title: Enhancing the informed consent process for critical care research: strategies from a thromboprophylaxis trial.
abstract: BACKGROUND
  Critically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers.
  
  
  OBJECTIVE
  To present strategies that may optimise the process of obtaining informed consent from substitute decision-makers for participation of critically ill patients in trials. We use examples from a randomised trial of heparin thromboprophylaxis in the intensive care unit (PROTECT, clinicaltrials.gov NCT00182143).
  
  
  METHODS
  3764 patients were randomised, with an informed consent rate of 82%; 90% of consents were obtained from substitute decision-makers. North American PROTECT research coordinators attended three meetings to discuss enrolment: (1) Trial start-up (January 2006); (2) Near trial closure (January 2010); and (3) Post-publication (April 2011). Data were derived from slide presentations, field notes from break-out groups and plenary discussions, then analysed inductively.
  
  
  RESULTS
  We derived three phases for the informed consent process: (1) Preparation for the Consent Encounter; (2) The Consent Encounter; and (3) Follow-up to the Consent Encounter. Specific strategies emerged for each phase: Phase 1 (four strategies); Phase 2 (six strategies); and Phase 3 (three strategies).
  
  
  CONCLUSIONS
  We identified 13 strategies that may improve the process of obtaining informed consent from substitute decision-makers and be generalisable to other settings and studies.
authors.affiliation: Critical Care Department and Keenan Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada.
authors.forename: Orla M
authors.initials: OM
authors.lastname: Smith
authors.forename: Ellen
authors.initials: E
authors.lastname: McDonald
authors.forename: Nicole
authors.initials: N
authors.lastname: Zytaruk
authors.forename: Denise
authors.initials: D
authors.lastname: Foster
authors.forename: Andrea
authors.initials: A
authors.lastname: Matte
authors.forename: France
authors.initials: F
authors.lastname: Clarke
authors.forename: Suzie
authors.initials: S
authors.lastname: Fleury
authors.forename: Katie
authors.initials: K
authors.lastname: Krause
authors.forename: Tracey
authors.initials: T
authors.lastname: McArdle
authors.forename: Yoanna
authors.initials: Y
authors.lastname: Skrobik
authors.forename: Deborah J
authors.initials: DJ
authors.lastname: Cook
mesh_terms: D032962:Consent Forms; D003422:Critical Care; D004282:Documentation; D032984:Ethics, Research; D006302:Health Services Research; D006801:Humans; D007258:Informed Consent; D007362:Intensive Care Units; D010358:Patient Participation; D013923:Thromboembolism / Q000517:prevention & control
keywords: Clinical research; Critical care; Informed consent; Intensive care; Randomized trials; Studies; Substitute decision-makers