What Is Informed Consent

What is informed consent?
Informed consent is the process by which a fully informed patient can participate in choices about her
health care. 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 the patient 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.
When is it appropriate to question a patient's ability to participate in decision making?
In most cases, it is clear whether or not patients are competent to make their own decisions.
Occasionally, it is not so clear. Patients are under an unusual amount of stress during illness and can
experience anxiety, fear, and depression. The stress associated with illness should not necessarily
preclude one from participating in one's own care. However, precautions should be taken to ensure the
patient does have the capacity to make good decisions. There are several different standards of decision
making capacity. Generally you should assess the patient's ability to:
 understand his or her situation,
 understand the risks associated with the decision at hand, and
 communicate a decision based on that understanding.
When this is unclear, a psychiatric consultation can be helpful. Of course, just because a patient refuses
a treatment does not in itself mean the patient is incompetent. Competent patients have the right to
refuse treatment, even those treatments that may be life-saving. Treatment refusal may, however, be a
flag to pursue further the patient's beliefs and understanding about the decision, as well as your own.
What about the patient whose decision making capacity varies from day to day?
Patients can move in and out of a coherent state as their medications or underlying disease processes
ebb and flow. You should do what you can to catch a patient in a lucid state - even lightening up on the
medications if necessary - in order to include him in the decision making process.
What should occur if the patient cannot give informed consent?
If the patient is determined to be incapacitated/incompetent to make health care decisions, a surrogate

decision maker must speak for her. There is a specific hierarchy of appropriate decision makers defined
by state law (also see the DNR topic page). If no appropriate surrogate decision maker is available, the
physicians are expected to act in the best interest of the patient until a surrogate is found or appointed.
Is there such a thing as presumed/implied consent?
The patient's consent should only be "presumed", rather than obtained, in emergency situations when
the patient is unconscious or incompetent and no surrogate decision maker is available. In general, the
patient's presence in the hospital ward, ICU or clinic does not represent implied consent to all treatment
and procedures. The patient's wishes and values may be quite different than the values of the
physician's. While the principle of respect for person obligates you to do your best to include the patient
in the health care decisions that affect his life and body, the principle of beneficence may require you to
act on the patient's behalf when his life is at stake.

What Is Informed Consent

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What Is Informed Consent

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What is informed consent?

What are the elements of full informed consent?

 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

How much information is considered "adequate"?

What sorts of interventions require informed consent?

When is it appropriate to question a patient's ability to participate in decision making?

 understand his or her situation,

 understand the risks associated with the decision at hand, and

 communicate a decision based on that understanding.

What should occur if the patient cannot give informed consent?

If the patient is determined to be incapacitated/incompetent to make health care decisions, a surrogate

Is there such a thing as presumed/implied consent?

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