Informed Consent

A decisionally capable patient's legally binding treatment decision reached voluntarily and based on information about risks, benefits, and alternative treatments gained from discussion with a health care practitioner.

Several legal principles form the basis for informed consent. The right of knowledgeable self-determination and choice obligates the health care practitioner to inform patients of the risks and benefits of alternative treatments. The constitutional right to privacy, as well as the concept of personal liberty and restraints on state interference with independent action and choice, allows capacitated persons to choose individually appropriate medical care from among available treatment options.

Self-determination (the concept that "every adult of sound mind has the right to decide what shall be done with his own body"), or autonomy, is the foundation of the legal and ethical doctrine of informed consent. When decision making is preceded by discussion with a health care practitioner who provides the patient with the information necessary for choosing among options, the patient's consent or refusal is said to be informed and is ethically valid and legally binding. All states require that informed consent of the capacitated patient precede medical intervention. The patient has the legal and ethical right to make an informed choice, ie, to consent to or refuse care, even if the likely outcome of the refusal is death. The physician is legally and ethically obligated to promote this right to all patients, even to those who are unsophisticated or difficult to inform.

Informed consent arises from discussion between the patient and physician. The patient asks questions that elicit relevant information, and the physician shares facts and insights along with support and advice. Treatment decisions belong to the patient or surrogate, but the physician has a responsibility to offer guidance.

The process of informed consent may be more arduous for elderly patients than for younger patients because of age-related conditions, such as sensory deficits or impaired cognition. For example, many elderly patients who cannot understand or evaluate alternatives are treated as if they can because they nod in agreement or do not actively question a proposed intervention. Such consent is rarely valid but is rarely questioned. Conversely, patients with hearing deficits are difficult to reach in conversations and thus are sometimes bypassed in the decision-making process. In addition, patients may be overly influenced by family members, by the process of "learned helplessness" during institutionalization (a special problem in long-term care facilities), or by the physician.

One way to augment the patient's voice is to allow sufficient time for discussion of preferences. Another is to talk with the patient alone, although many elderly patients, out of dependence or suspicion, request that a family member be present. If the patient exercises autonomy by delegating decisional authority, then that decision should be respected. For example, if the patient says in response to questions, "Do whatever my daughter wants," then the physician should consult the daughter. Even so, the physician should periodically attempt to inform the patient and include him in discussions.

The right of informed consent carries the implicit right of informed refusal. A decision to refuse treatment--even if seemingly senseless--does not mean that the patient is incompetent or insane. The most common reasons for a patient's refusal of care are misunderstanding and miscommunication between the physician and patient. The first sign of reluctance, therefore, should not be taken as a final refusal of care; rather, an initial refusal that seems contrary to the patient's best interest is reason to continue rather than conclude the discussion. Physicians are ethically bound to encourage acceptance of the therapeutic recommendation judged to be in the patient's best interest, and most patients' refusals are reversed with attention, extended discussion, and even some cajoling. Advocacy, however, even in the patient's best interest, must stop short of coercion, duplicity, or deceit. Almost never does a court order intervention over a capable patient's clear and consistent refusal.

A patient's refusal of treatment does not constitute attempted suicide, nor does a physician's compliance with a capacitated patient's decision to refuse or reject life-sustaining treatment constitute physician-assisted suicide. Rather, the subsequent death is considered to result from the underlying disease process rather than from an affirmative action causing death. The patient's right to choose almost always supersedes the physician's responsibility to provide customary and indicated medical care.

Intractable conflicts between physicians and patients about appropriate treatment are relatively rare and should be approached first as events to be negotiated or mediated. If these actions fail, the physician may need to help the patient find a new physician and then withdraw from the case. A new physician with a different philosophy, personal ethic, and temperament may be able to relate more easily to the patient.

In some states, an exception to the informed consent process, called therapeutic privilege, allows a physician to withhold information when, in the physician's judgment, the patient would suffer direct and immediate harm as a result of the disclosure. This doctrine is rarely used, however; mere upset or even anguish over grim news does not qualify. When the doctrine is used, the physician should frequently reevaluate the patient's state of mind to ensure that disclosure is made as soon as the danger of serious adverse effects has abated sufficiently.