title: Conduct of emergency research in patients unable to give consent--experiences and perceptions of patients, their consent providing next of kin, and treating physicians following a prehospital resuscitation trial.
abstract: OBJECTIVE
  According to a directive of the European Parliament, informed consent is required to conduct a clinical trial also in emergencies when the patient is unable to provide consent. In these cases surrogate consent can be obtained from the patient's next of kin. There are no reports describing how patients and their next of kin perceive this policy. The perceptions of patients and their spouses involved in an emergency trial conducted under surrogate consent were surveyed.
  
  
  METHODS
  A survey was sent to survivors of prehospital cardiac arrest, to consent providers regardless of patient outcome, and to physicians who had recruited the patients.
  
  
  RESULTS
  11 (92%) patients, 17 (68%) consent providers, and all physicians returned the survey. All held a positive attitude towards emergency research and were willing to participate without own consent in a trial approved by an institutional review board (IRB). Opinions among responding groups were similar albeit a significant difference regarding the perceived capability of the consent provider to decide upon patient's enrolment. Spouses felt able to provide consent, but physicians were sceptical of this. Patients and their spouses would have appreciated additional information regarding the index trial after the acute phase.
  
  
  CONCLUSIONS
  Emergency research was perceived positively by cardiac arrest victims and their spouses previously involved in a resuscitation trial. Possible own participation in an emergency trial without personal consent was considered acceptable. Patients and their spouses would prefer additional research information after enrolment.
authors.affiliation: Critical Care Medicine Research Group, Tampere University Hospital, TAYS PL2000, Tampere, Finland. antti.kamarainen@uta.fi
authors.forename: Antti
authors.initials: A
authors.lastname: Kämäräinen
authors.forename: Tom
authors.initials: T
authors.lastname: Silfvast
authors.forename: Sini
authors.initials: S
authors.lastname: Saarinen
authors.forename: Janne
authors.initials: J
authors.lastname: Virta
authors.forename: Ilkka
authors.initials: I
authors.lastname: Virkkunen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001291:Attitude of Health Personnel; D004632:Emergency Medical Services / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D058687:Out-of-Hospital Cardiac Arrest / Q000628:therapy*; D010820:Physicians / Q000941:ethics*; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000592:standards; D012151:Resuscitation / Q000941:ethics* / Q000379:methods; D013997:Time Factors