Opportunities to "consent" a patient abound on the wards. The aim of this section is to provide you with the tools required for the "basic minimum" as well as providing a more comprehensive picture of the informed consent process. You will find that the particular circumstances (e.g. the patient's needs or the procedure) will determine whether a basic or comprehensive informed consent process is necessary. (See also Informed Consent in the OR.)

What is informed consent?

Informed consent is the process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment. (Appelbaum, 2007)1It 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 has an opportunity to be an informed participant in her health care decisions. It is generally accepted that 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, she must be considered competent to make the decision at hand and her 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 she is participating in a decision-making process, not merely signing a form. With this understanding, the informed consent process should be seen as an invitation for the patient to participate in health care decisions. The physician is also generally obligated to provide a recommendation and share his 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 or simple consent entails letting the patient know what you would like to do; giving basic information about the procedure; and ensuring that the patient assents or consents to the intervention. Assent refers to a patient's willing acceptance of a treatment, intervention, or clinical care. Basic consent is appropriate, for example, when drawing blood in a patient who has given blood before. Sometimes consent to the procedure is implied (e.g. the patient came in to have blood drawn), but an explanation of the elements of the procedure remain necessary. 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 that the treatment being offered is the only or best option and/or there is low risk involved in the treatment If a patient does not consent under the paradigm of basic consent, then a fuller informed consent discussion is warranted.

How much information is considered "adequate"?

How do you know when you have provided enough information about a proposed intervention? 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, this standard is often inadequate, since most research 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 typical patient would need to know in order to understand the decision at hand.
• Subjective standard: what would this particular 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. (See also Truth-Telling and Law and Medicine.)

What sorts of interventions require informed consent?

All health care interventions require some kind of consent by the patient, following a discussion of the procedure with a health care provider. Patients fill out a general consent form when they are admitted or receive treatment from a health care institution. Most health care institutions, including UWMC, Harborview, and VAMC also 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 the culmination of a dialogue required to foster the patient's informed participation in the clinical decision.

For a wide range of decisions, explicit written consent is neither required nor needed, but some meaningful discussion is always 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 lay terms. (See also Research Ethics.)

Is it ever acceptable to not have a full informed consent?

Exceptions to full informed consent are:

• If the patient does not have decision-making capacity, such as a person with dementia, in which case a proxy, or surrogate decision-maker, must be found. (See Surrogate Decision-Making/No Legal Next of Kin.)
• A lack of decision-making capacity with inadequate time to find an appropriate proxy without harming the patient, such as a life-threatening emergency where the patient is not conscious
• When the patient has waived consent.
• When a competent patient designates a trusted loved-one to make treatment decisions for him or her. In some cultures, family members make treatment decisions on behalf of their loved-ones. Provided the patient consents to this arrangement and is assured that any questions about his/her medical care will be answered, the physician may seek consent from a family member in lieu of the patient.

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 have capacity 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 an indication that it is necessary to pause to discuss 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?

A patient's decision-making capacity is variable 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 and safe - in order to include her in the decision making process. Delirious patients have waxing and waning abilities to understand information. However, if a careful assessment is done and documented at each contact, and during lucid periods the patient consistently and persistently makes the same decision over time, this may constitute adequate decisional capacity for the question at hand.

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. In rare circumstances, when no surrogate can be identified, a guardian ad litem may have to be appointed by the court. Confer with social work and risk management if you have trouble finding a legal surrogate for the patient.

How does informed consent apply to children?

Children do not have the decision-making capacity to provide informed consent. Since consent, by definition, is given for an intervention for oneself, parents cannot provide informed consent on behalf of their children. Instead they can provide informed permission for treatment. For older children and adolescents, assent should always be sought in addition to the authorization of legal surrogates. Adolescents and mature minors are legally and ethically authorized to provide informed consent if they are emancipated, and in many states, including Washington, they may provide consent for matters regarding sexual and reproductive health, mental health, and substance abuse. See your state's legislation regarding mature minors and consent laws.

The primary responsibility of the physician is the well-being of the child. Therefore, if the parental decision places the child at risk of harm then further action may be indicated. When there are differences in opinion between the parents and physicians that cannot be resolved ethics consultation may be pursued, and legal avenues may be pursued when all other means have failed. Children should be included in decision-making at a developmentally appropriate level and assent should be sought when possible. (See Parental Decision Making.)

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, and the emergency interventions will prevent death or disability. 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 from the values of the physician. While the principle of respect for person obligates you to do your best to include the patient in the health care decisions that affect her life and body, the principle of beneficence may require you to act on the patient's behalf when her life is at stake.

Topics addressed:

• What is informed consent?
• What are the elements of full informed consent?
• How much information is considered "adequate"?
• What sorts of interventions require informed consent?
• Is it ever acceptable to not have a full informed consent?
• When is it appropriate to question a patient's ability to participate in decision making?
• What about the patient whose decision making capacity varies from day to day?
• What should occur if the patient cannot give informed consent?
• How does informed consent apply to children?
• Is there such a thing as presumed/implied consent?

Opportunities to "consent" a patient abound on the wards. The aim of this section is to provide you with the tools required for the "basic minimum" as well as providing a more comprehensive picture of the informed consent process. You will find that the particular circumstances (e.g. the patient's needs or the procedure) will determine whether a basic or comprehensive informed consent process is necessary. (See also Informed Consent in the OR.)

What is informed consent?

Informed consent is the process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment. (Appelbaum, 2007)1It 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 has an opportunity to be an informed participant in her health care decisions. It is generally accepted that 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, she must be considered competent to make the decision at hand and her 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 she is participating in a decision-making process, not merely signing a form. With this understanding, the informed consent process should be seen as an invitation for the patient to participate in health care decisions. The physician is also generally obligated to provide a recommendation and share his 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 or simple consent entails letting the patient know what you would like to do; giving basic information about the procedure; and ensuring that the patient assents or consents to the intervention. Assent refers to a patient's willing acceptance of a treatment, intervention, or clinical care. Basic consent is appropriate, for example, when drawing blood in a patient who has given blood before. Sometimes consent to the procedure is implied (e.g. the patient came in to have blood drawn), but an explanation of the elements of the procedure remain necessary. 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 that the treatment being offered is the only or best option and/or there is low risk involved in the treatment If a patient does not consent under the paradigm of basic consent, then a fuller informed consent discussion is warranted.

How much information is considered "adequate"?

How do you know when you have provided enough information about a proposed intervention? 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, this standard is often inadequate, since most research 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 typical patient would need to know in order to understand the decision at hand.
• Subjective standard: what would this particular 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. (See also Truth-Telling and Law and Medicine.)

What sorts of interventions require informed consent?

All health care interventions require some kind of consent by the patient, following a discussion of the procedure with a health care provider. Patients fill out a general consent form when they are admitted or receive treatment from a health care institution. Most health care institutions, including UWMC, Harborview, and VAMC also 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 the culmination of a dialogue required to foster the patient's informed participation in the clinical decision.

For a wide range of decisions, explicit written consent is neither required nor needed, but some meaningful discussion is always 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 lay terms. (See also Research Ethics.)

Is it ever acceptable to not have a full informed consent?

Exceptions to full informed consent are:

• If the patient does not have decision-making capacity, such as a person with dementia, in which case a proxy, or surrogate decision-maker, must be found. (See Surrogate Decision-Making/No Legal Next of Kin.)
• A lack of decision-making capacity with inadequate time to find an appropriate proxy without harming the patient, such as a life-threatening emergency where the patient is not conscious
• When the patient has waived consent.
• When a competent patient designates a trusted loved-one to make treatment decisions for him or her. In some cultures, family members make treatment decisions on behalf of their loved-ones. Provided the patient consents to this arrangement and is assured that any questions about his/her medical care will be answered, the physician may seek consent from a family member in lieu of the patient.

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 have capacity 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 an indication that it is necessary to pause to discuss 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?

A patient's decision-making capacity is variable 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 and safe - in order to include her in the decision making process. Delirious patients have waxing and waning abilities to understand information. However, if a careful assessment is done and documented at each contact, and during lucid periods the patient consistently and persistently makes the same decision over time, this may constitute adequate decisional capacity for the question at hand.

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. In rare circumstances, when no surrogate can be identified, a guardian ad litem may have to be appointed by the court. Confer with social work and risk management if you have trouble finding a legal surrogate for the patient.

How does informed consent apply to children?

Children do not have the decision-making capacity to provide informed consent. Since consent, by definition, is given for an intervention for oneself, parents cannot provide informed consent on behalf of their children. Instead they can provide informed permission for treatment. For older children and adolescents, assent should always be sought in addition to the authorization of legal surrogates. Adolescents and mature minors are legally and ethically authorized to provide informed consent if they are emancipated, and in many states, including Washington, they may provide consent for matters regarding sexual and reproductive health, mental health, and substance abuse. See your state's legislation regarding mature minors and consent laws.

The primary responsibility of the physician is the well-being of the child. Therefore, if the parental decision places the child at risk of harm then further action may be indicated. When there are differences in opinion between the parents and physicians that cannot be resolved ethics consultation may be pursued, and legal avenues may be pursued when all other means have failed. Children should be included in decision-making at a developmentally appropriate level and assent should be sought when possible. (See Parental Decision Making.)

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, and the emergency interventions will prevent death or disability. 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 from the values of the physician. While the principle of respect for person obligates you to do your best to include the patient in the health care decisions that affect her life and body, the principle of beneficence may require you to act on the patient's behalf when her life is at stake.

• Is this patient competent to consent?
• Which preference should be honored?