Context: ICU patients are often rendered incapable of
making decisions as a result of their illness. The accuracy with which
patients’ surrogates consent to research on their behalf is not
Objective: To determine if surrogate decision
makers provide accurate consent for intensive care research.
Design: Cross-sectional, paired, face-to-face
Setting: A large, managed-care, cardiac
Patients and participants: One
hundred elective cardiac surgery patients and their self-appointed
surrogates were enrolled.
agreed or declined to provide informed consent to two hypothetical
research trials. One trial represented minimal risk to those enrolled;
the other trial represented greater-than-minimal risk. Surrogates
attempted to predict the patients’ responses.
measures: The accuracy of surrogate consent was analyzed in a
fashion analogous to the evaluation of a diagnostic test. Predictors of
accuracy were evaluated using multiple logistic regression.
Results: Overall surrogate positive predictive value for
the low-risk study was 84.0% and for the high-risk study was 79.7%
(p = 0.72, McNemar test). Predictors of accurate consent were not
consistent across the two studies.
Surrogate decision makers for critical-care research resulted in
false-positive consent rates of 16 to 20.3%. Further assessment and
evaluation of the practice of surrogate consent for intensive care
research is, therefore, recommended.