Health Care Decision Making: Consent

A major shift in doctor–patient–family relations occurred in the last half of the twentieth century. Doctors now have less freedom to make paternalistic decisions about how to treat patients according to their own beliefs and feelings than they did in the 1950s. With a wider range of technical options, social trends emphasizing individual liberty and consumer preferences, and the weakening of traditional authority and trust in professionals, legal and moral arguments at the beginning of the twenty-first century emphasize patient/personal choice in directing medical decisions.

These trends have become embodied in the doctrine of informed consent. Backed by philosophical arguments concerning the importance of individual and family autonomy, ethicists, legal scholars, and judges have advanced the notion that patients or their valid surrogates have the right to or should, if they wish, determine which of the available medical alternatives to follow.

In most circumstances, minors are legally incompetent; that is, state statutes determine the age at which children become legally entitled to make binding decisions, including those about medical care. In general, children have limited legal rights to make medical decisions for themselves until age 18 years. As a consequence, like other legally incompetent patients, surrogates must authorize medical treatment for children. Usually, parents serve as the valid surrogates for their children. Moreover, informed consent, per se, has limited direct application in pediatrics. Valid consent requires adequate information and understanding, involves judgments about a proposed intervention, and reflects personal values bearing on the situation; thus consent can only be given by a patient with decisional capacity.⁶ Strictly speaking, parents or guardians give informed permission, a concept supported by the American Academy of Pediatrics.⁷

When parents or another surrogate provide informed permission for older children and adolescents, clinicians should seek the child’s assent when possible. By obtaining the child’s assent, clinicians empower children to the extent of their capacity and foster trust in and improve patient-physician relationships. According to the American Academy of Pediatrics, assent should include: “(1) Helping the patient achieve a developmentally appropriate awareness of the nature of his or her conditions; (2) telling the patient what he or she can expect with tests and treatment(s); (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); and (4) soliciting an expression of the patient’s willingness to accept the proposed care.”⁷ In certain situations, U.S. federal regulations require respecting the child’s wishes, such as in proposed participation of a minor in research that provides no substantive potential for individual benefit. In the clinical arena, when treatment refusal is not life-threatening, physicians should make an effort to understand the patient’s reasons for refusal and help him or her understand the consequences of such a decision.⁶

Certain legal and ethical exceptions exist where a “child” has decision-making authority for himself or herself. Almost all states have statutory provisions for children to obtain treatment for sexually transmitted diseases without parental or other surrogate consent. In many states, similar laws apply to children seeking contraception, care for pregnancy-related matters (sometimes including abortion), and mental health care, including care for substance abuse. Children may achieve legal status to make their own medical decisions when emancipated. Depending on the jurisdiction, emancipation may mean graduation from high school, joining the armed forces, living separately from and economically independent of parents, or being pregnant or being a parent. Thus under some circumstances a critically ill minor may be legally entitled to consent to or refuse treatment, even over and against parental wishes.

In addition to specific legislative rights for some children to consent for themselves, another legal notion may apply. Courts have used the theory of the “mature minor” in judging whether a child has the capacity and maturity to decide what is best for herself or himself. Such cases typically involve chronic or long-standing medical conditions where the minor has had an opportunity to observe the implications of the disorder; to experience the effects of the disease; and to reflect on the religious, moral, and factual matters relevant to medical decisions. Examples of such situations include adolescents with cystic fibrosis, end-stage renal disease, and muscular dystrophies. The mature minor doctrine allows that, in selected cases, the child may accept or decline life-sustaining treatment, such as dialysis, mechanical ventilation, and transplantation, with or without agreement from the family. Other situations might include those where long-standing and well-thought-out beliefs, such as those held by adolescent Jehovah’s Witnesses, would lead the child to refuse blood transfusions that otherwise might be essential for appropriate medical care. These cases require careful individual determinations about the actual capacities of the patient and the issues involved, and prudence may suggest judicial review. (This discussion does not imply that legal entitlement equals the best moral solution to dilemmas or disputes. However, the law recognizes that some children have legitimate independent claims regarding their medical care that may differ from the expressed wishes of their parents or guardians. This legal recognition suggests that, at times, professionals should support admittedly divisive stances that minor patients take.)

The right, in the law, of a “reasonable person” to accept or refuse offered medical treatment, however, involves some important qualifications. The legal reasonable person standard assumes a competent patient or surrogate. To make a valid choice, the patient or surrogate needs comprehensible information about the medical situation so that any choice reflects the range of alternatives and their consequences. Simply having the information does not suffice; the decision maker must actually exhibit an understanding of what he or she has learned. Finally, choices of individuals or surrogates should occur voluntarily, that is, free of any undue pressure, especially from health care providers.

Surrogate Decision Making: Parental Rights and Obligations

Theorists and courts have agreed that autonomous individuals can accept or reject medical treatment for almost any reason.¹⁵ Doctors have had to defer to adult patients’ whims, isolated false beliefs, and strongly held opinions about medical matters to satisfy society’s insistence on respecting individual liberty. (The need, in the end, to accept reluctantly that what a person believes to be an inappropriate course of action does not relieve the physician from the burden of trying to dissuade the patient from his or her view.) Parents and others with responsibility for surrogate decision making, however, must adhere to different standards. In the cases of individuals who have had an opportunity to express beliefs about desired or unwanted medical care, surrogates usually must use a standard known as “substituted judgment.” In these situations, surrogates attempt to decide what the particular patient would want under the specific circumstances based on their knowledge of the patient’s views. Written documents (such as “living wills”), oral discussions of particulars (such as the patient’s feelings about long-term mechanical ventilation after severe head injury), or a general understanding of the patient’s preferences and lifestyle all may form the basis of legally valid surrogate decisions.¹⁶ To the degree that young patients with sufficient decision-making capacity, such as adolescents with sickle cell disease at risk for cerebral vascular accident or those with muscular dystrophy at risk for cardiac or respiratory failure, have expressed views about possible treatments before becoming unable to express their wishes, the notion of substituted judgment also should prevail in pediatrics.

Far more commonly, however, substituted judgment makes no sense in pediatrics. It only can be a flight of the most fanciful imagination: just how might a toddler with a high spinal cord transection from a motor vehicle accident “think” about what he or she would want (death or a life on a ventilator)? Accordingly, most scholars in ethics and most courts have attempted to apply a different standard for making decisions for children, that of “best interests.” The standard enjoins the surrogate to take into account all relevant information about the patient’s condition and the alternative treatments (including, presumably, the resources available to obtain and maintain care) and decide, all things considered, on what course to follow.¹⁷

One term used by many persons, “quality of life,” has received considerable attention in these decisions. The phrase has been used to convey two substantially different concepts. Some persons reject quality-of-life considerations because they believe that parents, doctors, or others use it to make judgments about the social worth of the patient; that is, for some persons, quality of life implies something about the potential of the patient to contribute to the general social welfare (e.g., hold a job, pay taxes, or simply consume resources). Those who fear that social worth will equal quality of life strongly oppose taking quality-of-life evaluations into account in surrogate decisions. Most commentators mean something different. For them, quality-of-life considerations involve overall prognosis, including pain and/or suffering associated with the patient’s condition(s) and treatment(s); the practical likelihood of overcoming barriers to effective treatment, including the financial, social, and psychological resources available to the patient and family; and other nontechnical matters.

Aside from confusion about what meaning to assign to the phrase “quality of life,” it seems quite reasonable to weigh factors beyond simply what technical approaches can affect the child’s medical condition(s). Although fears about inappropriate discrimination against the handicapped have a legitimate basis, history raises at least equivalent, if not overriding, concerns about excessive and inhumane treatment, whether in obeisance to the technologic imperative or in pursuit of a vitalist belief.¹⁸ Examples include overzealous neonatal intensive life support in the face of increasing complications and parental objections, such as that detailed in The Long Dying of Baby Andrew,¹⁹ or the use of artificial hydration and nutrition over surrogate objection, which took place in the highly publicized Terri Schiavo legal battle.

Arriving at an adequate, practically useful definition of “best interest” has eluded the efforts of many in the pediatrics, social work, legal, and ethics communities. Without a clear notion of what constitutes the best interests of the child, it has been difficult to establish readily applicable limits on surrogate decision making. A lively debate continues about the acceptability of including “third party” or parent/family considerations in decisions for or about children, especially life-and-death decisions.

The difficulty for the pediatric intensivist lies in knowing when parental or other surrogate decisions fall outside some socially or morally adequate range. These difficulties involve medical uncertainty about diagnosis and prognosis, varying community standards regarding many different practices (especially the existence of state laws on religious exemptions from child abuse and neglect laws), and changing social attitudes about lifestyle. Concrete examples of these problems illustrate the dilemmas.

Consider a critically ill child with intestinal failure. During the past few years, several treatments have been offered to children with short bowel syndrome and some severe motility disorders who approach exhaustion of their options for total parenteral nutrition. Controversy exists about the effectiveness of enteral feeding,^20,21 operations for improving intestinal function,²² and small bowel transplantation.²³

For each of these approaches, we know little about the long-term outcomes. No one has attempted a straight-on comparative trial of these radically divergent treatment methods, in part because of strong beliefs about which intervention works best. Unfortunately, these convictions have little or no basis in scientifically valid research. Some intensivists caring for a patient with short bowel syndrome believe that because neither the surgical approach nor intensive medical treatment has proven long-term benefit, parents should remain free to accept or reject each intervention and accept palliative/hospice care. Others believe it necessary to challenge parental refusal in court.

Resolving such a dilemma requires consideration of the general question of how much physicians need to know about any therapy, especially of the therapies they recommend, before justifiably attempting to impose treatment, through judicial means, on reluctant patients and families. A helpful question might be the following: what would the doctor choose for her or his own family? A study of neonatologists, pediatric cardiologists, and pediatric cardiac surgeons noted considerable discrepancy between what the physicians recommended to parents of newborns with hypoplastic left heart syndrome (HLHS) and what they would want for their own child. A significantly greater proportion of the physicians accepted nonsurgery—and the inevitability of death—for themselves compared with what they recommended to families.²⁴

With regard to community standards of care, the majority of states have laws limiting the application of child abuse and neglect standards in cases in which parents invoked religious practices as the reason for delays in, or refusal of, medical care for their children. The manner in which religious exemption laws have been used, either in decisions not to intervene (i.e., order treatment or prosecute criminal cases when a child has been harmed) or as a primary defense in court, has varied greatly across jurisdictions. Most persons agree that parental religious beliefs should not prevent children from receiving clearly beneficial treatment that would permit the children to accept or reject their parents’ faith when the children become more mature.²⁵ The difficulty comes in deciding what conditions warrant intervention and what treatments confer obvious benefits.

Criminal prosecutions in California, Massachusetts, Arizona, Florida, and elsewhere remind the pediatric community that certain religious convictions, in these cases Christian Science convictions, favor prayer over antibiotics for meningitis, surgery for bowel obstruction, and other standard medical treatments.²⁶ Assuming timely diagnosis and intervention, deaths of children could have been prevented, and the likely medical outcome would have been excellent. Yet in some cases that may involve pediatric intensive care, the need for treatment and its benefits leave room for doubt.

Some pediatric cardiothoracic surgeons have taken on the challenge of correcting congenital heart defects by using cardiopulmonary bypass without supplemental blood. At the request of families who are Jehovah’s Witnesses, these surgeons agree to operate by using saline solution in the bypass circuitry. Documentation of their success has long been available in the peer-reviewed medical literature.²⁷ Witnesses believe that doctors can frequently provide adequate treatment without using the blood or blood products that their faith cannot accept. In other circumstances, pediatricians may request and receive court permission to treat sick children with blood transfusions when routine use of blood relies on tradition and not scientifically established need. For example, a child with an acute lung injury may receive packed red blood cells to maintain the hemoglobin above 10 mg/dL. Few data support a clear medical need for this intervention, and emerging data would refute the need for empiric transfusion.²⁸ In that and other circumstances involving the children of Jehovah’s Witnesses, clinicians ought to think twice before seeking court orders to perform blood transfusions.

Although understandable, psychosocial factors that lead physicians, anxious to protect their patients, to assert professional control do not constitute an ethical justification for action. In light of the importance of religious freedom in the history and political system of the United States, intensive care professionals should consider giving great deference to personal beliefs, especially in medically marginal or uncertain circumstances.

If there is debate about the proper role of parental religious views in determining medical care for children, we have utter confusion about the role of so-called third-party considerations, such as the impact of a child’s disease and treatment on the parents and other family members. Some authors have suggested that when substantial uncertainty exists about the benefits of treatment, when the burdens of treatment seem weighty (e.g., multiple operations, long-term hospitalization, or toxic drugs), or when the ability of the patient to experience human pleasures will be seriously compromised, parents can and should consider the impact of the child’s treatment on the family as a whole.²⁹ Such concerns might include temporal, fiscal, and psychological resources that the sick child will consume and that might otherwise be available to siblings or other dependents.

These matters can become quite confusing, as the following case suggests. A 6-month-old child was referred to a distant center for consideration of organ transplantation. The message to the family at the referring hospital had been heard by the parents as ambivalent; that is, the parents believed the doctors in their hometown were not entirely convinced of the value or likelihood of the success of transplantation. The transplantation physicians believed the child was an excellent candidate for the procedure and had a favorable prognosis (65% or better 1-year survival, at the time). The parents hesitated to accept treatment, stating that transplantation would mean that the mother’s recent reentry into her career would be derailed, that they did not want the (considerable) expense of chronic immunosuppressive medication, and that, all things considered, transplantation seemed more of a burden to the family than they thought they could tolerate.

The situation caused considerable distress among the staff at the referral center. Had the parents said, “No, thank you, we’d rather take the money we’ll have to spend on antirejection drugs and buy a sailboat,” the staff would not have hesitated to challenge their decision-making authority. However, the parents stated coherent and serious concerns. Given the nontrivial risk of complications and the actual burdens of treatment (e.g., lifelong immunosuppression with possible serious infection, malignancy, and toxic injury from medications), their refusal of the “standard of care” (not experimental treatment) seemed difficult to accept but sufficient to prevent an attempt to obtain court intervention. No doubt some other centers would have reacted differently.

With regard to unorthodox parental preferences concerning treatment, courts have not always acted to support mainstream physicians. In one older but still important New York State case, the “Matter of Hofbauer,” the courts supported the parents’ choice of a licensed physician who agreed to treat the child’s Hodgkin’s disease with “nutritional or metabolic therapy, including injections of Laetrile.”³⁰ The Court of Appeals of New York decided it could not and should not choose among treatments, each of which was supported by physicians legally practicing within the state. Following that view, parents only need to find a licensed practitioner to endorse their preferred approach to prevail in court. Doubtless the limits on parental or other surrogate decisions will continue to be debated by those concerned with pediatric ethics, laws, and medicine. For the time being, only a rough consensus exists that the best interests of the child should remain the guiding principle in most cases. When doctors and parents experience serious difficulty in defining or predicting what action will best serve the child’s interests, other considerations become more important. Other legitimate concerns include the family’s religious views or moral commitments, the family’s resources, and the ordinary and reasonable plans and projects of family members.³¹ Adherence only to narrow technical goals of treatment has little place in the provision of advanced pediatric intensive care.

Conscientious Objection to Participation in Proposed Interventions

The shift in medical authority from physicians to patients/family members has prompted some concern about loss of professionals’ moral agency. Some physicians, nurses, and others have responded by claiming a “right” to refuse participation in some proposed or offered medical interventions, calling this “conscientious objection” based on religious or other strongly held personal beliefs. Curlin and colleagues³² have articulated these concerns most clearly. Although many of the targeted practices concern reproduction, such as the provision of contraceptives or performing abortions, some interventions reach into the PICU, including offering nonsurgical palliative care for infants with hypoplastic left heart syndrome, procuring solid organs for transplantation after death declared by cardiac criteria, and use of palliative sedation at the end of life. In each of these situations some intensivists believe that participation violates their moral codes, and they invoke conscientious objection.

Some persons have pointed out problematic features of these claims of conscientious objection. Frader and Bosk³³ noted the historical development of professional codes and their link to social status and an ethic of dutiful subservience of the professional’s personal well-being to that of the patient’s best interests. In many contemporary claims of conscientious refusal to provide care, the professionals assert the importance of not participating in any aspect of the behavior they see as wrong, including discussing options with the patient or providing referrals to those who might engage in discussion or provide the service. Given the relative paucity of knowledge and skill patients possess, Frader and Bosk see this extended form of conscientious objection as abandoning the professionals’ responsibility to fulfill the ethical and legal responsibilities encompassed by the doctrine of informed consent.³³

May and Aulisio³⁴ note the importance of distinguishing between the formal complicity of acts, for example, taking the patient to die in the operating room to facilitate rapid removal of organs after death, and morally weaker material complicity in which one’s behavior may lead to the undesirable outcome. May and Aulisio suggest that one cannot avoid material complicity in a world with social interaction and that material complicity, although real, is not strong enough to avoid the basic professional duty of telling the family of a dying patient about the possibility of organ donation after cardiac death.³⁴

In controversial matters in which substantial numbers of professional colleagues and patients/family members consider a legally available option reasonable, such as nonoperative care of a child with HLHS, conscientious refusal appears to return to medical paternalism and may place undue burdens on patients and families to seek out professionals willing to talk about all the alternatives within the scope of standards of care.³⁵

Pediatric Intensive Care and “Experimentation”

Experimentation has two rather common meanings. In the first sense of the term, experimentation refers to research; that is, the scholarly pursuit of generalizable knowledge. Many children receiving intensive care become “subjects” of research when their care follows protocols designed to assess the value of some element of the treatment. Sometimes the research element of the child’s care is incidental, possibly even trivial, such as whether one brand of monitoring equipment speeds the jobs of the health care professionals more than another. To the extent that the research determines essential aspects of patient care and may affect outcome, however, doctors must approach such experimentation somewhat differently from their usual practice; that is, experimental treatments (or diagnostic procedures) require greater attention to parental authorization. As noted previously, children may receive treatment by court approval, over and against parental wishes, when the therapy constitutes the standard of care. By contrast, parents may, under regulations governing the use of federal research funds, refuse to enter children into research protocols and may withdraw their children from such projects at any time.³⁶

The other meaning of experimentation concerns the “use” of the patient for the learning and practice of trainees. When and under what circumstances the subjection of critically ill children to additional risk or discomfort related to education can be justified poses a number of difficult questions. First, the patients and their families represent a captive population. The majority of pediatric intensive care takes place in training institutions. Only rarely do parents have an opportunity to express a meaningful preference about which PICU should provide care for their child, given the relative scarcity of units, the relationship of any particular unit to other persons or facilities that parents have chosen (e.g., surgeon, oncologist, or hospital setting), and emergency situations in which legal, bureaucratic, triage, or other considerations leave little room for parental wishes. Unlike the wider “health care market,” parents have few substantive choices about their child’s ICU.

Second, training must occur. New generations of pediatricians, pediatric nurses, pediatric intensivists, and other specialists need to accrue experience so that they learn to care competently for subsequent critically ill children. Even with use of modern instructional aids, including realistic artificial models, animal laboratory experience, and intellectual preparation, the novice medical professional must perform her or his first intubation, central line placement, and other relatively risky procedures on actual patients.

The intensivist faces an uncomfortable dilemma: parental choice is severely constrained, yet the education must continue. Whether parental permission, even in the somewhat unlikely event of full disclosure and understanding, could be given freely can easily be questioned.

The institutions of medicine (i.e., the practitioners and the organizations that provide the care and the training) must do a better job of telling patients and surrogates that we continually need to teach people how to provide lifesaving care. Greater efforts at public education would at least help convince many persons of the long-term benefits of medical education. More importantly, the profession and the organizations need to promise and actually provide adequate supervision of trainee practice. It is one thing for a new ICU fellow to accomplish her or his first rapid sequence intubation in a trauma victim with a faculty mentor at her or his side, ready to advise or take over as needed, and quite another for the trainee to be thrown into the thick of the action with only telephone connection, if any, to an experienced consultant. The dual responsibilities of better education of patients and families and sufficient supervision need more attention from the intensive care community.

What should happen if parents know about and refuse involvement of trainees, despite realistic assurances of adequate supervision? Administrators may suggest holding fast to prevent the establishment of undesirable precedents. Although the worry is legitimate, one wonders if expending the time and energy involved in such a battle results in unreasonable delays in needed patient care, alienates the parties, and undermines the trust needed to facilitate treatment. Flexibility and interpersonal skill might accomplish more than rigid bureaucratic responses. Moreover, parental protest of this sort may reflect underlying anxiety about what is happening to their child or their role in whatever troubles have afflicted the patient. Direct inquiry regarding the parents’ fears and guilt may provide greater benefit for all concerned than a confrontation over the educational mission of the unit.

Finally, the matter of practice on insensate or (newly) dead patients deserves mention, if not resolution. In these situations, doctors legitimately claim that the patient or former patient cannot “appreciate” any harm, and substantial benefit may derive from such “harmless” practice. Two problems arise, however. First, in our society we generally hold that dying patients, permanently unconscious individuals, or even dead bodies have interests. Religious and secular laws specify, often in great detail, what constitutes dignified treatment of bodies. In addition, formerly competent individuals have the legal right to specify how they wish to be treated should they become incompetent or die (e.g., via living wills, donor cards, and declarations about funeral arrangements, such as the desire to be buried or cremated). Thus how one construes harm to the body may vary, depending on perspective, and there is no guarantee that the patient or family will see things in the same way as do the doctors. The second problem derives from the first. Because most people hold that former persons and bodies have interests, one needs to determine those interests and obtain permission for the proposed action (assuming a coincidence of interests). Most doctors and other health care professionals do not want to ask permission to use bodies for practice. They fear a premorbid request will trigger unwarranted concern that the physicians will not do everything possible to prevent death and that a postmortem request will only add to family grief, not to mention the guilt and discomfort of the staff. Although this discussion may seem abstract or even absurd, picture a scene in which a resident is attempting a difficult intubation on a recently dead patient and a parent unknowingly slips into the room or through the closed curtain. Without proper prior authorization, it seems likely the discovery would produce an unwelcome response.

References are available online at http://www.expertconsult.com.