What is
informed consent?
Informed consent is the process by which fully
informed patients can participate in choices
about their healthcare. It originates from the legal and ethical
right the patient has to direct what happens to her body and
from the ethical duty of the physician to involve the patient
in her health care.
What are the elements of full informed consent?
The most important goal of informed consent
is that patients have an opportunity to be
an informed participant in his health care decisions. It is
generally accepted that complete informed consent
includes a discussion of the following elements:
- the
nature of the decision/procedure
- reasonable alternatives
to the proposed intervention
- the relevant risks, benefits,
and uncertainties related to each alternative
- assessment
of patient understanding
- the acceptance of the intervention
by the patient
In order for the patient's consent to be valid, he must be
considered competent to make the decision at hand and his
consent must be voluntary. It is easy for coercive situations
to arise in medicine. Patients often feel
powerless and vulnerable. To encourage voluntariness, the
physician can make clear to the patient that he is participating
in a decision, not merely signing a form. With this understanding,
the informed consent process should be seen
as an invitation to him to participate in his health care
decisions. The physician is also generally obligated to provide
a recommendation and share her reasoning process with the
patient. Comprehension on the part of the patient is equally
as important as the information provided. Consequently, the
discussion should be carried on in layperson's terms and the
patient's understanding should be assessed along the way.
Basic consent entails letting the patient know what you would
like to do and asking them if that will be all right. Basic
consent is appropriate, for example, when drawing blood. Decisions
that merit this sort of basic informed consent
process require a low-level of patient involvement because
there is a high-level of community consensus.
How much information is considered "adequate"?
How do you know when you have said enough about a certain
decision? Most of the literature and law in this area suggest
one of three approaches:
- reasonable physician standard: what would
a typical physician say about this intervention? This standard
allows the physician to determine what information is appropriate
to disclose. However, it is probably not enough, since most
research in this area shows that the typical physician tells
the patient very little. This standard is also generally
considered inconsistent with the goals of informed
consent as the focus is on the physician rather
than on what the patient needs to know.
- reasonable
patient standard: what would the average patient
need to know in order to be an informed participant in
the decision? This standard focuses on considering what
a patient
would need to know in order to understand the decision
at hand.
- subjective standard: what would this patient
need to know and
understand in order to make an informed decision?
This standard is the most challenging to incorporate into
practice, since
it requires tailoring information to each patient.
Most states have legislation or legal cases that determine
the required standard for informed consent.
In the state of Washington, we use the "reasonable patient
standard." The best approach to the question of how much
information is enough is one that meets both your professional
obligation to provide the best care and respects the patient
as a person with the right to a voice in health care decisions.
What sorts of interventions require informed consent?
Most health care institutions, including UWMC, Harborview,
and VAMC have policies that state which health interventions
require a signed consent form. For example, surgery, anesthesia,
and other invasive procedures are usually in this category.
These signed forms are really the culmination of a dialogue
required to foster the patient's informed participation in
the clinical decision.
For a wide range of decisions, written consent is neither required
or needed, but some meaningful discussion is needed. For instance,
a man contemplating having a prostate-specific antigen screen
for prostate cancer should know the relevant arguments for
and against this screening test, discussed in layman's terms.
Informed consent is the process
by which fully informed patients can participate
in choices about their healthcare.
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