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What is Informed Consent?

what is informed consent

We all know that medical malpractice is the failure of medical professionals to meet the medical standard of care through either act or omission. As a result, the patient often suffers major injuries, illnesses, and even wrongful death. Many people don’t realize that lack of informed consent is also a form of medical malpractice. 

Informed consent is an ethical and legally mandated requirement for healthcare professionals before medical treatment. Informed consent means telling the patient all pertinent information about a procedure – what it is, risks, benefits, what happens if they refuse treatment, etc. – so that they can make an informed decision about their healthcare. If a healthcare provider fails to provide informed medical consent, and the patient suffers harm as a result, they could face a medical malpractice lawsuit. Below, Chicago medical malpractice attorneys at Curcio Law Offices break down everything you need to know about informed consent laws and how they relate to medical negligence.

If you or a loved one has suffered catastrophic injuries, illnesses, or wrongful death as a result of negligent medical professionals, you may have grounds to take legal action. Call 312-321-1111 to schedule a free consultation at Curcio Law Offices today.

What is Informed Consent?

All patients have the legal right to fully understand the ins and outs of a medical procedure so that they can make decisions accordingly. This is called informed consent. It is one of nine core principles listed in the American Medical Association’s Code of Ethics. Opinion 2.1.1 in the AMA Code of Ethics states this regarding informed consent:

“Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making.”

So obtaining informed consent from patients is firstly an ethical requirement, secondly a legal responsibility, and thirdly an administrative process in United States medical care. Once the informed consent process is complete, all patients must fill out a medical consent form or provide verbal consent to their medical team, depending on specific state laws. Either way, informed consent laws require doctors to document such consent in the patient’s medical records.

Why is Informed Consent Important in Healthcare?

Informed consent is vital in healthcare for several reasons, including respecting patient autonomy, providing information about risks and benefits, and allowing individuals to make decisions about their medical care. Additionally, obtaining informed consent allows the doctor to create a trusting relationship with the patient, and it helps reduce legal liability on both sides.

Respecting Bodily Autonomy

Most medical procedures are invasive in some way. The procedure either allows the doctor to see inside a patient’s body via scans or tests or it allows the doctor to physically see inside a patient’s body through cameras or open surgery. In this way, medical care is intimate, uncomfortable, and scary for many patients. Therefore, ensuring patients feel in control of their bodies and healthcare is crucial to having all the information necessary to make decisions.

Providing Information

Most average people do not understand the inner workings of the human body and how medications, treatments, and procedures can improve or worsen their current condition. It is up to the doctor to explain the medical issue and how the proposed treatment can improve the issue. This allows patients to ask questions and seek clarification before giving consent.

Reducing Legal Liability

As previously stated, obtaining a patient’s consent before a procedure is crucial to medical ethics and law. Informed consent requires both parties – the patient and the doctor – to be on the same page to protect themselves from legal liability should anything happen.

Creating Trust

Finally, communicating effectively and obtaining consent builds trust between the patient and the doctor. There must be a certain level of trust so the patient can feel comfortable putting their health and life in someone else’s hands. A good level of trust is important for improving patient satisfaction and healthcare outcomes.

The Informed Consent Process

To obtain valid informed consent, healthcare providers must follow a specific informed consent process. The main elements of consent include explaining the nature of the procedure, explaining the risks and benefits of the procedure, offering reasonable alternatives to the procedure, explaining what happens if the patient refuses treatment, and finally, assessing a patient’s understanding of everything discussed.

Explaining The Nature of The Medical Procedure

Patients must be fully informed about the nature of the medical procedure, understand what it entails, and why it is recommended to treat their condition.

Explaining Risks and Benefits of the Medical Procedure

Patients must be aware of the potential benefits and risks related to the medical treatment. Even if a specific treatment has a minimal risk of another health complication, the patient deserves to know this. This information allows them to weigh the pros and cons before making a decision and filling out medical consent forms.

Explaining Reasonable Alternative Treatments to the Medical Procedure

If patients are too scared or uncomfortable with the proposed treatment, their doctor should offer reasonable alternatives to the procedure that can still offer relief. The doctor should also break down the risks and benefits of proposed alternatives.

Explaining What Happens If the Patient Refuses the Medical Procedure

Even after learning about the risks and benefits of a specific treatment, a patient may want to refuse treatment entirely. At this point, the doctor should help the patient understand the consequences of refusing the recommended medical treatment, including further harm to their health.

Assessing a Patient’s Understanding of the Medical Procedure

At the end of the informed consent discussion, Healthcare providers must assess the patient’s ability to make an informed decision. This means they must ensure the patient comprehends all information provided. Patients have the right to ask questions and seek clarification at this point.

If the patient consents to the medical treatment, they must fill out a written consent form or provide verbal consent, depending on specific state laws.

Which Medical Procedures Require Informed Consent?

Informed consent applies to all medical procedures, from routine testing and treatment options to more invasive interventions. The complexity of the informed consent process may vary based on the nature of the medical treatment.

Common examples of medical procedures and treatments that require a thorough informed consent process include:

  • Chemotherapy, radiation, and other cancer treatments;
  • Any type of surgery;
  • Vaginal birth after c-section (VBAC);
  • Labor and delivery interventions, including an episiotomy or forceps delivery;
  • Biopsies;
  • Treatments involving potentially addictive and high-risk medications such as opioids;
  • Medical tests that require cameras going inside the body, such as colonoscopies and endoscopies;
  • Medical implants;
  • Anesthesia;
  • Blood transfusions;
  • Genetic testing;
  • Vaccinations;
  • A clinical trial or research procedure that involves participation from human research subjects (this includes psychological research trials);
  • Clinical trials and research procedures that require participation from medical students
  • Any transfer of someone’s personal information.

Can You Withdraw Informed Consent?

Yes, patients and research participants have the right to withdraw their informed consent at any point during their medical treatment. Withdrawing informed consent means the patient no longer wishes to proceed with the medical procedure or treatment they initially agreed to. Patients must understand that they can change their minds about their healthcare decisions, even after initially giving consent. Healthcare providers must respect a patient’s right to withdraw consent without any coercion or pressure. 

Patients should communicate their decision to their healthcare provider as soon as possible to ensure that the medical team can adjust the treatment plan appropriately. 

Withdrawal of consent should not result in any adverse consequences or retaliation from the healthcare provider, as respecting patient autonomy remains paramount throughout the healthcare process.

Finally, withdrawal of informed permission must be documented in a patient’s medical records via a signed form or a verbal agreement. 

Exceptions to Obtaining Informed Consent

While informed consent is a fundamental principle in healthcare, there are situations where obtaining formal consent may not be feasible or necessary. Common exceptions include incapacitation, medical emergencies, or being underage.

Incapacitation

In cases where a patient lacks decision-making capacity due to a medical emergency or mental illness, healthcare providers may proceed with immediate intervention to prevent harm, even without signed consent forms. In many incapacitation cases, a medical “surrogate” must be identified in order to provide informed consent on behalf of the patient. Medical surrogates are most commonly spouses or family members.

Emergency Situations

Emergency medical situations may necessitate immediate medical care without the ability to obtain informed consent from the patient. In most cases, doctors assume the patient would consent to whatever it takes to save their life unless they have explicitly stated otherwise before the medical emergency.

For example, if an older adult with a history of heart complications signs a DNR – do not resuscitate – then medical professionals cannot violate the patient’s wishes and do whatever it takes to keep them alive.

Children

Minors often do not have the mental capacity to fully understand the details of their medical condition and the proposed treatments that can help them. So obtaining parental permission for the child’s medical care is crucial here. 

However, some states have a “mature minor” exception, which states that minors of a certain age (or very mature) can have complete medical decision-making capacity without parental permission. 

Other laws called “medical emancipation” allow minors to completely exclude their guardians from any involvement in their health care. Instead, courts may assign a different medical surrogate to give consent on behalf of the child until they become an adult. This is very common in cases of child abuse or neglect.

Is Lack of Informed Consent a Form of Medical Malpractice?

Yes, a failure to obtain patient consent can be a form of medical malpractice. If the healthcare provider proceeds with medical treatment without laying out all the information, risks, and benefits of the treatment, and the patient suffers major harm as a result, then the patient may have grounds to file a medical malpractice claim.

Medical malpractice involves a breach of the medical standard of care that harms the patient. Failure to obtain informed consent can be seen as a breach of the standard of care, as it represents a failure to uphold the patient’s right to make informed decisions about their healthcare.

Can You Sue a Health Care Provider for Lack of Informed Consent?

Yes, patients who have experienced a lack of informed consent and suffered harm as a result may have grounds to pursue legal action against the healthcare team responsible. However, pursuing a medical malpractice case can be complex, requiring establishing the 4 D’s of negligence.

Duty of Care

It must be established that the healthcare provider owed the patient a duty of care, which is a legal obligation to provide competent and appropriate medical care.

Breached Duty of Care

The plaintiff (the patient) must demonstrate that the healthcare provider breached the standard of care by failing to obtain informed consent or provide adequate information.

Causation

There must be a direct link between the breach of the standard of care and the patient’s injuries or damages. In other words, it must be shown that the lack of informed consent directly led to harm.

Damages

The plaintiff must provide evidence of the damages suffered due to the lack of informed consent. These damages can include physical harm, emotional distress, additional medical expenses, or any other losses.

Consultation With a Medical Malpractice Attorney

If you believe that you or a loved one has been a victim of medical malpractice due to a lack of informed consent, it is essential to consult with an experienced medical malpractice attorney at Curcio Law Offices. They can evaluate your case, help you gather evidence, and guide you through the legal process.

Medical Malpractice Damages

In medical malpractice cases involving a lack of informed consent, plaintiffs may be eligible for various types of damages, depending on the case’s specific circumstances. These damages can include compensatory damages and, in some cases, punitive damages.

Compensatory Damages

Compensatory damages aim to compensate the plaintiff for their losses. They may cover medical expenses, lost wages, physical pain and suffering, emotional distress, and other economic and non-economic losses resulting from the lack of informed consent.

Punitive Damages

In some cases, punitive damages may be awarded to punish the healthcare provider for their reckless or intentionally harmful actions. However, punitive damages are typically only awarded in cases involving extreme misconduct in a medical practice.

Call Chicago Medical Malpractice Lawyers at Curcio Law Offices Today

If you believe that you or a loved one has suffered harm due to a lack of informed consent or any other form of medical malpractice, our experienced Chicago medical malpractice lawyers at Curcio Law Offices are here to help. We understand the importance of obtaining informed consent, prioritizing patient autonomy, and upholding medical ethics.

Our legal team is committed to advocating for your legal rights and seeking justice on your behalf. We have a proven track record of representing clients in medical malpractice cases, with more than $40,000,000 recovered in combined settlement amounts. Our Chicago medical malpractice attorneys will tirelessly work to ensure you receive the compensation you deserve for your injuries and losses. Call 312-321-1111 to schedule a free consultation at Curcio Law Offices today.

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