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How Informed Is Informed Consent?

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"I understand what you're saying but it all feels a bit crazy to me y'know? I mean, I walked in here feeling fine. Sure I have a little shortness of breath when I'm on the gym bike for an hour, but I'm fine, and now you're telling me I have cancer and need to get either surgery or radiation? How am I even supposed to decide?" 

The patient before me was well educated; he worked as a lawyer in some niche area for a firm I had never heard of but sounded impressive. He had an early glottic cancer, so both surgery and radiation were potential options. I had gone over the laryngoscopy video as well as described the situation using a large larynx model that we keep in our clinic. He had asked thoughtful questions, and I could see his mind working as he tried to process all the information that had just been laid out to him. Over the course of the next two weeks, as he met with the radiation oncologist and returned for further discussion, what began as a fairly routine clinic encounter prompted me to think deeper about the notion of informed consent.

Informed consent is a daily feature of modern medicine. From the "consent" that patients are required to give for a telehealth visit to the signature on a surgical consent form, informed consent is an ever-present aspect of the practice of medicine. Yet its meaning is a slippery concept. At the most basic level, it implies that the person giving permission or consent has received sufficient information to make an educated decision. Legally, various standards have been proposed such as the reasonable patient standard, which states, "What would the average patient need to know to be an informed participant in the decision?"

In practice, meeting any such standard quickly becomes a lot more murky. In medical school, we are taught to tailor information to the education level of the patient. The average reading education level in the U.S. is said to be at the eighth grade level. Best practice recommendations for written information suggest aiming for the sixth to seventh grade level, according to the National Institute for Health, or even lower to a fourth to sixth grade level, according to the Agency for Healthcare Research and Quality. Meanwhile, health care has become so specialized in certain fields such as oncology that even a "general" oncologist may not be able to understand all the treatment nuances and provide meaningful input on a subspeciality cancer patient. 

All of this preamble returns me to the patient I mentioned at the beginning. Is it even possible for a patient to make an informed decision in care as specialized, as nuanced, as oncology care? How is one individual to weigh the pros and cons of a particular cancer treatment that may have symptoms and side effects 10 or even 20 years down the line? As an otolaryngologist who has seen many laryngeal cancer survivors from across the spectrum of disease treated with a range of modalities, I have the benefit of the long view. Yet for the patient, this is their "N of 1." As physicians, we have a greater understanding of the spectrum of options and potential outcomes; for a patient, all they have is their own lived experience and the medical information they receive in the clinic room or what they research themselves. 

The informed consent discussion involves no less than the merging of our personal experience, the medical literature, and our assessment of the unique individual case before us, followed by an attempt to distill our recommendations down to a level of detail and tone that we think the patient will be able comprehend in order to render a decision. Having done this thousands of times for all manner of procedures, from the most simple to those that are so complex even non-otolaryngology physicians would struggle to know how to move forward, I wonder how often it is even possible to make an informed decision.

While informed consent historically has been conceptualized as the laying out of facts about the various options and potential pros and cons for each, with the goal of a patient making a clinical decision, there are other values to the consent process. Often neglected in the discussion is the important role the informed consent process plays in building trust and understanding between the physician and patient. The process of informed consent involves laying out the facts and describing the options and painting a picture for the patient about what the future might entail should they opt for a particular option. In its most therapeutic form, it should not be a one-sided conversation. It is an opportunity to better understand a patient's expectations about the road ahead and a chance to respond to their concerns and any fears.

This is best illustrated in situations where there really is only one option forward, and yet informed consent still involves much more than signing on a dotted line. For example, for a young healthy patient with a tumor stage I anterior tongue cancer, the obvious next step is surgery. Typically, other modalities of treatment are not in the conversation, and the only real alternative of doing nothing but observing is hardly an alternative at all. Yet even in this case, going over the procedure, the expected recovery process, and potential complications plays an important role in allowing a patient to prepare themselves for the future ahead. Thus, informed consent serves multiple purposes — fulfilling a legal check box and allowing rapport to be built, expectations to be set, and deeper wishes and goals to be explored. 

How do you approach complex informed consent conversations? Share your insight in the comment section below.

Dr. Neelaysh Vukkadala completed his residency in otolaryngology-head and neck surgery at Stanford University and is currently a laryngology fellow at UCLA. He is interested in medical ethics, quality improvement and teaching. He enjoys writing, hiking and landscape photography and can be found on Instagram at @picturesbynv. Dr. Vukkadala was a 2022-2023 Doximity Op-Med Fellow.

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