Informed consent is a process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the said procedure.  Informed consent is both an ethical and legal obligation of medical practitioners in the US and originates from the patient’s right to direct what happens to his/her body. Implicit in providing informed consent is an assessment of the patient’s understanding, rendering an actual recommendation, and documentation of the process. The Joint Commission requires documentation of all the elements of informed consent “in a form, progress notes or elsewhere in the record.” The following are the required elements for documentation of the informed consent discussion: (1) the nature of the procedure, (2) the risks and benefits and the procedure, (3) reasonable alternatives, (4) risks and benefits of alternatives, and (5) assessment of the patient’s understanding of elements 1 through 4.

It is the obligation of the provider to make it clear that the patient is participating in the decision-making process and avoid making the patient feel forced to agree to with the provider. The provider must make a recommendation and provide his/her reasoning for said recommendation.

Issues of Concern

Adequacy of Informed Consent

The required standard for informed consent is determined by the state. The three acceptable legal approaches to adequate informed consent are (1) Subjective standard: What would this patient need to know and understand to make an informed decision? (2) Reasonable patient standard: What would the average patient need to know to be an informed participant in the decision? (3) Reasonable physician standard: What would a typical physician say about this procedure?

Many states use the “reasonable patient standard” because it focuses on what a typical patient would need to know to understand the decision at hand. However, it is the sole obligation of the provider to determine which approach is appropriate for a given situation.

Exceptions to Informed Consent

Several exceptions to the requirement for informed consent include (1) the patient is incapacitated, (2) life-threatening emergencies with inadequate time to obtain consent, and (3) voluntary waived consent.  If the patient’s ability to make decisions is questioned or unclear, an evaluation by a psychiatrist to determine competency may be requested. A situation may arise in which a patient cannot make decisions independently but has not designated a decision maker. In this instance, the hierarchy of decision makers, which is determined by each state’s laws, must be sought to determine the next legal surrogate decision maker. If this is unsuccessful, a legal guardian may need to be appointed by the court.

Children and Informed Consent

Children (typically under 17) do not have the ability to provide informed consent.  As such, the parents must give permission for treatments or interventions. In this case, it not termed “informed consent” but “informed permission.”  An exception to this rule is a legally emancipated child who may provide informed consent for himself. Some, but not all, examples of an emancipated minor include minors who are (1) under 18 and married, (2) serving in the military, (3) able to prove financial independence or (4) mothers of children (married or not). Legislation regarding minors and informed consent is state-based as well. It is important to understand the state laws.