Informed consent is a legal document in all 50 states. It is an agreement for a proposed medical treatment or non-treatment, or for a proposed invasive procedure. It requires physicians to disclose the benefits, risks, and alternatives to the proposed treatment, non-treatment, or procedure. It is the method by which fully informed, rational persons may be involved in choices about their health care.
Informed consent stems from the legal and ethical right an individual has to decide what is done to his or her body, and from the physician's ethical duty to make sure that individuals are involved in decisions about their own health care. The process of securing informed consent has three phases, all of which involve information exchange between doctor and patient and are part of patient education. First, in words an individual can understand, the physician must convey the details of a planned procedure or treatment, its potential benefits and serious risks, and any feasible alternatives. The patient should be presented with information on the most likely outcomes of the treatment. Second, the physician must evaluate whether or not the person has understood what has been said, must ascertain that the risks have been accepted, and that the patient is giving consent to proceed with the procedure or treatment with full knowledge and forethought. Finally, the individual must sign the consent form, which documents in generic format the major points of consideration. The only exception to this is securing informed consent during extreme emergencies.
It is critical that a patient receive enough information on which to base informed consent, and that the consent is wholly voluntary and has not been forced in any way. It is the responsibility of the physician who discusses the particulars with the patient to detail the conversation in the medical record. A physician may, at his or her discretion, appoint another member of the health care team to obtain the patient's signature on the consent form, with the assurance that the physician has satisfied the requirements of informed consent.
The law requires that a reasonable physician/patient standard be applied when determining how much information is considered adequate when discussing a procedure or treatment with the patient. There are three approaches to making this discussion: what the typical physician would say about the intervention (the reasonable physician standard); what an average patient would need to know to be an informed participant in the decision (the reasonable patient standard); and what a patient would need to know and understand to make a decision that is informed (the subjective standard).
There is a theory that the practice of acquiring informed consent is rooted in the post-World War II Nuremberg Trials. At the war crimes tribunal in 1949, 10 standards were put forth regarding physicians' requirements for experimentation on human subjects. This established a new standard of ethical medical behavior for the post-WW II human rights age, and the concept of voluntary informed consent was established. A number of rules accompanied voluntary informed consent. It could only be requested for experimentation for the gain of society, for the potential acquisition of knowledge of the pathology of disease, and for studies performed that avoided physical and mental suffering to the fullest extent possible.
Today, all of the 50 United States have legislation that delineates the required standards for informed consent. For example, the State of Washington employs the second approach outlined as the reasonable patient standard (what an average patient would need to know to be an informed participant in the decision). This approach ensures that a doctor fulfills all professional responsibilities and provides the best care possible and that patients have choices in decisions about their health care. However, the patient's competence in making a decision is considered. This points to the issue of the patient's mental capacity. Anyone suffering from an illness, anticipating surgery, or undergoing treatment for a disease is under a great deal of stress and anxiety. It may be natural for a patient to be confused or indecisive. When the attending physician has serious doubts about the patient's understanding of the intervention and its risks, the patient may be referred for a psychiatric consultation. This is strictly a precaution to ensure that the patient understands what has been explained; declining to be treated or operated on does not necessarily mean the person is incompetent. It could mean that the person is exercising the right to make his or her own health care decisions.
Although the law requires a formal presentation of the procedure or treatment to the patient, physicians do express doubt as to the wisdom of this. Some believe that informing patients of the risks of treatment might scare them into refusing it, even when the risks of non-treatment are even greater. But patients might have a different view. Without the complete story, for example, a patient might consent to beginning a particular course of chemotherapy. Convinced by the pressures from a pharmaceutical company, it is conceivable that a doctor will use an agent less effective than a newer treatment. By withholding information about treatment alternatives, the physician may be denying the patient a choice and, worse, perhaps a chance of an extended life of greater quality.
Undeniably, physicians in surgery, anesthesia, oncology, infectious disease, and other specialties are faced with issues regarding informed consent. As the federal government takes a more active role in deciding the extent to which patients must be informed of treatments, procedures, and clinical trials in which they voluntarily become enrolled, more and more health care providers must become educated in what must be conveyed to patients. This is emphasized by the report of a case in which a federal court (Hutchinson vs. United States [91 F2d 560 (9th Cir. 1990)]) ruled in favor of the physician, despite his failure to advise his asthmatic patient, for whom he had prescribed the steroid, prednisone, of the drug's well-known risk of developing aseptic necrosis (bone death), which did occur. The practitioner neglected to inform the patient that there were other drugs available with much less serious side effects that could have treated the asthma. However, a higher appellate court reversed the ruling and found the physician guilty. Apparently, the patient had used more conservative drugs in the past with good results. The court believed that if the physician had merely advised the patient of the more serious side effects of prednisone and offered the patient more conservative treatment, the physician would have avoided liability.
Nursing professionals have a greater role than they might believe in evaluating whether or not consent is informed. When a nurse witnesses the signature of a patient for a procedure, or surgery, he or she is not responsible for providing the details. Rather, the role is to be the patient's advocate, to protect the patient's dignity, to identify any fears, and to determine the patient's degree of comprehension and approval of care to be received. Each patient is an individual, and each one will have a different and unique response depending on his or her personality, level of education, emotions, and cognitive status. If a patient can restate the information that has been imparted, then that will help to confirm that he or she has received enough information and has understood it. The nurse is obligated to report any doubts about the patient's understanding regarding what has been said or any concerns about his or her capacity to make decisions.
The result of informed consent is greater safety and protection for patients, physicians, and society.
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L. Fleming Fallon Jr., MD,DrPH