INFORMED CONSENT MEDICAL TREATMENT
Category: Internal Medicine
Abstract : Informed consent Definition 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 b
Informed consent
Definition
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.
Description
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.
Results
The result of informed consent is greater safety
and protection for patients, physicians, and society. See also Do not
resuscitate order; Patient confidentiality; Patient rights.
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