Why substitute decision makers provide or decline consent for ICU research studies: a questionnaire study

Research participants’ opinions of delayed consent for a randomised controlled trial of glucose control in intensive care

“…Participants in this study preferred relatives to make consenting decisions on their behalf when they were unable. Relatives were mostly a spouse or partner and adult children, similar to the identity of relatives who provided consent for research in a Canadian ICU [6]. No patients or substitute decision makers withdrew or withheld consent for data usage subsequent to enrolment using delayed consent at the Royal North Shore Hospital.…”

“…No patients or substitute decision makers withdrew or withheld consent for data usage subsequent to enrolment using delayed consent at the Royal North Shore Hospital. A survey of substitute decision makers who were approached for consent for research in ICU found those who had declined would have changed their decision to agree when asked 24-48 h later because of more time to consider the study and changes in the patient's condition [6].…”

“…The need for immediate treatment can mean that patients or their substitute decision makers do not have the time necessary to make informed decisions, and it can be difficult to access the substitute decision maker in time to enroll the patient into a clinical trial [1,2]. When available, substitute decision makers can be emotionally overwhelmed from the circumstances of the patient's illness and have been reported to experience anxiety, depression, and fatigue [3][4][5], such that they are unable to consider participation of the patient in research [6]. Delayed consent involves the enrolment of patients who lack decision making capacity into a clinical trial before obtaining consent.…”

Considering the vulnerabilities of surrogate decision-makers when obtaining consent for critical care research

“…Mehta and colleagues surveyed 95 SDMs who had previously been approached about enrolling their critically ill relative into a clinical trial to learn why they had agreed (72%) or declined (28%) to participate [6]. Those SDMs who had agreed to enroll their loved one most frequently cited that the research study might help others (N = 62, 91%), that research is important for medical progress (N = 60, 88%), that they trusted the medical team (N = 59, 87%), and that they believed the patient would have agreed to participate (N = 48, 71%).…”

ICU research: the impact of invasiveness on informed consent

“…Nonetheless, this was an increase on our pilot study. Such participation rates are not rare in ICU research [20,23,24,36,37], especially for complex questionnaires on vignettes. This is undoubtedly due to patients' considerable residual fatigue and other impairments after recent ICU stays (Fig.…”