Informed consent - adults

To obtain your informed consent, your provider may talk with you about the treatment. Then you will read a description of it and sign a form. This is written informed consent.

Or, your provider may explain a treatment to you and then ask if you agree to have the treatment. Not all medical treatments require written informed consent.

What Treatments Need Informed Consent?

Medical procedures that may require you to give written informed consent include:

• Most surgeries, even when they are not done in the hospital.
• Other advanced or complex medical tests and procedures, such as an endoscopy (placing a tube down your throat to look at the inside of your stomach) or a needle biopsy of the liver.
• Radiation or chemotherapy to treat cancer.
• High risk medical treatment, such as opioid therapy or treatment with corticosteroids.
• Most vaccines.
• Some blood tests, such as HIV or genetic testing. Most states have eliminated this requirement in order to improve rates of HIV testing.

What Should Occur During the Informed Consent Process?

When asking for your informed consent, your doctor or other provider must explain:

• Your health problem and the reason for the treatment
• What happens during the treatment
• The risks of the treatment and how likely they are to occur
• How likely the treatment is to work
• If treatment is necessary now or if it can wait and the consequences of waiting
• Other options for treating your health problem
• Risks or possible side effects that may happen later on

You should have enough information to make a decision about your treatment. Your provider should also make sure you understand the information. One way a provider may do this is by asking you to repeat the information back in your own words.

If you would like more details about your treatment choices, ask your provider where to look. There are many trusted websites and other resources your provider can give you, including certified decision aids.

What is Your Role in the Informed Consent Process?

You are an important member of your health care team. You should ask questions about anything you do not understand. If you need your provider to explain something in a different way, ask them to do so. Using a certified decision aid may be helpful.

You have the right to refuse treatment if you are able to understand your health condition, your treatment options, and the risks and benefits of each option. Your doctor or other health care provider may tell you they do not think this is the best choice for you. But, your providers should not try to force you to have a treatment you do not want to have.

It is important to be involved in the informed consent process. After all, you are the one who will receive the treatment if you give your consent.

Other Tips

Informed consent is not needed in an emergency when delayed treatment would be dangerous.

Some people are no longer able to make an informed decision, such as someone with dementia (for example, advanced Alzheimer disease) or someone in an altered mental state such as a coma. In both cases, the person would not be able to understand information to decide what medical care they want. In these types of situations, the provider would try to obtain informed consent for treatment from a surrogate, or substitute decision-maker.

Even when your provider does not ask for your written consent, you should still be told what tests or treatments are being done and why. For example:

• Before they have the test, men should know the pros, cons, and the reasons for a prostate specific antigen (PSA) blood test that screens for prostate cancer.
• Women should know the pros, cons, and the reasons for a Pap test (screening for cervical cancer) or a mammogram (screening for breast cancer).
• Anyone who is being tested for an infection that occurs after sexual contact should be told about the test and why they are being tested.

References

Emanuel EJ. Bioethics in the practice of medicine. In: Goldman L, Schafer AI, eds. Goldman-Cecil Medicine. 26th ed. Philadelphia, PA: Elsevier; 2020:chap 2.

United States Department of Health and Human Services website. Informed consent. www.hhs.gov/ohrp/regulations-and-policy/index.html. Updated June 30, 2020. Accessed March 31, 2022.

Last reviewed October 24, 2021 by David C. Dugdale, III, MD, Professor of Medicine, Division of General Medicine, Department of Medicine, University of Washington School of Medicine, Seattle, WA. Also reviewed by David Zieve, MD, MHA, Medical Director, Brenda Conaway, Editorial Director, and the A.D.A.M. Editorial team..