title: Informed Consent Should Be a Required Element for Newborn Screening, Even for Disorders with High Benefit-Risk Ratios.
abstract: Over-enthusiastic newborn screening has often caused substantial harm and has been imposed on the public without adequate information on benefits and risks and without parental consent. This problem will become worse when genomic screening is implemented. For the past 40 years, there has been broad agreement about the criteria for ethically responsible screening, but the criteria have been systematically ignored by policy makers and practitioners. Claims of high benefit and low risk are common, but they require precise definition and documentation, which has often not occurred, undermining claims that involuntary testing is justified. Even when the benefits and risks are well established, it does not automatically follow that involuntary testing is justified, a position supported by the widespread tolerance for parental refusal of immunizations and newborn screening.
authors.affiliation: Norman Fost, M.D., M.P.H., Professor Emeritus of Pediatrics at the University of Wisconsin, founded the Bioethics Program and the Child Protection Team at UW in 1973. He was been Chair of the Hospital Ethics Committee since 1984, and, for 31 years, chaired the Health Sciences Institutional Review Board. Dr. Fost has received lifetime achievement awards from the American Academy of Pediatrics and the Office of Human Subjects Protection, and was the first recipient of the Patricia Price Browne Prize in Bioethics. He has served on the FDA Pediatric Advisory Committee and is a member of the NIH Recombinant DNA Advisory Committee.
authors.forename: Norman
authors.initials: N
authors.lastname: Fost
mesh_terms: D006801:Humans; D007231:Infant, Newborn; D007258:Informed Consent; D015997:Neonatal Screening; D016017:Odds Ratio; D033282:Parental Consent; D018570:Risk Assessment