The informed consent process is ubiquitous throughout the healthcare system. Clinicians who offer care, particularly those who perform invasive procedures, and researchers seeking to answer questions are required to ensure that patients understand the potential risks and benefits that result from the procedures they are offered. These patients are asked to acknowledge their understanding by signing a document—an informed consent form.
Explore this issue:December 2017
But what constitutes understanding? This question stands at the crux of the ever-evolving definition of informed consent. Initially, the focus steered toward the “consent” aspect of the process; current interpretations tend to focus on how “informed” the patient should be.
Since the 1950s, the notion of reasonableness has been critical to the process of informed consent. To date, approximately half of U.S. states have legally adopted the most current definition of informed consent, which essentially indicates that a physician is required to disclose information on the benefits and risks of a procedure that a “reasonable person” would want to know. In the other states, informed consent is still based on a “professional standard,” in which physicians are required to inform patients only of the risks and benefits of a procedure that another physician would find reasonable.