The Evolution of Informed Consent

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.”

Whether relying on the professional standard or the “reasonable person” criterion for informed consent, the question of how much information to share with patients to fulfill the obligation of informed consent remains controversial. “Should we mention all possible risks, even the super rare ones that could unnecessarily worry patients? Or should we simply mention the common ones?” asked Dr. Hong.

According to William McVisk, legal counsel for the American Board of Otolaryngology, clinicians are typically only required to inform patients about the most significant risks of a procedure and not about the many remote risks. “Most procedures have a lot of risks, and you’re not required to inform the patient of every single one of those risks, because you could spend a couple of hours doing so,” he said, underscoring that his perspective is that of an attorney who practices in a state in which informed consent is defined by the professional standard.

One challenge that physicians should keep in mind, according to Dr. Hong, is evidence that patients often get different information from different sources and can have poor recall as to what they’ve been told about the potential risks and benefits of a procedure. “The challenge is that patients hear different things from different surgeons, and they also likely hear and read different information from family and friends and on the internet, which could lead to confusion and poor understanding of their surgical procedure,” he said.

Dr. Hong and his colleagues found evidence of this disparity in a prospective study they published in 2016 that evaluated recall of surgical risks and benefits in 84 parents of children who underwent consultation for adenotonsillectomy and/or tympanostomy tube insertion (Otolaryngol Head Neck Surg. 2016;155:332–339). The study found that only one-third of parents recalled the risks of surgery discussed during the informed consent consultation. An even more important issue, said Dr. Hong, is the finding that the risks and benefits discussed by one surgeon often differed from those mentioned by a different surgeon.

He suggested that surgeons should adapt their discussions around informed consent to each individual patient depending on need. “I think the surgeon should take each interaction separately and try to determine how much (or less) information should be shared with the patient so that they are well informed,” he said.

McVisk advised otolaryngologists to make sure they inform each patient of the important risks of the procedure and to document in the patient’s chart or medical record that they discussed the risks, noting which risks were discussed.

Dr. Grady suspects that physicians could use more education on why informed consent is important. During a recent experience she had talking to a group of surgeons about informed consent, she found that while most surgeons understood that a document needed to be signed prior to a procedure, the surgeons appreciated little beyond that.

“Maybe the form is just one little piece of what they should be doing when they are talking to their patients,” she said, adding that they should also be giving the patient the opportunity to understand the details of what is going on, and giving him or her a choice about it.

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Mary Beth Nierengarten is a freelance medical writer based in Minnesota.