• Melissa A Terry, Daniel E Freedberg, and Marilyn C Morris.
• 1Department of Medicine, Division of Digestive and Liver Diseases, Columbia University Medical Center, New York, NY. 2Department of Pediatrics, Critical Care Medicine, Columbia University Medical Center, New York, NY.
• Crit. Care Med. 2017 Sep 1; 45 (9): 1450-1456.

ObjectivesSeeking consent for minimal risk research in the ICU poses challenges, especially when the research is time-sensitive. Our aim was to determine the extent to which ICU patients or surrogates support a deferred consent process for a minimal risk study without the potential for direct benefit.DesignProspective cohort study.SettingFive ICUs within a tertiary care hospital.PatientsNewly admitted ICU patients 18 years old or older.InterventionsWe administered an eight-item verbal survey to patients or surrogates approached for consent to participate in a minimal risk, ICU-based study. The parent study involved noninvasive collection of biosamples and clinical data at the time of ICU admission and again 3 days later. If patients had capacity at the time of ICU admission, or if a surrogate was readily available, consent was sought prior to initial sample collection; otherwise, a waiver of consent was granted, and deferred consent was sought 3 days later. Quantitative and qualitative data were analyzed.Measurements And Main ResultsOne hundred fifty-seven individuals were approached for consent to participate in the parent study; none objected to the consent process. One hundred thirty-five of 157 (86%) competed the survey, including 94 who consented to the parent study and 41 who declined. Forty-four of 60 individuals (73%) approached for deferred consent responded positively to the question "Did we make the right choice in waiting until now to ask your consent?" three of 60 (5%) responded negatively, and 13 of 60 (22%) made a neutral or unrelated response. The most common reason given for endorsing the deferred consent process was the stress of the early ICU experience 25 of 44 (61%).ConclusionsMost patients and surrogates accept a deferred consent process for minimal risk research in the ICU. For appropriate ICU-based research, investigators and Institutional Review Boards should consider a deferred consent process if the subject lacks capacity and an appropriate surrogate is not readily available.

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