Overview

Have you signed an informed consent form before your surgery? Are you injured due to your physician’s negligence? Are you worried about how it is going to affect your litigation? Never worry. This blog tries to discuss what informed consent is and how it can influence your claim suits.

FDA has regulated requirements and guidelines for an informed consent form, which is an essential component in the course of action followed in medical examination. According to FDA, getting the informed consent signed from the subject is only a part of the process. It involves many other components. Let’s explore them here.

It is the responsibility of healthcare providers to inform their patients about the risks and benefits of medical treatment and obtain their informed consent. If they fail to do so, the patient will not be aware of the procedure, the threat that prevails. Furthermore, failing to obtain informed consent makes the healthcare provider violate the duty of care.

The majority of medical malpractice lawsuits occur when the doctor fails to discuss the risk that follows. Through informed consent, a doctor gets an opportunity to let the patient know about the treatment course. The doctor cannot withhold any diagnosis from the patient. This cannot be done even at the request of the patient’s family. Therefore the doctor has to listen to the patient carefully to understand their feelings and wishes.

An informed consent form can restrict most of the unnecessary treatments without the assent of the patient. Thus, in a way it can reduce the number of medical malpractice lawsuits.

What is an informed consent form?

Informed consent is a two-way conversation between you and your health care provider. In the United States, informed consent is both an ethical and a legal requirement for medical practitioners.

Informed consent means that the patient agreed to the procedure after receiving important information about it. The physician must explain to the patient why the therapy is being performed. Here, you have the right to control what happens to your body. After getting all the information, you can give agreement or permission for care, treatment, or services.

Before undergoing treatment, it is the right of every patient to obtain information and ask questions about the therapy. A mentally capable person can make his own decisions for an informed consent form. The doctor cannot proceed with the medical treatment until an adult patient provides his consent.

Procedures where you need informed consent

NCBI stresses that every human being should know what clinical trial they will undergo and consent to the treatment. When the patients had to undergo the following procedures, they needed to give their consent.

  • Complicated procedures
  • Surgeries
  • Different types of blood transfusions
  • Vaccinations
  • Chemotherapies
  • Anesthesia
  • Other radiation therapies

Legal requirements in an informed consent form

The state determines the standard for required informed consent. The information given to the patient must be in a language that the subject or the representative understands. There are four legal requirements for informed consent.

Decision-making capacity

Capacity is the basis of informed consent. It means that if you are a patient, you should understand what is given in the form. Understanding what is stated in the form helps you be aware of the consequences of choosing each option. Further, you can communicate your wishes to your healthcare provider if you decide on your own.

Disclosure

In medical treatment, the doctor need not impart every detail of the test, treatment process, or procedure to the patient. But the doctor or health care provider must provide the patient with enough information. The information stated by the doctor should help the patient to make an informed decision. The victim only needs the details that a reasonable person would expect to make an intelligent decision. The information should include the risks, as well as the probability of each risk and the benefits. Therefore the doctor’s disclosure should provide you with a thorough understanding and answer to all your questions.

Documentation of consent

Before beginning any treatment, including screening procedures, the doctor or the healthcare provider should get informed consent from the patient or the guardian. To make it clear for the patient, the doctor should give the treatment followed, and the significant risk in the process in a written consent form. Both the doctor and the patient should sign with the date in the consent form. For children under the age of 18, the parent can take responsibility and sign the form. By signing, the parent is aware of all the information about the treatment of the child. The patient can also have the right to request a copy of the signed consent form from the doctor.

Competency

Competency is a legal term that describes a person’s ability to make decisions based on the information provided. Here, in an informed consent form, the person or the guardian who makes the decision should be accountable for the decision made. As a result of this perspective on competency, there should be no disparity between the patient’s understanding of the information, her preference, and her choice.

Goals of an informed consent form

Let’s try to understand the goal of an informed consent form. It will help you to know your rights before signing one.

  • It should give all information about the undergoing process to the subject.
  • It should answer all the questions of the subject before making a decision.
  • Ensure that the subject understands all of the information.
  • Obtain the subject’s informed, voluntary consent to participate.
  • Throughout the treatment, continue to inform the subject.
  • Continue to reaffirm the subject’s consent to participate throughout the process of therapy.

Informed consent law 

Informed consent law requires the disclosure of the doctor about the risks in the proposed medical procedure. Further, the doctor should also discuss the issues of the alternatives for patients to make informed decisions.

In the case of non-emergency treatment, if your doctor fails to get informed consent, he may face charges. It may be civil charges such as gross negligence or criminal charges such as battery which is the unauthorized touching of the patient. In a civil suit, the plaintiff should show two elements.

  • First, you must demonstrate that the treatment or procedure was performed without getting any informed consent.
  • Second, you must demonstrate that if you had known about the risks in the ongoing treatment, you would have chosen not to have it done and thus avoided the injury.

When is informed consent not necessary?

Don’t think that the physician should always get consent before providing the necessary care. There are certain situations in which the doctor does not need informed consent from the patient. They are:

  • In an emergency to save the patient’s life, the doctor can treat without the informed consent form.
  • Patients may arrive at the hospital unconscious and require immediate care. There may be no way to obtain consent from a spouse or family member. In this case, the law would generally allow a doctor to perform emergency surgery even without informed consent.
  • For routine medical treatment, there is an exception. If tests post no risk to patients, there is no need for informed consent.

Right to refuse treatment in informed consent law 

If you are a legally competent individual, you have the right to choose or reject the ongoing medical treatment. You may opt not to receive a recommended treatment for a variety of reasons. This can create dysfunction of organs in your body or even death. When you refuse a recommended treatment, it indicates that you and the doctor have different perspectives on the situation. You may be already aware of the risks and benefits of the treatment that you undergo. Therefore your wishes are respected when you decline the medication.

If you refuse treatment, you may be asked to sign an Against Medical Advice (AMA) form. Signing the form helps protect the health care provider from legal liability for not providing the disputed treatment. Refusing a test, medical treatment, or procedure does not always imply that you are refusing all medical care. Anyone who denies the recommended care should always be offered the other best treatment.

Can I pursue a lawsuit after signing an informed consent?

Informed consent forms show the risks associated with a medical procedure and may release your doctor from liability if he fails to provide complete information. You may believe that by signing a consent form, your doctor is completely vindicated of all liability.

If the procedure goes wrong and you are injured resulting from medical malpractice, you may be perplexed. Consent forms, however, do not entirely absolve doctors from liability. If you are injured due to medical malpractice, you may be able to file a claim even if you signed a consent form before the procedure.

Based on the terms of the consent form, the doctor and hospital may be released from the type of liability. Signing a consent form does not absolve other types of medical negligence such as misdiagnosis, medication errors, surgical errors, and anesthesia mistakes.

To establish a medical malpractice case, you must demonstrate that your doctor or another medical professional was careless and violated their duty of care while treating you. Essentially, this entails that the doctor did not do everything possible to treat your condition, resulting in injury.

Even if you have signed a consent form acknowledging that you are aware of the risks of a procedure, a doctor can breach their duty of care by failing to provide appropriate treatment or being negligent. You may be able to file a medical malpractice claim in the following circumstances.

  • The informed consent form is meaningless in the case of negligence. The negligence of the doctor or the hospital in taking care of the patient can result in suffering. You can still file a medical malpractice claim against your doctor or hospital in this case, even if your complication was correctly listed on your informed consent form.
  • You may be able to file a malpractice claim if the complication in the medical treatment is not enumerated as a risk of your medical procedure.
  • If your doctor has made a different decision than what you have chosen and results in injuries, you may be able to pursue a medical malpractice

Pros of an informed consent form

  • It ensures that patients understand the risks associated with treatment.
  • The patient is aware of the risks, and by agreeing, the doctors can take specific life-saving measures if necessary.
  • Informed consent fosters trust between doctor and patient by ensuring thorough comprehension.
  • It also lowers the risk for both the patient and the doctor. When the doctor clearly explains the risks and options, the patients can make the best decision for themselves. This reduces the risk, and there is less chance for a doctor to face legal action.

Cons of an informed consent form

  • Many people sign the consent form without understanding the risk it poses. It leads to misunderstanding and results in withdrawal of the process at later stages of the ongoing treatment.
  • When children under the age of 18 are involved in treatment, parental consent must be obtained. If the child is over the age of seven, the child’s approval is also required. Difficulties arise when the parent consents but the child refuses to assent.

Final Thoughts

We put a lot of faith in the healthcare professionals who give us medication, treat us, or perform complex procedures on us. This trust makes us sign informed consent without much worry.

In medical therapy, a doctor needs to give the patient all the information about the procedure. Clear documentation of the process and the course of action will provide thorough knowledge to the patient. An informed consent form will provide you with enough information. Do not be in a hurry to sign the document. Get a clear understanding of what is being said. Consider whether the treatment is necessary. Then sign the form to indicate your agreement.

A health care provider’s negligence and medical error can trigger harm. Furthermore, you may be subjected to different treatment without your knowledge. Touching a patient without their consent may subject the doctor to a civil or criminal battery charge. Even if you sign an informed consent form, you can still file a lawsuit in these cases. An efficient medical malpractice lawyer can assist you in obtaining compensation.