What is Informed Consent in Healthcare?

Informed consent is a process in healthcare that includes interactive dialog between the health care professional and the patient. Informed consent enables patients to make decisions with their healthcare provider and is a requirement for many treatments and procedures.  In this post, we will review what is informed consent in healthcare. We review what does informed consent mean, why is informed consent important in healthcare, what should be reviewed for informed consent, and when informed consent is not required.

What is Informed Consent in Healthcare?

Before many medical treatments and procedures, healthcare providers must obtain your informed consent. This is so you can decide which treatments you want to receive and make decisions with your healthcare provider. To have informed consent, the health care professional must:

• educate you on all the potential benefits, risks, and alternatives involved in the treatment or procedure, and then,
• obtain your written consent.

A patient must be competent to understand and make a voluntary decision whether to have the procedure, treatment, or intervention. Informed consent is a legal obligation, but it is also an ethical obligation for medical providers in the United States and originates from the patient’s right to direct what happens to their body.

What Should the Doctor Review? The Informed Consent Process

Health care providers have a duty to disclose information to the patient to make a reasonable decision regarding their treatment. Before asking for your informed consent in healthcare, the provider should review:

• The diagnosis.
• The purpose of the treatment or procedure.
• Benefits and risks of the treatment or procedure.
• The alternatives to the proposed treatment and the risks and benefits of the alternative treatment or procedure.
• Risks and benefits if the patient does not receive any treatment or procedure.

The patient, or the patient’s legally authorized representative, must consent to the treatment and sign and date the informed consent documents. Once you sign the form, the healthcare provider can move forward with the procedure.

If you do not want a procedure or treatment, you can choose not to sign the form. Unless you agree, your provider will not be able to give some treatments.

Preparing for your health care visits can make a world of difference. When talking with the provider, providing them specific health information and asking clear questions will make the most of your time and better understand the medical issues and treatment plan. For more information about preparing for a doctor’s visit, please read our blog post  Caregiver Guide: Preparing Health Information for Medical Appointments

Why is Informed Consent Important in Healthcare?

Although a health professional cannot guarantee a positive outcome when prescribing treatment or doing a procedure, informed consent at least ensures you understand the risks and benefits of the treatment.

Informed consent in healthcare is also the law. You have the right to ask questions and get information before agreeing to treatments and procedures. When you agree to certain treatments, you and your doctor must sign paperwork indicating your understand the risks associated with the treatment.

Informed consent also creates trust between the provider and the patient. It is a process of communication between your provider and you. It ensures the doctor explained the procedure and risks, so the patient can make an informed decision. The health care professional must provide enough information to enable the patient to make an informed decision and the best choice for their circumstances.

Why is Informed Consent Important in Healthcare? Patients Have Rights

So why is informed consent important in healthcare? You have the right to choose your health care, which means you can agree or refuse a recommended medical treatment or procedure. If you decide to have it, informed consent may be a requirement first. Informed consent means that the provider thoroughly explained the procedure, including risks, benefits, and alternatives. Signing the informed consent form means you made a voluntary and educated decision.

Why is Informed Consent Important in Healthcare? Patient Safety

Patient safety has been a critical focus in health care. Recognizing that patients have the right to make an informed, voluntary decision about their healthcare is the underlying principle of informed consent.

There are challenges to obtaining informed consent. Some have questioned whether a patient’s signature is a sufficient indication of understanding. We have seen a shift to focus more on communication and understanding and less focus on the signature. Providers generally recognize there may be barriers to obtaining consent, for example, if the language is too high of a reading level.

What does Informed Consent Mean?

Informed consent is a critical patient right, and it means:

• You can make an informed decision.
• Your provider gave you information about your health condition and treatment options, and you understand your health condition and treatment options.
• You voluntarily decide what health care treatment you want to receive and give your consent to receive it.

What Types of Procedures Need Informed Consent? 

These are the types of medical treatment or procedures that require written informed consent:

• Most surgeries, regardless of where performed
• Blood transfusions
• Anesthesia
• Advanced or complicated medical procedures and tests, for example, an endoscopy (inserting a tube down your throat to see the inside of your stomach) or a needle biopsy
• Chemotherapy or radiation treatment
• High-risk treatment, for example, opioid therapy
• Most vaccines
• Research or Clinical Trials
• Some blood tests

When Informed Consent is Not Required 

Exception to Informed Consent

Some circumstances may not require informed consent in healthcare. Meaning, there can be an exception for informed consent. Below are examples when informed consent is not required:

• Minor Children. In most states, if the patient is younger than 18, a parent or guardian will need to give consent on their behalf. However, some states allow emancipated teens, married parents, or the military to provide their consent. State legislation varies regarding minors and informed consent. This makes it essential to understand the state laws.
• Incapacitated Patient. Another person can make medical decisions for a patient if they are not able to provide consent. This may happen if you are in a coma or have a condition like advanced Alzheimer’s disease. Sometimes it is not clear whether a patient can make a decision; usually, a psychiatrist evaluation determines competency in these circumstances. This is an example of an exception to informed consent.

Delegate Decisions

• The facility should look further for consent if the patient is not able to provide it. In these situations, the hospital must check their records for the patient’s advance directives, medical power of attorney, or the patient’s representative. For example, they may have previously designated a decision-maker with an Advance Directive. As soon as the patient is capable of understanding their rights, the health care provider must give the patient that information. However, if this is unsuccessful, the court may appoint a legal guardian.

Court-Appointed

• Sometimes people need a court-appointed surrogate or proxy. This is when a judge chooses someone to make decisions for you, but only if you become unable to make your own decisions. Some states have family agency acts that choose which family members may act on behalf of a patient if the patient does not have an advance directive or medical power of attorney.

Emergencies

• Informed consent is not always a requirement in emergency situations, especially when delayed treatment would be dangerous. A provider may look for your closest relatives for consent. However, if they are not available, or if you are in a life-threatening situation, a healthcare provider can perform the necessary life-saving procedures without consent. In these situations, the physician should inform the patient/surrogate at the earliest opportunity and obtain consent for ongoing treatment in keeping with these guidelines.

Sensitive Discussions

Sometimes a diagnosis or upcoming procedure makes people think about possible unwanted outcomes, like what happens if they end up on a ventilator or have other complications. Discussions about end-of-life care can be sensitive and stressful for both the caregiver and care receiver.

Family caregivers face the challenge of being objective and staying open to their loved one’s wishes while keeping their feelings and opinions in check.  For more information about advance care planning and suggestions on preparing for sensitive discussions, read our post Sensitive Discussions About End of Life Care

Summary

Providers must obtain informed consent in healthcare before they perform many medical treatments and procedures. The provider gives the patient pertinent information about the procedures to decide which treatments they want to receive. Why is informed consent important in healthcare? Informed consent in healthcare enables patients to make informed decisions about whether they want to have treatments or medical procedures. In addition, patients have the right to choose what treatments they want to have.