Medicolegal principles: Informed consent

Published on 07/02/2015 by admin

Filed under Anesthesiology

Last modified 22/04/2025

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Medicolegal principles: Informed consent

J. Robert Sonne, JD

Informed consent is the process of providing sufficient information to the patient or surrogate decision maker to allow that patient or surrogate decision maker to fully participate in respective decisions regarding medical care. This process includes securing authorization from the patient or surrogate decision maker for any proposed surgical or significant diagnostic treatment or procedure.

Along with the moral and ethical obligations that are involved in obtaining informed consent, there are also associated legal requirements. Various state, federal, and accreditation (e.g., Joint Commission) statutes, regulations, and guidelines govern and address the legal parameters of the informed consent process. In addition to general process requirements, legal proscriptions often dictate specific informed-consent provisions for certain treatment or diagnostic procedures (for example, HIV/AIDS testing). Investigation into specific state and federal law on informed consent is encouraged.

In situations in which patients have filed lawsuits, central questions often arise as to whether the anesthesia provider acted within the limits of the patient’s consent and whether the patient was given sufficient information to adequately consent to the proposed treatment or diagnostic procedure. Such lawsuits are generally brought under negligence or battery theories.

The informed-consent process

Informed consent for anesthesia often occurs when the patient and anesthesia provider meet moments before the surgical procedure is scheduled to begin. For anesthesia providers, the informed consent process should occur before administration of preprocedure sedation and generally should include a discussion of the elements outlined in Box 236-1. It is largely impractical to discuss all associated risks related to a specific anesthesia treatment or procedure. Thus, in determining what relevant risks to discuss, the physician should consider discussing those procedure or treatment risks that are most common and most severe. In defining how much information a physician should disclose, there are two dominant standards. The “professional” standard holds that the anesthesia provider must disclose information that other anesthesia providers possessing the same skills and practicing in the same or similar community would disclose in a similar situation. The “materiality” standard considers what a reasonable patient would have considered important in making a decision.

During the informed-consent discussion, the anesthesia provider is encouraged to ask patients if they have questions or other concerns about the proposed treatment or procedure. Good communication is often an effective deterrent against future patient complaints and legal claims. During this process, the patient also is generally asked to review and sign a written informed-consent form before the proposed surgical or significant diagnostic treatment or procedure. Whether a signed written informed-consent form is warranted may vary based on applicable state, federal, and accreditation statutes, regulations, or guidelines (e.g., see Center for Medicaid Services Conditions of Participation guidelines). Informed-consent forms generally list the specific procedure or treatment to be performed and may include specific risks, complications, or alternatives. Such forms also may include language indicating that not all discussed risks, complications, or alternatives are expressly listed in the form. Overall, the informed-consent form serves as valuable evidence that the informed process occurred and that the patient consented to the recommended treatment or procedure.

As noted previously, good documentation is effective in preventing and defending complaints and legal claims. Consequently, anesthesia providers are additionally encouraged to timely dictate or otherwise enter a note into the medical record (independent of the signed informed-consent form) that substantiates that the informed-consent discussion occurred. In preparing this note, the anesthesia provider should consider listing the most significant discussed risks and alternatives and should expressly note the patient’s consent and election to proceed.

Obtaining informed consent when treating the incompetent or minor patient

If the patient is unable to make his or her own health care decisions or is a minor (under age), an appropriate surrogate decision maker most likely needs to be consulted to make decisions and consent to the patient’s care and treatment.

If the patient is an incompetent adult, informed consent is generally obtained from the patient’s legal guardian or health care power of attorney. If the patient does not have either a legal guardian or a health care power of attorney, state laws often provide a priority list of surrogate decision makers. These state statutes usually provide highest priority to spouses and then proceed to other family members (e.g., adult children, parents, siblings, grandchildren) and individuals (e.g., domestic partners, close friends). If no surrogate decision maker is available or willing to provide informed consent, some state statutes allow attending physicians to make and consent to health care decisions. This form of consent, however, is typically only permitted after additional approval is obtained from a hospital ethics committee or a second physician.

If the patient is a minor, informed consent is usually obtained from the patient’s parents or legal guardian, with assent obtained from the minor, if possible. In certain circumstances, however, a minor may consent without approval from a parent or legal guardian. For example, some states may allow a minor to independently consent to his or her own care if the minor is emancipated, married, in the United States military service, or homeless. In addition, states may allow a minor to independently consent to care related to sexually transmitted diseases, substance abuse treatment, HIV testing, contraception, abortion, or sexual assault. Anesthesia providers are encouraged to review applicable state law for consent exceptions for minors.