Informed Consent

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KEY POINTS

• Informed consent is a law that requires you to give permission before you have surgery, procedures, treatments, or enroll in a clinical research study.
• Be sure to ask all of your questions so that you fully understand your condition and treatment choices. You can refuse the test or treatment as long as you understand the risks and possible problems if you do so.
• If you are severely hurt and need emergency treatment, you may be treated without informed consent.

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What is informed consent?

Informed consent is a legal procedure that requires you to give permission before you have a medical or surgical procedure. It’s also required before you join a clinical research study.

Be sure to ask all of your questions so that you fully understand your condition and treatment choices. Your healthcare provider will explain everything to you and answer your questions. You will be asked to sign a form. The form confirms that you have received the information, understand what you were told, your questions were answered, and that you give permission for the test or treatment. Do not feel rushed. You should feel comfortable taking your time to read the whole document so that you know exactly what you are signing. This will help you play an active role in your healthcare.

What do I need to know?

Before you have a test or treatment, you need to know:

• What condition or illness you have or may have
• Why a particular test or treatment is needed or recommended
• The benefits of having the test or procedure
• The risks and problems that might happen as a result of the test
• The chances of success for the recommended test or treatment
• How long the recovery period after the test or treatment, if any, is likely to be
• Other options besides the test or treatment being recommended

You can choose to refuse the test or treatment as long as you understand your options and the risks and possible problems if you do not take your provider’s advice.

Are there any special rules?

Sometimes you can be treated without informed consent. For example, if you are severely hurt and you need emergency treatment, you may not be able to give consent. People who cannot legally make their own decisions cannot give consent for themselves. Each state has laws about when informed consent is needed and when treatment may be given without it.