Important Considerations When Obtaining Informed Consent

According to the Patient Self-Determination Act, patients have the right to make decisions about their care. Informed consent is a communication and documentation process between a patient and a licensed independent provider. There are regulatory, state, and federal mandates that apply to the informed consent process. Do you know the elements of the informed consent process and your role in the process?

Elements of Informed Consent

The informed consent process for a surgical procedure includes a discussion about the:

• patient’s diagnosis and planned surgical procedure;
• potential risks of, benefits of, and alternatives to the procedure;
• likelihood of the patient achieving their goals; and
• responsibilities of the attending surgeon if the procedure is scheduled to overlap with another surgical procedure.

It is best practice to ensure that the patient understands the information provided by using the teach-back method. The provider obtaining consent confirms that the patient understands by asking the patient to explain the procedure, why the procedure will be performed, and what the risks of the procedure are in their own words.¹ The conversation is documented on the surgical procedure consent form that contains the facility name; the full procedure name (with no abbreviations); a statement that the procedure, risks, benefits, and alternatives were discussed with the patient; the patient’s or legally authorized patient representative’s signature; the licensed independent provider’s signature; a witness signature; and date and time of the signatures. The provider obtaining informed consent will also document the elements of the conversation in a note in the patient’s chart. It is the responsibility of the provider obtaining consent to explain the procedure and verify understanding with the patient. Patients have the right to refuse or withdraw consent at any time before the start of the procedure.

Signatures

The patient must sign the consent after the conversation takes place and before they receive any mind-altering medications. If the patient is unable to sign their own consent, a legally authorized representative (power of attorney or legal guardian) or a substitute decision maker (spouse or next of kin) may sign the consent on behalf of the patient. When determining the priority for a substitute decision maker, nurses should reference their state’s guidance for more information (Sidebar 1). The licensed provider will sign the form after the patient or patient representative signs the consent. Finally, the witness will sign the consent. When the witness signs the consent, they verify the name of the patient, the signature of the patient (or representative), the name of the surgery, and the name of the provider.

Sidebar 1. Example Priority List for Substitute Decision Makers in Pennsylvania

1. A spouse (unless a divorce is pending) or adult children of the patient
2. A parent
3. An adult brother or sister
4. An adult grandchild
5. A close friend or relative who has knowledge of the patient’s preferences and values
   

Special Considerations

Minors (people under the age of 18) are generally not permitted to provide their own consent. In this case, the minor’s parent or legally authorized representative (guardian or the court of law) may give consent on their behalf. However, emancipated minors may give their own consent if they have the mental capacity to understand their condition and the proposed treatment. An emancipated minor is a person who has graduated high school, has married, is pregnant or has borne a child, has joined the military, or is declared emancipated by a court of law.

Patients may need translation services during the informed consent process. It is important for nurses know how to identify the translation services offered at their facility. Services may include live interpreters, telephonic services, video interpretation, or translated consent forms. Good communication between the physician’s office and the surgical services department ensures that translation services are set up prior to the patient’s arrival.

The patient may not be able to give their consent in emergency situations that are a threat to life. In this event, two physicians may confirm the necessity of surgical intervention with supporting documentation and proceed with the surgery. Documentation should include the nature of treatment, the risk to the patient’s life, efforts to obtain informed consent, and a statement that delay of treatment would increase the risk to the patient’s life.

Telephone consent may be obtained when the patient is unable to provide their own consent and the authorized representative is not immediately available. A witness should be present and able to hear both parties during the conversation. Telephone consent should be documented on the facility's approved form. Information for telephone consent includes the name of the person giving consent, the relationship of the patient to the person giving consent, the date and time of the conversation, and the signatures of the provider obtaining consent and the witness to the conversation.

The Nurse’s Role in Informed Consent

The perioperative nurse supports the informed consent process. The nurse may arrange for translation services or serve as the witness on the consent. The nurse is responsible for verifying a completed surgical consent before the patient is transferred to the surgical suite. During the preoperative interview, the nurse should ask the patient to state the procedure they are scheduled for in their own words when confirming the surgical consent with the scheduled procedure. If the patient seems unsure about their procedure or has questions, it is best practice to have the licensed provider who obtained consent clarify the procedure and expectations for the patient. If there is a discrepancy between the informed consent document and the scheduled surgical procedure, this must be escalated to the attending physician for resolution before the patient is transferred to the surgical suite.

Find Out More

There are variations in the informed consent process based on state mandates and the accreditation process that a hospital follows (eg, The Joint Commission, DNV). To learn more about the practices at a particular facility, nurses can ask their preceptor the following questions:

1. What procedures require informed consent?
2. Can the informed consent process be delegated? If so, who can it be delegated to?
3. Who can give consent on behalf of the patient (substitute decision maker) if they are incapacitated?
4. What must be documented on the consent form?
5. What is the duration of the consent?
6. Who can sign the consent form as a witness?
7. What is the facility’s process for telephone consent?
8. What is the facility’s process for emergency surgery consent?
9. Does the facility have translated consent forms?
10. How do you locate and schedule or operate the translation services offered at the facility?
    

References:

1. Use the Teach-Back Method: Tool #5. Agency for Healthcare Research and Quality. Reviewed September 2020. Accessed June 17, 2024.
   https://www.ahrq.gov/health-literacy/improve/precautions/tool5.html

AORN Resources 

AORN members can access: 

• Guidelines in Practice: Patient Information Management - AORN Journal
• Information Management - Kyle - 2023 - AORN Journal - Wiley Online Library

If your facility subscribes to eGuidelines+, you can access:

• Information Management | AORN eGuidelines+