What Is Informed Consent

An informed consent document is a piece of paper that can give your doctor permission to run tests or give you certain types of treatments. It's important to understand what might be in this document and what you're required (and not required) to do with the form.

patient signing document
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Definition

Have you ever walked into your healthcare provider's office and been handed a stack of papers to sign?

Among the papers, you probably found insurance information requests and HIPAA information about the privacy and security of your records. Included, too, may have been an "informed consent" document.

Informed consent documents are used in various legal situations. They're also used when you volunteer for medical research studies. They have a very specific purpose when given to you by a doctor who's treating you for a medical condition or performing a routine check-up, In these cases, the document authorizes your doctors to provide medical services. By signing it, you give permission for them to perform these treatments or interventions.

A surrogate, or legal representative, can sign the informed consent document if the patient is:

  • Unable to understand the medical information provided
  • Cannot assess the possible outcomes from treatment
  • Unable to make a decision about medical choices

An informed consent document may be given to you as a traditional print document or as an electronic form.

Legal Purpose

The concept of informed consent is based on state laws. It requires your doctors to provide information about your treatment including:

  • Benefits
  • Risks
  • Alternatives or other options

The legal purpose of the consent is to protect you, the patient. Having this permissions process in place ensures that your doctor provides you with information you need to make a decision about your health care. This information may be provided for a test, procedure, or any treatment before it's performed.

You can change your mind about your treatment or other health care decisions even after you've agreed to a plan and signed the informed consent plan. You always have the right to stop or switch treatments.

In an emergency situation, a doctor may not be able to get consent from you or your representative. In these situations, your doctor can start treatment without consent. Your doctor should get official permission from you as soon as possible. Full consent must be given for any further or ongoing treatment.

Recap

You may get a form from your doctor for "informed consent." This is to protect you by ensuring that your doctor gives you all the information you need to make a well-informed decision about your health care.

If you're unable to make a decision, someone you've given permission to

Guidelines

You've likely heard this advice before: "Don't sign anything until you know what you are signing." That also applies to informed consent documents.

If you are asked to sign an informed consent document, follow these guidelines:

  1. Understand that signing the form tells your doctors that they have permission to go forward with recommended treatments, tests, or procedures. Before you agree with this, be sure you understand:
    -What your other options are: Could something else be done instead?
    -What could happen during the process
    -What could happen as a result of the treatment
  2. There's no rule that says you must sign the form as soon as it's handed to you. Sometimes, the informed consent form is mixed with other documents that must be signed before you see the doctor. Confirm with the doctor's office what needs to be signed immediately and what you can take home to review before signing.
  3. When your doctor describes the tests, procedures, benefits, and risks to you, take the time to repeat them back to be sure you understand them. That will give your doctor a chance to clarify any information you may not fully understand.
  4. Finally, recognize that your signature on the form provides no guarantees that the treatment will relieve your health problem or cure you. Unfortunately, medical treatment can never provide a guarantee. However, understanding why you need the test or treatment, how it will happen, and what the risks and alternatives are, could improve the chances it will be successful.

Summary

In order to make the best decisions about your health, you need to have all the facts about your medical care options. An informed consent document is supposed to help you with this by summarizing the benefits and risks of the service your doctor recommends.

Before you sign anything, be sure your doctor answers all of your questions, Also, remember that even after signing an informed consent document, you can change your mind about your treatment plan you follow.

A Word From Verywell

Although it's tempting, resist the urge to race through the many forms you may get at a doctor's office. Go through each to get a full picture, and look, especially, for the informed consent document. Take your time to review the positive and possible negative things that can occur if you follow the doctor's plan. Based on the information in that document, you must also be prepared to do your own research to learn more about the benefits and the risks of all your options.

These steps ensure that you are not only informed, but that you're also an empowered patient who knows their rights.

Frequently Asked Questions

  • Is an informed consent form a legal document?

    Yes. it is a permanent record that you and your doctor discussed certain treatments or facts and you made a decision based on that information. However, you are not legally bound to stick with that decision. You can always change your mind about your treatment or health care.

  • At what age can you give a doctor permission for medical treatment?

    In the United States, you must be 18 years or older to give informed consent to a doctor. For minors who are 17 or younger, a parent or legal guardian makes all medical decisions.

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4 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Gossman W, Thornton I, Hipskind JE. Informed Consent. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. Available from: https://www.ncbi.nlm.nih.gov/books/NBK430827/

  2. American Medical Association. Informed Consent.

  3. American Cancer Society. What Is Informed Consent?

  4. Hein IM, De Vries MC, Troost PW, Meynen G, Van Goudoever JB, Lindauer RJL. Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children’s competence to consent to clinical research. BMC Medical Ethics. 2015;16(1):76. doi:10.1186%2Fs12910-015-0067-z