The Evolution of Informed Consent

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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.

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.

This is important for court cases in which malpractice is adjudicated based on the legal standard of informed consent of that particular state, but what does it mean in clinical practice or the research arena?

Christine Grady, RN, PhD, chief of the department of bioethics at the National Institutes of Health Clinical Center in Bethesda, Md., recently described the changing face of informed consent (N Eng J Med. 2017;376:856–867). She stated that informed consent has become more regulated and legalistic in recent years, which seems to have led to a shift from prioritizing patient protection to protecting institutions and providers. “This has led to a problem in the way we do informed consent in that it has become more complicated and driven more by institutional concerns and less focused on helping the person get the information they need to decide whether to participate in an ENT procedure or in a clinical study,” she said.

It is hard to say what specific information should be shared with patients during surgical consent … Should we mention all possible risks, even the super rare ones that could unnecessarily worry patients? Or, should we simply mention the common ones?” —Paul Hong, MD

Gaps in Physician and Patient Understanding

“The informed consent process is complex since it involves human interaction,” said Paul Hong, MD, MSc, an associate professor in the division of otolaryngology–head and neck surgery at Dalhousie University in Halifax, Nova Scotia. “It is hard to say what specific information should be shared with patients during surgical consent and whether we should be more standard when discussing surgery.”