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Reimagining Informed Consent: From Disclosure to Comprehension

SSRN Electronic Journal(2023)

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Abstract
Half a century ago, the legal doctrine of informed consent was presumably transformed, in order to enshrine the ethical goals of ensuring autonomous, voluntary, and informed decision making in medicine into law. The reasonable patient standard introduced in Canterbury v. Spence and Cobbs v. Grant sought to center the patient, by requiring that the physician disclose all information that a reasonable person in the patient’s position would consider material to her decision making. However, those efforts, while laudable, have proven inadequate to achieving the ethical principles they were intended to achieve.The legal doctrine of informed consent’s focus on the adequacy of physician disclosures – both in documents and conversations – emphasizes ritual over relationships. It has proven to be both needlessly adversarial and backward-looking, leading physicians to assume more disclosure is better for the purposes of preventing liability. In effect, the law’s onerous legal requirements necessitate over-disclosure at the expense of patient understanding, rendering it ineffective at actually informing voluntary decision making. And the objective reasonable person standard has proven inadequate in shifting the emphasis from physician disclosure to patient comprehension.This Article introduces a new element to an informed consent claim: subjective patient understanding of the risks, benefits, and alternatives of the proposed intervention. This proposal transforms the standard for informed consent to emphasize patient comprehension and consent, rather than solely focusing on physician disclosure, in order to ensure the lofty ethical goals of clinical informed consent.
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Key words
informed consent,disclosure
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