By Kevin Klauer, DO, EJD

Chief Medical Officer, TeamHealth, Knoxville, TN

Dr. Klauer reports no financial relationships relevant to this field of study.

Informed consent is critically important with respect to patient autonomy and individual choice. However, the purpose and intent often are lost and relegated to nothing more than signing a form. The informed discussion is critical to the informed consent process and meeting the applicable standard of care for obtaining informed consent. Thus, the content of that discussion is more important than a signature on a form, which frequently doesn’t include enough details about the information shared with the patient. The concept of shared decision-making adds complexity to the idea of informed consent.

Shared decision-making and informed consent are related conceptually, but distinctly different in effect. They both address the necessary focus on patient autonomy and patient-centered care. However, merely including patients in the decision-making process (when appropriate) and conversing with a patient about treatment options is no surrogate for informed consent and its required elements. Ideally, shared decision-making is used when reasonable treatment options exist for a specific injury or disease entity. However, the need to obtain informed consent for the proposed treatment is an entirely different question.

History of Informed Consent

Historically, informed consent finds its roots in common law, emphasizing that, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.”1 In this context, informed consent was applied in terms of battery, as opposed to the current (and more appropriate) context: the tort of negligence. In the 1960s, this doctrine evolved, including the addition of a requirement calling for information to be provided about the associated risks of the proposed treatment and any treatment alternatives that may be available.2

In 1972, Canterbury v. Spence brought new clarity to this concept by using the “reasonable patient” standard to define the scope of required disclosure. Although every possible detail, obscurity, or remote risk need not be disclosed, the practitioner must disclose what a reasonable patient would want to know about the proposed treatment or procedure.3

In this case, a laminectomy was performed. However, despite the physician’s knowledge that the procedure may result in paralysis in 1% of patients, he did not disclose this risk. As we see frequently in claims, the unlikely becomes the unfortunate reality. The procedure was performed, and then the patient fell out of bed, resulting in paralysis.

Although we’ll never know if the fall or the procedure was the cause of his paralysis (a question of causation), this case emphasized the patient’s perspective, identifying that a material risk is one when a reasonable person would want to be informed about a potential risk. A physician must recognize the patient’s position, identifying what a reasonable person would consider a risk and would need to know to make an informed decision.3

Case Law

Currently, state statutes are split between the reasonable professional standard/professional standard (what a physician under similar circumstances would consider necessary to inform the patient about) and the reasonable patient standard. Recognizing the need for patient autonomy and a focus on patient-centered care may have fueled momentum in favor of the more patient-centric approach.

A minority of states have adopted a hybrid approach, using the professional standard, but incorporating the requirement to include additional information that the practitioner knows the patient may want. Although the “reasonable professional” or “professional standard” is the historical approach, the Canterbury case has given ample notice to all physicians that considering the patient’s position is critically important to obtaining informed consent.

Further emphasizing the “reasonable patient” standard is Nixdorf v. Hicken.4 The surgeon left a needle in the patient and was determined to have a duty to disclose information about the patient’s treatment, including the patient’s condition after treatment. Additional case law has imposed more obligations on the clinician.

Gates v. Jenson held that specific interests (financial or personal) that may influence the physician’s judgment must be disclosed (i.e., consent for a research protocol in which a physician has a proprietary interest in the subject matter).5

Jandre v. Physicians Insurance Company of Wisconsin noted that all diagnostic tests that may rule out a possible condition be disclosed.5 Of particular importance is the common requirement to inform a patient about risks that are specific to his or her situation.

For instance, if a patient is an aspiring pianist, risks to the hands may be greater to that person than they are to the average patient. It is wise to inquire about a patient’s vocation to make certain such details are covered in the informed discussion.5

State Statutes

State statutes vary and are complex, including exceptions and jurisdiction-specific nuances. However, two exceptions are fairly standard. The first is implied (emergency) consent. If the patient is unconscious or rendered incapable of providing his or her informed consent and the benefits of treatment outweigh the potential risk of harm, informed consent is not required. However, the wise clinician will document the circumstances requiring implied consent. It is worth emphasizing that this exception does not include when a clinician is very committed to the treatment and believes it is the correct choice for the patient. The two elements of being incapable of providing informed consent and the benefits outweigh any potential harm from the associated risks are required for the use of emergency, implied consent.

In general, the following components should be included in the informed discussion for consent for a proposed treatment or procedure: an explanation of the proposed treatment, the risks and benefits associated with the proposed treatment, the anticipated outcomes, and any treatment alternatives (including non-treatment).6

Additionally, medical decision-making capacity should be verified and documented. Considering the required elements for a valid informed consent, the distinction between informed consent and shared decision-making becomes clearer. For instance, treating an ankle sprain with analgesics, ice, a stirrup splint, and crutches vs. ice, analgesics, and progressive weight bearing may be an appropriate shared decision-making discussion. However, neither of these two options or any of the proposed treatments would require informed consent.

The applicable standard of care for informed consent is misapplied frequently. Some institutions require informed consent for all procedures (i.e., laceration repairs), while others do not obtain informed consent routinely for the administration of tissue plasminogen activator (tPA) for ischemic stroke.

A reasonable approach to follow when considering which procedures or treatments require informed consent is whether the risks and benefits of the proposed treatment are intuitive to the reasonable patient. Thus, patients who present to the ED for a laceration repair generally understand that the wound will be examined, irrigated, and repaired in some way. The routine laceration does not require consent beyond the general consent for treatment. However, if the patient’s laceration repair will include a technique with additional risk or staff will administer moderate sedation, consent would be required.

Regarding tPA, many institutions have used the “standard of care” argument for not obtaining informed consent. Whether a treatment option is considered the standard of care or simply a standard is not germane to the question, which is whether a reasonable patient or a reasonable professional (dependent on jurisdiction) would believe the risks and benefits should be disclosed. In other words, the risks and benefits of tPA are not intuitive and should be disclosed to the patient. The “standard of care” argument is illogical and without basis. Consider the standard of care for acute appendicitis as an illustration. Although non-surgical approaches (antibiotics alone) are under investigation, most would agree that the standard of care is appendectomy. Therefore, if the same logic applies to this scenario, consent no longer would be needed for appendectomy or the provision of general anesthesia.

Delegation and Documentation

Two important concepts that deserve adequate treatment with respect to informed consent or refusal are delegation and documentation. The consent process should be performed by the practitioner who will perform the procedure, and that consent is valid only for that specific practitioner to perform the procedure, unless otherwise disclosed and agreed to by the patient. It is not appropriate to delegate this process to another individual such as a hospital employee (e.g., a nurse).3 However, once the informed discussion occurs, the act of signing applicable forms may be delegated.

Although standards for delegation may vary by jurisdiction, this approach is the safest and most risk-protective. In August 2017, the Pennsylvania Supreme Court issued a decision supporting this requirement. The justices ruled that surgeons are duty bound to provide information about risks and benefits of a procedure, as well as information about alternatives, to obtain informed consent. Further, the court stressed that the surgeon must be the one who delivers the information personally to the patient.7

Detail the Conversation

The need for a consent form is debated frequently. Although obtaining and documenting informed consent is required, the means for documenting the patient’s consent is not mandated. Generally, consent forms are preferred, as they are a universally accepted standard.3 To deviate from that standard may call into question if informed consent actually was obtained. However, documentation of the informed consent process in the medical record may be an excellent alternative for a consent form. Many consent forms lack a description of the informed discussion. Although a patient may have signed the form, indicating he or she has agreed to a particular procedure or treatment, a signature alone does not verify that the standard of care for obtaining informed consent was met. Such incomplete documentation offers a false sense of confidence and actually may result in increased liability exposure as opposed to protection.

Ideally, both (documentation of the informed discussion and the signed consent form) would be entered into the medical record, but documentation of the informed discussion is much more risk-protective than an incomplete consent form without components of the informed discussion noted on that form or, alternatively, reflected in the medical record. Although not equivalent to informed consent, when shared decision-making occurs, documentation of that conversation may mitigate professional liability risk.

REFERENCES

  1. Schloendorff v. Society of New York Hospital, 105 N.E. 92 (1914).
  2. Sfikas PM. A duty to disclose. Issues to consider in securing informed consent. J Am Dent Assoc 2003;134:1329-1333.
  3. Furrow B, Greaney T, Johnson S, et al. Health Law: Cases, Materials, and Problems. 6th edition. St. Paul: West Publishing; 2008.
  4. Nixdorf v. Hicken, 612 P2d 348 (Utah 1980).
  5. Murray B. Informed consent: What must a physician disclose to a patient? Virtual Mentor 2012;14:563-566.
  6. Youngberg BJ. The Risk Manager’s Desk Reference. 2nd edition. Gaithersburg: Aspen Publishing; 1998.
  7. Robeznieks A. Informed-consent ruling may have “far-reaching, negative impact.” AMA Wire, Aug. 8, 2017. Available at: http://bit.ly/2vHz40E. Accessed Sept. 5, 2017.