Accountability for Informed Consent in Healthcare
Laura M. Cascella, MA, CPHRM
Issues related to informed consent are a persistent area of concern in healthcare and a source of liability exposure. MedPro malpractice claims data show that more than one-fourth of all communication-related malpractice cases involve allegations associated with informed consent.1 Many of these allegations are related to inadequate consent processes and failure to manage patient expectations.
Because of these risks and the important role that informed consent plays in patient-centered care and shared decision-making, healthcare providers and organizations should assess their consent policies and protocols to identify improvement opportunities and monitor for adherence. An initial task during the assessment should focus on reviewing policies related to accountability for the consent process, including responsibility for having the consent discussion with the patient, responding to follow-up questions, and completing appropriate documentation.
MedPro maintains that the informed consent process is a nondelegable duty. This position has been upheld in case law, including a notable court ruling in Pennsylvania. That case, Shinal v. Toms,2 involved a patient who was undergoing surgery to remove a brain tumor. The patient was referred to a neurosurgeon who met with her to discuss surgery options and risks.
A few days after the consultation, the patient called the medical center with several follow-up questions related to scarring, the need for radiation therapy, and timing of the procedure. The neurosurgeon’s physician assistant (PA) answered the patient’s questions, and later the PA provided the patient with additional information about the surgery and obtained her signature on the informed consent form.
After suffering severe injuries during the procedure, including brain injury and partial blindness, the patient filed a lawsuit alleging inadequate informed consent.3 In a 4-3 ruling in favor of the plaintiff, the Pennsylvania Supreme Court held that:
Informed consent requires direct communication between physician and patient, and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patient’s informed consent belongs solely to the physician.4
Although this ruling was controversial, it raised a warning flag and gave healthcare providers and organizations a reason to carefully consider their consent policies and who is involved in the informed consent process.
Over the years, MedPro has consistently advised policyholders that the healthcare provider who is performing the surgery, procedure, or treatment must conduct informed consent discussions with the patient — or in certain cases, the patient’s guardian or authorized representative.
Qualified staff members may also participate in the informed consent process by providing general educational information and reinforcing specific information that the treating healthcare provider has communicated to the patient. However, if a patient has questions or is wavering about a decision, staff should refer the patient back to the treating practitioner.
Although these examples of staff involvement are generally accepted practices in many healthcare settings, providers should stay alert to state laws, evolving professional guidance, and other potential cases that might establish case law related to informed consent.
Further, healthcare providers should avoid the common misperception that a signed consent form, by itself, demonstrates consent. The form merely documents one phase of the informed consent process. For patients to be truly “informed,” they must understand the information that they have received from their healthcare providers. Thus, as part of the consent process, providers should consider:
- Each patient’s understanding of their condition and the proposed treatment plan
- Each patient’s overall capacity to understand
- Cultural considerations and personal values that might affect each patient’s decision-making
- Any communication barriers that could impede the consent process
Additionally, patients should have ample time during appointments to ask questions, voice concerns, and clarify information with the treating provider.
For more information about the framework for informed consent and legal/professional considerations, see MedPro’s guideline titled Risk Management Strategies for Informed Consent. For curated resources on this topic, see MedPro’s Risk Resources: Informed Consent.
Endnotes
1 MedPro Group communication-related cases, closed 2012-2023.
2 Shinal v. Toms, 162 A. 3d 429 (Pa: Supreme Court 2017); Justia, Shinal v. Toms M.D. (majority). Retrieved from https://law.justia.com/cases/pennsylvania/supreme-court/2017/31-map-2016.html
3 Crane, M. (2017, November 30). Legal risks of delegating informed consent to an NP or PA. Medscape. Retrieved from www.medscape.com/viewarticle/887074
4 Shinal v. Toms, 162 A. 3d 429 (2017)
