Informed Consent

Consent of the patient is a prerequisite for any medical intervention. However, that consent often does not need to be explicit. For emergency care, consent is normally presumed, referred to as the doctrine of presumed consent. For interventions considered routine and unlikely to cause harm (eg, routine phlebotomy, placement of an IV line), circumstances are typically considered to imply consent. For example, by holding out their arm, patients are presumed to indicate consent to receive certain routine interventions. For more invasive or risky interventions, express informed consent is always required.

To give informed consent, patients must have legal and clinical capacity. Health care professionals obtaining informed consent must be qualified to explain the potential harms and benefits of the intervention and to answer appropriate questions. United States federal law requires that health care professionals take reasonable steps to communicate adequately with patients who do not speak English or who have other communication barriers (1).

Ethical and legal authorities generally agree that health care professionals are obligated to ensure, at a minimum, that 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 clinician’s professional opinion as to the best alternative

• Uncertainties associated with each of these elements

Health care professionals should be clear about the prospects of recovery with treatment and, if treatment is successful, what life will be like afterward. Generally, these discussions are noted in the medical record, and a document describing the discussion is signed by the patient.

Increasingly, health care professionals are supplementing informed consent discussions with patient decision aids (PDAs, eg, educational literature with graphics, photographs, and diagrams; decision grids; videos; website-based interactive programs such as sequential questions with feedback). PDAs might even include structured personal coaching. Evidence shows that using PDAs enhances patients’ knowledge of treatment options and their potential harms and benefits (2). Patients using PDAs also feel less conflicted about decisions and rate themselves as less passive and less often undecided.

Patients also have the right to refuse treatment. Although health care professionals are ethically bound to provide sufficient information and to encourage decisions judged to be in the patient’s best interest, patients have the right to refuse treatment. A patient’s refusal of treatment is not considered to be attempted suicide or evidence by itself of diminished capacity, nor is the health care professional's compliance with the patient’s refusal legally considered physician-assisted suicide. Rather, the subsequent death is considered legally to be a natural consequence of the disease process itself.

A refusal of care, if puzzling, should prompt the health care professional to initiate further discussion. If the patient's capacity seems questionable, such capacity should be assessed, but assessment should not be done or sought solely because the patient is refusing treatment. If refusal of treatment will hurt other people, such as a minor child or other dependent, ethical and legal consultation should be sought.