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Get informed about informed consent​​​​​​​​​​

Voluntary and written informed consent protects patients from unsanctioned procedures and the healthcare provider from claims of an unauthorized procedure. In an emergency, the healthcare provider may need to intervene as a lifesaving measure without the patient’s consent; however, every effort must be made to contact his or her family. Informed consent is necessary for: 

  • invasive procedures

  • procedures requiring sedation or anesthesia

  • nonsurgical procedures that carry more than a slight risk to the patient

  • procedures involving radiation.

Before the patient signs the consent form, the healthcare provider must provide a clear and simple explanation of what the procedure entails. He or she must also inform the patient of the benefits, alternatives, risks, and possible complications of the procedure and what to expect. You may be asked to have the patient sign the consent form and witness the signature, but the person who will perform the procedure must inform the patient and obtain his or her consent.

If the patient has doubts and hasn’t had the opportunity to investigate alternative treatments, he or she may request a second opinion. Never pressure a patient to give consent. Refusing to undergo a procedure is a legal right. If a patient refuses or withdraws consent, you must document the refusal and relay the information to the healthcare provider.

The patient must sign the consent form before psychoactive premedication is administered because consent may not be valid if it’s obtained while the patient is under the influence of medications that can affect judgment and decision-making capacity. The patient personally signs the consent form if he or she is of legal age and is mentally capable. If the patient is a minor, neurologically incapacitated, or incompetent, permission must be obtained from a surrogate (usually a responsible family member, preferably next of kin) or legal guardian. Emancipated minors (married or independently earning a living) may consent for themselves. Follow state regulations and your facility’s policy. 

Remember to make sure that patients understand what they’re signing. Have the consent form available in multiple languages or have a trained medical interpreter available. Alternative formats of communication, such as Braille, large print, or a sign interpreter, may be needed if the patient is elderly or has a hearing or vision disability. If you have doubts that the patient understands, notify the healthcare provider immediately.

Witnessing a consent form

Before witnessing a patient’s signature on the consent form:

  • Make sure the patient is competent, awake, alert, and aware of what he or she is doing. The patients shouldn’t be under the influence of alcohol, illicit drugs, or prescribed medications that impair understanding or judgment.

  • Ask whether the healthcare provider explained the diagnosis, proposed treatment, and expected outcome to the patient’s satisfaction. Also ask if he or she understands all that was said.

  • Ask whether the patient has been told about the risks of the procedure, the possible consequences of refusing it, and alternative treatments.

  • Ask whether the patient has any concerns or questions about the condition or the treatment. If the patient does, help get answers from the healthcare provider.

  • Tell the patient that he or she can refuse the treatment without having other care or support withdrawn and that consent can be withdrawn after giving it.

  • Notify the healthcare provider immediately if you suspect that the patient has doubts about the condition or the procedure, hasn’t been properly informed, or has been coerced into giving consent.


This article originally appeared in the January/February 2008 issue of Nursing made Incredibly Easy! © 2008 Lippincott Williams & Wilkins, Inc. ​

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