title: Parental permission for pilot newborn screening research: guidelines from the NBSTRN.
abstract: There is broad recognition of the need for population-based research to assess the safety and efficacy of newborn screening (NBS) for conditions that are not on current panels. However, prospective population-based research poses significant ethical, regulatory, and logistical challenges. In the context of NBS, there have been a variety of approaches that address parental decision-making in pilot studies of new screening tests or conditions. This article presents an ethical and legal analysis of the role of parental permission by the Bioethics and Legal Work Group of the Newborn Screening Translational Research Network created under a contract from the National Institute of Child Health and Human Development to the American College of Medical Genetics and Genomics. Circumstances are outlined in which a waiver of documentation of permission or a waiver of permission may be ethically and legally appropriate in the NBS context. These guidelines do not constitute American Academy of Pediatrics policy.
authors.affiliation: University of Utah, Salt Lake City, Utah;
authors.forename: Jeffrey R
authors.initials: JR
authors.lastname: Botkin
authors.forename: Michelle Huckaby
authors.initials: MH
authors.lastname: Lewis
authors.forename: Michael S
authors.initials: MS
authors.lastname: Watson
authors.forename: Kathryn J
authors.initials: KJ
authors.lastname: Swoboda
authors.forename: Rebecca
authors.initials: R
authors.lastname: Anderson
authors.forename: Susan A
authors.initials: SA
authors.lastname: Berry
authors.forename: Natasha
authors.initials: N
authors.lastname: Bonhomme
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Brosco
authors.forename: Anne M
authors.initials: AM
authors.lastname: Comeau
authors.forename: Aaron
authors.initials: A
authors.lastname: Goldenberg
authors.forename: Edward
authors.initials: E
authors.lastname: Goldman
authors.forename: Bradford
authors.initials: B
authors.lastname: Therrell
authors.forename: Jill
authors.initials: J
authors.lastname: Levy-Fisch
authors.forename: Beth
authors.initials: B
authors.lastname: Tarini
authors.forename: Benjamin
authors.initials: B
authors.lastname: Wilfond
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000592:standards*; D006801:Humans; D007231:Infant, Newborn; D015997:Neonatal Screening / Q000941:ethics* / Q000592:standards*; D010290:Parents; D010865:Pilot Projects; D020458:Third-Party Consent / Q000941:ethics*
keywords: informed consent; newborn screening; parental permission; research; research ethics