The policy of obtaining informed consent from a patient is based on the principle of ethics. The rationale is that all medical patients should both understand, and agree to, the type of medical care that they will be receiving. It simply is not ethical for a patient to agree to treatment that could greatly impact their health without being provided all known and pertinent information from which to base their decision.
Informed consent involves an agreement, between a patient and treating physician, whereby the patient allows their treating physician to undertake specific treatment.
There are two important parts to informed consent:
- A patient has the right to decide what happens to his or her body. A doctor may have an opinion about what the patient should choose to do but the decision belongs to the patient and the patient alone. A doctor is not permitted to pressure any patient into a decision as the decision must be voluntary and free from duress.
- A medical professional has a duty to provide the patient with enough information to make a decision that is educated in regards to whether or not they want to follow the medical professional's recommendation for treatment.
To make the best decision possible for their health, patients must trust their medical professionals to provide them with the most up-to-date and relevant information possible. To aid the process, it may comfort patients to know that there are certain items that medical professionals are required to discuss with their patients prior to commencing a treatment plan or procedure.
The History of Informed Consent
Informed consent laws first began at the beginning of the 20th century when the Supreme Court heard a case where a doctor admitted to deceiving his patient in order to convince her to have an operation. The Supreme Court decided that American citizens have a right to knowledge and consent prior to undergoing a medical procedure.
Schloendorff v. The Society of the New York Hospital (105 N.E. 92) 1914, involved a doctor who removed a tumor when the patient had only consented to a diagnostic procedure. The court determined that every human being of adult years and sound mind has a right to determine what shall be done with their own body and that a surgeon who performs an operation without their patient's consent is guilty of committing an assault on the patient.
In the 1950s, medical patients acquired the right to be told of the possible positive and negative effects of the treatment their medical professional was recommending.
In 1972, the 1950s law took a larger step forward as medical professionals were required to specifically disclose the risks pertaining to a treatment or procedure in a way the patient could understand. In other words, the medical professionals were required to speak in “layman's terms.”
Today, if informed consent is not obtained from a patient by a medical professional, the medical professional is at risk of not only civil litigation, but criminal as well. Performing treatment on an uninformed, unwilling person is no different from attacking a person and committing battery. The legal term for a harmful or offensive touching without permission is battery. Battery is a criminal offense, and it can also be the basis of a civil lawsuit. The key element of battery is that the touching is unauthorized, not that it be intended to harm the person. Therefore, forcing a procedure on an uninformed, unwilling patient could constitute the criminal offense of battery.
What Must be Disclosed?
The case of Canterbury v. Spence, 409 U.S. 1064 93 S. Ct. 560 34 L. Ed. 2d 518 1972 U.S., found that when it comes to informed consent, a physician must disclose:
(1) The condition being treated;
(2) The nature and character of the proposed treatment or surgical procedure;
(3) The anticipated results from the proposed treatment or surgical procedure;
(4) The recognized possible alternative forms of treatment; and
(5) The recognized serious possible risks, complications, and anticipated benefits involved in the treatment or surgical procedure, as well as the recognized possible alternative forms of treatment, including non-treatment.
Who is Obligated to Disclose?
The obligation to disclose falls on the patient's treating physician. Other medical staff that may have come into contact with the patient – nurses, assistants, referring physicians – do not have a duty to disclose because they are not the ones that will actually either be performing the procedure or administering the treatment.
Since informed consent is considered to be the process of communication between the treating physician and the patient, the conversation needs to be held between the two as well as anyone that would be considered to be the treating physician at any time. The court in Perna v Pirozz, 92 N.J. 446,457 A.2d 431, New Jersey, 1983, found that if the patient agrees to a surgery with one physician, another physician is not able to substitute into the exact same procedure without the patient's consent. Therefore, if the originally approved physician does not perform the surgery but the surgery takes place regardless, the original physician is subject to malpractice if consent was not previously obtained from the physician.
The court in Canterbury established what a medical professional must discuss with a patient. However, a physician may sometimes find it difficult to ascertain how much information is needed to be disclosed before a patient can be able to give their informed consent. To help with this, courts have adopted different standards by which a medical professional may be required to follow:
- Reasonable Physician Standard
- Reasonable Patient Standard
- Subjective Standard
The Reasonable Physician Standard is a standard of disclosure of information used in the wording of informed consent documents, based on customary practice or what a reasonable practitioner in the medical community would disclose under the same/similar circumstances.
The Reasonable Patient Standard is a standard by which the medical professional must provide information from the viewpoint of the patient.
The Subjective Standard focuses on the patient's specific ailments and what information that particular patient would need to know in order to make an informed decision regarding treatment.
The physician has the responsibility to make certain that the patient has understood the information that has been disclosed. This may be done both verbally and in writing. When the physician takes the time to discuss the recommended course of action in regards to the patient's treatment, it is usually best to discuss the risks, benefits and alternatives in a conversational format. This usually helps the patient feel relaxed and places them in a state that is more conducive to understanding. After the conversation is had, the treating physician may want to provide the patient with written versions of what was discussed. This allows the patient to review the discussed information as many times as they wish before coming to a decision on whether they would like to proceed with, or refuse, the recommended treatment.
However, it is possible that the patient is not capable of consenting to treatment due to a lack of capacity.
A person must be assumed to have capacity unless it is established that they lack capacity. For informed consent to be properly obtained, the patient must be considered to be medically competent, and obtain the requisite capacity, to be able to give consent in a way that they understand the procedure being performed; appreciate the reason for the proposed procedure; and are aware of the risks of the procedure and the expected outcome.
In some instances, a physician may disclose all the material that is possible to cover, but the patient may lack the requisite capacity to give informed consent to treatment. A lack of capacity may exist for many reasons, including: unconsciousness; mental health conditions; learning disabilities; brain damage and intoxication by way of alcohol or drug use.
The rules to consent are nuanced. Adults deemed to obtain the requisite capacity have the right to refuse a recommended treatment or procedure, even if the refusal is counterproductive to their own health.
If it has been determined that the patient is unable to make an informed decision regarding treatment due to a lack of capacity, the treating physician should make all subsequent medical decisions with the patient's best interest in mind. Best interests include what the patient's wishes would be if they were competent; the patient's general well-being; and the patient's religious beliefs.
If the patient is deemed incapable of being able to properly give consent, the physician should make a strong attempt to gain consent from another person on behalf of the patient before proceeding with treatment if at all possible. If an agent was not previously appointed or a conservator has not been put in place by the patient or the patient's family, the physician should try to bring in a surrogate for the purposes of making health care decisions on behalf of the patient. This person should know about the patient's condition; be actively involved in the patient's life; be willing and able to make the decision in an informed manner; and have no conflict of interest with the patient. Examples of such a person include; the patient's spouse; the patient's parent or guardian; the patient's sibling; or a relative of the patient.
If the patient is in need of medical help and the situation is an emergency, the physician is generally excused from needing to obtain informed consent from the patient or a family member since it is likely that any delay would be detrimental to the health of the patient.
How to Consent
While it is the treating physician that must disclose the requisite information to the patient, Natanson v. Kline, 350 P2d 1093, Kansas, 1960 found that it is the patient, and no one else, that must make the final decision as to whether or not they would like to go forward with the plan that the treating physician has put forth. “A man is the master of his own body and he may expressively prohibit the performance of life-saving surgery or other treatment."
When it comes to a patient giving their informed consent to a proposed treatment or procedure, there are two ways in which the consent may be conveyed – expressly or impliedly.
Express consent is considered to be specific permission that is given by one person to another person.
Another way of giving consent is through an act that demonstrates implied consent. Implied consent is an assumption of permission, not specific permission that is inferred from the actions of a person.
Regardless of whether the consent provided by the patient was given expressly or impliedly, for the consent to be considered valid, it must have been be obtained from a competent patient who understood the procedure to be performed, as well as the associated risks, benefits, complications, and possible alternatives. The consent must have been given under the patient's own volition and not as a result of threat or duress.
Informed Consent Exceptions
While healthcare treatments usually require consent from the patient, there are a few exceptions to the rule.
- Lack of consciousness
- Where an attempt is made to prevent the patient from suffering or continuing to suffer significant pain or a decline in health
- Where time is of the essence in order to save the patient's life
- Where wasting time would cause serious damage to the patient's health
- Treatments authorized by law
- Patients under 18 years of age
The court in Barnett v. Bacharach where the court held that in an emergency situation where the patient lies unconscious, a surgeon may carry out the duties of a doctor in the best interest of the patient even if those duties include performing a procedure that was never discussed with the patient. The court felt that ruling otherwise would make all physicians more concerned about potential litigation rather than saving lives.
Can Consent be Limited or Withdrawn?
It is never too late for a patient to change their mind about a procedure or treatment (unless a surgery was consented to and the procedure has already been completed). A patient can legally change their mind at any time, even if they have already started treatment. Most consent forms state that a patient has the right to stop treatment even after signing the consent form. If the patient has changed their mind, they must contact the treating physician as soon as possible.
If a patient wishes to withdraw their consent, they may do so orally or in writing. The withdrawal does not need to have a reason behind it. The only requirement is that the patient is of sound mind when making the withdrawal request.
After receiving the withdrawal request, the treating physician will likely confirm that that the patient embodies the requisite capacity to make such a withdrawal decision. Additionally, the treating physician will likely attempt to confirm that the patient understands the risks associated with the withdrawal. Finally, the treating physician will likely make sure that the patient's decision to withdraw their consent to treatment is documented in the patient's clinical records. The patient will then likely be asked to sign the updated clinical record to reflect accuracy.
Informed consent exists to protect the patient and their rights. At no time should a patient feel trapped or compelled to follow a treatment plan that they may have agreed to at an earlier time. Consent is to be completely voluntary, free from pressure and duress and thus, a change of mind is always permitted.
Informed consent is one of the most important ethical elements of the medical profession. It preserves a patient's right to control what happens to their body while allowing physicians to do their jobs without constant worry over potential litigation.
Healthcare is collaborative and the true success comes from a physician and patient working in tandem to find the best plan that puts the patient in the best position to restore their health.
Competence and voluntariness are the keys that drive a patient's informed decision regarding treatment. It is vital that patients are given all of the information they need in order to choose what is right for them. If a patient rejects a physician's treatment plan, that is their choice. A physician may advise a patient on what they think is the best course of action but they may not mandate or enforce.
A patient is free to change their mind at any point regarding treatment to which they may have previously consented. It is rare that a patient is well versed in treatment plans and the process may initially appear both daunting and overwhelming. This feeling can create a sense of panic in a patient, causing a scenario where a patient may initially agree to a procedure only to later regret that decision once they have calmed down and are in better position to make an informed decision. The converse is also true in that a patient is free to initially decline a physician's treatment plan, only to later reconsider and agree to go forward with the recommendation. In this case, as long as the patient's health has not reached a stage where the treatment is no longer applicable, there should be no reason why the plan may not continue as originally prescribed.