Health Rights.am

What is informed consent?

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?

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 law. 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.

An Extract from Ethics in Medicine: University of Washington School of Medicine