<p>This paper argues that viewing informed consent as an autonomous action is problematic because it is based on an idealized conception of the person and of autonomy. Instead, informed consent should be viewed as the objective activity of real, concrete persons. In this activity, an individual, acting as a subject, authorizes a specific object for a particular purpose. A person’s choice is fundamentally constrained by the reality of both the object and the subject (the individual themselves). Accordingly, individuals must understand the nature of the object and its relevance to their own situation in order to make appropriate decisions. However, since cognitive activity is fundamentally constrained by practical conditions, there is no assurance that individuals can achieve sufficient understanding when making a consent decision. Therefore, the cognitive goal of informed consent should not be to ensure complete understanding in advance but to maximize the likelihood that sufficient understanding will be achieved. The appropriate cognitive threshold must also vary according to the actual circumstances of each individual. On this basis, the paper proposes a more complete informed consent process consisting of three stages: pre-consent communication, post-consent verification, and consent process optimization.</p>

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Reconceptualizing Informed Consent as the Objective Activity of Real Person

  • Cong Pang

摘要

This paper argues that viewing informed consent as an autonomous action is problematic because it is based on an idealized conception of the person and of autonomy. Instead, informed consent should be viewed as the objective activity of real, concrete persons. In this activity, an individual, acting as a subject, authorizes a specific object for a particular purpose. A person’s choice is fundamentally constrained by the reality of both the object and the subject (the individual themselves). Accordingly, individuals must understand the nature of the object and its relevance to their own situation in order to make appropriate decisions. However, since cognitive activity is fundamentally constrained by practical conditions, there is no assurance that individuals can achieve sufficient understanding when making a consent decision. Therefore, the cognitive goal of informed consent should not be to ensure complete understanding in advance but to maximize the likelihood that sufficient understanding will be achieved. The appropriate cognitive threshold must also vary according to the actual circumstances of each individual. On this basis, the paper proposes a more complete informed consent process consisting of three stages: pre-consent communication, post-consent verification, and consent process optimization.