title: An open letter to institutional review boards considering Northfield Laboratories' PolyHeme trial.
abstract: At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme and saline in the field and, still without consent, randomized between PolyHeme and blood after arrival at an emergency department. The Federal regulations that govern the waiver of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood-the standard treatment for hemorrhagic shock-is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards.
authors.affiliation: University of Hawaii, Manoa, USA.
authors.forename: Ken
authors.initials: K
authors.lastname: Kipnis
authors.forename: Nancy M P
authors.initials: NM
authors.lastname: King
authors.forename: Robert M
authors.initials: RM
authors.lastname: Nelson
mesh_terms: D001802:Blood Substitutes / Q000009:adverse effects / Q000627:therapeutic use*; D001803:Blood Transfusion; D004636:Emergency Service, Hospital / Q000941:ethics* / Q000331:legislation & jurisprudence; D004638:Emergency Treatment / Q000941:ethics*; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006454:Hemoglobins / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D012107:Research Design; D012771:Shock, Hemorrhagic / Q000628:therapy; D012965:Sodium Chloride / Q000627:therapeutic use; D012996:Solutions / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001802:Blood Substitutes; D006454:Hemoglobins; C509893:PolyHeme; D012996:Solutions; D012965:Sodium Chloride