Where there is risk, there must be choice.

Informed Consent.


Informed consent has been described by experts in several different ways, but consistently contains three common elements:

disclosure, capacity and voluntariness.

 
unsplash-image-AhAGyHoYqB0.jpg

Disclosure.

Disclosure requires a full, clear statement of the risks and benefits

unsplash-image-1kslaBtXBk8.jpg

Capacity.

Capacity requires an ability to understand the choice and make a decision..

unsplash-image-9cd8qOgeNIY.jpg

Voluntariness.

Voluntariness requires the absence of coercion or duress.

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- 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.