What to disclose? Revisiting informed consent.

Abstract

The requirement of obtaining informed consent before medical procedures is well established. With patients having greater access to information through information technology and owing to other factors, disclosure that goes beyond the traditional elements of the risks, benefits, and alternatives to an intervention is demanded from physicians. We asked if modern informed consent doctrine encompasses such physician-specific variables like professional experience, health, disability, training, qualifications, disciplinary history, FDA-regulatory status pertaining to a medical device, physician research and financial interests, and statistics related to medical outcomes. We searched two major legal databases and identified court opinions and legal reviews that have examined the scope of physician disclosure while obtaining informed consent. From this information, we summarized the prevailing state of informed consent law. Despite the expansion of information available to patients, courts have been hesitant to expand the informed consent doctrine to encompass physician-specific variables. Exceptions involve cases in which such variables directly impacted medical care and the patient could demonstrate their relevance in the informed consent process. Judicial decisions have subtly expanded the doctrine of informed consent beyond its traditional limits, at least in some cases. As informed consent law continues to develop, physicians should ask if information would be material to a reasonable patient while making medical decisions; if so, such information should be disclosed.