Informed Consent in Clinical Care

Abstract

INFORMED CONSENT IS A FUNDAMENTAL TENET OF THE US health care system, rooted in the ethical principles of respect for patient autonomy and enhanced patient wellbeing. As famously stated in a pivotal court case, “every human being of adult years and sound mind has a right to determine what shall be done with his own body.” Over the past century, that has come to mean that patients should be able to participate in decisions about their medical care, weighing the risks, benefits, and alternatives of a proposed intervention to ensure that the care they receive reflects their goals, preferences, and values. Although practice varies widely, the current reality of informed consent for medical and surgical interventions often falls far short of stated goals. In many settings clinical informed consent involves a laundry list of potential risks recited to a patient who has already committed to a procedure, followed by the requisite signatures on a form. It is not surprising that patient comprehension is often poor. In a recent study of patients who had just provided informed consent for elective diagnostic cardiac catheterization with possible percutaneous coronary intervention, 88% had mistaken beliefs about the benefits of the procedure. Without a basic understanding of risks, benefits, and alternatives, patients cannot meaningfully participate in decision making (although providing such information does not guarantee that patients will understand the information, use it, and use it wisely). Although failures of informed consent can have disastrous consequences, more commonly the process simply takes up valuable time and does little to promote patient autonomy or well-being, leading to cynicism of some physicians and patients who view informed consent as a legal nuisance without true meaning, and the conclusion of some scholars that expectations for patient understanding and involvement in medical care are unreasonable. Accumulating evidence suggests that the informed consent process can be improved. A recent systematic review identified 44 controlled trials of a wide range of interventions designed to improve patient comprehension in informed consent for medical and surgical procedures. While standardized measures of understanding in informed consent are lacking, the majority of these studies showed some benefit. The challenge lies in how to implement these research findings to achieve an agreed-on minimum standard of comprehension, with the overall goal of elevating the process of informed consent in clinical care to fulfill the ethical principles on which the process was founded. In this pursuit, 3 practical issues bear special consideration.