Informed Consent

What is informed consent?

Healthcare providers use informed consent to make sure you understand your diagnosis and your treatment options. This process involves ongoing and clear conversations between you and your healthcare provider. These conversations often lead to your decision to give consent for treatment.

Why is informed consent important?

The informed consent process is important for several reasons. It protects your ability to make your own decisions about medical treatment. It also protects your legal right to ask questions about recommended treatments.

The process also guides healthcare providers. It helps them to make ethical decisions about your healthcare, and it helps you and your provider make healthcare decisions together.

Which medical procedures or tests require informed consent?

In general, the following procedures and tests require informed consent:

• Anesthesia
• Any transfer of your personal information to another person or place like diagnoses, medical treatments or prognoses
• Biopsies
• Blood transfusions
• Cancer treatments like chemotherapy and radiation therapy
• Certain vaccines
• Childbirth interventions like forceps delivery or episiotomy
• Clinical trials
• Genetic testing
• Medical implants
• Medical students’ participation in treatment
• Most surgeries
• Treatment with high-risk medications like opioids
• Tests and medical interventions that go inside your body like endoscopy

Informed consent standards

The standards include informed consent types and principles. There are three types of informed consent and four principles.

What are the three types of informed consent?

The three types are:

• Implied consent. Your provider explains why they recommend a procedure. They explain what happens during the procedure. They answer your questions.
• Verbal consent. An example of verbal consent is when you agree to have tests or procedures. Your medical records will show you gave verbal consent.
• Written consent. Written informed consent applies when you accept a risk. That may be a risk of complications from treatment or tests, but it also applies to risks to your right to privacy.

What are the four principles of informed consent?

These are steps healthcare providers take to conclude you’re giving informed consent. They conclude that:

• You understand the medical information they provided
• They gave you the information you need to make an informed decision
• You understand the information
• You give your consent to have treatment (your provider will usually ask you to review and sign an informed consent document)

1. Your provider knows you understand the medical information

Medical terms and procedures can be confusing. Your provider wants to be sure you understand their recommendations. They want you to feel confident about your decisions. To that end, they may share medical information with videos, photographs or written guides. If the language your provider speaks isn’t your first language, you’ll work with a medical translator.

2. Your provider gives you enough information to make decisions

In general, your healthcare team should tell you:

• The name and nature of your condition (for example, if you have cancer, your provider should tell you the kind of cancer you have and the cancer stage)
• The name of the procedure or treatment that your provider recommends.
• The benefits and risks of the procedure or treatment
• The benefits and risks of other options, which include the option not to get the recommended treatment or procedure

3. Your provider believes you understand the information

Communication is key to the informed consent process. Your provider will discuss your situation with you. They’ll answer questions so they’re confident that you understand the recommendations. They must note this in the informed consent document.

4. You authorize the recommended treatment

Your formal approval is the essential and final step in the informed consent process. You may sign an informed consent form or give consent verbally. Either way, it’s important that you make decisions voluntarily.

Who oversees informed consent standards?

Several organizations oversee or provide guidance on informed consent. For example:

• The Centers for Medicare and Medicaid Services have informed consent requirements. Hospitals in the U.S. must follow these requirements to receive reimbursement.
• The American Medical Association has informed consent guidelines as part of the organization’s code of ethics.
• The U.S. Department for Health and Human Services has informed consent process requirement for people who participate in clinical trials.
• Most U.S. states have laws that outline informed consent procedures.

What are the exceptions to the informed consent process?

There are situations when a healthcare provider can provide treatment without going through the informed consent process. Your provider may start treatment without your informed consent if:

• You need immediate medical care, but you can’t communicate. In that case, your provider may start treatment and get your formal consent as soon as you can give it.
• You need care but you’re very sick or in a coma. In that case, your provider will see if you have an advance directive. This is a legal document that designates someone as your healthcare proxy. Your proxy can make decisions on your behalf.

They may also begin treating you without your informed consent if you waive your right to have informed consent.

Can children give informed consent?

In general, children under age 18 can’t give formal informed consent to treatment. That means parents or legal guardians give formal consent on a child’s behalf.

What does signing an informed consent document mean?

It means that you consent to having the specific treatment that your healthcare provider recommends. Importantly, it means you understand treatment benefits and risks. You also understand that there are alternative treatments.

But an informed consent document isn’t a contract. You can change your mind and take back your consent.

What happens if I don’t want the treatment that my healthcare provider recommends?

Your provider can’t give you treatment that you don’t want. They may recommend other treatments. And they’ll continue to treat your symptoms, like pain management treatment.