Home > Encyclopedia of Nursing & Allied Health > Informed Consent

Definition

Informed consent is a legal document in all 50 states, prepared as an agreement for treatment, nontreatment, or for an invasive procedure that requires physicians to disclose the benefits, risks, and alternatives to said treatment, nontreatment, or procedure. It is the method by which a fully informed, rational patient may be involved in choices about his or her health care.

Description

Informed consent stems from the legal and ethical right the patient has to decide what is done to his or her body, and from the physician's ethical duty to make sure that the patient is involved in decisions about his or her 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 the patient 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 patient 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 the 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 patient's 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.

Paul H. Ting, M.D., Assistant Professor of Anesthesiology at the University of Virginia and editor of the "About Anesthesiology" web site discusses why patients are apprehensive. "I think that people's greatest concerns are…whether they will live or die…whether they will feel any pain or be uncomfortable…whether they will be well taken care of (and I include in this whether their care will lead to a successful result and whether they will be treated with dignity)….

"The boilerplate consent form has good intentions; it is comprehensive and therefore should reflect that a comprehensive discussion was completed," said Dr. Ting. "The actual form itself is in place to protect the hospital and the physician. Legally, it is proof that things have been covered and the patient agrees to the procedure, risks, benefits, options, etc. However, the informed consent process (which the form merely is supposed to document) is in place for the protection of the patient. The process is in place to make sure that everything is discussed with the patient—all of the options, all of the common risks, the worst thing that can happen, etc."

The law requires that a reasonable physician 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 the average patient would need to know to be an informed participant in the decision (the reasonable patient standard); and what the patient would need to know/understand to make a decision that is informed (subjective standard).

Viewpoints

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.

As of 2001, most of the 50 United States had legislation that spells out the required standards for informed consent. For example, the State of Washington employs the second approach outlined as the reasonable patient standard. This ensures that the doctor fulfills all professional responsibilities and provides the best care possible and that the patient has a choice in decisions about his or her health care. However, the patient's competence in making a decision is considered. This points to the issue of the patient's "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 it is the law to formally present the procedure or treatment to the patient, physicians do express doubt as to its wisdom. Some believe that informing patients of the risks of treatment might scare them into refusing it 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 a chance of an extended life of greater quality.

The international community has also had much to say in this regard. Martin Tattersall, professor at the Sydney University Cancer Medicine Department, and Alan Langslands, professor in Radiation Oncology at Westmead, said in the August 1995 issue of the Medical Journal of Australia, "Our findings indicate the extent of variation in the practice of providing information to cancer patients commencing treatment…. The current double standard between former clinical trials (where ethics committees require that patients be given a 'plain language statement,' as well as giving their signed consent) and the 'usual' practice outside such trials, is apparently narrowing. The reasons for this may relate to the fear of litigation, rather than recognition of the need to provide full information." A litigious society such as the United States might be plagued by an even greater number of lawsuits than at present if informed consent were not legally mandated.

Professional implications

Undeniably, physicians in surgery, anesthesia, oncology, infectious disease—the list is endless—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 needs to 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 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 a much less serious side effect profile that could have treated the asthma. However, and despite this "neglect," 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 in evaluating whether the consent is informed or not than they might believe. When a nurse witnesses the signature of a patient for a procedure, or surgery, he or she is not responsible for providing its details. Rather, the role is to be the patient's advocate; to protect the patient's dignity; identify any fears; and determine his or her 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 the patient can restate the information that has been imparted to him or her, 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.

Randi B. Jenkins