What Is Informed Consent?

Informed consent is an important communication process that takes place between patients and their healthcare providers. It is a key part of the healthcare decision-making process.

During the informed consent process, your healthcare provider makes sure you understand your diagnosis, treatment options, and the benefits and risks of those treatment options. Importantly, informed consent also involves assessing whether you are able to provide consent to move forward with (or decline) care.

Depending on your treatment plan, you could be asked to sign an informed consent document that gives your doctor permission to run tests or give you certain therapies. It's important to understand what might be in this document and what you're required (and not required) to do with the form.

This article outlines what you should know about the consent process, including the difference between informed consent and implied consent, and steps you can take to ensure you're taking an active role in your medical care.

What Is Informed Consent?

By definition, the consent process gives patients the ability to decide what happens to their bodies and enables them to be active participants in their medical care. In short, no one should perform medical tests, procedures, or research on you without your permission.

There are two distinctly different types of consent: implied consent and informed consent (sometimes called express consent).

Informed consent requires providers, researchers, and others to provide the information patients need to understand and make decisions about their condition and the recommended care.

This can include information about your diagnosis, the benefits and risks of treatments (or no treatment), and how and by whom procedures will be carried out. For instance, if you are receiving care at a teaching hospital, you must be told if a medical trainee will be involved in your care or performing a specific procedure.

Your healthcare provider is required to ensure you fully understand the information you've been given, and will take steps to do so. They may provide information during a conversation, or use patient education materials like brochures, fact sheets, or videos. You should have the opportunity to ask questions and have them answered.

In the case of informed consent, your agreement (or lack thereof) to a treatment plan would be documented in your medical record. In some cases, you may be asked to sign an informed consent document.

Implied consent takes place in situations where a more formal consent is not needed. For instance, if you make an appointment to get have a blood sample drawn and roll up your sleeve, your consent is implied.

If a patient is unable to make decisions for themselves—for instance, a child or someone who is unconscious—then a surrogate (like a parent or spouse) is involved in the consent process.

Elements of Informed Consent

• There are four central elements of the informed consent process. These must be followed, and include:
• Decision-making ability: You must be able to make the decision. That means that you can understand the options available to you and the consequences of the proposed treatments (or of not being treated). Younger children, or patients who are unconscious, lack decision-making ability and would not be able to participate in the informed consent process.
• Information sharing: Your healthcare provider must disclose information on your diagnosis and their proposed treatments. This includes information on the effectiveness of the treatments, the benefits, and the risks. They must provide you a full picture of what you can expect.
• Understanding: One of the most important elements of informed consent is your understanding of the information. Ask questions to make sure that you fully comprehend what's being presented before you agree to treatments.
• Voluntary agreement: No one should pressure or force you to provide informed consent. Your agreement should never be given under duress.

When Is Informed Consent Required?

Consent in healthcare is about meaningful conversations and transparent actions between a provider and a patient.

Your healthcare provider will let you know what they are doing and why, whether they're performing a physical exam, prescribing a medication, or developing a more complex treatment plan that requires additional tests or procedures. The other providers on your care team will do the same.

In the majority of situations, the informed consent process happens before a test or treatment is performed.

Your provider will explain benefits and risks, as well as alternatives. You'll be given the opportunity to provide consent—informed (written or verbal) or implied—for everything you're asked to do. Your provider will note your consent in your record and, in some cases, document it with a signed form.

You won't need to provide written consent for some things, like a prescription for medication. The act of having your prescription filled implies your consent to taking the medicine.

Written informed consent is required for medical procedures such as:

• Surgeries (both inpatient and outpatient)
• Anesthesia
• Invasive medical procedures, such as colonoscopies or biopsies
• Placement of a medical device, such as an intrauterine device (IUD)
• Chemotherapy
• Radiation therapy
• Vaccines

Some laboratory tests, like an HIV blood test, require written consent, but not all do.

When Is Informed Consent Not Required?

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.

Providing Informed Consent

When you visit your healthcare provider's office, you'll most likely sign a "Consent to Treat" form. If you need additional procedures or tests, you'll provide additional consent as needed.

Documentation is an important step in providing informed consent. Depending on the situation, informed consent could be provided by signing a legal document, or it could be given verbally.

Either way, your healthcare provider must be able to prove that you authorized them to perform tests, treatments, or interventions.

If you are asked to sign a form, it could be provided to you electronically or in hard copy. If you provide verbal consent, your doctor will document it in your medical record.

Guidelines

If you are asked to sign an informed consent document, there are some steps you can take to make sure you're fully engaged in the process. Some guidelines are listed below.

Listen and Learn

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?

Ask For Time to Review

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.

Confirm Your Understanding

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.

Know the Limits

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.

It is also important to remember that you can, at any time, change your mind.

Summary

In order to make the best decisions about your health and medical care, you need to have all the facts about your medical care options and understand the role that you play. The informed consent process doesn't just include signing a form. Rather, it is at the core of the shared-decision making process between a patient and their healthcare provider. An informed patient is an empowered patient.

Your provider should discuss with you your diagnosis, the benefits and risks of the treatments or therapies they're recommending, as well as any alternatives. Before you provide consent, be sure all of your questions are answered and that you understand the information.

Don't forget that you can change your mind about your treatment plan even after you provide informed consent.