title: Roles and actions of IRBs as it relates to the process of drug and device development.
authors.affiliation: Mount Sinai School of Medicine, New York, NY 10029, USA. Jeff.Silverstein@mssm.edu
authors.forename: Jeffrey H
authors.initials: JH
authors.lastname: Silverstein
authors.forename: Carol
authors.initials: C
authors.lastname: Bienstock
mesh_terms: D018795:Device Approval; D017277:Drug Approval; D015195:Drug Design; D028744:Ethics Committees, Research / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D032984:Ethics, Research; D006801:Humans; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D014481:United States