title: Meeting the governance challenges of next-generation biorepository research.
abstract: Advances in clinical translational research have led to an explosion of interest in infrastructure development and data sharing facilitated by biorepositories of specimens and linked health information. These efforts are qualitatively different from the single-center sample collections that preceded them and pose substantial new ethics and regulatory challenges for investigators and institutions. New research governance approaches, which can address current and anticipated challenges, promote high-quality research, and provide a robust basis for ongoing research participation, are urgently required.
authors.affiliation: Institute of Translational Health Sciences, University of Washington, Seattle, WA 98195, USA. smfllrtn@u.washington.edu
authors.forename: Stephanie M
authors.initials: SM
authors.lastname: Fullerton
authors.forename: Nicholas R
authors.initials: NR
authors.lastname: Anderson
authors.forename: Greg
authors.initials: G
authors.lastname: Guzauskas
authors.forename: Dena
authors.initials: D
authors.lastname: Freeman
authors.forename: Kelly
authors.initials: K
authors.lastname: Fryer-Edwards
mesh_terms: D035041:Anonymous Testing; D018070:Biological Specimen Banks / Q000458:organization & administration*; D035843:Biomedical Research / Q000458:organization & administration*; D006801:Humans; D057170:Translational Research, Biomedical / Q000458:organization & administration / Q000639:trends