• Orla M Smith, Ellen McDonald, Nicole Zytaruk, Denise Foster, Andrea Matte, France Clarke, Suzie Fleury, Katie Krause, Tracey McArdle, Yoanna Skrobik, and Deborah J Cook.
• Critical Care Department and Keenan Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada.
• Intensive Crit Care Nurs. 2013 Dec 1;29(6):300-9.

BackgroundCritically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers.ObjectiveTo 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).Methods3764 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.ResultsWe 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).ConclusionWe identified 13 strategies that may improve the process of obtaining informed consent from substitute decision-makers and be generalisable to other settings and studies.Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

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