title: Human participants challenges in youth-focused research: perspectives and practices of IRB administrators.
abstract: The purpose of this research was to understand institutional review board (IRB) challenges regarding youth-focused research submissions and to present advice from administrators. Semistructured self-report questionnaires were sent via e-mail to administrators identified using published lists of universities and hospitals an Internet searches. Of 183 eligible institutions, 49 responded. One half indicated they never granted parental waivers. Among those considering waivers, decision factors included research risks, survey content, and feasibility. Smoking and substance abuse research among children was generally considered more than minimal risk. These findings are consistent with those from a study conducted by Mammel and Kaplan (1995), which investigated IRB practices concerning protocols involving adolescent participants. IRBs and investigators need to become aware of regulations' flexibility to ensure adequate participant protection. Investigators need to limit jargon and assumptions about participants' understanding of research objectives.
authors.affiliation: RTI International, Rockville, MD, USA.
authors.forename: Diane K
authors.initials: DK
authors.lastname: Wagener
authors.forename: Amy K
authors.initials: AK
authors.lastname: Sporer
authors.forename: Mary
authors.initials: M
authors.lastname: Simmerling
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Flome
authors.forename: Christina
authors.initials: C
authors.lastname: An
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Curry
mesh_terms: D000288:Administrative Personnel; D000293:Adolescent; D035841:Behavioral Research / Q000941:ethics*; D003625:Data Collection; D028744:Ethics Committees, Research; D006801:Humans; D033282:Parental Consent; D018570:Risk Assessment; D012907:Smoking; D019966:Substance-Related Disorders; D014481:United States