Consent in critical care trials: a survey of Canadian research ethics boards and critical care researchers.

Abstract: Purpose: Reliance on third party consent for patients without decision-making capacity presents unique challenges for critical care research. We compared the attitudes and beliefs of Canadian research ethics boards (REBs) and intensive care unit researchers toward the use of various consent models for a low-risk randomized controlled trial. Materials and Methods: Self-administered, scenario-based survey. Results: Sixty-two percent of eligible REBs (n = 83) and 78% of eligible researchers (n = 124) completed the questionnaire. The REBs were less comfortable endorsing alternative consent models when a substitute decision maker was unavailable, including consent provided by (a) the intensivist involved with the trial (2.0% vs 15.3%; P = .014), (b) the intensivist not involved with the trial (10.0% vs 36.7%; P = .001), (c) 2 physicians (the intensivist and another consultant, neither of whom is involved with the trial) (18.0% vs 54.1%; P < .001), and (d) 2 physicians involved neither with the trial nor the patient''s care (10.2% vs 52.0%; P < .001). In similar circumstances, REBs were less comfortable approving both deferred (8.0% vs 43.3%; P < .001) and waived (4.1% vs 22.4%; P = .005) consent. Conclusions: In this survey of scenarios involving low-risk critical care research, REBs were significantly more conservative in approving alternative consent models compared with investigators. [Copyright &y& Elsevier]