Chapter 1. Informed Consent for Procedures in the Emergency Department

This chapter is designed as a practical reference for the Emergency Physician (EP). It focuses on the unique challenges of informed consent in the Emergency Department (ED). It presents a practical guide for the informed consent process, reviews the exceptions, and offers suggestions on difficult scenarios of informed consent in the ED.

The right of a patient to make decisions about their body, including the refusal of recommended procedures and treatment, is an important concept in medical practice with foundations in law and medical ethics. Informed consent is the process of communication that demonstrates a physician's respect for a patient's right to make autonomous decisions about their healthcare. Informed consent is both an ethical practice and a legal requirement for all procedures and treatments.

Unique Challenges of Informed Consent in the ED

Each practice environment presents its own challenges to the process of obtaining informed consent. Physicians frequently fail to fulfill all the requirements of obtaining informed consent.1 The ED presents significant challenges, which, despite assumptions to the contrary, results in a greater need to spend time delivering information and engaging patients in their care decisions to the fullest extent possible (Table 1-1). Time pressure and acuity are the most critical factors that influence the care paradigm in the ED. Care provided in the ED spans the full continuum of care (nonacute care is increasingly sought in the ED) and addresses the full spectrum of society (patients from diverse health literacy, language origins, socioeconomic backgrounds, and other recognized vulnerable populations—elderly, children, prisoners). Emergency Physicians need to be prepared to address the broad clinical needs of diverse patients under pressure without the historical physician–patient relationship. Systemic constraints exacerbate this challenged professional context as patients have no choice in the treating physician or the treating facility, which is often dictated by EMS protocols. Tension may arise when a patient's wishes conflict with greater societal or institutional needs for efficiency and protocol compliance independent of the patient's preferences and needs. Examples include a trauma activation or a public health emergency. Increasing space constraints and crowding found in most EDs create a lack of privacy that can impede the free exchange of sensitive information. Procedural interventions in the ED are often concurrently diagnostic and therapeutic, further complicating informed decisions.

The torrent of complex medical information physicians provide patients is overwhelming in the most controlled settings, and is only made worse in the high emotion and high stress environment of the ED. Emergency Physicians often make rapid decisions with limited information on a daily basis. Many of our colleagues in other specialties may not share this skill, and our expectations of patients must be equally, if not more, tolerant. The absence of an ongoing physician–patient relationship offers no basis on which to build trust, elicit values, and draw preference knowledge. Lack of a prior relationship tests the EP's ability to establish an immediate rapport with the patient, and renders the patients' ability to express their values most important.

When there is uncertainty about a patient's preferences or a potential refusal, there may not be time to ponder the intricacies of medical ethics in the ED or to satisfy all the requirements of searching for the best surrogate decision maker. Many EPs will default to doing as much as possible in these difficult situations,2 but there is often enough time to make a considered decision before acting in the most aggressive fashion. While some say that it is easier to withdraw care once the clinical picture becomes clearer, this aggressive course of action must be balanced with the knowledge that EPs may be performing a painful or unwanted procedure on a patient who has previously made their wishes clear. Traditionally, informed consent was often bypassed under the presumption that a patient would want aggressive treatment. The scope of ED care and societal norms have shifted in recent years. Informed consent for procedures in the ED needs to reflect the current standards of practice.

Legal Foundation for Informed Consent

Consent originates in the legal doctrine of battery (touching of the body without permission). The notion of protecting a patient from the bodily trespass of a procedural invasion was framed by Justice Cardozo in 1914, “[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault, for which he is liable in damages….”3 By 1957, the notion of consent shifted from mere permission to an authorization following “the full disclosure of facts necessary to an informed consent.”4 Emerging at the same time as the bioethics movement's shift away from paternalistic medicine toward a patient's rights focus in medicine was Canterbury v Spence.5 This case resulted in an appeals court establishing a physician's duty to disclose the risks and benefits of a procedure and its alternatives and introduced the reasonable patient standard. The reasonable patient standard is what a reasonable patient would need to know to make an informed choice shifting away from the professional standard, what most physicians deemed necessary. Today, the standard for disclosure varies by state.6 As a result of the informed consent “duty,” the legal and risk management function of informed consent (consent process that meets institutional and/or legal parameters for formal recognition referred to as ‘effective consent’) overshadows the ethically driven process of informed consent (consent as communication process that demonstrates respect for a patient's autonomy referred to as ‘autonomous authorization’). Often conflated under the “informed consent,” these two aspects serve distinct functions. Both are necessary for valid informed consent and are addressed separately throughout this chapter.7

Legal Foundation of the Emergency Exception

The exception presuming permission to treat in an emergency has equally deep roots. Justice Cardozo's opinion continues, “[t]his is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained.”3 In Canterbury v Spence, “the emergency exception” is included as a privilege from the duty to disclose when “the patient is unconscious or otherwise incapable of consenting, and harm from a failure to treat is imminent and outweighs any harm threatened by the proposed treatments.” It also states that a “physician should, as current law dictates, attempt to secure a relative's consent if possible.” In the emergency context one may presume permission: (1) to do what is necessary when (a) there is imminent harm from nontreatment and (b) harm from nontreatment outweighs the harm from the proposed intervention; (2) where the patient is unconscious or unable to participate in care decisions; and (3) the patient's preferences are not known and no surrogate is immediately available to provide authorization.8

Ethical Foundation for Informed Consent

In an era of patients' rights and shared decision making, robust informed consent reflects a process of communication that secures that a patient “gives an informed consent to an intervention if (and perhaps only if) one is competent to act, receives a thorough disclosure, comprehends the disclosure, acts voluntarily, and consents to the intervention.”9

It is not uncommon to encounter the challenge of a patient refusing a recommended procedure or intervention in a healthcare environment where there is an expectation for more active patient participation in healthcare decisions. Central to a strong patient–physician relationship is the desire to promote patient well-being and simultaneously respect patient autonomy. Conflict between EPs and patients may arise when views of what is in a patient's best interest differ. Emergency Physicians with the greatest integrity come to work with the intention to act in the best interests of patients, and do so with a focus on the prevention and eradication of disease in order to preserve life and improve disability. After an EP has fully informed a capable patient about an intervention in an understandable way, the patient may consent or refuse the recommendation. An initial refusal of recommended treatment should begin a critical conversation that confirms all the elements of an informed refusal. Ultimately, this informed refusal process will respect patient autonomy by accepting a patient's view of well-being and may require honoring a refusal of the EP's recommendation.10

Emergency Physician's Role and Goals in Informed Consent Process

The EP's role in the informed consent process is to provide patients the information needed to make their own decisions. It is important not to overwhelm a patient with too much information or complex clinical decisions. Including patients in appropriate care decisions, such as the informed consent process for a procedural intervention, is an ethically important goal.

Emergency Physicians must pay particular attention to the informed consent process to accomplish the goal of respect for autonomy (Table 1-2). Foremost, EPs need to provide more information to the patient than they think is needed. Research indicates that patients need more information than physicians think they need in order to feel “informed” in the decision-making process.11 The need for a procedure seems obvious to the EP and the balance of the considerations clearly tips in the favor of “do it.” Emergency Physicians must slow down to fully explain the rationale for their recommendation with the patient and to offer the patient information that allows their meaningful consideration of the recommendation allowing them to reach their own decisions. A good guideline is to offer more time and information for procedures carrying greater risk.12 Emergency Physicians must make an effort to work against the features of the ED (Table 1-1 and presumption of consent) and allow patients who are capable of engaging in their care decisions to express autonomous authorization. This is achieved by giving patients sufficient information, in an understandable way, and by honoring their decisions.

Informed consent is the communication process that both demonstrates and protects a patient's self-determination by providing a patient with decision-making capacity with sufficient, understandable information and allowing the patient to make a voluntary, knowledgeable decision. There are five requirements that must be satisfied.13 These include the patient having decision-making capacity, the EP providing sufficient information, the patient understanding the information, the patient giving consent in a voluntary fashion without coercion, and the patient communicating their decision (Table 1-3).

Decision-Making Capacity

While the terms “competence” and “decision-making capacity” are frequently used interchangeably, their strict meanings are different. Competence is a legal term with broader applications related to financial matters and the determination of personal choices. Decision-making capacity is a clinical term that speaks to the specific capacity to make a particular clinical decision. Many people who are legally “incompetent” retain healthcare decision-making capacity. If the patient does not have decision-making capacity, informed consent cannot be obtained and it must be obtained from a surrogate decision maker, or the patient may fall into an exception from informed consent.

Determining Decision-Making Capacity

The determination that a patient has decision-making capacity is at the core of informed consent. By default, EPs assume that a patient has capacity and confirm this through routine dialogue with the individual. There are six elements that should be confirmed when there is a question about a patient's capacity to make an informed decision about procedures or treatment.14 The patient must be able to: understand and process the options, weigh the benefits and risks, apply a set of values and goals to the decision, arrive at a decision, communicate a choice, and demonstrate capacity to make the decision (Table 1-4).

Determination of capacity is a clinical decision based on the judgment of the EP regarding the patient's actual level of functioning and appreciation of the ramifications of the clinical situation. The degree of capacity needed to understand risks and benefits of suturing a finger laceration differs from a cardiac catheterization. As such, a patient may be able to understand one choice, but not another. An Alzheimer patient (who is pleasant, oriented to place and year) may be unable to appreciate the consequences of a decision. While this patient may have capacity for some tasks, they may lack the capacity to consent for a specific procedure such as a lumbar puncture.

The EP needs to assess the ability for the individual to weigh the risks in light of their own values. An example would be the ramifications of a fracture reduction on the dominant hand. A construction worker or musician may make a decision different than an individual whose livelihood does not depend on perfect hand function.

A recognized element of decision-making capacity is whether the patient's decision is consistent over time. This is not necessarily applicable specifically to the ED. A possible heuristic is whether the decision is consistent with the person's narrative and values as expressed consistently over time in life choices. The decision-specific nature of capacity acknowledges that the level of capacity needed depends on the complexity of the decision, with greater capacity needed for decisions with graver consequences. The degree of capacity needed to consent does not necessary equal the degree of capacity needed to refuse a recommended intervention.10 Informed refusal will be discussed later in this chapter.

Decision-making capacity is a dynamic process and changes depending on the patient's evolving condition and task in question. The ED patient may be able to participate to a greater or lesser extent depending on fluctuations in their condition and alterations of their sensorium from the administration of medications. Efforts should be made whenever possible to enhance the patient's decision-making capacity (reduce pain medication temporarily or visit patients at optimal times) in order to engage them to the fullest extent possible in their care.

Emancipated minor and adolescent laws vary from state to state.9 It is important to note that emancipated minors are legally recognized as adults and responsible for their own finances and care. They are able to provide fully informed consent. It is important for EPs to know their local laws where minors who are not emancipated may give consent for sensitive conditions or procedures such as those of a reproductive nature or substance abuse.

Informed consent may not be possible with some populations, such as young children and elderly with dementia. It is still possible to inform these patients of the procedure and to engage their assent. Unlike consent, assent is not determinative. It does offer the possibility of the individual participating in their care.15

Patients Lacking Decision-Making Capacity

It is not possible to obtain informed consent when a patient lacks decision-making capacity. Necessary treatment may be provided to patients who lack decision-making capacity without obtaining the patient's informed consent. However, EPs should make every effort to learn the patient's previously stated preferences for treatment (e.g., written advance directive or communication with a primary care provider). Efforts should be made to obtain consent from a surrogate decision maker if prior preferences are not available. A surrogate decision maker is a person entrusted with making healthcare decisions because they know the patient best and can bring the patient's values and goals into the clinical decision process. This role can be challenging for even the most capable decision makers. It is not uncommon for surrogates to have a role conflict between applying their own values and/or wishes and those of the patient.

Emergency Physicians must pay attention to the language used when asking a surrogate decision maker for consent. Frame the discussion with phrases asking what the patient would want in the situation such as “How would your father view this situation?” or “What would your father's preference be based on his values?” Avoid general phrases such as “What should we do?”, “What do you want us to do?”, or “What do you think he would want?” If the decision seems to stem from a role conflict, an EP can ask the surrogate “Why do you think he would choose that?” No prior conversation covers every clinical scenario perfectly and the gravity of the decision can frequently be overwhelming for the surrogate.10

The choice of a surrogate decision maker may be quite obvious in some cases such as the parent or legal guardian of a child. The choice can be more complex in other cases. Who may serve as a surrogate and their scope of authority varies by state. What if the appropriate surrogate is in question and there is no statutory guidance? A useful guide is that the surrogate's authority arises from a close relationship to the patient that affords accurate and informed communication of the patient's values. Challenges in resolving conflict between potential surrogates (e.g., siblings with different opinions regarding parental care) should be referred to an ethics committee or other institutional mechanisms to offer guidance unless emergent conditions make that impractical.

Information Transmittal

The EP must relate sufficient information about the procedure to the patient. This raises the questions of what information to present and how much to present. Relevant information includes the risks and benefits of the procedure, any alternatives to the proposed course of action, and the consequences of nonaction. The question remains how much information needs to be disclosed to patients, particularly in light of the potential that legal action may be taken if an EP does not obtain informed consent properly.16

There are two standards that are commonly used, and these standards vary by state. The traditional “professional standard” requires the EP to provide information based on what the profession's standard of practice would deem necessary to disclose for a patient to be informed. The more common “reasonable person standard” requires the EP to include all the information that a reasonable patient would want to know in order to make a knowledgeable decision. Information that should be communicated includes: the patient's current medical condition and how will it progress if no treatment is given, the treatment alternatives, the risks and benefits of each potential treatment and their probabilities, and the financial costs of each if those estimates exist. Finally, the EP should provide a personal recommendation as to the best alternative.17

Understandable Presentation of Information

Information must be given in a way that is understandable. The patient must be able to adequately weigh the benefits, burdens, and risks of the treatment in the context of their own beliefs, life, values, and goals. The obvious differential in knowledge and understanding between patients and EPs may be exacerbated by language barriers, literacy, numeracy, and low educational levels.18 Such barriers may be overcome by: speaking at a level easy for the patient to comprehend, being sensitive to patients who may be unable to read, and being sensitive of patients who may not be highly educated. Understanding is bidirectional and necessitates that EPs confirm that the patient understands what they are told.19 Communicating numbers, such as risk and probabilities, is the most complex task asked of EPs.20 Frame numbers in multiple ways and present outcomes in both positive and negative contexts to enhance informed consent.20 For example, “3 out of 4 children have no side effect but one in four will have nightmares from this medication.”

Language barriers are frequent in the ED and pose significant concern in obtaining and documenting informed consent.21 Understanding languages is situational. Although some EPs may have additional language (non-English) proficiency, it is imperative to know when to call an interpreter. Limited language skills allow the EP to extract critical clinical information. Patients may need more information than the EP's skills allow. Calling an interpreter may be essential for meeting a minimum standard of care.22

Voluntary Nature of the Decision

Forced treatment where any real choice is removed from the patient being involved in the decision-making process violates the doctrine of informed consent. Any form of coercion based on threats or intolerable consequences, such as the withholding of pain medication, would fall into this category. Emergency Physicians cannot manipulate patient decisions by withholding or distorting information that the EP believes may sway the patient toward a preferred course. Persuasion is permissible, and it is an obligation as trained professionals to synthesize the information and recommend a course of action. An appropriate recommendation includes laying out the risks, benefits, and reasoning behind one's recommendation as well as explaining the reasoning for not selecting an alternate approach. Emergency Physicians can also utilize the resources of the patient's family or significant others to provide arguments in favor of a particular course of treatment. The EP must be careful to avoid overwhelming the patient as the goal should be a shared solution by consensus and not forcing the patient to surrender to the wants of others.23 Strategies to approach a patient's refusal are discussed in depth later in this chapter.

Effective Informed Consent and Refusal

There is a difference between the autonomous authorization informed consent (information and dialogue) and the effective informed consent (to meet legal and institutional requirements). The EP should document the discussion of the benefits, burdens, risks, and alternatives addressed in the discussion with the patient in order for an autonomous authorization to be recognized as effective and, thus, the entire informed consent valid. Local institutional policies should be referenced to confirm an effective informed consent or refusal.7

Some hospitals have patients sign “blanket” consent forms agreeing to all emergency tests and treatments on their registration in the ED. Such consent forms provide no information regarding specific individual procedures. These forms are not acceptable because they fail to respect patient autonomy. Blanket consent forms cannot substitute for the usual informed consent process for procedures in the ED, where a dialogue with the patient is required.24

The Emergency Exception

Society's overriding assumption is that a person would want lifesaving treatment in an emergency situation. Consent to treatment is generally presumed under specific emergency circumstances where intervention is necessary to save life or limb, the harm of nontreatment is greater than the harm of the intervention, a patient is unable to participate in care decisions, and patient preferences are not known with no surrogate available. This emergency exception is not absolute. This is particularly true when there is clear evidence that the patient's wishes are contrary to the intervention being considered, such as a prehospital advance directive or wallet card stating no blood transfusions.

Some EPs believe that any patient in the ED qualifies for an emergency exception by virtue of the fact that they are in the ED. This is not true. Location by itself can be used neither to justify the emergency exception nor to infer an “implied consent” for broad ED care. Rather, the emergency exception may be invoked only when the patient will be harmed by the delay necessary to obtain informed consent.25 EPs should ask themselves a few brief questions to determine if a patient meets the criteria for an emergency exception to informed consent (Table 1-5).

Therapeutic Privilege

The therapeutic privilege is a disfavored concept but recognized exception. It excuses EPs from the duty to disclose in the limited circumstances where disclosure might create harm to the patient and interrupt the treatment process. This privilege is rarely invoked as it could almost negate the entire informed consent process. Therapeutic privilege may be applied when direct disclosure to a patient would create harm, generally recognized as occurring in some psychiatric conditions and for some cultural groups.26

Waiver of Informed Consent

While EPs have a duty to disclose information, patients may differ in how they approach their participation in care decisions. Some patients may prefer that another person, such as a close family member, receive healthcare information and make treatment decisions on their behalf (delegated autonomy). This may be due to personal preference or cultural variation. The delegation of the decision making must be confirmed with the patient and not assumed based on cultural norms. The delegation reflects a patient's right to waive informed consent. Their choice to delegate that right to another person demonstrates an autonomous choice that should be honored.27

Some patients may interrupt the informed consent process after only partial information is disclosed and elect to follow the EP's recommendation. If the EP confirms the patient's acceptance of the consequences of consent with only partial information, the EP may accept this as consent via waiver of the informed consent process.25 The EP may accept a waiver of consent if, like other decisions, the patient has capacity, understands that they are giving up an important right, and has made the request voluntarily. Emergency Physicians who are uncomfortable with this responsibility may ask the patient to designate another person to assume this role.

Implied Consent

Implied consent is also a disfavored concept. It may be considered to “apply” in the very limited circumstances when an EP is undertaking a clinical activity with a well-known risk/benefit profile.28 The most favored implied consent example is when a patient extends his or her arm for a blood draw. The volitional act of extending the arm is deemed as implied consent to the blood draw and its risks (pain and possible bruising). The assumption of “implied consent” poses a dangerous trap for EPs, since what an EP considers routine and well-known risks may differ greatly from what the patient knows. This is particularly true in the ED where there is little trust and no knowledge of the patient's health literacy.

Emergency Medicine research shows at least 50% of patients wanted time spent on “detailed” information, including a review of the risks of only 1% chance of occurrence. For example, while lumbar punctures are clinically safe and pose little risk, patients perceive this as an invasive procedure that requires more information for informed consent.11 It is important to note that implied consent is not sufficient when informed consent is required or possible.10

Unrepresented Patients/Patient Alone

A patient who is unable to participate in care decisions and has no surrogate decision makers is known as the “unrepresented patient” or the “patient alone.” These highly vulnerable patients have no social networks to assist the care team in navigating consent and care decisions, and attention to clinical decision making for this patient population is growing.29 Statutory guidance on decision making for this patient population varies by region. Institutional policies should be reviewed to determine whether a policy exists for decision making for the “unrepresented patient.” In the absence of such a policy, consultation with the ethics service is recommended and efforts should be made to develop a consistent and transparent approach to care decisions for this vulnerable population.27

Emergency Physicians often begin with the presumption that patients possess decision-making capacity to both consent and refuse procedures. It is notable that in practice, EPs may question a patient's capacity more readily when they disagree with recommendations.

Understand the Reasons for Refusal

A refusal for recommended intervention should be the beginning of an important conversation with the patient. On first encounter, a refusal of a recommendation may seem a rebuff or potential time challenge. Approach a refusal with openness and curiosity. Help the patient not feel cornered into following the recommendation while confirming their informed refusal. A refusal is an opportunity to learn how to practice persuasive reasoning. During the barrage of information disclosure, a patient might have misheard numbers or the proposed procedure may resemble a prior negative experience. Take time to listen to the patient's concerns and reasons for refusal. This can help navigate the informed refusal process.

Confirm the Adequacy of Information with an Emphasis on Understandability

With the patient's reasons for refusal in mind, EPs should reflect these reasons back to the patient so that they feel they have been heard. It is important for EPs to acknowledge the patient's perspective, even if they disagree with the reasons. This allows the patient to engage in listening as the EP provides additional information to support the recommendation. Normalizing an “irrational concern” allows the patient to feel “OK” and still follow the EP's recommendation. For example, “I can understand that your sister's complication from procedural sedation several years ago would give you some concerns about this recommendation. And I want to reassure you that today we take these additional steps.…” Tailor the revised recommendation to address the concerns of the patient and focus on making sure that the information provided is simple, direct, and understandable.

Address Barriers to Understanding

Significant efforts should be undertaken to enhance the patient's ability to understand the information when a refusal occurs. A professional interpreter must be utilized to compensate for any communication barriers to the patient's understanding in an informed refusal process. The EP should revisit all the information from the initial discussion of information that occurred with an informal interpreter (e.g., family member or healthcare provider). Residual misinformation can prolong a patient's refusal. Starting from the beginning of the clinical communication, even if it takes more time, can often remedy the situation. Use language or pictures tailored to a patient's lower educational or functional level when necessary.19 Anxiety and pain may contribute as a barrier to understanding and should be addressed as quickly as possible.

Confirm Capacity to Refuse Recommendations

Is decision-making capacity a potential issue? The EP must take steps to mitigate any factors leading to impaired decision making so that the patient may participate in their care to the fullest extent possible.

In the past, it was thought that patients with certain diagnoses by default lacked decision-making capacity. Many clinicians now recognize that patients with severe mental illness, early dementia, and some organic brain syndromes are at risk for impaired decision making but may possess decision-making capacity for selected procedures and treatments.14 However, there are certain Red Flag scenarios when an EP should scrutinize a patient's decision-making capacity with greater depth (Table 1-6). Actions or decisions with greater consequences require a more intense evaluation of the patient's capacity. A more careful evaluation of capacity is indicated when the patient's choice seems unreasonable or if the patient is unwilling to discuss their thought process. Chronic psychiatric and neurologic conditions remain a risk for, but should not be equated with, impaired decision making. Cultural, educational, and language barriers certainly impact a patients' decision making. High levels of anxiety, whether from untreated pain or the inevitable stress of the ED, are known to impair decision making as well.30

Many providers outside the ED setting will utilize psychiatric consultations to assist with the evaluation of a patient's decision-making capacity. The utility of such a consultation in the ED is frequently limited by time and consultant availability. Consultations in the ED may prove useful when evaluating a thought or delusional disorder that may impede understanding.

Effective Authorization: Documentation of Informed Refusal

Honoring a refusal of emergency treatment that would be beneficial or may result in decompensation or death is never easy. Use of the standard hospital “Against Medical Advice” form can create an adversarial relationship that an EP may find damaging to future patient interactions and the subsequent treatment plan. However, anecdotal reports include cases where patients reconsidered their decision when presented with such a document. It is important to document refusal of care, not only for medicolegal protection but also to confirm that clear communication with the patient had occurred.

Documentation recommendations when a patient refuses treatment should include the following elements: the patient has refused the recommended procedure, test, or treatment; the patient's reasons for refusal; the consequences of the refusal were explained to the patient including the alternatives, if any, being offered or performed in lieu of the recommended procedure. Documentation should also include statements that show the patient understood and continued to refuse the specific procedure or treatment and has the capacity to do so. Document that the patient's wishes are being honored against medical advice. It would be preferable if the EP could have the patient read this documentation followed by the patient signing the medical record below this documentation in acknowledgment.

Additional documentation is required when an EP recognizes a “Red Flag” scenario for impaired decision making or has other reasons for concern (Table 1-7). These are essential items that must be documented in these cases. Document the patient's medical condition and the procedure or treatment that is suggested, including the urgency and necessity. Document the patient's current decision-making abilities with a description of the impediments to capacity and the actions taken by the provider to maximize capacity. Additional documentation should include the availability of family or other surrogate decision makers and any relevant discussions.

Documentation will vary by institution and local laws. Being familiar with the appropriate measures to make an informed consent or refusal is effective and is a critical part of the informed consent/refusal process in the ED.31