title: Defining Research Risk in Standard of Care Trials: Lessons from SUPPORT.
abstract: Recent controversy surrounding the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) and the Office for Human Resource Protection's (OHRP) judgment that its informed consent procedures were inadequate has unmasked considerable confusion about OHRP's definition of research risks. The controversy concerns application of that definition to trials comparing multiple treatments within the existing standard of care. Some have argued that it is impossible for such trials to pose research risks on the grounds that all risks associated with a standard-of-care treatment should instead be considered risks of treatment. However, analysis of OHRP's definition demonstrates that some risks in such trials can be research risks.
authors.affiliation: California University of Pennsylvania, California, Pennsylvania, USA.
authors.forename: Joel K
authors.initials: JK
authors.lastname: Press
authors.forename: Caryn J
authors.initials: CJ
authors.lastname: Rogers
mesh_terms: D001766:Blindness / Q000517:prevention & control*; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D015337:Multicenter Studies as Topic; D010100:Oxygen / Q000008:administration & dosage; D033282:Parental Consent; D016032:Randomized Controlled Trials as Topic; D012106:Research; D012306:Risk; D059039:Standard of Care
chemical_list: D010100:Oxygen
keywords: informed consent; research risk; standard of care