title: How confidential trial negotiations and agreements between the Food and Drug Administration and sponsors marginalize local institutional review boards, and what to do about it.
authors.affiliation: School of Medicine, University of Utah, USA.
authors.forename: Howard
authors.initials: H
authors.lastname: Mann
mesh_terms: D001802:Blood Substitutes; D003299:Cooperative Behavior; D004345:Drug Industry / Q000941:ethics*; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006454:Hemoglobins / Q000627:therapeutic use; D006801:Humans; D007258:Informed Consent; D017008:Negotiating; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D012109:Research Support as Topic; D014481:United States; D014486:United States Food and Drug Administration / Q000941:ethics*
chemical_list: D001802:Blood Substitutes; D006454:Hemoglobins; C509893:PolyHeme