When comprehension fails despite repeated efforts, investigators have epistemic evidence that the candidate lacks decision-making capacity, triggering surrogate consent obligations rather than enrollment authorization.

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Candidate(as used in medical ethics): A person being considered for something, in this case someone being evaluated for their ability to make decisions.
Decision-making capacity(referring to people (like young children) who cannot legally or mentally make their own decisions): The mental and legal ability to understand information and make choices about your own care or life.
Enrollment authorization(as used in medical ethics and research): Official permission from a person to include them in a research study or medical program.
Epistemic: "Epistemic" relates to knowledge—how we know things, what counts as knowledge, and whether we can trust what we believe to be true. It comes from the Greek word for knowledge and is used to describe questions about the reliability and validity of our beliefs and understanding. For example, "epistemic humility" means acknowledging the limits of what you can actually know for certain.

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