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. Depending on your treatment plan, you may be asked to sign an informed consent document that gives your healthcare provider permission to do certain tests or procedures.
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.
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What Is Informed Consent?
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 first making sure you understand the risks and benefits, and then getting your permission to proceed.
Informed consent includes:
- Information about your diagnosis
- The benefits and risks of treatments (or no treatment)
- 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 will be performing a specific procedure.1
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. If you need additional procedures or tests, you'll provide additional consent as needed.
Your healthcare provider is required to ensure you fully understand the information you've been given. 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.
Your healthcare provider must be able to prove that you authorized tests, treatments, or interventions, so your agreement or refusal of a treatment plan will be documented in your medical record.
Elements of Informed Consent
Healthcare providers must follow four central elements of the informed consent process.
Decision-Making Ability
You must be able to make the decision. That means you can understand the options available to you and the consequences of the proposed treatments (or of not being treated). Children and patients who are unconscious lack decision-making ability and would not be able to participate in the informed consent process.
Who Can Provide Informed Consent for You?
The age when a minor can give consent for medical services varies by state.2
A surrogate, or legal representative, can also give informed consent (and sign an informed consent document) if the patient is:3
- Unable to understand the medical information provided
- Cannot assess the possible outcomes of treatment
- Unable to make decisions due to incapacitation or mental illness
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. It should also include the risks and benefits of refusing treatment. Your healthcare provider must provide a full picture of what you can expect.
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. It should also include the risks and benefits of refusing treatment. Your healthcare provider must provide 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.
Informed Consent vs. Consent to Treat
Most medical offices include a Consent to Treat form with its standard patient paperwork. When you sign this form, you're giving the healthcare provider permission to provide care and for the practice to bill your insurance. This form clearly states your right to discuss all procedures or treatments or to refuse them.4
Implied Consent vs. Informed Consent
Implied consent takes place in situations where a more formal consent is not needed. For instance, if you make an appointment to have a blood sample drawn and roll up your sleeve, your consent is implied.
When Is Informed Consent Required?
Except under specific circumstances, informed consent—whether written or implied—is required for any treatment or medical procedure and for any research study where there is more than minimal risk to the subjects. In the majority of situations, the informed consent process happens before a test or treatment is performed.
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 Have the Right to Change Your Mind
You can change your mind about your treatment or other health care decisions even after you've signed an informed consent form.5 You always have the right to stop or switch treatments.
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.
Types of Procedures
For some procedures, you may be asked to sign an informed consent document. Written informed consent is required for medical procedures such as:6
- 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.6
Emergency Situations
In an emergency situation, a healthcare provider may not be able to get consent from you or your representative. In these situations, treatment can be started without consent.3 Your healthcare provider should get official permission from you as soon as possible. Full consent must be given for any further or ongoing treatment.
Tips for Providing Informed Consent
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 healthcare providers 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
- What could happen without 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 a healthcare provider.
Confirm with your provider's office what needs to be signed immediately and what you can take home to review before signing.
Confirm Your Understanding
When your healthcare provider 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 healthcare provider 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.
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