D018579:Patient Selection / Q000941:ethics*; D014481:United States
keywords: federal regulations; neonatology; research ethics