Enhancing the informed consent process for critical care research: Strategies from a thromboprophylaxis trial

Critically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers. To present strategies that may optimise the process of obtaining informed consent from substitute decision-makers for pa...

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Bibliographic Details
Published in:Intensive & critical care nursing 2013-12, Vol.29 (6), p.300-309
Main Authors: Smith, Orla M., McDonald, Ellen, Zytaruk, Nicole, Foster, Denise, Matte, Andrea, Clarke, France, Fleury, Suzie, Krause, Katie, McArdle, Tracey, Skrobik, Yoanna, Cook, Deborah J.
Format: Article
Language:English
Subjects:
Clinical research
Closure
Consent
Consent Forms
Critical Care
Decision makers
Decision making
Documentation
Ethics, Research
Health Services Research
Humans
Informed Consent
Intensive care
Intensive Care Units
Medical research
Nursing
Patient Participation
Patients
Randomized trials
Sick people
Studies
Substitute decision-makers
Thromboembolism - prevention & control
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Summary:Critically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers. 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). 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. 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). 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.
ISSN:0964-3397
1532-4036
DOI:10.1016/j.iccn.2013.04.006