IntroductionThere is increasing interest in patient and family-centered methods to improve research consent processes in the intensive care unit (ICU) environment. Because of the complexities of ICU care, measures of impact from multiple perspectives, including patients, substitute decision makers (SDMs) and research personnel, are required.ObjectiveTo determine what outcome measures have been used to assess the quality of informed consent for adult ICU-based research.MethodsWe conducted a scoping review of ICU-based clinical research, involving adult patients, SDMs, and/or research personnel, that reported any outcome measure assessing the quality of informed consent. Screening and data charting were completed in duplicate. Charted data included study, participant and outcome measure characteristics. We summarized characteristics using descriptive statistics and narrative summaries.ResultsWe screened 18,164 unique citations, 102 full-texts, and included 9 studies. No studies used the same outcome measure. Most (n = 8, 89%) used a subjective questionnaire-based assessment of the consent process, while one (11%) measured quality by time to consent decision. We identified seven constructs assessed by outcomes: 1) consent discussion experience; 2) experience making consent decisions; 3) knowledge of parent study; 4) consent document experience; 5) perceived research risk; 6) experience of research, and 7) research processes.ConclusionsWe identified a limited, heterogeneous body of literature assessing the quality of informed consent for ICU-based research. This highlights an important gap and an unmet need for the development and validation of comprehensive outcome measures to evaluate the quality of informed consent from the perspectives of patients, SDMs and research personnel.