Informed Consent: It’s Not Just a Form

Informed consent in healthcare is based on the moral and legal premise of patient autonomy, which means patients fully participate in decisions about their treatment. Informed consent is a process, not just a form. This article will discuss the four components of informed consent and identify best practices for the informed consent process. It will also address a less common scenario, informed refusal. The following steps are essential in the informed consent process.

Determine capacity
Decision-making capacity is the basis for informed consent. Generally, capacity is apparent during a medical encounter if the patient can both demonstrate understanding of their condition and communicate their wishes. If a patient’s cognitive or mental status is questionable or clearly impaired, it may be necessary to use a formal screening tool to assess capacity.

It is important to assess and document decision-making capacity. If the patient is determined not to have decision-making capacity, thorough documentation is essential, especially if emergency treatment is required. Include the following in your documentation regarding patients who lack decision-making capacity:

• The reasons for determining capacity based on the screening performed.
• The identities of available surrogate decision-makers.
• Whether delay in treatment could result in serious harm or death. If a surrogate decision-maker cannot be quickly identified and a treatment delay could result in serious harm or death, emergency treatment may be provided without consent.¹

Provide necessary information
In order to provide informed consent, the patient must have enough information on which to base a decision. Thoroughly document in the medical record an informed consent discussion that includes the following:

• The risks and benefits of the proposed treatment and the risks and benefits of receiving no treatment at all as well as the likelihood of each in the context of the patient’s current medical condition. There are risks and benefits associated with all medical treatments. The informed consent process, if thorough, allows the patient to weigh the benefits of the treatment or procedure against its risks and make an “informed decision.” It also allows the patient to assess the risks and benefits of having no treatment at all. If the risks are not explained to the patient and injury occurs, the patient can claim that they would never have agreed to undergo the treatment if they had known of the risk.
• The alternatives to the proposed treatment. Communicate alternatives to the proposed treatment or procedure and document the discussion. For example, if a practitioner does not inform the patient of a less invasive treatment to manage their condition and harm occurs, the patient can allege that they would have chosen the other treatment option.

Medical malpractice arising from a lack of informed consent differs from its other forms. A physician can perform a procedure in a technically flawless manner that adheres to the acceptable standard of care and still be liable for malpractice. Consider the following case example:

A 48-year-old man presented to his cardiologist with complaints of shortness of breath, fatigue, and rapid heart rate. A transesophageal echocardiogram (TEE) was scheduled to find any clots around the heart prior to cardioversion. The patient stopped breathing shortly after TEE began, and his resuscitation took 12 minutes. The patient’s hypoxia resulted in permanent, catastrophic neurological deficits.

While the jury found that the cardiologist’s technique met the standard of care, it also concluded that the patient should have been advised of more conservative alternatives, such as treatment with medication. The jury found that informed consent was not properly obtained and awarded $33 million in damages.

Likewise, a practitioner may adhere to standard of care when performing a procedure or surgery but be sued if it becomes necessary to perform a previously unspecified procedure. Unless it is an emergency, the second procedure cannot be performed without additional informed consent. Consider the following case example:

A 29-year-old woman with no children presented to her OB/GYN complaining of severe abdominal pain and bleeding from a fibroid tumor. The patient signed a consent for the fibroid removal prior to surgery. While operating, the surgeon encountered multiple adhesions requiring removal via hysterectomy.

The decision to perform the hysterectomy was within the accepted standard of care. However, the possibility of performing a hysterectomy to remove fibroids was not noted in the consent form. A claim was filed, and the case ultimately settled.

Eliminate barriers to understanding
Communication issues may interfere with a patient’s ability to understand the information provided during the informed consent process. Language and sensory barriers can be addressed by using professional interpretive services. Trained interpreters should be used during the informed consent discussion in order to ensure accuracy and confidentiality while avoiding a conflict of interest.

Educational barriers can be addressed in the informed consent discussions and by using “plain language” consent forms and educational materials. It is recommended that patient educational materials be written below the sixth-grade reading level.

Ensure that consent is voluntary
Once patients receive and understand the necessary information, it must be evident that their consent is voluntary. In some cases, the practitioner’s personal or professional values may influence the informed consent discussion. For example, an orthopedic surgeon may advocate back surgery for a condition that might also be adequately treated by chiropractic medicine and not suggest this option as an alternative. Or an oncologist whose family member died of breast cancer following a lumpectomy may advocate mastectomy for patients who may be adequately treated with a less disfiguring procedure. While these situations do not represent intentional coercion, practitioners should be mindful of the potential for their own biases to influence patients’ self-determination and decisions.²

Consider informed refusal
Although informed consent receives much more attention, the practitioner should understand the concept of informed refusal. Competent patients always have the right to refuse proposed procedures or treatment, but those refusing all care or a critical portion of necessary evaluation or treatment may suffer harm. The practitioner should ensure that patients understand the risks and consequences of refusing a recommended medical treatment plan. Consider the following case example:

A 53-year-old man presented to the emergency department with complaints of chest pain. His chest X-ray, electrocardiogram, and laboratory testing were normal, but his cardiac risk factors prompted an offer of hospital admission for additional monitoring. The patient refused, indicating he wanted to go home. His wife was asked to persuade him to consent to admission. The refusal note in the chart reads as follows:

“Patient was offered admission x 2. He was alert and oriented and had the capacity to consent and refuse. I advised him of the possibility of acute coronary syndrome, the risks of treatment and non-treatment, and the possibility of death. Patient’s wife was present and wanted him admitted. Wife was enlisted to try and convince him, but the patient insisted on going home.”

The patient returned to the same emergency department 24 hours later in cardiac arrest. He could not be resuscitated and was pronounced dead.

The physician’s documentation clearly described a situation in which all efforts were made to inform the patient of the risks associated with refusing treatment and that the patient made an informed decision to refuse. The case brought against the practitioner was ultimately dismissed.

When a patient refuses necessary care, document the following elements of the informed refusal discussion in the medical record:

• Patient diagnosis.
• Details of the recommended treatment.
• Risks associated with the recommended treatment.
• Alternatives to the proposed treatment.
• Consequences of failing to treat the condition.
• Description of the education and counseling provided to the patient.³

Some organizations opt to use an informed refusal form, which should be retained in the patient’s medical record.

A well-crafted informed consent form and a well-documented medical record outlining your discussions with the patient can be an effective shield in the courtroom. In fact, they may prevent a lawsuit from ever being filed. Keep in mind, however, that informed consent is a process, not a form. It should reflect an interactive dialogue between the practitioner and the patient that is designed to provide the best medical care while respecting patient autonomy.

 
References:

1. Barstow C, Shahan B, Roberts M. Evaluating Medical Decision-Making Capacity in Practice.   Am Fam Physician. 2018 Jul 1;98(1):40-46.

2. Kelly M.  Risk Perception, Bias, and the Role of the Patient-Doctor Relationship in Decision Making about Cerebral Aneurysm Surgery. American Medical Association. Journal of Ethics. https://journalofethics.ama-assn.org/article/risk-perception-bias-and-role-patient-doctor-relationship-decision-making-about-cerebral-aneurysm/2015-01. Published January 15, 2015. Accessed February 17, 2021.

3. Kichler, D. “You Didn’t Tell Me That. Informed Refusal as a Defense.” Cooperative of American Physicians. https://www.capphysicians.com/articles/informed-refusal-defense. Published October 26, 2020. Accessed February 17, 2021.