1. An Alternative Consent Process for Minimal Risk Research in the ICU.
- Author
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Terry, Melissa A., Freedberg, Daniel E., and Morris, Marilyn C.
- Subjects
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INTENSIVE care units , *SEX surrogates , *TERTIARY care , *HOSPITAL admission & discharge , *HOSPITALS , *INFORMED consent (Medical law) , *COMPARATIVE studies , *CROSS infection , *EXPERIMENTAL design , *LONGITUDINAL method , *RESEARCH methodology , *MEDICAL cooperation , *PSYCHOLOGY of parents , *PATIENT psychology , *RESEARCH , *RESEARCH funding , *PSYCHOLOGICAL stress , *TIME , *EVALUATION research , *RELATIVE medical risk , *PSYCHOLOGICAL factors , *PSYCHOLOGY - Abstract
Objectives: Seeking 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.Design: Prospective cohort study.Setting: Five ICUs within a tertiary care hospital.Patients: Newly admitted ICU patients 18 years old or older.Interventions: We 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 Results: One 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%).Conclusions: Most 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. [ABSTRACT FROM AUTHOR]- Published
- 2017
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