Healthcare and Life Sciences Scholarship Winner 2017

Kendall Bielak — University of Virginia School of Medicine

Kendall Bielak is an M.D. candidate at the University of Virginia School of Medicine. Kendall argues that the conventions of informed consent are flawed because they focus more on protecting physicians from malpractice suits rather than offering patient preference. She calls for the proliferation of the subjective standard – a method of informed consent that emphasizes shared decision making between physician and patient, patient individuality, and patient autonomy.

Medicine and law are often considered distinct entities. At times, they can even seem at odds with each other. But the reality is, in modern times, medicine and law are intertwined and inseparable. There are countless contemporary issues that transcend the boundaries of one specialty and begin to muddy the waters of the other.

One such point of contention is the idea of true informed consent. For most, informed consent is currently a mere formality. Physicians lament the extra, unnecessary paperwork to cover legalities. The fear of a malpractice suit is so strong that the underlying essence of informed consent has been lost in a stack of paperwork. However, at the same time, patients also suffer from not truly understanding what they are consenting to. In this scenario—one that too often happens in the current medical world—neither party wins. The real challenge of a personalized, educational conversation about informed consent has yet to be adequately addressed by the law and consequently by many physicians.

Informed consent legally requires that physicians discuss important information about a treatment plan with all patients. Voluntary informed consent was first emphasized in the United States after the infamous Tuskegee Syphilis incident. In this experiment, patients were not informed about the study and were denied treatment for a curable disease. The injustices suffered by this vulnerable population as well as the atrocities executed during the Holocaust sparked the need for revaluation of proper voluntary informed consent of patients in experiments.

Yet, over the years, informed consent has become an unspecific checklist of items to protect the physician from a malpractice suit. It is a convention that often leads to misunderstanding. Patients often do not recall what was discussed with them, and physicians often do not ask about the patient’s preferences or goals for care. Some physicians worry that discussing the risks will lead to patients refusing a beneficial treatment. In some hospitals, patients fill out their informed consent on a computer screen with no physician in sight. It is not personalized and not a conversation. Civil malpractice lawsuits are used to discipline physicians that did not properly elicit consent from the patient. In response, many physicians push for tort reform to limit the amount of money that can be awarded from malpractice suits. To break this vicious cycle, physicians and lawyers should instead focus on creating informed consent practices that highlight shared decision making between the physician and the patient. This would help improve the patients’ understanding of their plan of care while also protecting physicians from avoidable malpractice suits.

Shared decision making, in my opinion, is the effective remedy. It is markedly different from merely “consenting the patient”—a phrase used by many physicians which suggests that the patient will agree to all the statements laid in front of them. Not only is this improper grammar, but it also highlights the issue that consent has been taken from the patient rather than given freely from the patient. Contrastingly, shared decision making emphasizes the conversation between a physician and patient. This is where the physician informs the patient about the nature of the treatment, benefits, risks, consequences, and credible alternatives. It then lets the patient contemplate and decide which option is best for them. It allows the patient to consider questions surrounding cultural acceptability, personal preference, quality of life, and more. At its core, shared decision-making focuses on patient autonomy rather than physician preference.

At present, there are two general schools of thoughts in U.S. state law that concern informed consent: the professional standard, and the patient-based standard. The professional standard focuses on what a “reasonable physician of ordinary skill would disclose in the same or similar circumstances” whereas the patient-based standard focuses on what a “reasonable patient in the same or similar situation would find material to make the medical decision”. Many physicians practice the professional standard, disclosing only what they think is necessary often in hard paternalistic style. Meanwhile, the patient-based standard is often more detailed for the patient but can still be lacking in personalization.

This is why many professionals are suggesting an alternative strategy called the subjective standard. The subjective standard states that physicians should provide an individualized consent process with information that the patient would find relevant as well as unique to their circumstance. Although similar, the patient-based standard asks what the average patient would find relevant rather than discussing what each individual patient finds relevant. In syntax, this is only a difference of a few words; yet in practice, this could be revolutionary for the patient that falls outside the scope of average. The hope among many is that this will become the new gold standard for physicians; however, for lawyers, this would be difficult to prove in a court of law. It would be extremely challenging to navigate hindsight bias where what is crucial information presently may not have been crucial information before the fact. In this scenario, what is good for the patient and what is good for the law are in direct conflict.

This divide is where we need to start implementing reform. The subjective standard needs to have integrity that can be upheld in the court of law. Perhaps this integrity could come in the form of permitting only the active physician and patient to discuss matters of informed consent. Additionally, perhaps informed consent forms should provide a checkbox that the patient was able to “teach back” the information discussed to the doctor. Maybe the informed consent form should not only address the checklist but also incorporate a patient’s past medical history, surgical history, and patient characteristics. Imagine a physician saying, “the risk of heart attack from this procedure is 1 in 10,000 but your risk based on your past medical history is actually 1 in 100”. This becomes even more important as many patients use Google to understand generalized risk but then do not understand their personal risk. Such a consent form would also allow physicians to discuss both short- and long-term goals of care during the consent process. For example, a physician would be able to easily recognize and highlight that a short-term removal of a fibroid might harm the long-term goal of becoming pregnant. These are a few ideas, but like any important issue, it will require much more thought and conversations between patients, physicians, and lawyers to settle rigorously and completely.

Change does not happen easily. Reform always takes time. Yet, adaptations that highlight patient preference and autonomy are critically important and can lead to greatly improved patient safety. Although the subjective standard is fluid, with time physicians and lawyers will both be able to reconcile its use in the clinic and the court.