1. Framing the Challenges: Clinical Scenarios

Little Mike is almost 7 months old and since birth his development has been normal - with one salient exception: he was born with an undescended testicle and spontaneous descent has not yet occurred. His pediatric urologist has recommended surgery, but his parents have adamantly refused this recommendation. What should the pediatric urologist do?

A woman in her 8 month of pregnancy has undergone ultrasound and hydronephrosis has been detected; she is referred to a pediatric urologist for consultation about a possible diagnosis of vesicoureteral reflux. To meet the criteria for valid decision making/informed consent or refusal, what should the pediatric urologist disclose to the mother about this condition and the options for treating it?

Fourteen year-old Andrew has been referred to the pediatric urologist for evaluation and treatment of enuresis. He is accompanied by his parents. In the course of the urologist's encounter with Andrew and his parents, the urologist begins to suspect that parental abuse-induced stress is the principal cause of Andrew's bedwetting. What should the urologist do?

2. The Historical, Legal, and Ethical Background

From a contemporary perspective, it is a curiosity of human history that, from time to time, children have been thought of, and treated as miniature adults. To say that such attitudes and behaviors betray an often tragic ignorance - particularly of the "facts" of human development - is an understatement. In every fundamental respect - including biology - children are decidedly different from their adult counterparts and, as such, need different approaches, particularly to the maintenance of health and the care and treatment of disease. And such differences at the bedside and in the clinic yield differences, as well, for clinical ethics.

Young children lack the cognitive capacity and the experience to engage in the decisional processes demanded by "informed consent or refusal" and other imperatives for ethically valid decision making. They cannot understand information about and evaluate the potential benefits and risks of alternative modes of treatment nor can they assess the impact of their choices, in the long term or on others. Thus, to invoke the language of principlism, it makes little sense to consider children as autonomous beings whose capacity for self-determination commands respect. Two qualifications of this line of argument are in short order, however. First, barring an organic condition that impairs the acquisition of the requisite cognitive capacity, children develop this capacity gradually and by degrees such that the degree of their involvement in clinical decision making should grow as their capacities advance. Second, children should be viewed as potentially autonomous beings; indeed, the obligation of the physician who cares for the young is to promote their healthy development – and thus their eventual realization of the autonomy that marks their progressive maturation as adults.

Health care decision making on behalf of children engages parents and clinicians in a collaborative process guided by the best interests of the child. Although often difficult to clarify and apply in any concrete set of circumstances, the best interests of the child are based upon a reasoned, evidence-based understanding of: the child's diagnosis, prognosis, and therapeutic options, analyzed in terms of the likely benefits, harms, and burdens of each option and placed within the context of the child's known history and open future. Determining the child's best interests requires a disciplined effort to set aside prejudices and bias, on the part of both clinicians and parents. This is not to say that either clinicians or parents have a minimal role to play in decision making. The interests and preferences of the parents (or parental surrogates) should be elicited, understood, and, in most circumstances, respected by clinicians; after all, parents are appropriately presumed to have the authority to speak, act, and choose on behalf of their children. At the same time, however, the important advocacy role of clinicians in caring for children should be recognized and appreciated - by themselves and by parents. Indeed, it is the duty of clinicians who care for children to help parents understand the likely consequences of the decisions they make on behalf of their children and to advocate for better decisions when parents wish to make choices that could cause harm to their children.

To what degree should children's preferences inform or shape the decisions made on their behalf by clinicians and parents? The answer to this question is dependent upon the specific context in which it arises. An infant or young child who fears vaccination may be soothed before and after the event, but that fear alone is not a sufficient reason to withhold a needed immunization, nor is discomfort with nebulizers a good cause for foregoing the needed dose of albuterol in a child with asthma. Indeed, these are not examples of grounded preferences, expressed by an individual with a stable sense of identity. As noted previously, however, the ability to express such preferences - and to form such an identity - grows with age, such that as one moves into the early to middle teen years, one's preferences, rightfully, command greater and greater degrees of respect. Indeed, even at earlier points on the developmental path - for example, in decision making on behalf of children of primary school age - age-appropriate information on diagnostic and therapeutic interventions should be communicated to a child and his or her assent to, or dissent from a recommended intervention should be elicited. Moreover, any strongly voiced dissent should be fully explored and considered. Assent and dissent are twin concepts used to indicate the range and significance of a minor's participation in health care decision making on his or behalf and are ethically and legally distinct from the parallel concepts of consent and refusal, which only a minor's parents (or rightful surrogates) have the authority to provide. Originating in the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, these concepts distinguish a child's agreement to (or disagreement with) treatment from legally valid consent (or refusal): only an adult with decision making capacity can consent to or refuse a recommended diagnostic or therapeutic intervention. The American Academic of Pediatrics recommends the following steps as integral to the process of eliciting a child's assent to or dissent from a recommended option for health care. The first step is to help the patient achieve a developmentally appropriate awareness of the nature of his condition. The second step is telling the patient what to expect, if the recommended intervention is implemented. The third step is to make a clinical assessment of the patient's understanding of the decisional circumstances and of the factors shaping his response. And the fourth and final step is soliciting some expression of the patient's willingness to accept the proposed diagnostic or therapeutic intervention. In summary, as general rules of thumb:

  • With infants and young children, parents are presumed to have the best interests of the children in mind and the power to authorize - or withhold authorization from - clinician-recommended interventions.
  • With children of primary school age (e.g., aged 5 or 6 to 11 or 12 years of age), parents and clinicians should encourage age-appropriate levels of participation in decision making, despite their lack of decision making capacity. Comprehensible information should be provided to children in this age range; their fears or concerns should be elicited, explored, and addressed; and their assent to or dissent from the recommended intervention should be sought. Although parents (or appropriate surrogates) retain the authority to consent to or refuse recommended treatment, a child in this age range should be accorded the opportunity to register her assent to the recommended therapy and, in the event that she objects to the recommendation, her dissent should be carefully considered by clinicians and parents. It is interesting to note, in this regard, that in 1976, an American Academy of Pediatrics Task Force on Pediatric Research, Informed Consent, and Medical Ethics recommended that "a reasonable safeguard for all physicians in all elective cases would be to get the written consent to surgery or treatment from any minor 13 years of age or older in addition to that of parent." Moreover, several Canadian provinces have enacted legislation that entitles children to make their own health care decisions and public policy in Great Britain is moving in this direction.
  • With adolescents, clinicians should engage in a more systematic process of determining a given adolescent's capacity for decision making, assessing his or her ability to understand and communicate information critical to the decision at hand; to think and make choices independently; to understand and evaluate the potential benefits, risks, and harms; and to identify and communicate the values at play in the decision at hand. As with children of primary school age, adolescents should have the opportunity to express their values and their preferences for treatment. As they gain in age and as their demonstrated capacity for decision making capacity grows, their assent to or dissent from treatment recommendations achieves greater and greater weight as well. There is some controversy over when this usually occurs - that is, when adolescents cross the threshold to respect for their preferences. Some have suggested that this threshold is reached, in general, around age 14 or 15.

Three categories of adolescent minors merit special consideration in this context. Mature minors are below the age of majority but they have, as just described, a demonstrated capacity for making the health care decisions at hand; in some jurisdictions, minors who show evidence of this capacity may be designated, more or less formally, as mature minors and accorded the highest degree of participation in health care decision making. Emancipated minors are, in general, adolescents whose life circumstances at least suggest that their capacity for decision making warrants greater respect. Such "life circumstances" include being married, living independently of parents, having financial responsibility for oneself, having children, or serving in the armed forces. Finally, statutory minors are designated as such by law (i.e., the laws of the different states), which specifies the health care services to which they can consent without parental involvement; such services usually include those involving the diagnosis and treatment of venereal or other contagious diseases, birth control or pregnancy, substance abuse, or outpatient mental health treatment.

3. The Ethics of Decision Making for Pediatric and Adolescent Patients: Consensus and Controversy

Although the preceding rules of thumb are supported by broad consensus among pediatricians, ethicists, and the public alike, the topic of this module is not free of controversy. Some of the controversies engage issues or questions that have been encountered in other modules: for example, how absolute should respect for the autonomy of the individual be? In this context, the question becomes should children, of any age, be treated as autonomous individuals capable of making their own choices? Or should the familial context in which children are usually raised - and the parents who preside in that context - prevail? In 1995, the American Academic of Pediatrics argued for an increased role for children in health care decision making but some critics of this proposal argued that parents should continue to have the greater say in decisions about pediatric care because parents have the responsibility for ensuring the pursuit and achievement of the family's developmental goals and these goals may compete or conflict with the goals of particular family members. In other words, the integrity of the family unit as a whole should outweigh the autonomy of a single member. Who has the authority and the responsibility for health care decision making is thus a question that can assume one of several forms.

Perhaps one of the more controversial topics is in the treatment and care of “intersex” children or more commonly referred to as children with Differences of Sex Development (DSD). The main issue surrounds whether urogenital surgery and gender assignment should be conducted early, at the time of diagnosis, or rather later when the patient is mature enough to understand the relative risks and any medical, social, emotional, sexual or reproductive outcomes of such surgeries. Whereas some stakeholders have advocated for a legislative moratorium on such surgeries, the Societies for Pediatric Urology and the American Urological Association believe that medical decision-making for children should remain the responsibility of parents and should be made as part of a shared and informed decision, after consulting with medical professionals and obtaining information from other reliable sources. In 2018, the American Medical Association’s Council on Ethical and Judicial Affairs (CEJA) concluded a two-year evaluation of this issue and recommended that physicians should “negotiate with parents/guardians a shared understanding of the patient’s medical and psychosocial needs and interests in the context of family relationships and resources” and “develop an individualized plan of care that will best serve the patient, basing treatment recommendations on the best available evidence and in general preferring alternatives that will not foreclose important future choices by the adolescent and adult the patient will become.” One-size-fits-all legislation that dictates – or negates – a particular course of treatment will not serve the diverse interests of patients or families faced with a decision about DSD.. Instead, each case should be managed individually based on the presenting medical condition, patient’s age, parent’s understanding of the various medical and surgical treatment options, including doing nothing, and ultimately a shared-decision making process.

Another related point of controversy in pediatric and adolescent decision making has to do with confidentiality, truth telling, and parental role. For example, should parents control information provided by clinicians to children in the context of specific treatment decisions or ongoing health care? Specifically, should parents have the authority to block a physician's disclosure of, for example, a diagnosis of terminal illness to a child? As previously argued, the physician's principal duty is to advocate for the child's best interests. If the physician concludes that providing - or withholding - information from a child is in the child's best interests, then the physician should respectfully state the case and, if necessary, use both persuasion and negotiation. In making such judgments, it is important that the physician take into account the child's capacities for understanding and communicating, the values and norms of the child's family, and the projected benefits and risks to the child of providing or withholding the information in question.

Another similar controversy often surrounds the question of whether clinicians should honor requests from children - and specifically, from adolescents - for confidentiality, for example, of the results of substance abuse or pregnancy testing. Some states have enacted parental notification laws that stipulate the circumstances under which disclosure to parents is mandated. Thus, it is important to be knowledgeable about the law in a given jurisdiction of practice. Here, too, however, in reasoning ethically about what to do in such situations, the physician should be guided by the adolescent's best interests. The practical difficulties of maintaining confidentiality should be fully explored, along with the potential harms and the perhaps unacknowledged benefits of disclosure to parents. Again, physicians should keep in mind that they are not caring for isolated, utterly self-sufficient individuals but rather for individuals whose growth and potential require careful nurturing, usually within the context of the family.

Refusals of recommended diagnostic and therapeutic interventions - by parents or children - are another area of some controversy. When the effectiveness of such interventions is limited or when such interventions impose significant burdens on the patient (or others), physicians should respect parental (or, in some cases, child) refusals and accord such refusals the decisive role in decision making. The more problematic situations are those in which the child has a life-threatening condition that can be effectively treated: for example, a child suffering trauma and need a blood transfused that is refused by his Jehovah's Witness parents. In deference to the Jehovah's Witness prohibition on receiving blood transfusions, parents of such a child may (and often do) refuse a recommended transfusion. Especially in the case of a younger child, however, it is arguably the physician's obligation to persuade the parents to permit the recommended life-saving therapy as being in the best interests of the child. In some jurisdictions, in fact, parents who refuse life-saving therapies for their children are liable to charges of neglect or abuse. If parents remain adamant in their refusal in such situations, it may be necessary to secure a court order to proceed with the blood transfusion or other recommended life-saving therapy. Perhaps the most difficult situations arise with serious illnesses for which there are effective interventions, but the interventions are burdensome as well. Here, refusals of treatment by either parents or child need to be carefully worked through and discussed and the option of seeking a court order in the face of a parental refusal should be weighed against the potential damage that litigation may do to the physician's relationship with parents and child.

4. Cases

The patient is four-months old and was born with ambiguous genitalia and testes; partial androgen insensitivity syndrome (PAIS) is the suspected cause. The patient's parents have been referred to your pediatric urological practice for further evaluation of, and a discussion of treatment options for their child. A well-educated couple, the parents indicate that they are aware that there is some controversy over the treatment of this and other "intersex" conditions and that they wish to consider, very carefully, the advantages and disadvantages of every treatment option, including the option of doing nothing for the time being. They have concerns, however, about gender identity and assignment, no matter what course they eventually choose to take.

Suggestions and recommendations for working through the case:

  1. Explain to the family that decision regarding treatment of “intersex” conditions is not a “one size fits all” decision and is best achieved through a multidisciplinary approach including but not limited to the patient, parents, pediatrician, pediatric urologist, endocrinologists, geneticists, psychiatrists and social workers.
  2. Conduct a search and analysis of the scholarly literature on the causes, evaluation, and treatment options for PAIS; identify and evaluate sources, in particular, of outcomes data on the treatment of PAIS.
  3. What are the recommendations of pediatric urological professionals for the treatment of PAIS and other "intersex" conditions?
  4. For patients and families affected by "intersex" conditions, one of the more prominent and best known advocacy organizations is the Intersex Society of North America. The Society's website can be found at: http://www.isna.org/. What is the Society's position on the treatment of "intersex" conditions?
  5. To their appointment with your pediatric urologic practice, the parents of the patient bring two articles on the ethical dimensions of the treatment of "intersex" conditions. One is by bioethicist Alice Dreger and is entitled "Ambiguous Sex or Ambivalent Medicine"; it can be found at: http://isna.org/articles/ambivalent_medicine . The other is by Milton Diamond and Keith Sigmundson and is entitled "Management of Intersexuality: Guidelines for Dealing with Individuals with Ambiguous Genitalia"; it can be found at http://www.ukia.co.uk/diamond/diaguide.htm . The parents ask you what you think about the critical analysis and therapeutic recommendations described in these articles and whether these recommendations are consistent with the profession's recommendations regarding the treatment approaches that are in the "best interests" of a child with an "intersex" condition.