Understanding Informed Consent and Your Patient Rights

Informed consent is part of the medical care process. Before a procedure, the healthcare provider must explain the procedure and your choices as the patient. Then you can consent. If you cannot consent, your legal guardian or appointed representative can do so on your behalf.

“Informed consent” is a medical term of art. This article explains the meaning of this term and the implications of no informed consent. It also explores the role of the doctor and the patient.

As a patient, you retain full legal autonomy to ask clarifying questions and to withdraw your consent. Consult a healthcare attorney near you if you believe a provider has violated your rights.

Informed Consent Defined

The specific definition of informed consent may vary by state. At its core, a patient must understand and agree to a procedure or test before treatment. A healthcare provider must inform the patient of the following:

• The potential benefits
• The risks
• The treatment or procedure that will be done
• The treatment alternatives

This can include a surgical procedure or a medical procedure. Failure to get a patient’s consent could lead to a malpractice action.

The patient must have an opportunity to understand the treatment or procedure, ask questions, and/or refuse treatment. Asking questions helps a patient make an informed decision. Once a patient understands the benefits and risks of the procedure, the healthcare provider can get the patient’s written consent.

Many providers use a consent form as part of the decision-making process. The patient must have decision-making capacity. This means there are no language or intellectual barriers. A certified medical translator must translate if a patient speaks a different language, or the informed consent form should be provided in multiple languages.

If the patient has a legal guardian, the guardian handles informed consent. They are responsible for understanding the procedure, risks, and side effects before deciding and can sign on behalf of the patient.

A physician must disclose information to the patient so they can make a reasonable decision about treatment. Most patients’ bill of rights includes informed consent.

The Doctor’s Role in Informed Consent

Physicians themselves (rather than related health care professionals) are the best choice to speak to the patient. The doctor should cover the following when discussing the matter with the patient:

• The patient’s diagnosis (if known)
• The patient’s right to refuse treatment
• The nature and purpose of the proposed treatment or procedure
• The benefits and risks of that proposed treatment or procedure
• The alternatives to the proposed treatment or procedure
• The alternative treatment options
• The risks and benefits of alternative treatments or procedures
• The risks and benefits of not receiving or undergoing any treatment or procedure
• Whether the patient’s health insurance covers the treatment
• An explanation of the consent document
• The patient, or the patient’s authorized representative, must sign and date the informed consent form
• The patient or their authorized representative must receive a copy of the informed consent

Once signed and dated, the form goes into the patient’s medical record.

The Patient’s Role in Informed Consent

A doctor must inform the patient about the benefits, risks, and alternative treatments. In the informed consent process, patients should listen carefully to the physician. They should always ask questions if they need clarification or more detailed information.

Clinical Trials and Informed Consent

Informed consent is not limited to medical procedures. A patient’s consent is also required to take part in clinical trials. Clinical trials are part of the medical research process.

Researchers test their theories in labs or on animals before moving to human subjects. Clinical trials are closely regulated because of the ethical issues when using humans as research subjects.

Informed consent in human trials stems from the Nuremberg Trials. These trials took place after World War II. The trials highlighted the atrocities of Nazi medical experimentation on unwilling subjects.

The Nuremberg Code followed the Nuremberg trials. It emphasized the need for consent in any human medical experimentation as a matter of medical ethics. A patient’s autonomy is necessary for informed consent.

Researchers often test new medications and treatments on humans before approval. Researchers use clinical trials for these tests. Some research participants may be among the first humans to try a new drug or procedure. So patient consent is a legal requirement.

Informed consent for a clinical trial follows the same steps as in other medical scenarios.

Clinical trial researchers are legally obligated to fully disclose all potential risks before you agree to participate. A local healthcare attorney can help ensure your rights are protected and hold non-compliant medical researchers accountable.

Exceptions: When Informed Consent May Not Be Necessary

Informed consent is not always possible or advisable. For instance, doctors often need to perform a life-saving procedure while a patient is unconscious and unable to consent.

Situations Not Involving Medical Procedures or Treatment

Some patient care procedures are so routine and non-invasive that informed consent is not an issue. One example is using a stethoscope. A physician and patient rarely discuss the benefits and risks of using a stethoscope. In other situations not involving medical treatments, informed consent is an absolute necessity.

Emergency Situations

In emergencies, there’s not always time to get a patient’s informed consent. This is true when the patient is unconscious or unable to communicate.

For example, doctors can use experimental drugs and devices without consent in emergencies. A special committee keeps track of the results. Also, provisions are in place to allow experimental use to stop immediately if needed.

Informed Consent From Minors and the Mentally Disabled

Obtaining informed consent is relatively uncomplicated when a competent adult seeks medical treatment. When mentally disabled individuals or children need treatment, obtaining informed consent is complicated.

Patients With Mental Disabilities

Mentally disabled persons often have legal guardians authorized to make medical decisions. Healthcare teams must ensure they receive informed consent from the right individual.

Patients Who Are Minors

Parents usually give informed consent for treatment for their minor children. Some states allow young adults under 18 an active role in their medical care and treatment. This includes the process of informed consent.

However, only some teenagers can make healthcare decisions under these laws. So, most states focus on “mature minors,” or those ready to understand the consequences of treatment. In those states, such young adults may consent without consulting their parents. For example, some jurisdictions have passed laws allowing minors to consent to specific healthcare treatments. These include:

• Substance abuse
• Mental health
• Sexual activity

Withdrawing Informed Consent

You have the right to withdraw your informed consent for a procedure or treatment. But there are important considerations for withdrawing consent depending on the stage of the procedure or treatment. For example, changing your mind about a procedure after it has started may not be possible if stopping it could cause harm.

Just as with giving informed consent, you must be mentally competent to withdraw it.

To withdraw your informed consent, let your physician or healthcare provider know immediately. You can notify them either in writing or orally. Make sure your provider understands and acknowledges your choice to withdraw consent. They should also document your decision in your medical record.

You can explain why you’re withdrawing consent, but you’re not required to do so. Your provider will discuss possible changes in your prognosis based on your decision to withdraw your consent.

Get Legal Help With an Informed Consent Issue

As a patient, you have a right to understand the risks and benefits of a procedure. If you believe you have experienced a violation of this right, an attorney can help. Speak to an experienced local healthcare law lawyer to learn how they can help.

FindLaw’s directory of healthcare attorneys can get you started. Enter your city or ZIP code for a list of qualified legal professionals near you. Because your state’s laws are relevant, your attorney should be licensed in your state. Your search results will also show important details about prospective attorneys, like ratings and whether they offer free case evaluations.