In the United States, the legal doctrine of simple consent dates from the 1914 decision in Schloendorff vs. The Society of New York Hospital regarding a case in which a surgeon removed a diseased uterus after the patient had consented to an examination under anesthesia, but with the express stipulation that no operative excision should be performed. The physician argued that his decision was justified by the beneficent obligation to avoid the risks of a second anesthetic. However, Justice Benjamin Cardozo stated:

Every human being of adult years and sound mind has a right to determine what shall be done with his body; and a surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable in ­damages … except in cases of emergency, where the patient is unconscious, and where it is necessary to operate before consent can be obtained.4

 

Having established that patients have the right to determine what happens to their bodies, it took some time for the modern concept of informed consent to emerge from the ­initial doctrine of simple consent. The initial approach appealed to a professional practice standard whereby physicians were obligated to disclose to patients the kind of information that experienced surgeons customarily disclosed.5 However, this disclosure was not always adequate for patient needs. In the 1972 landmark case, Canterbury vs. Spence, the court rejected the professional practice standard in favor of the reasonable person standard whereby physicians are obliged to disclose to patients all information regarding diagnosis, treatment options, and risks that a “reasonable patient” would want to know in a similar situation. Rather than relying on the practices or consensus of the medical community, the reasonable person standard empowers the public (reasonable persons) to determine how much information should be disclosed by physicians to ensure that consent is truly informed. The court did recognize, however, that there are practical limits on the amount of information that can be communicated or assimilated.5 Subsequent litigation has revolved around what reasonable people expect to be disclosed in the consent process to include the nature and frequency of potential complications, the prognostic life expectancy,6 and the surgeon-specific success rates.4 Despite the litigious environment of medical practice, it is difficult to prosecute a case of inadequate informed consent so long as the clinician has made a concerted and documented effort to involve the patient in the decision-making process.

 

 

Most patients sign a general consent for treatment. General consent for treatment is widely understood to cover history taking, standard examinations, and basic procedures such as venipuncture and blood analysis. General consent forms do not provide consent for more detailed, risky, or invasive procedures.

Informed consent requires two conditions: the patient possesses decision-making capacity, and the patient can make a voluntary choice free of undue influence. The process of informed consent begins with the delivery of information to the patient by the provider. The patient must then reach a decision and authorize the procedure or treatment.

Patient Capacity

Decision-making capacity (hereafter called "capacity") is the ability of the patient to make informed medical decisions. It is the provider's task to determine the patient's capacity.3The definition of capacity varies among jurisdictions, but, in general, capacity describes an individual's ability to make a decision based on personal values and comprehension of the likely consequences of that decision.4,5

One definition of capacity as it relates to health care is from Illinois law and reads: " 'Decisional capacity' means the ability to understand and appreciate the nature and consequences of a decision regarding medical treatment or forgoing life-sustaining treatment and the ability to reach and communicate an informed decision in the matter as determined by the attending physician."6 The American College of Physicians Ethics Manual describes decision-making capacity as "the ability to receive and express information and to make a choice consonant with that information and one's values."4

Competence, which is often incorrectly used interchangeably with capacity, is a legal term indicating a ruling by a court that a person is able to manage his or her own affairs.7

The capacity to make a medical decision is based on several basic abilities: the ability to receive information; to process and understand information; to deliberate about a decision; and to make, articulate, and defend choices. Generally, the physician assesses the above-listed patient abilities informally, by taking a history from an alert patient with no barriers to communication. Any barriers to communication as a result of language should be removed through translation, when possible, by an impartial medical translator.

Patients with altered mental status may not possess the memory or attention to receive and process the information and thus lack capacity.8,9 However, diagnoses often associated with altered mental status, such as stroke, psychiatric illness, or dementia, should not lead to a presumption of incapacity. Assess whether or not the disorder affects patients' cognitive abilities.5 Disagreement with the physician's plan does not indicate a lack of capacity if the decision was made in a rational way, which the patient can defend based on their values and beliefs.9 A patient's decision-making capacity may change over time in the ED based on changes in medical condition, for example, in patients recovering from intoxication, hypoglycemia, or hypoxia.

Capacity may depend on the complexity of the decision and consequences of accepting or rejecting the intervention. For example, a patient may be competent to make a minor decision but not a major decision at a given point in time.10 The more important the decision, the more important is the assessment.4,11

Factors useful to assess capacity are summarized in Tables 303-11 and 303-2.11


Factors for Emergency Providers to Consider When Determining Capacity

Presence of conditions impairing mental function

Presence of basic mental functioning (awareness, orientation, memory, attention)

The patient has understanding of specific treatment-related information

Appreciation of the significance of the information for the patient's situation

Patient's ability to reason about treatment alternatives in light of values and goals

Complexity of the decision-making task

Risks of the patient's decision

Patient's ability to describe, and consistency in reporting, the basis of their decision


Common Errors in the Assessment of Capacity

Assuming that if the patient lacks capacity for one type of decision, he or she lacks capacity for all decisions

Assuming that legal competence is the same as medical decision-making capacity

Presuming that capacity is constant over time

Assuming that a blood alcohol level is related to competence

Presuming that psychiatric disorders preclude adequate capacity

Failing to ensure the patient has relevant and consistent information before making a decision

Assuming that capacity should only be considered for refusal of treatment

Failure to recognize that the capacity to make decisions varies with the risks and benefits inherent in the decision

 

Adequate informed consent entails at least four basic elements: (a) the physician documents that the patient or surrogate has the capacity to make a medical decision; (b) the surgeon discloses to the patient details regarding the diagnosis what it means, the prognosis (the natural course of the condition without treatment),and treatment options sufficiently for the patient to make an informed choice; the proposed treatment (description of the procedure and what the patient will experience), the risks and benefits of the treatment, and the alternative treatments. The patient then can choose what he or she wants to do. The procedure must be in accordance with the patient's goals and values. (c) the patient demonstrates understanding of the disclosed information before (d) authorizing freely a specific treatment plan without undue influence

Algorithm for navigating the process of informed consent. (From Childers R, Lipsett A, Pawlik T. Informed consent and the surgeon. J Am Coll Surg. E-pub Jan. 21, 2009. Copyright 2009, with permission from Elsevier.)

These goals are aimed at respecting each patient’s prerogative for autonomous self-determination. To accomplish these goals, the surgeon needs to engage in a discussion about the causes and nature of the patient’s disease, the risks and benefits of available treatment options, as well as details regarding what patients can expect after an operative intervention.7,8,9,10,11,12,13,14

If a patient has capacity to make a given decision, his or her wishes should be respected.

Free Choice

Informed consent must be voluntary and free of coercion. The choice must be free of manipulation or threats by providers, family, or other outside influences, and free of emotional or physical coercion.2

Information Necessary for Patient Decision Making

The physician must provide the patient with the information needed to make a reasoned, informed decision. Generally, the provider performing the procedure should be the one to obtain consent. A delegate such as a resident or nurse practitioner may obtain consent, but the supervisor is responsible to ensure that consent was truly informed.12 The required information for decision making is the diagnosis; the nature and purpose of treatment; risks and consequences of treatment; alternatives and their risks and benefits; and prognosis if treatment is or is not accepted.12

How much information is necessary to meet the above requirement depends on the standard of disclosure being applied. There are two standards, each used in a large number of states, that address the details of the disclosure for consent.12 The "reasonable person standard" for informed consent requires providers to give the patient all the information a "reasonable person" would need to make the same decision under similar circumstances.13 The alternate standard is the less stringent "professional standard" for informed consent, which requires disclosure to be the same as any reasonably prudent, similarly trained physician would provide in a similar circumstance.12 Emergency providers are well served to give more, not less, information to the patient.

Discussion and Decision

Give the patient the opportunity to ask questions while considering the decision. The patient can be made realistically aware of ED time constraints for decision making, but without using coercion. Patients willing to continue should then give explicit authorization for the treatment or procedure. If the patient agrees too easily, has no questions, or is not engaged in the process, review the situation for barriers to communication such as language issues. A patient who is unable or unwilling to express a preference for a particular course of action may be presumed to lack capacity.14

 

 

Informed consent can be challenging in certain clinical settings. For example, obtaining consent for emergency ­surgery, where decisions are often made with incomplete information, can be difficult. Emergency consent requires the ­surgeon to consider if and how possible interventions might save a patient’s life, and if successful, what kind of disability might be ­anticipated. Surgical emergencies are one of the few instances where the limits of patient autonomy are freely acknowledged, and surgeons are empowered by law and ethics to act promptly in the best interests of their patients according to the surgeon’s judgment. Most applicable medical laws require physicians to provide the standard of care to incapacitated patients, even if it entails invasive procedures without the explicit consent of the patient or surrogate. If at all possible, surgeons should seek the permission of their patients to provide treatment, but when emergency medical conditions render patients unable to grant that permission, and when delay is likely to have grave consequences, surgeons are legally and ethically justified in providing whatever surgical treatment the surgeon judges necessary to preserve life and restore health.4 This justification is based on the social consensus that most people would want their lives and health protected in this way, and this consensus is manifest in the medical profession’s general orientation to preserve life. It may be that subsequent care may be withdrawn or withheld when the clinical prognosis is clearer, but in the context of initial resuscitation of injured patients, incomplete information makes clear judgments about the patient’s ultimate prognosis or outcome impossible.

The process of consent can also be challenging in the pediatric population. For many reasons, children and adolescents cannot participate in the process of giving informed consent in the same way as adults. Depending on their age, children may lack the cognitive and emotional maturity to participate fully in the process. In addition, depending on the child’s age, their specific circumstances, as well as the local jurisdiction, children may not have legal standing to fully participate on their own independent of their parents. The use of parents or guardians as surrogate decision makers only partially addresses the ethical responsibility of the surgeon to involve the child in the informed consent process. The surgeon should strive to augment the role of the decision makers by involving the child in the process. Specifically, children should receive age-appropriate information about their clinical situation and therapeutic options so that the surgeon can solicit the child’s “assent” for treatment. In this manner, while the parents or surrogate decision makers formally give the informed consent, the child remains an integral part of the process.

Certain religious practices can present difficulties in treating minor children in need of life-saving blood transfusions; however, case law has made clear the precedent that parents, regardless of their held beliefs, may not place their minor ­children at mortal risk. In such a circumstance, the physician should seek counsel from the hospital medicolegal team, as well as from the institutional ethics team. Legal precedent has, in general, established that the hospital or physician can proceed with providing all necessary care for the child.

Obtaining “consent” for organ donation deserves specific mention.15 Historically, discussion of organ donation with families of potential donors was performed by transplant professionals, who were introduced to families by intensivists after brain death had been confirmed and the family had been informed of the fact of death. In other instances, consent might be obtained by intensivists caring for the donor, as they were assumed to know the patient’s family and could facilitate the process. ­However, issues of moral “neutrality” as part of end-of-life care in the intensive care unit have caused a shift in how obtaining ­“consent” for organ donation is handled. Responsibility for obtaining consent from the donor family is now vested in trained “designated requestors” (or “organ ­procurement ­coordinators”)16 or by “independent” intensivists who do not have a therapeutic clinical relationship with the potential donor.17 In this way, the donor family can be allowed to make the decision regarding donation in a “neutral” environment without erosion of the therapeutic relationship with the treating physician.

The process of informed consent also can be limited by the capacity of patients to assimilate information in the context of their illness. For example, despite the best efforts of surgeons, evidence suggests that patients rarely retain much of what is disclosed in the consent conversation, and they may not remember discussing details of the procedure that become relevant when postoperative complications arise.18 It is important to recognize that the doctrine of informed consent places the most emphasis on the principle of autonomy precisely in those clinical situations when, because of their severe illness or impending death, patients are often divested of their autonomy.

 

 


Notes

  • Do not force adult Jehovah's Witness patients to accept blood products (or force any competent adults to accept any treatment they don't want!), and do not give a treatment behind a competent patient's back without consent because it's “in his or her best interest.”
  • If a child has a life-threatening condition and the parents refuse a simple, curative treatment (e.g., antibiotics for meningitis), first try to persuade the parents to change their minds. If they will not, your second option is to get a court order to give the treatment and get hospital support services involved. Do not give the treatment until you talk to the courts if you can avoid it.
  • Let competent people die if they want to do so. Never force treatments on adults of sound mind. Respect wishes for passive euthanasia but avoid active euthanasia.
  • Living wills and do-not-resuscitate (DNR) orders should be respected and followed if done correctly. For example, if in a living will the patient says that a ventilator should not be used if he or she is unable to breathe independently, do not put the patient on a ventilator even if the spouse, son, or daughter makes the request.
To give informed consent, patients must have legal and clinical capacity. Health care practitioners obtaining informed consent must be qualified to explain the risks and benefits of the intervention and to answer appropriate questions. The law requires that health care practitioners take reasonable steps to communicate adequately with patients who do not speak English or who have other communication barriers.

Full disclosure

Ethical and legal authorities generally agree that health care practitioners are obligated to ensure, at a minimum, that patients understand:

· Their current medical status, including its likely course if no treatment is pursued


· Potentially helpful treatments, including a description and explanation of potential risks and benefits


· Usually, the practitioner's professional opinion as to the best alternative


· Uncertainties associated with each of these elements


Generally, these discussions are noted in the medical record, and a document describing the discussion is signed by the patient.

Although practitioners are ethically bound to provide sufficient information and to encourage decisions judged to be in the patient's best interest, patients still have the right to refuse treatment. A patient's refusal of treatment is not considered to be attempted suicide, nor is the health care practitioner's compliance with the patient's wishes legally considered physician-assisted suicide. Rather, the subsequent death is considered legally to be a natural consequence of the disease process itself.

A refusal of care, if puzzling, should prompt the health care practitioner to initiate further discussion. If refusal of treatment will hurt other people, such as a minor child or other dependent, ethical and legal consultation should be sought.

 

Consent and Surrogate Decision Making

When immediate decisions are medically required, the doctrine of presumed consent applies (see above). In other circumstances, consent must be obtained.

Children: For most nonemergency medical decisions affecting minors, medical care cannot proceed without a parent's or guardian's consent. The parent's or guardian's decision can be overridden only if a court determines that the decision constitutes neglect or abuse of the minor. In some states, minors can consent to certain medical treatments (eg, treatment of sexually transmitted diseases, prescriptions for birth control, abortion) without parental permission. Individual state law must be consulted.

Adults: When adult patients lack capacity to consent to or refuse medical treatment, health care practitioners must rely on an authorized surrogate for consent and decision making. All surrogates¾whether appointed by the individual, by default, or by the court¾have an obligation to follow the expressed wishes of the patient and to act in the patient's best interests, taking into account the patient's personal values to the extent known.

If adult patients already have a court-appointed guardian with authority to make health care decisions, the guardian is the authorized surrogate. If patients who lack capacity have a durable power of attorney for health care, the agent or proxy appointed by that document is authorized to make health care decisions within the scope of authority granted by the document. Generally, specific instructions that are given in a living will, health care declaration, or other advance directive executed by patients while capacitated can be relied on.

If the decision of an authorized agent or proxy seems to conflict directly with instructions in a living will, the outcome depends on the scope of discretion given to the agent or proxy. Normally, the durable power of attorney for health care confers broad decision-making discretion on the agent. Nevertheless, the health care practitioner should determine whether the document gives the agent broad discretion beyond the written instructions or limits the agent to the written instructions. Legal advice may be needed.

If patients have no authorized surrogate, health care practitioners usually rely on the next of kin or even a close friend. However, the exact scope of authority and the priority of permissible surrogates vary by state. Typically, the order of priority is a spouse (or domestic partner in jurisdictions that recognize this status), an adult child, a parent, a sibling, then possibly other relatives or a close friend. If more than one person has the same priority (eg, several adult children), consensus is preferred, but some states allow health care practitioners to rely on a majority decision.

If a patient's decision-making capacity, a surrogate's authority, or the ethical or legal appropriateness of a particular treatment decision is disputed, consultation with an institutional ethics committee or similar body is advisable. If agreement on an ethically and legally sound resolution cannot be reached, health care practitioners may need to request court review. Many institutions make the ethics committee available on short notice (eg, in 1 or 2 days); judicial review is typically more time-consuming.

Scope: Patient choice is not limitless. For example, health care practitioners are not required to provide treatments that are medically inappropriate, such as those that are against generally accepted health care standards. However, sometimes there are legitimate differences of opinion regarding what is inappropriate. Labeling a treatment as "futile" does not generally help if said treatment may affect outcomes other than mortality or morbidity that are important to the patient. Physicians do not have to act against their conscience, but if they cannot comply with a requested course of action, they may have a responsibility to try to transfer a patient to another physician or institution of the patient's choice.


Consent of the patient is a prerequisite for any medical intervention.

However, that consent often does not need to be expressed.

For emergency care, consent is normally presumed.

For interventions considered routine and unlikely to cause harm (eg, routine phlebotomy, placement of an IV line), circumstances are typically considered to imply consent. For example, by holding out their arm, patients are presumed to indicate consent to receive certain routine interventions.

For more invasive or risky interventions, express informed consent is always required.

To give informed consent, patients must have legal and clinical capacity. Health care practitioners obtaining informed consent must be qualified to explain the risks and benefits of the intervention and to answer appropriate questions. The law requires that health care practitioners take reasonable steps to communicate adequately with patients who do not speak English or who have other communication barriers.

Full disclosure

Ethical and legal authorities generally agree that health care practitioners are obligated to ensure, at a minimum, that patients understand:

· Their current medical status, including its likely course if no treatment is pursued


· Potentially helpful treatments, including a description and explanation of potential risks and benefits


· Usually, the practitioner's professional opinion as to the best alternative


· Uncertainties associated with each of these elements


Generally, these discussions are noted in the medical record, and a document describing the discussion is signed by the patient.

Although practitioners are ethically bound to provide sufficient information and to encourage decisions judged to be in the patient's best interest, patients still have the right to refuse treatment. A patient's refusal of treatment is not considered to be attempted suicide, nor is the health care practitioner's compliance with the patient's wishes legally considered physician-assisted suicide. Rather, the subsequent death is considered legally to be a natural consequence of the disease process itself.

A refusal of care, if puzzling, should prompt the health care practitioner to initiate further discussion. If refusal of treatment will hurt other people, such as a minor child or other dependent, ethical and legal consultation should be sought.

 

Consent and Surrogate Decision Making

When immediate decisions are medically required, the doctrine of presumed consent applies (see above). In other circumstances, consent must be obtained.

Children: For most nonemergency medical decisions affecting minors, medical care cannot proceed without a parent's or guardian's consent. The parent's or guardian's decision can be overridden only if a court determines that the decision constitutes neglect or abuse of the minor. In some states, minors can consent to certain medical treatments (eg, treatment of sexually transmitted diseases, prescriptions for birth control, abortion) without parental permission. Individual state law must be consulted.

Adults: When adult patients lack capacity to consent to or refuse medical treatment, health care practitioners must rely on an authorized surrogate for consent and decision making. All surrogates¾whether appointed by the individual, by default, or by the court¾have an obligation to follow the expressed wishes of the patient and to act in the patient's best interests, taking into account the patient's personal values to the extent known.

If adult patients already have a court-appointed guardian with authority to make health care decisions, the guardian is the authorized surrogate. If patients who lack capacity have a durable power of attorney for health care, the agent or proxy appointed by that document is authorized to make health care decisions within the scope of authority granted by the document. Generally, specific instructions that are given in a living will, health care declaration, or other advance directive executed by patients while capacitated can be relied on.

If the decision of an authorized agent or proxy seems to conflict directly with instructions in a living will, the outcome depends on the scope of discretion given to the agent or proxy. Normally, the durable power of attorney for health care confers broad decision-making discretion on the agent. Nevertheless, the health care practitioner should determine whether the document gives the agent broad discretion beyond the written instructions or limits the agent to the written instructions. Legal advice may be needed.

If patients have no authorized surrogate, health care practitioners usually rely on the next of kin or even a close friend. However, the exact scope of authority and the priority of permissible surrogates vary by state. Typically, the order of priority is a spouse (or domestic partner in jurisdictions that recognize this status), an adult child, a parent, a sibling, then possibly other relatives or a close friend. If more than one person has the same priority (eg, several adult children), consensus is preferred, but some states allow health care practitioners to rely on a majority decision.

If a patient's decision-making capacity, a surrogate's authority, or the ethical or legal appropriateness of a particular treatment decision is disputed, consultation with an institutional ethics committee or similar body is advisable. If agreement on an ethically and legally sound resolution cannot be reached, health care practitioners may need to request court review. Many institutions make the ethics committee available on short notice (eg, in 1 or 2 days); judicial review is typically more time-consuming.

Scope: Patient choice is not limitless. For example, health care practitioners are not required to provide treatments that are medically inappropriate, such as those that are against generally accepted health care standards. However, sometimes there are legitimate differences of opinion regarding what is inappropriate. Labeling a treatment as "futile" does not generally help if said treatment may affect outcomes other than mortality or morbidity that are important to the patient. Physicians do not have to act against their conscience, but if they cannot comply with a requested course of action, they may have a responsibility to try to transfer a patient to another physician or institution of the patient's choice.

 

Reference

1. http://www.nejm.org/doi/full/10.1056/NEJMra1108646?query=TOC#t=article

Informed consent is the legal standard under which providers educate patients (those who have the capacity to make medical decisions or their surrogates) about proposed treatments and alternatives.1 The desirability of informed consent is based on the belief that it fosters the twin concepts of patient well-being and autonomy. Informed consent also provides a legal basis for autonomy.

Providers should act in their patients' best interests while preserving autonomy whenever possible. The American College of Emergency Physicians Code of Ethics2 recognizes this dual obligation in stating that emergency physicians "serve the best interest of their patients by treating or preventing disease or injury and by informing patients about their condition." The code of ethics goes on to say, "Adult patients with decision-making capacity have a right to accept or refuse recommended health care, and physicians have a concomitant duty to respect their choices. This right is grounded in the moral principle of respect for patient autonomy and is expressed in the legal doctrine of informed consent."2

BASIC ELEMENTS OF INFORMED CONSENT

Most patients arriving at the ED sign a general consent for treatment. General consent for treatment is widely understood to cover history taking, standard examinations, and basic procedures such as venipuncture and blood analysis. General consent forms do not provide consent for more detailed, risky, or invasive procedures.

Informed consent requires two conditions: the patient possesses decision-making capacity, and the patient can make a voluntary choice free of undue influence. The process of informed consent begins with the delivery of information to the patient by the provider. The patient must then reach a decision and authorize the procedure or treatment. Each part of the process is considered individually.

Patient Capacity

Decision-making capacity (hereafter called "capacity") is the ability of the patient to make informed medical decisions. It is the provider's task to determine the patient's capacity.3The definition of capacity varies among jurisdictions, but, in general, capacity describes an individual's ability to make a decision based on personal values and comprehension of the likely consequences of that decision.4,5

One definition of capacity as it relates to health care is from Illinois law and reads: " 'Decisional capacity' means the ability to understand and appreciate the nature and consequences of a decision regarding medical treatment or forgoing life-sustaining treatment and the ability to reach and communicate an informed decision in the matter as determined by the attending physician."6 The American College of Physicians Ethics Manual describes decision-making capacity as "the ability to receive and express information and to make a choice consonant with that information and one's values."4

Competence, which is often incorrectly used interchangeably with capacity, is a legal term indicating a ruling by a court that a person is able to manage his or her own affairs.7

The capacity to make a medical decision is based on several basic abilities: the ability to receive information; to process and understand information; to deliberate about a decision; and to make, articulate, and defend choices. Generally, the physician assesses the above-listed patient abilities informally, by taking a history from an alert patient with no barriers to communication. Any barriers to communication as a result of language should be removed through translation, when possible, by an impartial medical translator.

Patients with altered mental status may not possess the memory or attention to receive and process the information and thus lack capacity.8,9 However, diagnoses often associated with altered mental status, such as stroke, psychiatric illness, or dementia, should not lead to a presumption of incapacity. Assess whether or not the disorder affects patients' cognitive abilities.5 Disagreement with the physician's plan does not indicate a lack of capacity if the decision was made in a rational way, which the patient can defend based on their values and beliefs.9 A patient's decision-making capacity may change over time in the ED based on changes in medical condition, for example, in patients recovering from intoxication, hypoglycemia, or hypoxia.

Capacity may depend on the complexity of the decision and consequences of accepting or rejecting the intervention. For example, a patient may be competent to make a minor decision but not a major decision at a given point in time.10 The more important the decision, the more important is the assessment.4,11

Factors useful to assess capacity are summarized in Tables 303-11 and 303-2.11


Factors for Emergency Providers to Consider When Determining Capacity

Presence of conditions impairing mental function

Presence of basic mental functioning (awareness, orientation, memory, attention)

The patient has understanding of specific treatment-related information

Appreciation of the significance of the information for the patient's situation

Patient's ability to reason about treatment alternatives in light of values and goals

Complexity of the decision-making task

Risks of the patient's decision

Patient's ability to describe, and consistency in reporting, the basis of their decision


Common Errors in the Assessment of Capacity

Assuming that if the patient lacks capacity for one type of decision, he or she lacks capacity for all decisions

Assuming that legal competence is the same as medical decision-making capacity

Presuming that capacity is constant over time

Assuming that a blood alcohol level is related to competence

Presuming that psychiatric disorders preclude adequate capacity

Failing to ensure the patient has relevant and consistent information before making a decision

Assuming that capacity should only be considered for refusal of treatment

Failure to recognize that the capacity to make decisions varies with the risks and benefits inherent in the decision

If a patient has capacity to make a given decision, his or her wishes should be respected.

Free Choice

Informed consent must be voluntary and free of coercion. The choice must be free of manipulation or threats by providers, family, or other outside influences, and free of emotional or physical coercion.2

Information Necessary for Patient Decision Making

The physician must provide the patient with the information needed to make a reasoned, informed decision. Generally, the provider performing the procedure should be the one to obtain consent. A delegate such as a resident or nurse practitioner may obtain consent, but the supervisor is responsible to ensure that consent was truly informed.12 The required information for decision making is the diagnosis; the nature and purpose of treatment; risks and consequences of treatment; alternatives and their risks and benefits; and prognosis if treatment is or is not accepted.12

How much information is necessary to meet the above requirement depends on the standard of disclosure being applied. There are two standards, each used in a large number of states, that address the details of the disclosure for consent.12 The "reasonable person standard" for informed consent requires providers to give the patient all the information a "reasonable person" would need to make the same decision under similar circumstances.13 The alternate standard is the less stringent "professional standard" for informed consent, which requires disclosure to be the same as any reasonably prudent, similarly trained physician would provide in a similar circumstance.12 Emergency providers are well served to give more, not less, information to the patient.

Discussion and Decision

Give the patient the opportunity to ask questions while considering the decision. The patient can be made realistically aware of ED time constraints for decision making, but without using coercion. Patients willing to continue should then give explicit authorization for the treatment or procedure. If the patient agrees too easily, has no questions, or is not engaged in the process, review the situation for barriers to communication such as language issues. A patient who is unable or unwilling to express a preference for a particular course of action may be presumed to lack capacity.14

DOCUMENTATION OF CONSENT

When obtaining informed consent, it is the process that is most important. Some states have specific requirements regarding written consent.12 Where specific requirements regarding written consent are not present, oral consent is generally as good as written consent except that written documentation signed by the patient can aid the provider should the consent process be challenged later on.12 At a minimum, the chart or consent form (material forms are required by Medicare for all nonemergency surgical procedures) should reflect who obtained consent; the provider(s) authorized to perform the treatment; that information on risks, benefits, and alternatives were disclosed; and that the patient had the opportunity to ask questions.12,13,15 Ideally, the chart will contain both a signed consent form and a well-documented recap of the consent process.16

EXCEPTIONS TO INFORMED CONSENT

There are a number of exceptions to the right to informed consent in response to specific healthcare situations. These exceptions include emergencies; therapeutic privilege; public health imperatives, such as the treatment of certain diseases; patient waiver of consent; and, rarely, emergency research.12,17 Of these, only emergencies and public health imperatives are applicable to clinicians working in the ED on a day-to-day basis.

Emergencies

Emergency providers should render needed emergency treatment even in situations where consent cannot be obtained or ascertained in a timely fashion due to the nature of the illness. Implied consent, the basis of this exception, is that a reasonable person would give consent to emergency or lifesaving treatment.12,18 If treatment can be delayed without harm, obtain consent before treatment. Should the situation change during treatment, obtain consent before further treatment.

Public Health Imperatives

Public health imperatives are situations where the public good may limit individual patient autonomy. Patients with high-risk communicable diseases,19 such as severe acute respiratory syndrome and tuberculosis, and patients with mental illness who pose a danger to themselves or the public are examples. Each state has regulations regarding communicable diseases and mental health law, and providers should be familiar with rules in their practice location. When patients meet criteria for health department–mandated treatment and quarantine, yet do not give consent, consult hospital infectious disease staff and local health officials as soon as possible.

WHEN INFORMED CONSENT CANNOT BE OBTAINED

If a patient does not have the capacity to give informed consent for a condition where no exception exists or once an emergency has been stabilized and nonemergent decisions need to be made, providers should identify a surrogate decision maker or directive.2,9 First, inquire about advance directives or healthcare powers of attorney that can provide guidance or specify a decision maker (see chapter 300, "Death Notification and Advanced Directives"). In the absence of a power of attorney, state law may determine the patient's decision maker. A typical decision-making progression would be: spouse, adult children, parents, adult siblings, and the nearest relative not previously described.20 Surrogates are expected to help providers determine what the patient would want in a particular situation and should not substitute their values for the patient's. Should no person be available for treatment decisions, providers should proceed with the patient's best interest in mind and involve hospital counsel to begin a guardianship process if the patient's lack of capacity is likely to be of significant duration.10

INFORMED REFUSAL

Patients may refuse part of a treatment plan, refuse to be evaluated entirely, or wish to leave before the completion of the planned evaluation. In these situations, the physician should ensure there are no miscommunications or misunderstandings at the root of the refusal.10 Often, when issues are clarified, an agreement can be reached. Second, correct issues that may prevent an open, noncontentious discussion—such issues may be a blanket, a call to the patient's personal physician, or additional pain medication.10,21 Finally, try to develop an alternative to the original plan that does not significantly alter the risk to the patient. For instance, a patient may not want a certain procedure but would be willing to accept admission for further evaluation.10

When communication and negotiation between the patient and provider fail and the patient possesses decisional capacity, the patient may choose to refuse care or end the encounter "against medical advice."