title: Ability of family members to predict patient's consent to critical care research.
abstract: OBJECTIVE
  A European Union Directive provides for the designation of a surrogate who can consent to or refuse inclusion of an incapacitated patient in research studies. The accuracy with which surrogates consent to research on behalf of patients has not been evaluated in the intensive care unit (ICU).
  
  
  METHODS
  A prospective multicenter study was conducted in ten ICUs of the French Famirea study group between July and October 2004. Two hypothetical studies were simultaneously submitted to the patient, surrogate, and physician at the time that the patient was discharged to a ward. One study involved minimal risk and the other greater-than-minimal risk to the patients.
  
  
  RESULTS
  With the minimal risk study there was patient-surrogate discrepancy in 32% of cases and patient-physician discrepancy in 25%. Corresponding figures with the greater-than-minimal risk study were 42% and 46%. None of the collected variables differed significantly between cases with and without patient-surrogate discrepancy.
  
  
  CONCLUSIONS
  Family members designated to serve as surrogate decision makers may fail to accurately consent to research for critically ill patients in one-third to nearly one-half of cases.
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Medical Intensive Care Unit and Biostatistics Department, Saint-Louis Teaching Hospital, Paris, France.
authors.forename: Magali
authors.initials: M
authors.lastname: Ciroldi
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Medical Intensive Care Unit, Cochin Teaching Hospital, Paris, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Cariou
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Medical-Surgical ICU, Delafontain Hospital, Saint-Denis, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Adrie
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Raymond Poincaré Teaching Hospital, Garches, France.
authors.forename: Djilali
authors.initials: D
authors.lastname: Annane
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Strasbourg Teaching Hospital, Strasbourg, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Castelain
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Avicenne Teaching Hospital, Bobigny, France.
authors.forename: Yves
authors.initials: Y
authors.lastname: Cohen
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.
authors.forename: Arnaud
authors.initials: A
authors.lastname: Delahaye
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.
authors.forename: Luc Marie
authors.initials: LM
authors.lastname: Joly
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Pontoise Hospital, Pontoise, France.
authors.forename: Richard
authors.initials: R
authors.lastname: Galliot
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Saint-Joseph Hospital, Paris, France.
authors.forename: Maité
authors.initials: M
authors.lastname: Garrouste-Orgeas
authors.affiliation: Saint Marguerite Teaching Hospital, Marseille, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Papazian
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Michel
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Medical Intensive Care Unit and Biostatistics Department, Saint-Louis Teaching Hospital, Paris, France.
authors.forename: Nancy Kenstish
authors.initials: NK
authors.lastname: Barnes
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Medical Intensive Care Unit and Biostatistics Department, Saint-Louis Teaching Hospital, Paris, France.
authors.forename: Benoit
authors.initials: B
authors.lastname: Schlemmer
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Medical Intensive Care Unit and Biostatistics Department, Saint-Louis Teaching Hospital, Paris, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Pochard
authors.affiliation: Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France. elie.azoulay@sla.ap-hop-paris.fr.|Medical Intensive Care Unit and Biostatistics Department, Saint-Louis Teaching Hospital, Paris, France. elie.azoulay@sla.ap-hop-paris.fr.
authors.forename: Elie
authors.initials: E
authors.lastname: Azoulay
mesh_terms: D000328:Adult; D000368:Aged; D003422:Critical Care; D005190:Family / Q000523:psychology*; D005260:Female; D005602:France; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D010817:Physician-Patient Relations; D011446:Prospective Studies; D019727:Proxy / Q000523:psychology*; D012106:Research