Informed consent is a critical component of patient care. It is an opportunity for patients to learn about treatment options and ask probative questions about procedures. The informed consent process is the best way for most patients to evaluate benefits and personal risk of treatment. While it is essential for the healthcare provider who is performing the informed consent process to be fully knowledgeable, is the treating physician the only medical professional that can reliably obtain informed consent? The Pennsylvania Supreme Court thinks so.
In 2017, the Pennsylvania Supreme Court ruled in Shinal v. Toms MD that a physician may not obtain informed consent through an intermediary. While this ruling has had immediate implications for the practice of medicine in Pennsylvania, other states are taking notice and reevaluating their practices for obtaining informed consent. While it is not yet a nationwide ruling, healthcare administrators are erring on the side of caution and establishing institution-level rules insisting that physicians obtain patients informed consent themselves. This fear of litigation is even extending to clinical trial enrollment, as some institutional review boards are insisting that physician investigators obtain informed consent prior to clinical trial participation.
Shinal v. Toms MD
The Pennsylvania Supreme Court decision was based on a procedure performed by Stephen Toms MD on Megan Shinal in 2008. The procedure was a total resection of a recurrent craniopharyngioma, during which Dr. Toms perforated Ms. Shinal’s carotid artery leaving her with permanent neurologic deficits. Dr. Toms discussed the risks and benefits of subtotal versus total tumor resection along with the surgical risks. Ms. Shinal consented to surgery, but at the time of this consultation had not decided whether to pursue total versus subtotal resection. The patient signed the informed consent form in the presence of a physician assistant who discussed issues regarding incision location, scarring, and the need for adjuvant radiation.
Ms. Shinal’s attorneys argued that the form did not include a discussion about the risks specific to total vs. subtotal resection. The lawsuit claims that Toms failed to adequately explain the risks of surgery and that had the patient known about the lower risk subtotal resection, she would have chosen that option.
The initial jury was instructed to consider whether Dr. Toms legally provided all of the necessary information to obtain informed consent either himself or through a qualified provider, in this case the physician’s assistant. The jury returned a verdict in favor of the surgeon, which was upheld by an appellate court. However, the Pennsylvania Supreme Court reversed that ruling in a 4 to 3 decision. The Court ruled that the physician may “not fulfill through an intermediary the duty to provide sufficient information to obtain a patient’s informed consent.” Because of this “intermediary” language, clinical and research institutions across the country are broadly interpreting this to mean that physicians are the only people legally capable of obtaining informed consent.
Clinical practice v. The law
Prior to this pivotal Pennsylvania case, physicians broadly interpreted their responsibility in the informed consent process as one that could be passed to a competent provider. In teaching hospitals, this is often the role of the intern or medical student. In other places, obtaining informed consent is under the purview of the physician assistant, nurse practitioner, or surgical nurse. Personal and professional ethics dictate that surgeons would provide initial consultation with the patient during which time treatment options would be discussed along with risks and benefits (the fact that Dr. Toms did this is in the Shinal case is not in dispute). The process of actually signing of the informed consent forms—while legally important and binding—is often considered in clinical practice as a rather menial task provided that the patient has actually been informed and has actually provided consent. From a clinical perspective, as long as the person obtaining consent has adequate knowledge of the risks and benefits of the procedure and can explain these issues such that the patient can make an informed decision, it should not matter that the healthcare provider is a physician.
The Court held that only the physician could perform this task. In their decision they cite other rulings that held that the physician’s education, training, and unique relationship with the patient mean that “the physician is in the best position to know the patient’s medical history and to evaluate and explain the risks of a particular operation in light of the particular medical history.”
The Court’s interpretation on the physician’s role in modern medicine seems rather antiquated. While the physician does play a profoundly important role in a patient’s life, it is no longer a unique role. Nurse practitioners are admirably filling the role of patient care in ways that only physicians once did. Moreover, many medical professionals have the requisite knowledge and competency to obtain informed consent without the skills necessary to actually perform the procedure itself. Team-based medical practice has been the norm for several decades. Holly Fernandez Lynch and coauthors write in the New England Journal of Medicine the Court’s insistence that “the treating physician personally provide all consent-related disclosures is an anachronism in a team-based health care system.” With this ruling, the court has severely restricted the process of informed consent and, in so doing, seems to have endorsed a model of healthcare from the last millennium.
How Shinal v. Toms MD affects you
Obviously, the immediate impact of this decision applies to medical practices that operate within the Commonwealth of Pennsylvania. Certainly within Pennsylvania, physicians must now take a primary role in obtaining informed consent. Some organizations have interpreted this ruling to mean the physician who is primarily responsible for the surgery must obtain informed consent. This systematically changes pre-surgical workflow, especially in larger institutions and training hospitals.
The ruling has been applied unevenly outside of Pennsylvania. If you have not reviewed your institution’s informed consent policies within the past year, it would be prudent to do so. Jurisdictions around the country are looking at the Pennsylvania ruling as a sign of what’s to come, or at least a potential legal vulnerability. If you operate your own practice and perform procedures that require informed consent, it seems reasonable to at least consider a novel workflow in which the primary physician provider obtains informed consent from consultation to witnessing the patient’s signature. Hospital administrators should be working closely with their legal departments to review the informed consent process and minimize legal exposure. Unfortunately, higher levels of legal responsibility may ultimately translate to higher professional liability insurance premiums; however, there is no direct evidence to suggest that this has happened to date.
Clinical researchers should follow the requirements laid out by their local Institutional Review Board. The FDA states that an “investigator” must obtain informed consent, and that investigator does not have to be a physician as long as they are able to perform those study functions. However, just as clinical organizations are taking an expansive interpretation of the new Pennsylvania case law, trial sponsors may soon do so as well. It seems prudent to be aware of the current and potential future changes to the informed consent process, and to assess your unique level of professional legal exposure. As it stands now, however, the only fully legally defensible position is for the physician who is primarily responsible for performing the procedure to obtain informed consent.