Epistemological Foundations of Understanding for Informed Consent

Abstract: Although it's widely agreed that informed consent plays a crucial role in clinical and research decision-making, there's still ambiguity regarding the level of understanding required for it to be considered informed. This lack of clarity makes it difficult to compare different levels of understanding and identify evidence-based strategies to improve the informed consent process. This paper deploys two notions of understanding, "objectual understanding" and "explanatory understanding," based on epistemological literature to address this issue. Applying these accounts to the concept of informed consent shows that there are two distinct ways of understanding that ought to be achieved for a patient to provide informed consent, characterized here as "personalized understanding" and "factual understanding." With this reframing, we can better assess patient comprehension and evaluate interventions to support understanding throughout the informed consent process.