Reforming Informed Consent to Include Comprehension: A Proposal to Promote Equity in Medical Decision-Making

The ethical goals of the legal doctrine of informed consent are lofty. The law requires that clinicians explain the risks, benefits, and alternatives of proposed treatments to patients, and to respect patient autonomy through voluntary, informed medical decisions aligned with individual values and preferences. Yet in practice, patients often struggle to comprehend the risks and alternatives of a proposed medical intervention. Since investigators began analyzing the sufficiency of informed consent, it has been recognized that the current rules, which focus solely on clinical disclosures, are inadequate in addressing disparities associated with education, race/ethnicity, and age.

Despite technically “adequate” disclosures under the legal doctrine of informed consent, patients may consent to major procedures with little substantive grasp of the risks. Shifting the law’s emphasis from disclosures alone to disclosure and comprehension will better align the ethical goals of informed consent with the legal rules that govern it.