Controversies in Informed Consent

Emergency Situations

Medicine presumes that patients want life-sustaining treatment unless they have declared otherwise.^[20] As such, the requirement to obtain informed consent to the extent described previously is overridden by the exigencies of emergency care. Anesthesiologists should communicate as much information as the time and circumstances permit.

The confusion arises when treatment is needed but there is some evidence that the patient would prefer not to receive treatment. An important ethical distinction is whether the intervention is reversible. When it is reversible, such as an unconscious patient who arrives in the emergency room needing tracheal intubation and a relative claims that the patient does not want to be resuscitated (i.e., DNR order) but does not have the proper documentation, therapy should be instituted. When the preferences are clarified, therapy may be withdrawn if appropriate. When the intervention is irreversible, however, the ability to trade a slight burden for improved clarification and documentation of a patient's wishes does not exist. For example, consider the Jehovah's Witness who emergently needs blood and is unable to communicate his or her preferences for transfusion therapy. Giving blood to a Jehovah's Witness creates an irreversible contamination. Although emotionally unsettling, the legal and ethical consensus leans toward providing care in these circumstances, based on the idea that the refusal of potentially life-sustaining treatment must be based on an unambiguous declaration.

Refusing to Provide Care

Anesthesiologists may refuse to provide care when they ethically or morally disagree with the procedure or situation, such as the elective termination of pregnancy. Although physicians have an obligation to altruistically provide care, this requisite does not always oblige physicians to subjugate their morals. Moreover, society and medicine have a fundamental interest in preserving the moral fabric of individual physicians. Anesthesiologists should perform care that violates their consciences and possibly weakens their moral constitutions only in critical, presumably life-or-death, circumstances. Practically, an anesthesiologist who ethically or morally disagrees with a patient's choice will have difficulty in providing the care requested. In a nonemergent situation, such an anesthesiologist should withdraw from or refuse patient care. The anesthesiologist may then be obligated to make a reasonable effort to find a competent and willing replacement. In some cases, anesthesiologists may find the requirement to locate a willing colleague ethically objectionable.^[49]

Physicians may also ethically refuse to provide care if they believe the patient's choice is too inappropriate or likely to result in harm. Determining that an anesthetic choice is inappropriate is difficult and should not be invoked lightly or out of convenience. The patient's choice and the resultant risks must be sufficiently extreme as to, for example, elicit a similar response from at least several other anesthesiologists. Anesthesiologists also may refuse to provide care if they do not feel qualified to provide the needed care. Anesthesiologists may not refuse care when refusal is not based on an ethical or moral disagreement. For example, it is unethical for an anesthesiologist to refuse to care for patients based on race, gender, or disease status, such as patients infected with the human immunodeficiency virus.^[50]

Jehovah's Witness

Jehovah's Witnesses interpret biblical scripture to prohibit taking in blood because it holds the "life force," and anyone who partakes of it shall be "cut off" from eternal life after death.^{[51] [52] [53]} To fully honor this desire, anesthesiologists need to be experts in methods of optimizing oxygen-carrying capacity and limiting transfusion therapy.^{[54] [55] [56]} Jehovah's Witnesses have different interpretations about the prohibition of blood transfusions, and the clinician must actively clarify what the patient considers acceptable.

Wholly acceptable anesthetic techniques to reduce blood loss include deliberate hypotension, deliberate hypothermia, and hemodilution. Most Jehovah's Witnesses accept synthetic colloid solutions, dextran, erythropoietin, and preoperative iron supplementation. Some Jehovah's Witnesses accept autologous banked blood or cell-saver blood, and some accept blood removed at the beginning of surgery and returned in a closed loop. Jehovah's Witnesses colloquially refer to options that are a matter of individual choice as "matters of conscience." Although blood components, autologous blood, and banked blood are generally unacceptable, these specifics must be discussed with the patient. Documenting acceptable interventions crystallizes the patient's desires and provides legal documentation for the anesthesiologist. Anesthesiologists must be certain they are capable of fulfilling the patient's requests; otherwise, they should not agree to provide anesthesia. The anesthesiologist and surgeon should provide nonemergent care to the patient only if all parties can agree on the approach to blood management.

Case law strongly supports the right of the adult patient to refuse blood products.^[57] Case law is in flux for the pregnant patient who is pregnant, and in these cases, the courts are more likely to intervene and mandate transfusion. Ambiguity in legal rulings results from the fact that issues relating to transfusions of Jehovah's Witnesses are based on case law.

Confidentiality

Patients have privacy when they are physically and emotionally free from intrusion and they sanction the use

3180

Genetic Testing

Although anesthesiologists rarely interact with genetic information, the increasing role and sensitivity of genetic information mandates a basic understanding of issues relating to genetic information. Informed consent for genetic testing requires special consideration because it consists of uncertain, probabilistic information that may reclassify a patient and perhaps family from healthy to an irremediably at-risk status.^[59] Fear of loss of health insurance or job discrimination has led patients to avoid testing.^[60] Although more than one half of the states in the United States have statutes prohibiting insurance or job discrimination, these statutes provide incomplete protection because it is difficult to prove discrimination.^[61] A consensus statement suggests that consent for genetic testing should include the purpose of the test, practical aspects of the test, counseling to help patients anticipate possible results of the test, and help for the patient to understand the potential implications of having a predisposing gene present, not present, or of equivocal status. It should also discuss psychological implications, insurance risks, potential employment discrimination, options to redress these problems, and issues of confidentially. ^[59]

Pediatric Informed Consent

Patients, parents, other surrogate decision-makers, and physicians use the concepts of best interests, informed assent, and informed permission to guide decision-making about health care for minors^[62] ( Table 89-1 ). The best interests standard is used when the ability to apply self-determination is impossible, such as with an infant or a child with severe developmental delay. This inability therefore requires a surrogate decision-maker, usually a parent, to select the care that is in the child's best interests. The difficulties arise in determining who will make the decision and in the assumption that there is always one best choice. Parents who are present and capable of participating in the decision-making process are well suited to be the primary decision-makers for their children. This

TABLE 89-1 -- Elements of consent and assent as defined by the American Academy of Pediatrics, Committee on Bioethics

Consent

1. Adequate provision of information, including the nature of the ailment or condition; the nature of the proposed diagnostic steps or treatment and the probability of their success; the existence and nature of the risks involved; and the existence, potential benefits, and risks of recommended alternative treatments, including the choice of no treatment

2. Assessment of the patient's understanding of the previous information

3. Assessment, if only tacit, of the capacity of the patient or surrogate to make the necessary decisions

4. Assurance, insofar as it is possible, that the patient has the freedom to choose among the medical alternatives without coercion or manipulation

Assent

1. Helping the patient achieve a developmentally appropriate awareness of the nature of his or her condition

2. Telling the patient what he or she can expect with tests and treatment

3. Making a clinical assessment of the patient's understanding of the situation and the factors influencing how he or she is responding, including whether there is inappropriate pressure to accept testing or therapy

4. Soliciting an expression of the patient's willingness to accept the proposed care

Adapted from Informed consent, parental permission, and assent in pediatric practice. Committee on Bioethics, American Academy of Pediatrics. Pediatrics 95:314–317, 1995.

is in part because of society's respect for the concept of the family and the assumption that parents care greatly for their children. It is also reasonable to assume that the child will incorporate some of the parents' values as the child grows and matures, making the values of the parents a practical approximation of the future values of the child. For these reasons, parents have extensive leeway in determining what is in a child's best interests. By the same token, there is wide latitude of what constitutes acceptable decision-making in today's multicultural society, and it is often believed that there may not be one best choice, but several reasonable and good choices, depending on how the patient and family weigh benefits and burdens.

When a child becomes older, informed assent should be incorporated in the process. Informed assent acknowledges that although most pediatric patients cannot legally consent to medical care, pediatric patients should share in decision-making to the extent their development permits. The participation of children should increase as they grow older and depends on the patient's maturity and the consequences involved in the decision.

Pediatric caregivers are moving away from the concept of obtaining informed consent from the parent and are replacing it with the concept of informed permission. Informed permission has the same requirements as informed

3181

Anesthesiologists should attempt to achieve informed permission from the parent or surrogate and assent as appropriate from the pediatric patient ( Table 89-2 ). Because infants and young children have no decision-making capacity, assent is not a viable option, and anesthesiologists should obtain informed permission from the parent. School-age children are developing decision-making capacity, and anesthesiologists should seek informed permission from the parent and assent and participatory decision-making from the patient. Such situations may include whether to sedate a 6-year-old child before an inhalation induction, to use an inhalation or intravenous induction of anesthesia in an 8-year-old child, and to place an epidural for postoperative analgesia in a 12-year-old child. Some young adults and adolescents older than 14 years have developed a decision-making capacity, and anesthesiologists should try to fulfill the ethical requirements of consent while obtaining assent.

Confidentiality for adolescents is complex and involves balancing the patient's confidentiality with the parents' desire to know. The difficulty is that the possible loss of confidentiality may lead the adolescent to curtail or delay seeking medical care or to be less forthright about information, particularly when the care involves sexually transmitted infections, contraception, and mental health. ^{[63] [64] [65]} A number of professional statements and state laws support the right of adolescents to seek confidential medical care or the right of physicians to use discretion in notifying parents based on the increased decision-making capacity of adolescents and the public health implications of insufficient adolescent health care.^[66]

Resolving Disagreements in Pediatric Decision-Making

Parents and medical personnel may disagree about what is in the best interests of the child. One way to decide what is in the best interests of the child is to define what choices fall outside of the range of acceptable decision-making. The extent to which the physician intervenes between a patient and his surrogate's decision depends primarily on how harmful the decision is to the patient. Criteria to make this determination include the amount of harm to the child by the intervention or its absence, the likelihood of success, and the overall risk-to-benefit ratio. ^[67] The continuum between unacceptable and acceptable treatment is clear at the extremes but ambiguous in the middle. For example, although postoperative epidural pain therapy may be optimal, it is generally acceptable for the parents to choose to forgo regional analgesia and use parenteral analgesia. It is unacceptable, however, for the parents to refuse all forms of pain therapy. Although anesthesiologists must respect the diversity of values in society and the relationship between the parent and the child, decision-making that imperils the health of a child needs to be challenged. The anesthesiologist who believes the parents are choosing an unacceptable treatment should determine the basis of this judgment, address those specific concerns, and involve other caregivers to offer an assessment of the appropriateness of care and to engage the parent in discussion. ^[68] Charging parents with not acting in the child's best interests has significant social, fiscal, and familial ramifications. However, if the anesthesiologist believes the parents have chosen unacceptable treatment after exhausting other options, the anesthesiologist should report the situation to proper child welfare authorities for possible legal action.

This situation is more complicated when the minor expresses significant decision-making capacity and refuses a nonemergent procedure. Anesthesiologists should respect the right of pediatric patients not to assent to a procedure and should go out of their way to avoid coercing or forcibly making the child have the procedure. Achieving the patient's assent may necessitate further discussions with the patient, parents, and other providers, and such discussions may best take place away from the operating room. When the parents and child disagree, clinicians should seek the assistance of others experienced in conflict resolution to help resolve the dispute with a minimum of rancor.^[69]

Refusing Transfusion Therapy in Pediatric Patients

There are at least two distinct situations in which there may be a desire to refuse transfusion therapy in a pediatric patient. The first is when surrogate decision-makers, such as parents, wish to refuse blood on behalf of their child. This has presented itself most commonly in the care of the children of Jehovah's Witnesses. The courts have uniformly intervened to deny the ability to refuse transfusion therapy based on the legal doctrine of parents patriae, the obligation of the state to protect the interests of incompetent patients.^{[57] [70] [71] [72]} The second situation occurs when a minor, nearing the age of majority, requests to refuse transfusion therapy, such as in the case of a 17-year-old adolescent who has embraced the Jehovah's Witness religion.

3182

Obtaining informed permission and assent for the care of a child of a Jehovah's Witness should squarely address the transfusion issue. The patient and family should be informed that attempts will be made to limit the need to give a blood transfusion, and the anesthesiologist should clarify which interventions are acceptable.^[56] The family should know, however, that in a life-threatening situation, the anesthesiologist will seek a court order authorizing the administration of life-sustaining blood, except in the situation of a mature minor. Anesthesiologists should be familiar with the local mechanism (e.g., contacting hospital counsel) for obtaining a court order authorizing transfusion. When the likelihood of requiring blood is high or the local judiciary is not that familiar with case law for Jehovah's Witnesses, the anesthesiologist may choose to obtain the court order before the operation.

In elective procedures that may be safely delayed, the patient and family may also consider postponing the procedure until the child is of sufficient age and maturity to decide about transfusion therapy. The problem lies in whether the delay may increase the risk of harm or decrease the likelihood of a good outcome. This decision requires the same balancing as discussed previously in determining the best interests for a child. Questions that affect the decision include the quantitative change in risk or benefit, the quality of the risk or benefit, and the significance of it. For example, it may be easier to wait on a procedure that is purely cosmetic than to wait on a procedure that may lead to permanent injury and a shortened life.

Emancipated Minor Status and Mature Minor Doctrine

Some patients younger than 18 years have the legal right to consent to treatment.^{[73] [74]} The term emancipated minor refers to minors who have been given the global right to make their own health care decisions. This status varies by state but is generally awarded to patients who are married, parents, in the military, or economically independent, and it may include patients who are pregnant. The mature minor doctrine holds that minors who have decision-making capacity are legally and ethically capable of giving informed consent in specific situations as determined by a court. Although particulars vary, the mature minor doctrine in general requires patients to be at least 14 years old and tends to permit decisions of lesser risk. The nearer the child is to majority (usually 18 years old), the more likely the court is to grant the child the ability to consent.

The Pediatric Patient and Abortion (see Chapter 60 )

Even though pediatric patients who are pregnant may be considered emancipated, many states require some form of parental involvement such as parental consent or notification before an elective abortion in an adolescent. If a state requires parental involvement, the ability of the minor to circumvent this regulation by seeking relief from a judge, known as judicial bypass, must be available. Requirements and enforcement of statutes vary from state to state. The need for parental involvement in cases of minors having abortions is not always legally straight-forward, and it may be best to consult with hospital counsel in determining these issues. Although this is an area in which honorable people disagree, it is worth noting that the American Academy of Pediatrics and the American Medical Association (AMA) have issued statements affirming the rights of adolescents to confidentiality when contemplating an abortion.^{[75] [76]}

Maternal-Fetal Conflicts (see Chapter 58 )

The interests of women and fetuses usually converge, but when the interests of a woman and her fetus differ, there is the potential for conflict. Sometimes, for example, women refuse a recommended diagnostic or therapeutic procedure, such as cesarean delivery for fetal indications. As in any case of informed refusal, physicians should address any informational reasons the woman is refusing therapy, such as a lack of understanding or faulty knowledge. Beyond that, physicians may choose to respect the patient's autonomy and not proceed, to encourage the woman to seek health care from a different provider, or to seek judicial involvement.^[77] Physicians must realize the extraordinary social, physical, psychological, and spiritual costs of violating individual liberty.

Before seeking judicial involvement, physicians should keep in mind the fallibility and limitations of medical judgment and knowledge.^[77] Physicians should seek judicial involvement only when they are highly confident that nonintervention will cause harm to the fetus, that the recommended treatment will substantially reduce harm to the fetus, that the risks to the woman are relatively small, and that no comparably effective but less-intrusive option exists. Particularly relevant to anesthesiologists is the position of the American College of Obstetricians and Gynecologists on forced cesarean section. "Even in the presence of a court order authorizing intervention, the use of physical force against a resistant competent woman is not justified. The use of force will substantially increase the risk to the mother, thereby diminishing the ethical justification of such therapy."^[77]