Informed Consent

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Informed consent is the act of agreeing to allow something to happen, or to do something, with a full understanding of all the relevant facts, including risks, and available alternatives. That full knowledge and understanding is the necessary factor in whether an individual can give informed consent. This type of consent applies to many situations in life, including making decisions about medical care and legal issues, as well as entering into contracts. To explore this concept, consider the following informed consent definition.

Definition of Informed Consent

Noun

  1. Consent given only after having been informed of the facts, benefits, risks, and alternatives.

Origin

1965-1970       U.S. Medical-Legal Concept

What is Informed Consent

The law recognizes that a person can only legally consent to something, whether that is to allow something to occur, or to perform some act, if that person has been informed of, and understands the facts of the situation. It is only with a full comprehension of the risks and benefits of the decision, as well as an understanding of the possible alternatives, that any individual can consider whether an action would be in his best interests.

The obtaining of informed consent is especially important in the medical field, as failing to receive such approval leaves medical professionals liable for injuries that may occur. Informed consent is also vital when entering a contract, as if one party is not fully informed, or if all information has not been disclosed, that uninformed party may be able to back out of the contract.

Informed Medical Consent

In a doctor’s office, hospital, or other medical setting, healthcare providers are required to obtain informed medical consent before treating a patient. In general, informed medical consent means advising the patient of reasons the treatment is needed, the benefits of having it done, the risks of harm that may occur, and any alternative treatments that may be considered.

There are legal requirements for obtaining informed medical consent, as well as its documentation, though they vary from state to state. Typically, the information presented to the patient or legal guardian must be fully understood. The patient and medical professional share this responsibility, since the doctor does not automatically know what the patient does and does not understand. Informed medical consent must be given willingly, as it is not valid if obtained under pressure or duress.

In most states, it is the responsibility of the physician treating a patient to confirm that informed consent has been obtained. When discussing the course of treatment, the physician should disclose:

  • The patient’s diagnosis
  • The nature and reason for the treatment or procedure
  • The benefits of the procedure or treatment
  • The risks of the procedure or treatment
  • The alternative treatments available
  • The risks and benefits of forgoing the proposed treatment or procedure

The patient, or legal guardian, must sign and date the informed consent documents, and be given a copy. There are, of course, certain situation in which it is not required of healthcare professionals to obtain consent before acting. These are considered emergency situations in which the patient’s health or safety may be at risk if treatment is delayed because consent cannot be obtained.

Such a situation occurs if the patient is unconscious or otherwise unable to understand or acknowledge consent. It also applies to seriously ill or injured minor patients whose parents or legal guardian cannot be reached beforehand. Even in emergency situations, medical personnel are generally allowed only to provide the level of treatment that is necessary to alleviate the worst of the problem, until proper consent can be obtained.

Risks of Treatment that Must Be Disclosed

When obtaining informed consent, doctors do not have to inform the patient of each and every possible risk, but he must advise of the important risks. In most states one of two is used to determine just what risks are required to be disclosed.

  1. Would other doctors disclose that risk? If a medical case becomes the subject of a civil lawsuit, this issue would boil down to whether the undisclosed risk was statistically important enough to be disclosed, and whether it is commonly disclosed by other doctors in similar circumstances. This question would be answered by expert witnesses for each party, who are asked in court whether they would have personally informed a patient of the risk in question.
  2. Would another reasonable patient have made a different decision if informed of that particular risk? This question could only be compared to a patient with the same medical condition and medical history as the plaintiff, asking whether he would have made a different choice regarding the treatment if he had been advised of that particular risk.

Informed HIPAA Consent

The Health Insurance Portability and Accountability Act of 1996, widely known as “HIPAA,” establishes certain standards in the healthcare industry. HIPAA protects workers’ health insurance benefits when they lose or change their jobs, and places restrictions on how information can be shared with researchers conducting studies.

Among laypeople, HIPAA is most known for its privacy restrictions on patients’ protected health information (“PIH”). All healthcare providers, and other entities that use the personal information of patients, are required to obtain a signed HIPAA consent form before they are allowed to release or share any patient’s information. The actual type of information protected includes the status of the patient’s health, any information related to the provision of healthcare, and even payment information that can be linked to an individual.

The HIPAA privacy rule bars providers from sharing any information regarding individual patients to research studies without first obtaining a signed consent form from the patient. To properly obtain informed HIPAA consent, the form must advise the patient how their health and other personal information will be used, and how it will be kept private. Individuals who believe their personal information has been improperly handled can file a complaint with the U.S. Department of Health and Human Services.

HIPAA privacy regulations also define conditions when health plan providers are permitted to disclose protected health information of a patient. For example, if certain information is vital to public safety, such as certain communicable diseases, the provider must disclose a patient’s status to the U.S. Department of Health and Human Services. According to HIPAA privacy regulations, a valid consent form must contain the following specific elements:

  • It must be written in plain language that any reasonable patient can understand
  • It must inform the patient that his information may be used for treatment, payment, or future care
  • It must inform the patient of his right to review the form before signing
  • It must indicate the patient’s right to request restrictions on release of his health information
  • It must inform the patient he has a right to revoke the consent in writing, but that actions taken prior to the signing are not subject to revocation
  • It must include the patient’s signature and date
  • The original signed form must be kept by the provider for a minimum of six years

Informed Financial Consent

While the U.S. does not have specific laws requiring informed financial consent, as many other nations have, every person has the right and responsibility to ask questions about how transactions, services, and even healthcare will affect their bank account. In the case of making a purchase, or entering into a contract, the person has the right to ask questions about the total amount he will be required to pay, including any interest or other fees. It is highly recommended that a written receipt be obtained for every transaction.

As it applies to medical care, informed financial consent involves asking questions about costs for services provided beforehand, when possible. In the U.S., hospitals and other medical providers are required to send detailed bills after the care has been provided. As a patient, however, questions about potential costs of tests, treatments, medications, supplies, and other expenses can and should be asked.

Because it is not required that healthcare providers obtained “informed financial consent” before ordering expensive tests, medications, and other treatment options, the patient himself is the last line of defense, so to speak, when it comes to keeping his costs down. This is especially important if the patient is uninsured.

Another issue to be aware of is whether more than one doctor will be involved in treatment. If so, the patient will receive bills from several sources, such as each of the doctors’ billing services, imaging (x-rays, CT scans, etc.), laboratory, and other departments.

Informed Consent Form

An informed consent form is used to protect doctors and other professionals from being held liable in the event something goes wrong. Each facility or entity may design its own forms, though there are certain elements that should be included in the forms to ensure its effectiveness should it be referred to later. Consent forms are used by a variety of industries, though they are most commonly and widely used in the medical field. An informed consent form for medical use is generally more detailed and specific than forms for other purposes.

A well-made informed consent form clearly outlines the service or treatment to be performed, as well as the risks and benefits involved. The language should be clear and easy to understand, and the form should be printed on plain paper in a font that is comfortable to read. The provider of the service or treatment should be clearly identified on the form, including contact information, and the client or patient’s name should be clearly printed.

It is important to provide enough room for the patient to fill in any information required, such as address and phone number, and the signature and date blocks should be clearly labeled. While some providers use the same informed consent form for adults and children alike, it is a good idea to provide a separate consent form for children, in which the parent or guardian is informed of the required information, and the signature and date block allows the person signing the form to clearly state his or her relation to the child.

Examples of Informed Consent Problems

Informed consent is not just another form a patient or client needs to sign so the provider can get on with his job. Unfortunately, in a world that relies on pages and pages of information, many of which require a signature or acknowledgement, this has become a serious issue. The fault lies, not only with the providers, but with the patients and clients who are unwilling to wade through a complicated, and lengthy, document that they are unlikely to understand, before signing and moving forward.

The following are examples of informed consent problems that commonly occur. When it comes to providers’ responsibilities in obtaining informed consent, there are certain thinks to keep in mind.

  • Method of Disclosing Risks – the most likely risks, including the most severe risks, such as death, or brain damage, should be specifically disclosed, though a lengthy description of how this might occur is not necessary. When providers skip through the risks, without encouraging a discussion about the procedure and the risks, the patient or client cannot truly give informed consent.
  • Skipping the Details – a surprisingly large number of doctors and other professionals are too casual about the details of properly obtaining informed consent. Many fail to explain the risks with a healthcare professional present as a witness, or to have the patient and/or witness sign and date the necessary consent forms. Doctors are also cavalier about signing the consent documents as the treating physician, or fail to fully complete the patient’s information.
  • Asking a Sedated Patient to Give Consent – it is not uncommon for patients to be given a mild sedative, or a narcotic pain reliever to make them more comfortable while arrangements are made for further treatment, such as surgery, or admission to the hospital. This makes the patient legally incapable of giving informed consent, so consent forms should be signed prior to such sedation, or they should be signed by the patient’s nearest relative, such as his spouse or parent. In this case, the name and relationship should be clearly documented.
  • Obtaining Consent for Only One Procedure, When a Second Procedure May be Needed – if informed consent is obtained for a procedure or surgery which may bring about additional information that makes it necessary to do an additional procedure, the second procedure cannot be performed without consent.

For example:

Emily has been having sever abdominal pain and bleeding, and her OB/GYN has determined that she has fibroid tumors that must be removed. As she is being prepared for the surgery, the staff has her sign a consent form for the fibroid removal, but there is no mention on the form of a hysterectomy. If, while the surgeon is operating, he determines that a hysterectomy is necessary, he has no consent for the procedure.

Doing the procedure without explicit consent exposes the doctor, and the hospital, to serious liability if something goes wrong, or if Emily is upset because she may have chosen an alternative treatment. If he decides not to proceed with the surgery, with the though of rescheduling a hysterectomy, Emily is exposed to the additional risks of another major surgery.

This example of informed consent could have been made legal had the doctor discussed the possibility of needing to do a hysterectomy with Emily, as well as the potential risks and alternatives beforehand. Both procedures could have been included on the consent form for Emily’s signature.

Malpractice Lawsuit Over Failure to Obtain Informed Consent

In 1964, Ralph Cobbs was treated by his family doctor, Jerome Sands, for an ulcer. Even with treatment, his symptoms worsened to the point that Dr. Sands deemed it necessary to perform surgery, a decision which was confirmed by another doctor. Dr. Sands advised Cobbs of the general risks of undergoing general anesthesia for surgery, and what would be done in the surgery, though he failed to mention risks of the surgery itself. A two-hour surgery repaired the ulcer, though after Cobbs had been discharged eight days later, he again began having severe abdominal pain.

Cobbs returned to the hospital and went into shock, requiring emergency surgery. He was experiencing bleeding caused by an artery near his spleen that had been severed, and the spleen had to be removed. There were further complications, including the too-rapid absorption of an internal suture, and other issues. About a month later, Cobbs experienced another gastric ulcer, so doctors operated and removed half of is stomach.

Cobbs filed a medical malpractice lawsuit against the surgeon as well as the hospital, claiming that the surgeon failed to inform him of the serious risks involved in the surgery on his stomach. Cobbs claimed that, had he known of those risks and potential alternative treatments, he may had made a different choice. At trial, the jury ruled in favor of Cobbs, awarding him over $68,000 in damages between the hospital and doctor.

The defendants appealed the trial court’s decision on the issues of (1) the jury’s disregard of expert testimony in determining the doctor’s actions to be negligent, and (2) whether the jury had been properly instructed on the doctor’s duty to properly obtain informed consent. The appellate court reversed the judgment of the trial court, remanding the case to the trial court for a new trial. The appellate court specifically suggested principles for creating guidelines in determining the issue of informed consent.

Related Legal Terms and Issues

  • Civil Lawsuit – A lawsuit brought about in court when one person claims to have suffered a loss due to the actions of another person.
  • Damages – A monetary award in compensation for a financial loss, loss of or damage to personal or real property, or an injury.
  • Defendant – A party against whom a lawsuit has been filed in civil court, or who has been accused of, or charged with, a crime or offense.
  • Liable – Responsible by law; to be held legally answerable for an act or omission.
  • Medical Malpractice – Any unskilled, improper, or negligent treatment of a patient, or failure to provide appropriate treatment, by a healthcare professional, which results in injury to the patient.
  • Plaintiff – A person who brings a legal action against another person or entity, such as in a civil lawsuit, or criminal proceedings.