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Informed Consent


Thaddeus Mason Pope

, JD, PhD, Mitchell Hamline School of Law

Reviewed/Revised Oct 2023

People have the right to information about potential harms, benefits, and alternative treatments when making decisions about medical care, and they have the freedom to accept or refuse care. Before performing any invasive test or providing medical treatment, doctors must obtain permission from a competent patient in a manner that is informed and voluntary. The process is known as informed consent. (See also Overview of Legal and Ethical Issues in Health Care Overview of Legal and Ethical Issues in Health Care Most adults have the legal right to make their own health care decisions. However, poor health can jeopardize people’s ability to exercise their legal rights. Safeguarding these rights requires... read more .)

The process of informed consent should involve discussion between the individual and the doctor. Patients should be encouraged to ask questions about their condition and treatment options, and doctors should share facts and insights along with support and advice. Doctors should present the information in a way that is understandable to the patient and communicates the harms and benefits clearly. United States federal law requires that doctors take reasonable steps to communicate adequately with patients who do not speak English or who have other communication barriers.

Increasingly, health care professionals use patient decision aids (PDAs) to help communicate medical information. PDAs include educational literature with graphics, photographs, and diagrams; decision grids; videos; website-based interactive programs, such as programs that ask questions and provide feedback. PDAs might even include structured personal coaching. People who use PDAs may feel less conflicted about medical decisions.

Informed consent is substantially achieved when patients understand

  • Their current medical status, including its likely course if no treatment is pursued

  • Potentially helpful treatments, including a description and explanation of potential harms, benefits, and burdens

  • Usually the health care professional's opinion as to the best alternative

  • Uncertainties associated with each of these elements

Typically, a document summarizing the discussion is signed by the patient for any major treatment decisions.

If the patient is incapable of giving informed consent (incapacitated), the doctor turns to the person (agent) named in a health care power of attorney Health Care Power of Attorney Health care advance directives are legal documents that communicate a person’s wishes about health care decisions in the event the person becomes incapable of making health care decisions. There... read more . If none exists, the doctor may turn to another authorized surrogate decision maker Default Surrogate Decision Making If a person is unable to make decisions about personal health care, some other person or people must provide direction in decision making. The general term for such person is surrogate decision... read more . If urgent or emergency care is needed and an authorized decision maker is not immediately available, the doctrine of presumed consent applies. People are presumed to consent to any necessary emergency treatment unless they have specifically previously refused such treatment.

Refusing care

People who have legal and clinical capacity have the right to refuse any medical care. They may refuse care even if it is something almost everyone else would accept or something that is clearly life-saving. For example, a person having a heart attack can decide to leave the hospital even if that may lead to death. Even if other people think the decision is wrong or irrational, the decision to refuse treatment cannot be used by itself as proof that the person is incapacitated. In many cases, people refuse treatment based on fear, misunderstanding, or lack of trust. But refusal may also be a product of depression Depression Depression is a feeling of sadness and/or a decreased interest or pleasure in activities that becomes a disorder when it is intense enough to interfere with functioning. It may follow a recent... read more , delirium Delirium Delirium is a sudden, fluctuating, and usually reversible disturbance of mental function. It is characterized by an inability to pay attention, disorientation, an inability to think clearly... read more , or other medical conditions that can impair the person's capacity to make health care decisions.

A refusal of care should prompt the doctor to initiate further discussion to determine why the patient refuses care and whether any concerns the patient has about accepting care can be corrected. For example, patients who refuse care because they cannot afford it could be helped to apply for public benefits such as Medicaid or be told that a suitable payment plan could be arranged. A patient's competent refusal of treatment is not considered to be attempted suicide, nor is the doctor’s compliance with the patient's refusal legally considered medical aid in dying Physician Aid in Dying (formerly, Assisted Suicide) Suicide is death caused by an act of self-harm that is intended to be lethal. Suicidal behavior includes completed suicide, attempted suicide, and suicidal ideation (thoughts and ideas). Suicide... read more (formerly called doctor-assisted suicide). Rather, any subsequent death is legally considered to be a natural consequence of the disease process itself.

Sometimes, a patient's refusal of treatment may harm others. For example, patients who refuse treatment of certain infectious diseases, such as tuberculosis, place other people at risk of infection. Also, people who refuse to allow treatment of others, such as a minor child or a dependent adult, may place that other person’s health at risk. In such cases, doctors often consult lawyers, judges, and experts in ethics.

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