Informed Consent and Patient Understanding: Ethical and Legal Considerations for Healthcare Providers

What happens when constraints such as a language barrier make it difficult for your patient to understand the risks, benefits, and alternatives to the plan of care?

A physician handing over a consent agreement to a patient.

(Originally published September 2021. Updated February 2022)

Informed consent forms are a routine part of most patient visits. But don’t overlook this standard practice — a lack of proper informed consent can lead to adverse legal and ethical consequences.

Patient informed consent forms have two primary goals. First, they ensure that your patient understands and freely offers their consent. Second, they protect you against liability for failing to obtain a patient’s consent to treatment. But what happens if constraints, like language barriers, make these goals harder to accomplish? Do physicians and other healthcare professionals really face lawsuits over consent issues?

Legally, informed consent requirements attempt to ensure that patients control their bodies.  Providing informed consent usually requires healthcare providers to cover various topics relating to the patient’s treatment, such as the nature of the treatment a patient might receive, possible risks and benefits of treatment, optional alternatives, and the risks and benefits of refusing treatment.

Healthcare providers who do not obtain informed consent open themselves up to the risk of medical malpractice lawsuits. Even further, the informed consent given by a provider to a patient typically must be “adequate.” 

In the event of a lawsuit, the court will look at the facts. Generally, the courts evaluate adequacy by asking what a reasonable clinician would provide to the patient under the same or similar circumstances. Testimony of expert witnesses, who discuss the common and accepted practices in that particular field, help establish the parameters of “reasonable.” In short, courts base their rulings on informed consent on accepted industry practices and the specific circumstances of each case.

When working with patients who may not understand English, providers may be unsure how to obtain informed consent. A 2016 case from Illinois shows how understanding isn’t the only factor in assessing the effect of consent forms that the patient has signed. 

In Mizyed v. Palos Community Hospital, a patient had signed consent forms acknowledging that he understood his treating physicians were not hospital employees.  However, he was a native Arabic speaker who could speak only limited English and read neither language.

While hospitalized, the patient contracted an infection and sued both his physician and the hospital. The court dismissed his case against the hospital because the consent forms’ terms explicitly stated that its physicians were not employees.

Additionally, the Illinois Appellate Court, First District focused on the fact that the patient’s daughter understood English. She reviewed the forms and instructed the patient to sign them.  Although his daughter later acknowledged that she did not read the forms, the hospital had no way of knowing that she did not communicate the form’s terms to the patient.

In this case, the hospital avoided legal consequences in the patient’s lawsuit because of his signature on the consent forms. But, aside from liability, what about the patient’s true understanding of the parameters of his treatment? The goal of consent forms is to actually obtain a patient’s consent to the terms of his treatment.

Physicians and other healthcare providers are in the best position to assess likely treatment risks. Therefore, providers bear the responsibility of educating their patients about those risks. They should do so not just to follow the law but because it’s the ethical way to proceed with treatment.  

In our view, informed consent should be patient-centered. A patient-centered approach tailors care to the needs of each patient and allows patients to participate in decision-making actively. Patient-centered informed consent forms respect the patient’s typically lower level of medical knowledge and understanding.  It requires more than just a signature. It requires a conversation. This holds especially true when the patient and provider have a language barrier.

Patients who feel that they received treatment to which they didn’t consent may feel betrayed by their providers. As a result, they become distrustful of the medical system. This does patients and providers a disservice, and it undermines the patients’ dominion over their bodies. 

Furthermore, a lack of trust can fuel a malpractice complaint when a known (but not fully comprehended) risk comes to fruition. Some courts, like the court in Mizyed, may spare healthcare providers if they obtain a signature. Still, the best business and ethical practices establish trust between the patient and their provider. In doing so, they also prevent disgruntled patients.

What if I use telehealth?

The use of telehealth may complicate matters further. With the patient behind a screen, it becomes more difficult to effectively communicate, especially if the patient does not speak English. Moreover, connectivity problems, sound issues, or background noise can limit patient focus and understanding when providing patients the information they need to make an informed decision.

Here are some of the ways to make informed consent more “informed” when utilizing telehealth.

Inform patients of the considerations they should make ahead of a telehealth visit.

The environment in which a patient participates in a telehealth visit can have a huge impact on the ability to understand. Urge patients to find a quiet, comfortable space to access the telehealth session ahead of the visit. Such language could be included in your intake paperwork, or in an email reminder to the patient ahead of their appointment. Considerations should be written in a way that the patient can understand. 

A telehealth visit should be no different than an in-person visit in this regard. Ensure discussions about informed consent take place first thing during the appointment.

Include a discussion of how telehealth changes the scope of the visit.

A key part of informed consent is understanding what you as a medical professional can and cannot do. Make sure your discussion of informed consent includes details about how the visit on telehealth takes place and what limitations telehealth places on the visit and their care.

Give the patient opportunities to ask questions.

Giving patients the opportunity to ask questions or request clarification is key when using telehealth, since connectivity or sound issues may disrupt the conversation. Don’t rush the conversation, and take pauses to make sure you’re addressing the patient’s needs.

Confirm mutual understanding between you and the patient.

Try to ensure that the contents of the conversation are understood clearly by each patient. For patients that do not speak English, utilizing an interpreter may be helpful. Giving patients a written summary of the conversation to look at can also be helpful for non-native speakers and visual learners alike. 

See our related article “Obtaining Informed Consent In Telehealth.”

Key Points to Remember

  • Illiteracy doesn’t exempt patients from the terms of the consent forms that they sign. When a person signs a document, the act of signing it generally signifies that they had an opportunity to review and understand the document’s terms.
  • A patient’s inability to understand English is not a determinative factor in assessing the effect of their signed consent forms. Still, the best business and ethical practices establish trust between the patient and their provider, which can be hindered by a language barrier. Practices that work to reduce this language barrier may have happier and more knowledgeable patients. 
  • While providers are generally not required to warn patients about “remote” risks, the determination of what qualifies as a “remote risk” is often subjective.
  • A failure to obtain a patient’s informed consent to treatment constitutes grounds for a medical malpractice lawsuit.  In a typical case, the patient asserts that they would have made a different decision if the provider had informed them of the risks of treatment. 
  • Using telehealth might make consent conversations more difficult. Healthcare practices should have policies to ensure that an adequate informed consent conversation takes place whether the patient is at the office or at home.

The patient’s goals and values should drive provider-patient relationships.  Providers should obtain genuine and comprehensive consent each time they treat a patient, even if a language barrier exists. Providers should pay attention to body language, leave space for patients to reflect and ask questions, and be sure to pose follow-up questions intended to elicit affirmative responses from the patient about the impending treatment.

A Healthcare Attorney Can Help

Obtaining informed consent begins with customized forms for your practice and medium of communication (i.e., in-office vs. telehealth). However, true consent requires a conversation about the risks, benefits, and alternatives to the plan of care. An experienced attorney can help prepare forms that may jumpstart these conversations for you and your patients. If you operate in one of the states where Jackson LLP practices, book a free consultation to learn if our informed consent services fit your needs.

This blog is made for educational purposes and is not intended to be specific legal advice to any particular person. It does not create an attorney-client relationship between our firm and the reader and should not be used as a substitute for competent legal advice from a licensed attorney in your jurisdiction.

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