Informed Consent
Jennifer L. Reed
Richard M. Ruddy
Introduction
Every person has the right to be informed regarding their medical care and then consent to or dissent from the proposed treatments. A person’s age and mental capacity may impact on the degree of self-determination exercised in receiving medical care. In this chapter, the concept of informed consent is developed in relation to the pediatric emergency physician, the patient, and the parent or guardian. This chapter discusses the legal principles of informed consent and provides definitions of the concept of informed consent, minor consent, dissent, and leaving against medical advice. Specific informed consent issues relating to adolescents are discussed. The chapter concludes with some illustrative examples of common problems of informed consent in the pediatric emergency department (ED) and options for solution. References are provided for the reader seeking further in-depth discussion of informed consent.
Legal Principles
Consent for medical treatment is a fairly recent notion. As late as 1847, the American Medical Association Code of Ethics stated, “The obedience of a patient to the prescriptions of his physician should be prompt and implicit. He should never permit his own crude opinions as to their fitness to influence his attention to them” (1). In 1914, Justice Cardozo (Schloendorff v. New York Hospital made a statement that began the ideal of consent: “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.” Later came an interest not just in consent but also in its quality (1,2). In 1957, the case of Salvo v. Leland Stanford Jr. University Board of Trustees resulted in a legal decision that is believed to be the birth of informed consent. The court stated that it is the physician’s duty to disclose “any facts which are necessary to form the basis of intelligent consent by the patient to the proposed treatment” (1). This simply means that for consent to be valid, the patient must be given sufficient information to understand the nature of the treatment. This decision marked the beginning of the shift of medicolegal cases based on assault, battery, and tort law to ones based on negligence or malpractice (Table 9.1).
In the early 1970s, another shift occurred, characterized by an emphasis on the requirement that disclosure of information regarding medical therapy fit the patient’s needs. The 1972 Canterbury v. Spence decision stated that “the scope of the physician’s communication to the patient … must be measured by the patient’s need, and that need is the information material to the decision” (3). The American Medical Association endorsed this theory at that time, asserting that “the patient’s right of self-decision can be effectively exercised only if the patient possesses enough information to enable an intelligent choice” (3).
The concept of informed consent is somewhat more complex, and often imprecise, when applied to consent for minors. Two centuries ago, English common law held that the father’s right of custody of his children took precedence over the mother’s and all other’s (4). In colonial times, children had no constitutional rights, so parents had absolute control over them. This is known as “parental sovereignty” and is still widely applied by the courts today. In 1912, in the case of Luka v. Lowrie, the court decided that in an emergency any child may be treated without parental consent, which was a break from the traditional ideal of parental sovereignty (4). However, in 1933, in the case of Zuman v. Schultz, it was decided that non- emergency treatment of a child without the consent of a parent can give rise to assault and battery charges against the physician rendering care (4). This decision reinforced the ideal of parental control. In 1967, the Supreme Court ruled that a
child may be treated differently from an adult by a government entity (referring to a government-funded hospital) only if the difference accrues to the child’s benefit (4). This means that lack of consent should not keep a minor from receiving medical care equivalent to the care that would be given to an adult. This has been interpreted to include treatment at all medical facilities, not just at ones that are federally funded. In 1971, the voting age dropped from 21 to 18 years of age, and subsequently the age of majority in each state dropped to 18.
child may be treated differently from an adult by a government entity (referring to a government-funded hospital) only if the difference accrues to the child’s benefit (4). This means that lack of consent should not keep a minor from receiving medical care equivalent to the care that would be given to an adult. This has been interpreted to include treatment at all medical facilities, not just at ones that are federally funded. In 1971, the voting age dropped from 21 to 18 years of age, and subsequently the age of majority in each state dropped to 18.
TABLE 9.1 Legal Terminology | |
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Definitions of Informed Consent
According to Holder, informed consent is “the duty (of the physician) to warn a patient of the hazards, possible complications and expected and unexpected results of a proposed treatment” (4). Informed consent should contain the following five basic elements (5,6,7):
The patient and/or parent should be told the diagnosis and prognosis in lay terms.
The nature and purpose of the proposed treatment should be explained in detail.
The significant risks and consequences of the proposed treatment should be discussed. Significant risk is best interpreted to mean any consequent event of treatment with a high probability of occurring or with a devastating enough result that a person would want to know about it.
The probability and degree of success of the proposed treatment should be communicated.
All feasible alternative treatments and their benefits, risks, and success rates should be discussed.
The last four elements are referred to as the “reasonable patient standard” (6), which is the information that any reasonable patient and/or parent would need in order to make an informed decision about the treatment (Table 9.2).
The content of the communicated information can vary depending on the geographic location and the individual situation. Such variation results the existence of “local practice standards.” Recently the court system has shifted away from local to more national standards for informed consent (4). Given the “information highway” that exists, as well as the greater access to information that most people now have, this shift toward national standards is not surprising. The specifics of the information rendered should be adapted to the ability of the patient or parent to understand.
TABLE 9.2 Components of Informed Consent | |
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After discussing consent, the physician needs to ensure that these elements of informed consent are present: capacity, disclosure, comprehension, voluntariness, and consent or refusal (8). Each is important to document in the medical record, especially when consent is refused. Capacity is the patient’s or parent’s (or guardian’s) ability to understand the information and make a decision. The physician must assess whether the patient or parent understands the options for treatment, the consequences of the options, and the personal costs and benefits of the treatment (1,7). The physician must also ensure that there is sufficient disclosure of the information required to make an informed decision, including the purpose, risks, and benefits of the proposed treatment and alternatives to the treatment. The physician should consider the apparent level of intelligence of the patient or parent and his or her ability to express choice. Evidence of patient and parent comprehension should be communicated back to the physician by the patient or the parent. Lastly, the physician must be assured that the patient or parent is voluntarily making the decision without external coercion. The physician should also seek to understand the reasonableness of the choice that is made when obtaining consent. Strictly speaking, if the patient lacks the capacity to give consent, the physician must obtain consent from a third party. The physician should not allow the lack of consent to unduly affect the patient’s health.
In an emergency setting, other types of consent are important to understand for anyone providing care to children. Whenever a patient enters a hospital ED to be treated, he or she is asked to sign a general consent form (3). This usually involves signing the ED record and agreeing to evaluation and treatment. The giving of consent usually takes place at registration, and little or no information on medical care is exchanged before the form is signed. The general consent form should be thought of as a statement of willingness to be examined and have minor treatment done. It is not informed consent, and all significant interventions, unless immediately life saving, will require further consent by the patient or parent. In expressed consent, the patient or parent is aware of the proposed care, agrees to such, and in some manner demonstrates a willingness to proceed (3). This is common when the physician wants to obtain a blood sample and the parent approves of the test being done. An additional subtype is implied consent (2,5), which is consent implied by the actions of the patient but without specific agreement. An example is when a patient rolls up a sleeve to receive an injection. A
subtype of implied consent is implied parental consent. For example, parents send their child to the ED for care of a laceration, and phone approval is obtained. It is reasonable to infer that the parents would want the care to be definitive at that visit. Physicians may treat any minor seeking emergency care if they believe that any reasonable parent would agree to treatment. The legal term for this implied parental consent is “in loco parentis.” Deferred consent is consent after the fact. An example is treatment with epinephrine for severe bronchospasm given to an obtunded patient and getting consent after the patient has improved (3). There is legitimate debate as to whether this is informed consent or deferred assent to what already was done.
subtype of implied consent is implied parental consent. For example, parents send their child to the ED for care of a laceration, and phone approval is obtained. It is reasonable to infer that the parents would want the care to be definitive at that visit. Physicians may treat any minor seeking emergency care if they believe that any reasonable parent would agree to treatment. The legal term for this implied parental consent is “in loco parentis.” Deferred consent is consent after the fact. An example is treatment with epinephrine for severe bronchospasm given to an obtunded patient and getting consent after the patient has improved (3). There is legitimate debate as to whether this is informed consent or deferred assent to what already was done.
An important subtype of consent for an ED physician is emergency consent (3,5). The definition of an emergency is not uniform, but the term broadly applies to situations in which “immediate treatment is deemed necessary to prevent loss of life or permanent disability and the patient lacks the capacity to make independent decisions.” The physician is allowed and expected to act in the patient’s best interests. Most states have broadened this to include those conditions that require prompt treatment, such as alleviating pain, suturing, and fracture reduction (5). The physician does not have to be certain that harm will eventually result but only has to recognize that it is a reasonable possibility. The laws pertaining to emergency consent are deliberately broad to encourage treatment without fear of liability. States such as South Carolina, North Carolina, and Oklahoma require a second opinion if surgery is contemplated (5). Although a second opinion is not required by law elsewhere, if a short delay will not be critical, many institutions choose to obtain a second opinion.
In 1985, Congress passed the Emergency Medical Treatment and Active Labor Act (EMTALA). Passage of this act was in direct response to the patient “dumping” issue (9). Many private hospitals were refusing uninsured patients and sending them to public hospitals for economic reasons only. EMTALA applies to any hospital that receives federal funding. Since EMTALA is a federal law, it supersedes any state laws, including laws applying to minors. Under EMTALA, a medical screening exam (MSE) must be conducted on any patient (including a minor) regardless of the acuity of the complaint if that patient, or any person acting on the patient’s behalf (including another minor), requests that an MSE be done. Attempts should be made to contact the parent or guardian, but an MSE exam should not be delayed if the physician is unable to obtain consent. If the physician deems no emergency medical condition exists after an MSE exam is performed, then he or she should delay further treatment until consent is obtained from the parent or guardian. It is key to use the commonsense principle that an acute though not serious condition can be treated (based on the principle of implied consent). If an emergency condition exists, a physician must render treatment under the stabilization requirement of EMTALA or state law. EMTALA empowers a physician to examine, treat, stabilize (including by means of surgical intervention if emergently necessary), and transfer to an appropriate higher-level hospital without the consent of the parent or guardian (9).