Surrogate Informed Consent: A Qualitative Analysis of Surrogate Decision Makers' Perspectives.

Abstract

Rationale: Clinical critical care research often hinges on surrogate informed consent, as patients commonly lack decision-making capacity because of their acute illness. The surrogate informed consent process has been identified as having flaws and needing improvement. A better understanding of surrogates' perspectives is required to understand and address these shortcomings and thereby improve this process. Objectives: To explore the perspectives of surrogate decision makers of critically ill, mechanically ventilated patients about being approached about having their loved one participate in hypothetical research studies. Methods: We performed semistructured qualitative interviews of surrogate decision makers of critically ill, mechanically ventilated patients, exploring their decisional needs surrounding participation in research. These interviews were recorded and transcribed verbatim. A thematic analysis of transcripts was performed with an iterative group framework using a mixed inductive and deductive approach. Results: A sample of 21 surrogate decision makers were interviewed. Thematic saturation was achieved by the consensus of the investigators. We identified trust as a unifying domain for the themes that emerged through the analytic process. Embedded within the domain of trust, two central themes became apparent: knowledge-based trust and context-based trust. Knowledge-based trust includes subthemes of logistics, accountability, and mutual respect, whereas context-based trust includes trust in the individual clinicians and trust in the hospital system. Conclusions: Our findings highlight the nuanced layers of trust central to the surrogate informed consent process. To enhance the surrogate informed consent process for participation in critical care research studies, it is crucial that researchers recognize the inherent importance of trust to ensure an effective informed consent process.