Understanding Informed Consent: Why and When It’s Necessary

Informed consent isn’t just a form – it’s a two-way process of communication that presents an opportunity for patient engagement and shared decision-making. Adhering to appropriate informed consent practices protects both patients and providers.

Why Informed Consent Is Essential

It’s hard to understate the importance of appropriate informed consent. When healthcare providers follow informed consent best practices, patients experience increased autonomy and capacity and have more realistic expectations and increased levels of satisfaction. When providers do not follow best practices, they risk professional liability claims and noncompliance with regulations. 

A lack of informed consent is a common allegation in medical malpractice lawsuits and may lead to settlements or verdicts in favor of the plaintiff. In some cases, a failure to obtain informed consent is considered an allegation of battery. Well-documented informed consent is the key to a strong defense.

When to Obtain Informed Consent

Informed consent is necessary for:

• Invasive procedures
• All surgery (major and minor)
• High-risk treatments and medications
• Procedures that require the use of anesthesia or sedation
• Chemotherapy
• Radiation therapy
• Diagnostic procedures involving contrast or dyes
• Electroconvulsive therapy
• Blood and blood products
• Experimental procedures
• Clinical trials
• Off-label use of medications and medical devices

You should also obtain informed consent for any other treatment or procedure that the medical staff determines will require a specific explanation and discussion.

Unique Situations Involving Informed Consent

Although informed consent is important, there are times when it simply isn’t possible or needed. 

Emergency situations are one of the most common scenarios in which it may be necessary to bypass informed consent. If the injury or illness is life threatening, consent is typically considered to be implied for surgeries, procedures, medications, and other treatments to save the patient’s life. It is imperative to ensure there are no advance directives or other orders outlining a patient’s wishes that would be contrary to lifesaving measures.

In some cases, providers may claim a therapeutic privilege exemption to informed consent because the risk of disclosure poses a threat to the patient – for example, by exacerbating a psychiatric condition or causing severe emotional distress. 

In these scenarios, practitioners must use their best clinical and professional judgment and should consider seeking a second opinion, if time permits. It’s important to document the practitioner’s reasoning in the medical record, including specific details of the life-threatening condition or threat to the patient that requires care without informed consent. 

It’s critical to know your state regulations. For example, Wisconsin requires written informed consent in many situations, but temporary oral consent obtained by telephone is allowed when a parent or guardian is providing consent in emergency situations or where time and distance requirements make it impossible to obtain written consent before treatment and when delaying treatment would result in harm. Providers in Wisconsin must document oral consent, which is only valid for 10 days. All state regulations may vary and are also subject to change. 

Taking Responsibility for Informed Consent

The practitioner, surgeon, or proceduralist performing the treatment needs to take responsibility for obtaining informed consent. In the case of anesthesia, this means the practitioner administering the anesthesia must obtain informed consent using a separate process and form. The informed consent process should detail the risks, benefits, and alternatives to treatment, including no treatment at all. 

Although the practitioner needs to take responsibility for informed consent, healthcare providers can delegate some tasks associated with informed consent. These include:

• Acting as a liaison between the practitioner and patient
• Ensuring consent forms and appropriate medical record documentation are completed properly
• Reviewing a chart before a procedure to verify documented informed consent
• Referring any specific patient questions to the practitioner
• Witnessing the informed consent process

Reducing Risk in the Informed Consent Process

Following best practices for informed consent can help empower patients and reduce liability, but consistency is key. Establish informed consent policies and procedures, verify they align with regulatory and accreditation requirements, and educate your practitioners and staff.
When you create or refine your policies and procedures, ensure they include the following: 

• Address and document all elements of informed consent. These elements include the diagnosis/patient’s condition; the proposed treatment (site/side), risks, benefits, and likelihood of success; alternative treatments, risks, benefits, and likelihood of success; prognosis if the patient does not receive treatment; the name of the practitioner(s) performing the surgery or procedure; and patient understanding, questions answered, date/time and signature of the patient or legal representative.
•  Educate patients. Use interpreters and/or educational materials in the patient’s primary language at a fifth-grade reading level utilizing plain language. Check the patients’ understanding, for example, by asking them to explain the information in their own words, and document confirmation of their understanding. 
• Identify special considerations. Special accommodations or processes may be necessary for minors if there are language barriers or when a disease, sensory impairment, or stressor may interfere with the patient’s ability to understand or make decisions. Assess the patient’s ability to receive information, process and understand information, deliberate, and make and articulate a choice. Document all of this. For minors, it is necessary to obtain informed consent from both parents when there is shared custody. Also follow state regulations regarding what minors can consent to.
• Document informed refusal. Patients can refuse care or change their minds. If a patient refuses care, ask for the reason, explain the associated risks, and offer treatment alternatives. Document the decision using an informed refusal form.

These informed consent best practices will help providers engage patients in their care. While the ultimate goal is to improve patient outcomes, following informed consent best practices should also reduce the potential for liability. Reach out to Coverys for more information and resources. 

This article is based, in part, on “Informed Consent & Disclosure,” a presentation by Christen Marx, RN, BSN, MEd, CPHRM, LNC.