title: Characterizing the level of risk in pediatric research: an ethical examination of the federal regulations.
abstract: Federal regulations require that the level of risk posed by pediatric research be classified as "minimal," "greater than minimal," or "a minor increase over minimal" Interpretation of the meaning of the levels has produced a significant literature exploring the ethical basis for making these determinations. This article examines the ethical basis of a variety of approaches proposed in the literature for classifying pediatric research risk. These approaches strive to take into account how society decides which risks are routinely accepted for children outside of research. It is concluded that ways of classifying risk should compare research risks to normal risks for children without special disability and take into account the concerns of the research subject's community.
authors.affiliation: Cook Children's Health Care System, Fort Worth, Texas, USA. maynard.dyson@cookchildrens.org
authors.forename: Maynard
authors.initials: M
authors.lastname: Dyson
authors.forename: Kayhan
authors.initials: K
authors.lastname: Parsi
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence*; D035082:Federal Government; D033161:Government Regulation; D006805:Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence*; D006801:Humans; D007223:Infant; D033242:Minors / Q000331:legislation & jurisprudence*; D010372:Pediatrics / Q000941:ethics / Q000331:legislation & jurisprudence; D018570:Risk Assessment; D014481:United States