Case Summary

As the neonatologist on service, you plan to speak with the family of a full-term infant. The infant was born to a 34-year-old woman via uncomplicated vaginal delivery and admitted to the NICU for further evaluation of ambiguous genitalia. After meeting with the infant’s parents, the father requests immediate medical and surgical intervention to make their “son look like the boy he’s supposed to be,” explaining that boys are more highly regarded in his culture. The mother remains silent.

Case Questions

• Who should make medical decisions for an infant and on what basis should he/she decide? • What if there is disagreement between parents or among family regarding the best course of action? • What are some ethical frameworks and perspectives to approach ethical conflicts in the NICU? • What is the difference between informed consent and informed parental permission? • What are the rights of an infant? The rights of the parent(s)? • What are the best interests of the infant? Who determines this? What about the interests of the parents and family? • What if the infant’s parents refuse a recommended treatment? • What if the infant’s parents request a medical intervention not offered by the physician? • What are some practical approaches to help resolve conflicts between an infant’s parents and the clinical providers?

Case Discussion

Who should make medical decisions for an infant?

Traditionally, parents are accorded the right to make decisions on behalf of their children. This notion of parental authority dates back as early as Ancient Rome when offspring were regarded as actual property or commodities that could be killed, traded or sold by the male head of the family or ‘paterfamilias,’ usually the father.1 Under Roman law, this power granted to the father was referred to as ‘Patria Potestas.’1 While societal norms have changed significantly, parental authority is still widely recognized today, and extends to medical decision-making as well.2-4 This right is now also balanced by parental responsibility, the obligation of parents to care for and support their children. Common justifications for parental authority include:

1) “Parents are responsible for bringing up their children, and that responsibility necessarily requires having rights for decision-making;

2) Apart from the children, parents will be the ones most likely to have to live with the consequences of any decisions made; 3) Parents know the child best; 4) Affection and close family ties make parents most likely to reach decisions based on the child’s best interest.”2 5) Children generally grow up to share many of their parents values.3

Parental authority is not absolute, however. While an adult with decisional capacity has the right to accept or refuse any offered medical treatment for him or herself, even if it results in harm or death, this does not extend to parental authority. In 1914, Justice Benjamin Cardozo (Schloendorff), found that a surgeon committed an assault when he removed a woman’s fibroid tumor without her informed consent.5 Cardozo wrote that:

“Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages. This is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained.”5

In contrast, this right (informed refusal of treatment, possibly resulting in harm or death) does not extend to parental authority. Parents do have the right to give informed parental permission for treatment for their children. However, parents generally do not have the right to refuse recommended medical treatment for their children that would “likely prevent significant harm, suffering, or death,” as stated by the AAP Committee on Bioethics.3,4,6 For instance, parents cannot refuse a live-saving treatment for their child, such as a transfusion or an antibiotic, because of a religious or cultural objection.6 The U.S. Supreme Court eloquently confirmed that, “Parents are free to become martyrs themselves. But it does not follow that they are free, in identical circumstances, to make martyrs of their children before they have reached the age of full and legal discretion when they can make that choice for themselves.”7

Certain groups of minors who have not yet reached the legal age of majority (18 years in most states, although this may vary) are recognized as ‘emancipated’ and accorded the right to make medical decisions and consent to or refuse treatment, just as competent adults, although this varies by state. Such minors may include those who are 1) married, 2) on active military duty, 3) self-supporting and not living at home, 4) pregnant, 5) parents or 6) declared to be emancipated by a court.8,9 It is important to recognize these rights, as well as potential limitations in certain situations, and attempt to optimize care. For example, it may be beneficial for teenage parents of a critically ill newborn to identify a trusted more senior family member or friend to help them understand, advocate, and guide them through difficult decisions together with the medical team.

Finally, in some cases, the biological parents may not be the appropriate decision-makers. For example, an infant may be in the custody of a relative, surrogate or adoptive parent(s), a court-appointed guardian, or the state. When caring for an infant, it is crucial to identify the appropriate legal decision-maker(s) to ensure appropriate and timely

communication and care. If the infant is the product of a surrogate or gestational carrier, a legal contract dictating who will be the decision-maker(s) for the infant will often be available. Information regarding decision-makers should be clearly documented in the medical record and communicated amongst the clinical team.10 When it is not immediately obvious who the appropriate legal guardian is, this should be discussed as soon as possible with hospital legal counsel.

What if there is disagreement between parents or among family regarding the best course of action?

Communication between all parties involved is key. Disagreements sometimes arise from misunderstanding or misinterpretation, which open communication and clarification can help resolve. Respectfully soliciting opinions, perspectives, values, questions and concerns from involved parents is a crucial first step when attempting to resolve disagreement. For example, a particular cultural perspective, piece of personal history, or misinterpretation could emerge that could help explain a particular view and resolve confusion. Encourage parents to discuss these issues openly and/or privately, if needed, to aid in mutual agreement or compromise. Persisting parental preferences should generally outweigh those of other family members, but the best interests of the child should remain paramount. The ethical frameworks outlined below may provide additional help.

What are some ethical frameworks and perspectives used to approach challenging ethical cases involving infants in the NICU?

The principle-based approach that has largely dominated modern medical ethics is a good place to start, yet should be deepened by complementary frameworks to adequately address such complex issues, including feminist ethics, ethics of care, virtue ethics, case- based ethics and narrative ethics.3,4,11

Principle-Based Ethics The four major ethical principles commonly invoked in ethical discussion and decision- making, championed by Beachamps and Childress are: 1) respect for autonomy, 2) beneficence, 3) nonmaleficence, and 4) justice.11 The principles, briefly summarized below, may be applied to the ethical dilemma at hand to help guide action.

Respect for Autonomy Literally, autonomy means ‘self-rule,’ derived from the Greek auto and nomos.3,4,11 Within a medical context, autonomy implies the ability of a person to make meaningful medical decisions for oneself, free from coercion, misinterpretation or other limiting factors.11 Respect for a person’s autonomy recognizes individual beliefs, opinions and perspectives, and allows an individual the freedom to make informed medical decisions regarding treatment or nontreatment. This principle forms the basis for informed consent, and is generally highly regarded in western cultures. Respect for autonomy, however, is not absolute and should be considered along with other ethical principles and perspectives.3,4,11 It is important to note that Respect for Autonomy is not relevant in the

NICU, as infants are inherently incapable of making a decision themselves, relying instead on parental authority, an important yet somewhat weaker right.

Beneficence This principle dictates that a physician is obligated to ‘do or produce’ good for the benefit of his or her patients, to promote their well-being.11 This includes protecting the rights of others and preventing harm, which overlaps with the principle of nonmaleficence. Beneficence may at times conflict with autonomy, such as when a competent decision- maker refuses a treatment that would clearly benefit him or her.2-4,11 Again, such conflict is irrelevant in the NICU as infants are not autonomous.

Nonmaleficence Nonmaleficence states that a physician is obligated to ‘do no harm’ (primum non nocere) willingly to his or her patients.3,4,11 In medicine, however, many treatments intended to do good must be weighed against their inherent potential harms.3,4,11

Justice The principle of justice broadly implies that equal persons ought to be treated equally. This concept can be applied at the individual level, at a community level, as well as the societal level, such as with resource allocation.11

Feminist Ethics A feminist ethics perspective approach allows for “consideration of a broader notion of autonomy”, which includes the relationships and “contexts in which women live, the difficulty they often have in accessing treatment services, and their endurance of systematic oppressions related to ethnicity, socioeconomics, and politics.”11-14 This consideration of relationships is important when making medical decisions with families. In addition, feminist ethics addresses the care of groups that have traditionally experienced oppression, domination and bias, such as women, minorities and children.11- 14

Virtue Ethics An approach utilizing virtue ethics in medicine emphasizes decision-making based on certain qualities or characteristics thought to be essential to a good person, such as truthfulness, fairness, integrity, temperance, compassion and fortitude.11 Virtue ethics asks, “What would a virtuous person do?” and action appropriately follows from this admittedly circular approach. In neonatology, physicians often seek to imitate an esteemed senior physician and mentor.

Ethic of Care Using an ethic of care approach, or care-based ethics, focuses on elements of decision- making that some feel have been historically neglected in medicine, such as compassion, care, love, and empathy.11-14

Case-based Ethics

A casuistic or case-based approach seeks to identify similar situations or cases and examine ethical approaches used, as well as relevant outcomes, that could provide further direction for the current case.11 Typically, a paradigm or precedent case is used to compare and contrast with the case at hand. Thorough knowledge of the details and nuances of both cases is essential. Thus, cases that closely resemble the paradigm case ought to be treated similarly.

Narrative Ethics This approach focuses on understanding the patient’s or family’s unique personal story or narrative to form the basis for ethical reflection and decision-making. Narrative ethics may also be useful as an informative teaching instrument when educating families or clinicians.

What is the difference between informed consent and informed parental permission?

As mentioned above, respect for autonomy forms the basis for informed consent, whereby fully informed, competent adults are accorded the right to voluntarily make medical decisions without coercion, including the right to refuse an unwanted therapy, even if this may result in serious harm or even death.3-5,9,13 Such decisions are made by the patient with adequate information and understanding of the treatment options, including nontreatment, and potential outcomes or consequences. Strictly speaking, one cannot give “informed consent” for another individual. When a patient is unable to given informed consent on his own behalf, a surrogate decision-maker provides informed permission. Parents typically fill the role of surrogate decision-makers for an infant patient and provide informed parental permission on his or her behalf.1,2,5

What are the rights of an infant? What are the rights of the parent(s)?

An infant has the right to treatment that has a reasonable chance of resulting in extension of life.3,4,11 As the AAP states, “All children are entitled to effective medical treatment that is likely to prevent serious harm, or suffering, or death.”6 However, at the same time, an infant has the right to mercy, to not experience unecessary suffering or pain from treatments that are unlikely to be beneficial.3,4 An infant also has the right to justice, including fair and equal treatment.3,4,11

The parents, as surrogate decision-makers, have the right to accurate and complete information necessary to make informed decisions on behalf of their children. They do not have the right to make decisions, however, that would clearly harm their child without significant benefit.3,4,11

What are the ‘best interests’ of the infant? Who determines this?

The best interests of the infant generally include life and optimal health, but in the face of illness may require a careful benefit/burden analysis with consideration and comparison of all relevant factors involved. In some instances, quality of life may perhaps outweigh quantity of life, depending on prognosis, harm of proposed therapy, and individual values

and judgments.3,4,11 As discussed, the best interests of the infant are generally determined by the parents or other appointed decision-maker, given the emotional and psychological bond parents typically share with their children, the responsibility parents have to raise their children as they see best, and the consequences of their decisions, which they must live with. Regardless of who is making this benefit/burden analysis, however, it is inevitably quite subjective.

Do the interests of others, such as parents or extended family, matter when making decisions for an infant?

A strict definition of a child’s best interests would take into account only the benefits and burdens of a proposed treatment as it pertains to the child. However, a broader definition recognizes others’ significant interests that may be involved, such as parents and siblings, and places the child in the context of immediate and extended family.3,4,11,15 For example, a mother may be weighing the benefits of continued aggressive life-sustaining treatment for her critically ill premature infant, including possible survival with severe neurologic impairment, with the psychological, physical and financial burdens of extensive chronic medical care and its impact on her husband and other children. Weight given to the best interests of the parents and family may be justified in some circumstances, as in the preceding example. However, there may be other situations when allotted weight may not be justified, perhaps if it is determined that the parents simply do not wish to care for a child who may be likely to have significant neurologic impairments. While it may be important to consider such other interests, the interests of the infant should remain paramount.3,4,11,15

What if the parents refuse a recommended treatment? Can the parents be forced to have their child undergo a medical therapy?

Parents may sometimes decide to pursue a treatment that a physician may not agree with or choose for her own child, but is still within the realm of acceptable treatment options. Families should be given wide discretion and such decisions should generally be respected.3,4

Rarely, however, parents may refuse a treatment recommended by the medical team, which will likely result in serious harm or death. As mentioned, an adult with decisional capacity has the right to accept or refuse any offered medical treatment, as Justice Cardozo affirmed in 1914 (Schloendorff), even if this means that harm could result.5 However, this right accorded to adults does not extend to individuals, even parents, making decisions on behalf of children. In general, all children have the right to “effective medical treatment that is likely to prevent serious harm, or suffering, or death.”6 Thus, if parents reach a decision that is clearly opposed to the child’s best interests, with likely significant negative consequences, the neonatologist and medical team should first engage in further conversation, time permitting, to understand their rationale and aid them in reaching an alternative decision that is mutually agreed upon. For example, it may be acceptable to defer vaccination, but not antibiotics for a confirmed blood-stream infection. If the parents persist in their decision, the medical

team should carefully consider overriding their decision, with court assistance if necessary and if time allows.3,4,11,16,17

What if the parents request an intervention not offered by the team?

The parental right to refuse therapy for their child in certain situations does not extend to the right to demand a therapy. All appropriate therapies should be offered to parents as indicated, as determined by currently available data and established standards of care, not simply by request. Possible justifications for refusing a parental request include: • Futility: the requested treatment cannot accomplish the desired goal. • Patient’s best interest: the burdens to the patient clearly outweigh the benefits. • Feasibility: the requested treatment is not available or is otherwise not possible. • Distributive justice: the treatment is a limited resource that has been allocated to another patient. Note that decisions regarding resource allocation should be made at an institutional level or higher, such as societal, but not at the level of the individual patient at the bedside. Reasons for denial of such requests should be clearly explained to families.17

What are some practical approaches to help resolve such conflicts?

The medical team involved should seek to provide a safe environment for discussion and open communication. Preserving a therapeutic relationship between the patient’s family and the medical team is paramount to maintain trust, provide optimal care and allow for continued conversation, which may result in realignment of goals and interests.

Recognizing physician limitations in their ability to prognosticate, a second opinion should be obtained if possible. Second opinions may be sought from colleagues at one’s own center and/or another institution. Ethics consultation from an ethics committee should also be sought, if time allows, in situations of moral distress, conflict resolution or ethical uncertainty”.3,4,18,19 When agreement has been unsuccessful, ethics consultations might help facilitate communication and ideally help achieve mutually agreeable decisions regarding treatment plans.16 “Neonatologists, staff and families should be aware of this potentially valuable resource” at their own institutions, know how to access it, and are encouraged to use it for such complex cases.18

Conclusion with Suggestions

Generally, an approach that utilizes a variety of ethical perspectives and frameworks, and promotes trust, respect and communication between the medical team and families, to optimize the care of the infant is recommended. Second opinions and ethics consultation should be sought, time permitting.

Acknowledgements

We would like to thank Dara Brodsky, MD, Sadath Sayeed, MD, JD, Christine Mitchell, RN, MS, MTS, Charlotte Harrison, JD, MPH, PhD, Judi Friedson, RN, MS and Judith Johnson, JD for their thoughtful reviews of this work.

References & Resources

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17. Merucrio M. The ethics of newborn resuscitation. Semin Perinatol. 2009 Dec;33(6):354-63. 18. American Academy of Pediatrics Committee on Bioethics. Institutional ethics committees. Pediatrics. 2001;101:205–209. (Reaffirmed Oct 2008). Mercurio MR. The role of a pediatric ethics committee in the newborn intensive care unit. J Perinatol. 2011;31(1):1-9