Informed Consent Challenges: A Mixed-Methods Study of Hospital Ethics Consultations

AbstractIntroduction: Hospital ethics committees guide healthcare workers and patients through complex consent issues. Prior research highlights gaps in consent forms and information delivery, but little is known about real-world ethics consults on consent. This study examines common challenges in consent discussions and compares patient and consult characteristics of consent-related versus other consults. De-identified ethics consult notes and patient data from Vanderbilt University Medical Center, a quaternary care academic medical center (2014-24), were analyzed. Consults were classified as consent or nonconsent related. Chi-square, Fisher's exact, and Wilcoxon rank-sum tests compared characteristics, while logistic regression assessed associations between consent themes. Among 4,127 ethics consults, 137 (3.3%) were consent related. Compared to nonconsent consults, consent consults involved more adult (96.4% vs. 84.2%, p = .005) and female (58.4% vs. 19.0%, p = .001) patients and were more often low in complexity (36.5% vs. 22.8%, p < .001). Common issues included capacity (65.0%), surrogate decision-making (46.0%), communication barriers (38.0%), treatment timing (29.2%), goals of care (20.4%), patient refusal (19.7%), and sensitivity/invasiveness concerns (13.1%). Capacity concerns increased the odds of surrogate decision-making issues (OR = 2.97, 95% CI: 1.51-6.30). Advance directive completion was linked to older age (p = .031) and goals-of-care discussions (50.0% vs. 17.5%, p = .018). Consent-related consults differ in patient demographics and complexity, with capacity, surrogate decision-making, and communication barriers as key concerns. This study provides actionable insights to improve consent protocols, patient-clinician interactions, and ethical decision-making.