Informed Consent

What is informed consent?

Informed consent is a formal conversation between you and your healthcare provider about your treatment plan. It’s required by law, as well as by the medical code of ethics. Your provider explains what the treatment is, what it can do and what risks it may have. You get to ask questions and decide if you want to go ahead. If you say “Yes,” that’s called giving your consent.

What is the purpose of informed consent?

Informed consent protects you and your healthcare provider. It makes sure you get the facts you need before treatment starts. This helps you feel more confident and prevents confusion or surprises later. It also helps you take part in your care and make the best choice for yourself.

What medical procedures require informed consent?

In general, you need to give informed consent any time there’s a risk with a test or treatment. That includes physical risks and even privacy risks. Your provider will explain what’s involved so you can decide if you agree. That includes risks to your privacy. Specific tests and treatments that are likely to require informed consent include:

• Anesthesia
• Biopsies
• Blood transfusions
• Cancer treatments like chemotherapy and radiation
• Childbirth interventions like forceps delivery or episiotomy
• Clinical trials (research studies)
• Genetic testing
• Medical implants
• Surgery
• Treatment with high-risk medications, like opioids
• Tests or procedures that go inside your body, like an endoscopy

Additionally, you’ll give informed consent any time your personal medical records are transferred to another person or place.

What does it mean to give my informed consent?

When you give your informed consent, you say it’s OK for your healthcare provider to move forward with a certain treatment or test. You understand what they’ve explained and feel ready to decide.

You might give your signature on a document that says you understand the risks, benefits and other options. But signing the paper doesn’t mean you have to keep going. You can change your mind at any time — even after giving consent.

Who sets the standards for informed consent processes?

In the U.S., several organizations help set the rules for informed consent:

• The Centers for Medicare and Medicaid Services. They set the rules U.S. hospitals must follow if they want to get paid by the government.
• The American Medical Association. They have a Code of Medical Ethics that includes clear guidelines for how doctors should handle informed consent.
• The U.S. Department of Health and Human Services. They make rules for informed consent in clinical trials
• U.S. state laws. Each state can also have its own laws about how informed consent should work.

What are the exceptions to informed consent rules?

Sometimes, providers can treat you without going through the full informed consent process. Your provider might start treatment without your informed consent if:

• You need care right away, but you can’t communicate. In this case, your healthcare provider might treat you without asking first. They’ll try to talk to your family if they can or ask you once you’re stable.
• You’re too sick to decide. If you’re in a coma or very ill, your provider will check if you have an advance directive or someone legally allowed to decide for you. They may also treat you right away if you say it’s OK to skip consent.
• You’re a minor. If you’re under the age of 18, usually a parent, legal guardian or someone else (surrogate) will make healthcare decisions for you. But some states let older minors make their own choices in certain cases.