INFORMED CONSENT
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
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.
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.3 The 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
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 |
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.
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
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.
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
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
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.
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 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.
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
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.”
ED DEPARTURE AGAINST MEDICAL ADVICE AND ED ELOPEMENT
Approximately 1.4 million patients left hospital EDs against medical advice in 2010, representing 1% of patients.22 Studies have documented poor outcomes in patients leaving against medical advice.23,24 Characteristics of patients who leave against medical advice include lack of insurance, male, younger age, alcohol or drug dependency, psychiatric illness, and low income.23,24 Patients often have serious complaints such as chest pain, abdominal pain, or trauma. Patients give many reasons for their desire to leave, including outside obligations such as family or pets, the wish for treatment at another hospital, concerns for cost of treatment, fear of recommended treatment, a desire for tobacco, drugs, or alcohol, narcotic requests, or improvement in the condition that prompted the ED visit.25
To proceed with an against-medical-advice discharge, assess the patient’s capacity, with special attention to barriers limiting capacity. Alcohol use and psychiatric diagnoses are not absolute barriers to discharge against medical advice, with the exception of suicidal and homicidal patients. Document the patient’s behavior that clearly demonstrates there was no impairment of capacity by intoxication or mental illness. Educate the patient about the risks associated with refusing to complete evaluation and/or treatment. Discuss the patient’s reasons for leaving, because these often present opportunities for negotiation and convincing the patient to continue care.9 Use plain language and avoid medical terms. Given the medical-legal and patient risks of against-medical-advice discharge, make a substantial effort to convince the patient to remain but do not resort to threats. Incorrect statements such as “insurance will not pay for this visit if you leave against medical advice” may further damage the patient–provider relationship and discourage the patient from returning.26,27 Model documentation of an against-medical-advice discharge should contain the following elements21,28:
Documentation of capacity (ideally with examples and examination clearly noted)
Discussion of the risks reviewed with the patient including what diagnoses were being considered
Explicit documentation in the chart that the patient was leaving against medical advice and what treatments, procedures, and courses of actions were refused by the patient
Offers made of alternative treatments or courses of action
Efforts to involve family, friends, or clergy in the decision
Explanation of any potentially problematic entries in the chart such as nursing notes or abnormal laboratory values—for example, if the patient has an elevated serum alcohol level, document that the patient is clinically sober and has capacity, if true
Patient’s signature on the against-medical-advice form, and if patient refuses to sign, document that fact
Documentation of treatment and follow-up provided
Documentation that the patient was told he or she is welcome to return at any time
While the most important part of documenting an against-medical-advice discharge is the discussion with the patient addressing the items above, having the patient sign an actual against-medical-advice form may help provide further liability protection in three ways: “1) it may terminate the providers legal duty to treat a patient; 2) creation of the affirmative defense of ‘assumption of risk’; and 3) the creation of a record of evidence of the patient’s refusal of care.”29
When a patient leaves against medical advice, reasonable treatment should be provided as appropriate for the patient’s medical condition and concordant with the patient’s wishes. For example, provide antibiotics for infection, aspirin for chest pain, or stabilization for fractures. Tell the patient to return at any time. Provide a listing of resources for close follow-up and instruct the patient on signs and symptoms to prompt a return visit to the ED should the patient change his or her mind.9,21
It is also important to document situations when a patient leaves against advice or before treatment is completed without informing ED staff. Out of sight should not equal out of mind. Attempt to locate the patient within the facility and then check logical destinations. Often a phone call to the patient’s home, cell phone, or emergency contact can provide an opportunity to encourage the patient to return to the ED. Document such communication attempts and their outcome.
The concepts of patient capacity and informed consent and refusal, their exceptions, and the moral obligations that underlie them should be integrated into daily ED practice.
ISSUES IN THE ED CARE OF MINORS
A minor is generally considered to be anyone less than 18 years of age, and parental consent is generally required for the treatment of minors. However, society and the legal system have determined that, in some circumstances, older children may be able to make many medical decisions independent of their parents.30 Exceptions to parental consent for minors include emergencies, the treatment of certain diseases and conditions that are in the best interest of the minor or society, minors emancipated under law, and circumstances in which the best interests of the child are not being addressed by parents. State laws regarding minor care vary widely; providers caring for minors should review state regulations and call on legal counsel as needed.
Minors often present to the ED without a parent or legal guardian in the care of an alternate caretaker such as a grandparent, school teacher, babysitter, camp counselor, or social worker.
In the United States under the Emergency Medical Treatment and Active Labor Act (EMTALA), EDs are legally obligated to evaluate all patients presenting with a medical condition and stabilize any emergency condition identified. There is no requirement for consent in this situation.31,32 Providers have latitude in defining an emergency medical condition (EMC), especially if there is a delay in obtaining consent. It is always best to try to find parents or legal guardians while emergency care is being provided. Document all such efforts. Once the emergency condition is stabilized, the need for appropriate parental informed consent applies.
When an adult family member, such as a grandparent or adult sibling, brings the minor to the ED and has granted consent, care should be given while efforts are made to contact the parent or guardian. In the case of preplanned parental absence, not all U.S. states require a signed note from the parent authorizing treatment. In some U.S. states, laws authorize relatives to consent to medical treatment for minors under their care. However, if the treatment proposed carries a substantial risk and is not emergent, contact the parents or guardian before proceeding. Providers may obtain parental consent by telephone. In cases where no appropriate party can be reached to give consent, particularly in the case of invasive procedures, it is recommended that, when possible, the provider document a second opinion agreeing with the need to perform the procedure on an emergent basis.
Minors who have become independent from the care and control of their parent or guardian are considered emancipated and may provide consent as adults. The definition of emancipation varies, and some states do not have specific emancipation statutes.33 Common situations in which minors may be considered emancipated include minors who are married, enlisted in the U.S. armed services, pregnant or parents themselves, declared emancipated by a court, or self-supporting and not living at home.
The mature minor exception states that if a minor is sufficiently mature to understand the nature and consequences of a proposed medical treatment, then the minor should be able to consent or refuse treatment without parental involvement. The mature minor exception is accepted under common law and, in some states, under specific legislation. Requirements for the mature minor exception are as follows: the child should generally be at least 14 or 15 years old; the treatment should be beneficial, not elective, and of low risk; and the minor must meet the requirements of informed consent. Given the subjectiveness of this standard, it is prudent to carefully consider each individual case before treating a minor under the mature minor doctrine.34
If a minor is considered capable of providing informed consent for a given issue, then he or she should be considered equally capable of refusing that same treatment.
All states allow minors to access testing and treatment for sexually transmitted diseases without parental consent. In most states, the minor must be at least 12 years old, but some states have a higher age requirement.35,36 In some states, testing and/or treatment for human immunodeficiency virus may not be included in the exception.
Many states allow minors to consent to prenatal care and pregnancy-related care. In states lacking such statutes, minors are often provided prenatal care under the mature minor doctrine, particularly if the state allows minors to consent to other reproductive services.35,36 About two-thirds of the states have laws allowing a minor to consent to treatment for their own child.37
Nearly all states allow minors to access treatment for alcohol or substance abuse. A majority of states have no specific laws regarding access of mental health services, and of those that do, the range of services that can be accessed varies.38
The evaluation and treatment of sexual or physical abuse without parental consent is generally permitted. In many instances, these patients may be treated under the emergency exemption, because minors who have suffered physical or sexual abuse require prompt treatment. However, assuming that the parents are not the alleged perpetrators, seek parental involvement as early as possible.
The minor consenting to the treatment is generally responsible for the cost of treatment. Once a minor is treated under one of these statutes, the minor should be afforded the same confidentiality as an adult. In some states, certain exceptions exist if the provider feels that it is in the minor’s best interest to have the parent notified. The Health Information Portability and Accountability Act of 1996 (HIPAA) Privacy Rule generally defers to state law or other applicable laws that expressly address a parent’s ability to obtain health information about a minor including when a parent agrees to a confidential relationship between the physician and the minor.39 The hospital bill may pose a potential risk for breach of confidentiality if charged to a parent’s insurance carrier.
Providers should seek the assent and cooperation of older or “mature” minors even when parents are granting permission for treatment. If the proposed treatment is nonemergent and the older minor refuses to give assent, the minor’s decision should be strongly considered.
In almost all cases, parents make decisions they believe to be in their child’s best interests. However, situations arise when the physician wishes to override or delay the decision making of the parent. For example, if the parent is intoxicated, carefully consider the parent’s capacity to give informed consent or refuse care for the minor child. If parents disagree with a treatment plan based on religious or moral reasons, the court or child protective agencies may intervene if the disputed intervention is lifesaving. The American Academy of Pediatrics opposes religious doctrines that recommend opposition to medical attention for sick children and states that children who need medical care to prevent substantial harm or suffering should receive that care.40
PRIVACY, CONFIDENTIALITY, AND REPORTING
The ideas of privacy and confidentiality are important elements of ethics, religion, and law because they affirm the dignity and value of the individual.41 Respect for these rights has been a cornerstone of medicine since ancient times. The Hippocratic Oath reads, “All that may come to my knowledge in the exercise of my profession … I will keep secret and will never reveal.” The American College of Emergency Physicians Code of Ethics states that emergency physicians should “Respect patient privacy and disclose confidential information only with consent of the patient or when required by an overriding duty such as the duty to protect others or to obey the law.”42 The privacy of one’s physical person and the privacy of one’s personal information (confidentiality)43 are considered together in this chapter. All states and the federal government have laws that govern privacy and confidentiality, including mandatory or voluntary reporting requirements that may override considerations of individual patient privacy and confidentiality.
ED barriers to privacy and confidentiality include ED physical design, operational issues, the presence of visitors, students, and other individuals, and video technology.
Design and operational issues that impact privacy and confidentiality include the triage area, frequent movement of patients between beds, open ED areas for documentation and work, and patient placement for close observation to minimize risk from falls or self-harm.41,43 In addition, the growing problems of ED crowding and boarding lead to the use of hallway beds and nontraditional bed spaces, which greatly reduce the ability of staff to provide optimum privacy and confidentiality to patients.44 ED staff should be vigilant when conducting interviews, teaching, or communicating to maximize patient privacy and confidentiality.
Students of various disciplines, law enforcement, and visitors should respect patient privacy and confidentiality.45 Requests from patients to exclude healthcare students from observation or care should be considered, based on the patient’s reasons for the request and the specific situation, but not guaranteed.41,45 Obtain verbal consent from patients for the presence of students who do not participate in care, and accept refusals.
Law enforcement officials may engage in the collection of evidence and the interviewing of witnesses to crimes in the ED. Except where required by law, patients should have the option of whether or not to speak with law enforcement, and patient information releases, not expressly required by law, require the patient’s consent.46 Visitors should generally be allowed (as space permits), with consent from the patient.41 Patients should be asked verbal permission for providers to discuss personal information in front of the visitor. In some cases, disclosure of certain diseases, such as human immunodeficiency virus, to a third party requires a written consent.47 Providers should always consider the nature and gravity of the information being related to a patient and should try to give serious or very personal results and diagnoses in private, even if previously given permission to discuss in front of a visitor.
Patients brought to the ED in the custody of law enforcement pose unique challenges. The safety of staff and patients must be balanced with the privacy and confidentiality rights of the individual. The American College of Emergency Physicians recommends providing unbiased, attentive, and complete care to these patients and communicating instructions appropriate to the medical condition to correctional or law enforcement staff as indicated while maximizing patient privacy.48
Photography and video performed for the purposes of evidence collection, quality assurance, and documentation may be acceptable under certain circumstances, but patients should give consent except where not required under the law.49 Photography and filming for educational and publication purposes always require patient consent. Images recorded for nonmedical or educational purposes without consent (especially with cell phones) are generally prohibited.50,51 Obtain any necessary permissions from hospital administration and learn and follow all applicable policies and state laws surrounding filming and photography of patients in all circumstances. Cell phones, tablets, and laptop computers with identifiable patient information should be physically secured and protected with a password program, and images should never be sent via unencrypted email.
HIPAA is the most important U.S. law that protects the healthcare privacy and confidentiality of individuals. This legislation required the establishment of standards for the security, exchange, and integrity of electronic health information, and set rules for basic national privacy standards and fair information practices for health care.
The U.S. Department of Health and Human Services produced the “Standards for Privacy of Individually Identifiable Health Information,” also called the Privacy Rule, in 2000. The rule has been amended several times with a major revision in January of 2013, commonly referred to as the Omnibus Final Rule.52 These rules establish the obligations of “covered entities.” Covered entities include “health plans, health care clearinghouses, and health care providers (broadly defined to include anyone who furnishes, bills, or is paid for health care in the normal course of business) and business associates of these entities, who transmit health information in electronic form when dealing with an individual’s health information.”53 Only those parts of the privacy rule most applicable to emergency providers will be covered here.
Under HIPAA, health information (often referred to as protected health information [PHI]) is “any information, including genetic information, whether oral or recorded in any form or medium that (1) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual.”53 HIPAA also applies when PHI is transmitted or maintained by a covered entity. The rule also discusses individually identifiable health information, including demographic data such as name, Social Security number, date of birth, and other identifiers that “identify the individual or for which there is a reasonable basis to believe can be used to identify the individual.”53
PHI should be shared with the clear understanding that only the minimum amount of information required to accomplish the purpose of the disclosure will be released. These “minimum” necessary standards do not apply to information that is given to patients themselves, used for treatment, or required by law.54 Covered entities should have procedures in place, including limitations on access to electronic medical records, to ensure that users are able to obtain only that information necessary to their job or business purpose.
HIPAA allows covered entities to use PHI, without authorization, for purposes of treatment, payment, and operations. Treatment is the provision, management, and coordination of health care and related services, including consultations and referrals.55 The payment exclusion allows a healthcare provider to use PHI to obtain payment or be reimbursed for the care provided to an individual.55 Operations include a number of activities, including, but not limited to, quality improvement, employee evaluation and credentialing, auditing programs, and business activity such as planning, development, management, and administration.55 An exception to this rule is that psychotherapy notes often require written consent for their use except for treatment, certain legal matters, and the protection of the public from a serious threat.56
There are 12 national priorities, as shown in Table 303-3,57,58 in addition to treatment, payment, and operations usage, for which covered entities are allowed to disclose PHI without authorization. These disclosures are permitted by the law and have specific conditions or limitations to balance the privacy of the individual and the public interest for the information.57
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Under the privacy rule, the risk of every possible incidental use or disclosure of PHI does not have to be eliminated.57 Provided the incidental disclosure or use occurs as the unintentional result of a legitimate use or disclosure of PHI, the entity has in place reasonable safeguards (as defined in the rule), and has applied the minimum necessary standard, there is likely to be no violation of the rule.59
The HIPAA regulations also require that a notice of privacy practices be given to all patients, informing them of their rights regarding their health information.60 Patients are asked to sign these documents and receive a copy of the notice.
These rights to PHI include access to records in the patient’s preferred format, request for amendments, request for additional restrictions, notice of PHI use, and an accounting of disclosures made from their PHI.61,62,63,64 In general, most of these functions will be handled by a hospital’s medical records department, but requests to amend records must be addressed by the provider promptly (60 days). If the request is denied, the patient has the right to place a written statement in the medical record disagreeing with the denial.61
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