Informed Consent

Informed Consent

Informed consent is a legal and ethical process that ensures patients have sufficient information to make autonomous decisions about their healthcare. The NCLEX tests nurses on their understanding of who can obtain consent, the nurse's role, and how to handle special circumstances. For additional legal terminology, see the Safe Care Glossary.

Legal Elements of Informed Consent

For consent to be legally valid, all of the following elements must be present:

• Disclosure: The healthcare provider must explain the diagnosis, proposed treatment or procedure, expected benefits, material risks, alternative treatments (including no treatment), and the risks of alternatives.
• Comprehension: The information must be presented in a manner the patient can understand. This includes using appropriate language, avoiding excessive medical jargon, providing interpreter services when needed, and using teach-back methods to verify understanding.
• Voluntariness: The patient must give consent freely, without coercion, manipulation, or undue influence from healthcare providers or family members.
• Competence: The patient must have the legal and mental capacity to make the decision. Competence is a legal determination; capacity is a clinical determination.
• Consent: The patient must agree to the proposed treatment and sign the consent form.

Who Can Obtain Informed Consent

This is one of the most commonly tested concepts on the NCLEX regarding informed consent.

• The physician or provider performing the procedure is responsible for obtaining informed consent. This means explaining the procedure, risks, benefits, and alternatives. This responsibility cannot be delegated to the nurse.
• The nurse's role is to witness the consent. The nurse verifies that the patient signed the form, that the patient appears to understand the procedure, and that consent was given voluntarily. The nurse does NOT explain the procedure, risks, or alternatives -- that is the provider's responsibility.
• If the patient has questions about the procedure, the nurse should contact the provider to address those questions before the patient signs.
• If the nurse believes the patient does not understand the procedure or is being coerced, the nurse has an ethical and legal obligation to notify the provider and advocate for the patient. The nurse should not allow the procedure to proceed.

Exceptions to Informed Consent

There are recognized legal exceptions where treatment may proceed without standard informed consent:

• Emergency situations: When the patient is unable to give consent (unconscious, incapacitated) and a delay in treatment would result in death or serious harm, and no authorized surrogate is available. Treatment necessary to preserve life or prevent serious harm may proceed. This is based on the legal doctrine of implied consent.
• Therapeutic privilege: In rare circumstances, a provider may withhold information if disclosure would significantly harm the patient (e.g., cause severe psychological distress that would impair decision-making). This exception is narrowly applied and controversial.
• Patient waiver: A competent patient may voluntarily waive the right to receive information and ask the provider to make treatment decisions. This waiver should be documented.
• Court-ordered treatment: In certain situations (e.g., court-ordered psychiatric treatment, public health emergencies), treatment may be mandated by a court order.

Minors and Consent

Special rules apply when the patient is a minor (typically under 18 years of age):

• Parent or legal guardian provides consent for treatment of minors in most situations.
• Emancipated minors can consent for their own treatment. Emancipation typically applies to minors who are married, in the military, living independently and financially self-supporting, or declared emancipated by a court.
• Mature minor doctrine: Some states recognize that adolescents who demonstrate sufficient maturity and understanding may consent to certain treatments.
• Exceptions for minors: Many states allow minors to consent to treatment for sexually transmitted infections, substance abuse, mental health services, contraception, and prenatal care without parental consent.
• NCLEX tip: When a question involves a minor, first determine if the minor is emancipated. If not, look for parental consent. If the situation involves an emergency, implied consent applies regardless of age.

Mental Competency and Consent

Patients must be mentally competent to provide informed consent. Important considerations include:

• A patient who is oriented, alert, and able to understand information and make decisions is presumed competent.
• A diagnosis of mental illness does not automatically render a patient incompetent. Competency is assessed based on the patient's ability to understand information, appreciate its relevance, reason about options, and communicate a choice.
• Patients under the influence of sedating medications, anesthesia, or substances may lack capacity to consent. Consent obtained while a patient is impaired may not be legally valid.
• If a patient is determined to be incompetent, a legally authorized surrogate decision-maker (guardian, healthcare proxy, or next of kin per state law) may provide consent.

Advance Directives

Advance directives are legal documents that allow competent adults to express their healthcare wishes in advance, in case they become unable to make decisions.

• Living will: A written document specifying the types of medical treatment the patient does or does not want if they become incapacitated (e.g., mechanical ventilation, tube feeding, resuscitation).
• Durable power of attorney for healthcare (healthcare proxy): A legal document that designates a specific person to make healthcare decisions on the patient's behalf if the patient becomes unable to do so.
• DNR/DNAR orders: Do Not Resuscitate / Do Not Attempt Resuscitation orders must be signed by a physician. The nurse should verify the order is current and in the chart.
• Nurse's role: Nurses should ask patients on admission whether they have advance directives. Provide information about advance directives but do not influence the patient's decisions. Document the presence of advance directives in the medical record and ensure they are accessible.
• Under the Patient Self-Determination Act (1990), healthcare facilities receiving Medicare/Medicaid funding must inform patients of their right to create advance directives.

NCLEX Informed Consent Scenarios

• Scenario: A patient scheduled for surgery tells the nurse, "I'm not sure what the doctor said about the risks." The nurse should hold the procedure and notify the surgeon to re-explain the procedure and risks.
• Scenario: A patient signs a consent form while receiving IV pain medication. The nurse should question the validity of the consent and notify the provider, as the patient's capacity may be impaired.
• Scenario: A 16-year-old married patient presents for treatment. The nurse recognizes this patient as an emancipated minor who can consent independently.

For a quick reference, see the Informed Consent Cheat Sheet. Continue your review with the Safe Care Study Guide or practice with Safe Care Flashcards.