BACKGROUND: Most critically ill patients are incapable of providing informed consent for research. OBJECTIVE: We sought to determine patients' preferences for different consent frameworks for enrolling incapable patients into critical-care trials. DESIGN: Prospective observational and structured interview study. SETTING: Five university-affiliated hospitals in Ontario. PATIENTS: Two-hundred and forty consecutive capable and consenting survivors of critical illness. INTERVENTION: Participants considered four frameworks for enrolling incapable patients into clinical trials using a baseline scenario and three permutations for: risk (very low vs. high), treatment type (new vs. currently available), and availability of substitute decision-maker (yes vs. no). MEASUREMENTS AND MAIN RESULTS: For each scenario, patients chose their preferred framework and rated the acceptability of each framework using a seven-point Likert scale. Most (180/240; 76%) patients selected "consent by substitute prior to enrolment" as their preferred framework; this also received the highest baseline acceptability ratings ("acceptable" or "highly acceptable" 207/240; 87%). Modifying risk or treatment type did not substantially change these ratings. A minority of patients rated delayed consent as unacceptable or highly unacceptable in both the baseline scenario (48/240, 20% delayed to substitute; 57/240, 24% delayed to patient) and when a substitute was unavailable (34/240; 15%). CONCLUSIONS: Most survivors of critical illness found the usual practice of obtaining informed consent from a substitute decision-maker prior to enrolment in a clinical trial to be acceptable. Nearly half of patients considered foregoing informed consent to be unacceptable, whereas a minority considered enrolment followed by delayed consent to be unacceptable even when a substitute was unavailable. These approaches should, therefore, only be considered when deviating from the usual practice of obtaining consent from a substitute decision-maker is truly justified, such as where treatments being tested need to be delivered as soon as possible in order to be effective.
BACKGROUND: Most critically illpatients are incapable of providing informed consent for research. OBJECTIVE: We sought to determine patients' preferences for different consent frameworks for enrolling incapable patients into critical-care trials. DESIGN: Prospective observational and structured interview study. SETTING: Five university-affiliated hospitals in Ontario. PATIENTS: Two-hundred and forty consecutive capable and consenting survivors of critical illness. INTERVENTION: Participants considered four frameworks for enrolling incapable patients into clinical trials using a baseline scenario and three permutations for: risk (very low vs. high), treatment type (new vs. currently available), and availability of substitute decision-maker (yes vs. no). MEASUREMENTS AND MAIN RESULTS: For each scenario, patients chose their preferred framework and rated the acceptability of each framework using a seven-point Likert scale. Most (180/240; 76%) patients selected "consent by substitute prior to enrolment" as their preferred framework; this also received the highest baseline acceptability ratings ("acceptable" or "highly acceptable" 207/240; 87%). Modifying risk or treatment type did not substantially change these ratings. A minority of patients rated delayed consent as unacceptable or highly unacceptable in both the baseline scenario (48/240, 20% delayed to substitute; 57/240, 24% delayed to patient) and when a substitute was unavailable (34/240; 15%). CONCLUSIONS: Most survivors of critical illness found the usual practice of obtaining informed consent from a substitute decision-maker prior to enrolment in a clinical trial to be acceptable. Nearly half of patients considered foregoing informed consent to be unacceptable, whereas a minority considered enrolment followed by delayed consent to be unacceptable even when a substitute was unavailable. These approaches should, therefore, only be considered when deviating from the usual practice of obtaining consent from a substitute decision-maker is truly justified, such as where treatments being tested need to be delivered as soon as possible in order to be effective.
Authors: D P Sulmasy; P B Terry; C S Weisman; D J Miller; R Y Stallings; M A Vettese; K B Haller Journal: Ann Intern Med Date: 1998-04-15 Impact factor: 25.391
Authors: Nicole Davis; Anne Pohlman; Brian Gehlbach; John P Kress; Jane McAtee; Jean Herlitz; Jesse Hall Journal: JAMA Date: 2003-04-16 Impact factor: 56.272
Authors: K E A Burns; L Rizvi; O M Smith; Y Lee; J Lee; M Wang; M Brown; M Parker; A Premji; D Leung; M Hammond Mobilio; L Gotlib-Conn; R Nisenbaum; M Santos; Y Li; S Mehta Journal: Intensive Care Med Date: 2014-12-10 Impact factor: 17.440
Authors: Massimo Antonelli; Elie Azoulay; Marc Bonten; Jean Chastre; Giuseppe Citerio; Giorgio Conti; Daniel De Backer; François Lemaire; Herwig Gerlach; Goran Hedenstierna; Michael Joannidis; Duncan Macrae; Jordi Mancebo; Salvatore M Maggiore; Alexandre Mebazaa; Jean-Charles Preiser; Jerôme Pugin; Jan Wernerman; Haibo Zhang Journal: Intensive Care Med Date: 2010-02-23 Impact factor: 17.440