Threshold elements of informed consent take into account whether a patient has the ability to comprehend the treatment being discussed and whether the patient is giving consent voluntarily. The first threshold element to consider is whether the patient has capacity to give consent. Capacity refers to an individual’s actual ability to understand or form an intention with regard to some act such as consenting to treatment. The provider needs to evaluate if the patient has an adequate level of attention during the informed consent discussion, whether their judgment is sufficiently intact, and whether they are able to comprehend relevant instructions. The age of the patient, her cognitive capabilities, and her mental status are examples of factors which might prevent her from being able to give informed consent. If a patient lacks capacity to understand the information provided about the proposed treatment, then she is not capable of giving informed consent. Physicians regularly make determinations of capacity. When a patient lacks capacity, informed consent must be obtained from next of kin, a guardian, or some other person who can consent on the patient’s behalf.

It is important to recognize that capacity can be a moving target because it can vary over time and with different circumstances. A patient who has current capacity to consent to a procedure today may be disoriented later in the evening, and thus not able to partake in a different informed consent discussion. Likewise, a patient with a behavioral health disorder may not have capacity to consent to something as complex and serious as surgery, but still be able to consent to having an IV started, because they have the cognitive abilities to understand the latter.

Capacity is sometimes confused with the concept of competence, and the terms are often used interchangeably, but they are not interchangeable from a legal perspective. They each have unique definitions. Competence refers to one’s legal status as a decision-maker. Competence is a vague and ambiguous term because it is a broad concept that encompasses many different legal issues and contexts. In general, competence refers to some minimal cognitive or behavioral ability, trait, or required capability.

Competence in the civil context is commonly raised in two situations, legal age of majority, and mental disability. With some exceptions the age of majority is 18 and persons of this age are presumed to be competent. Incapacity secondary to mental disability may be slightly more nuanced depending on the context. In the discussion of consent to medical treatment, competency to consent might be questioned if the person is mentally ill, under the influence of drugs or alcohol, has a brain injury, or suffers from some other medical condition which causes mental disability such as Alzheimer’s disease. The question of competency and determination of incompetency can only be judicially determined. A person is presumed competent unless adjudicated incompetent. There is no established set of criteria, nor a single test, for determining a person’s competence. Rather, a judge weighs the evidence presented at a hearing which typically includes evaluations of decisional capacity by professionals such as physicians, psychologists, and social workers. The fact that a patient may be deemed incompetent or has been appointed a guardian does not meant they lack capacity to participate meaningfully in certain treatment decisions, or that their wishes should be ignored. To the degree that they are able to participate, there is a moral obligation to allow them to do so.

Capacity and competence do not always coincide. Minors are incompetent to make most healthcare decisions, yet as a matter of public policy they may have decisional capacity in certain circumstances such as pregnancy, sexually transmitted infections, and drug or substance abuse. To encourage minors to seek treatment under those circumstances, most states have granted minors, via minor treatment statutes, the ability to make certain healthcare decisions. Similarly, certain minors who are emancipated or married are considered mature minors who are recognized as competent decision-makers and may consent to treatment on their own behalf, or for their children (see above Sample State Statute: Who May Give Consent).

Voluntariness requires freedom of choice and freedom from controlling influence by others. Undue pressure from family members, clinicians, religious groups, ethnic custom, or others may invalidate a consent. Physicians need to preserve patient voluntariness.

Information elements of informed consent include disclosure, recommendation, and understanding. Disclosure refers to the key pieces of information that must be made known to the patient and understood by the patient. These include the nature of the therapy, purpose, risks and consequences, benefits, probability of success, feasible alternatives, and prognosis with no therapy.

Once that information is disclosed, a recommendation is made by the physician based on his or her expertise. Recommendations are often meaningful to the patient because without one, the patient may feel lost or overwhelmed. However, the final decision obviously rests with the patient. It is the physician’s responsibility to make sure the patient understands what has been discussed and to avoid confusing medical jargon. Asking a patient to describe in their own words their understanding of the proposed treatment is a helpful way to verify comprehension, as opposed to asking close-ended questions, such as “Do you understand?”

Most patients follow a recommended treatment plan, but ultimately it is their right to choose how to proceed. If they decide to undergo the treatment, they must provide authorization of their consent. If they decide not to undergo treatment, although uncommon in pregnant patients, their right to refuse treatment is still a common law right guaranteed by the 14th Amendment . Regardless of the patient’s decision, it is important for the physician to document the informed consent discussion so that the record reflects the patient made a well-informed decision. Sometimes refusal to treat involves an end of life issue. There is further discussion of this issue in section “Persistent Vegetative State and End of Life Medical Matters” where the Self Determination Act is addressed.