Ethical Issues in Pediatric Neurosurgery
Although there is no one definition of the term ethics, in general it encompasses the various approaches to understanding and examining moral behavior.1 The study of ethics can be broadly classified into two areas: normative ethics and nonnormative ethics. Normative ethics seeks to answer the question “What ought I to do?” for a given moral dilemma, whereas nonnormative ethics simply describes how people reason and act in moral situations, without commenting on the inherent “rightness” of their actions. From Aristotle to Aquinas to Kant to Rawls, philosophers have for millennia written about morality and what constitutes ethical behavior.
The application of ethical principles to health care decision making, however, is a relatively young field. Variously described as bioethics, biomedical ethics, and medical humanities, among others, as a branch of normative ethics it seeks to define, analyze, and guide decision making in medicine as it relates to the moral issues that confront both health care providers, patients, and their families or surrogates. The formal, if somewhat cumbersome, definition of bioethics is “…the systematic study of the moral dimensions—including moral visions, decisions, conduct, and policies—of the life sciences and health care, employing a variety of ethical methodologies in an interdisciplinary setting.”2
The last three decades have seen tremendous growth in the field of biomedical ethics. Virtually all medical schools and many residency programs incorporate ethics teaching and/or training into their curricula.3–6 While the issue of whether one can teach “virtuous behavior” to a physician (or any other individual, for that matter) remains contentious, there is little doubt that the proliferation of ethics teaching has resulted in a heightened awareness of ethical issues and dilemmas in medicine.
There is perhaps no other specialty in medicine that is confronted with ethical issues and dilemmas on a daily basis more than pediatric neurologic surgery. On an ongoing basis, pediatric neurosurgeons make medical decisions regarding problems ranging from severe congenital nervous system malformations, to premature newborns, to quality-of-life and end-of-life issues that have profound ethical, spiritual, and religious consequences.
The purpose of this chapter is to trace the history and development of modern biomedical ethics, review the basic principles of ethics and ethical frameworks, and provide an overview of some of the more common ethical issues faced by pediatric neurosurgeons. In addition, specific issues commonly encountered in practice are analyzed in an attempt to provide pediatric neurosurgeons with the tools necessary to assist them in reaching decisions when confronted with difficult ethical situations.
A common misconception regarding bioethics and those who provide an ethics consultation service is that there is one “right” answer for a given moral or ethical dilemma. Those who have sought the opinion of ethicists may often complain that in the end they are not given enough direction as to the correct course of action; in essence, they are not given an “answer.” Often, the correct course of action is profoundly influenced by the experience, cultural background, priorities, and subjective desires of the individuals involved, as well as their perceptions of the importance of the issues at hand. Similarly, this chapter does not purport to have any one answer for all the ethical problems encountered in the practice of pediatric neurosurgery. We cannot be worse off, however, for having examined in a critical and thoughtful way, from our own personal standpoint, the difficult issues that confront our young patients and their families. In the end, this ongoing reflection may, and perhaps should, result in a continual re-evaluation of our own biases toward what “one ought to do.” A bioethical analysis resides in a middle ground between things that seem to be incontrovertibly factual and those that are entirely subjective.
6.1 History of Biomedical Ethics
The roots of bioethics date back to the fifth century BC, when Hippocrates, considered the greatest physician of his era, codified his understanding of how a physician should act into the Oath of Hippocrates. Medical students today still recite a modified version of the original oath upon graduation. The birth of modern-day bioethics occurred in the late 1940s, largely in response to the atrocities committed by Nazi physicians during the Second World War. The trial of Nazi doctors at Nuremberg, Germany, from 1946 to 1947 resulted in the formulation of the Nuremberg Code, which outlines a list of requirements for the ethical conduct of research on human subjects.7 The Nuremberg Code has been largely replaced by the World Medical Federation Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects, last revised in 2008.8
What is now recognized as the field of bioethics began to evolve in the 1960s in response to rapid changes in medical technology and therapies. Over the course of the last three or four decades, bioethics has staked a claim as a distinct discipline within the traditional health sciences. Many health care institutions now have clearly identified ethics departments, usually functioning as a consultative service to other clinical departments, in addition to existing hospital ethics committees and institutional review boards (IRBs) or research ethics boards (REBs). Clinical bioethicists come from varying backgrounds, including philosophy, medicine, nursing, and law. Although the field is relatively new, the questions it seeks to address are timeless: “They turn on the meaning of life and death, the bearing of pain and suffering, the right and power to control one’s life, and our common duties to each other.”2
6.2 Ethical Frameworks
In both the teaching of bioethics and the application of bioethics to clinical medicine, ethicists use a variety of ethical frameworks—specific lenses through which a particular ethical issue can be seen—to better outline the crux of the ethical matter at hand. Although not an exhaustive summary, the following paragraphs give a brief introduction to some of the more commonly used ethical frameworks. For those interested in further reading about the individual frameworks, more detailed information is available in the references cited.
6.2.1 Principlism
The term principlism refers to what are commonly known as the “four pillars” of modern bioethics as outlined by Beauchamp and Childress1: autonomy, nonmaleficence, beneficence, and justice. These principles are the most commonly taught concepts in bioethics in medical schools today and are summarized below.
Respect for Autonomy
Autonomy (derived from the Greek words for “self-rule”), simply put, respects the ability of competent persons to make informed decisions regarding their medical care. In the last 30 years, the concept of autonomy has superseded the tradition of beneficent paternalism, in which patients essentially trusted that their physicians would make appropriate decisions, both medically and ethically, on their behalf. Autonomy is at the core of the concept of informed consent, in that a person cannot make a truly autonomous decision without fully understanding the risks, benefits, and alternatives to the proposed therapy. Pediatric neurosurgeons deal with the difficulties associated with the concept of autonomy in that many of our patients, by virtue of their age, disease, and developmental status or because of statutory restrictions, do not have the ability to make decisions on their own. As such, we must rely on substitute decision makers—in most cases, their parents. A common criticism of Western bioethics is the perceived overemphasis on the principle of autonomy.
Nonmaleficence
Primum non nocere (“first do no harm”), based on Hippocratic principles, effectively summarizes the principle of nonmaleficence. Because virtually every intervention in medicine, especially in pediatric neurosurgery, carries with it the potential to do harm, it may be better to express the principle of nonmaleficence in terms of exposure to undue risk of harm or deliberate intent to harm. The principle of nonmaleficence and the importance of intent are often cited when withholding versus withdrawing treatment and killing versus letting die are contrasted.
Beneficence
Beneficence refers to the act of doing or producing good or performing acts of kindness and charity.9 In the context of medical interventions, the intent or hoped-for outcome of an intervention must have a reasonable chance of producing some benefit to the patient or, conversely, of preventing or lessening the harm coming to the patient from his or her disease.
Justice
Perhaps the most controversial of the four principles, justice is variously described as what is fair or deserved, or what one is entitled to. “Distributive” justice “…refers to fair, equitable, and appropriate distribution determined by justified norms that structure the terms of social cooperation.”1 The allocation of health care resources at all levels (micro, meso, and macro), rationing, and priority setting in health care institutions are all issues in which the principle of justice plays a key role.
Although beyond the scope of this chapter, the ongoing heated debate on health care reform in the United States centers on different interpretations of the definition of justice as it applies to the allocation of health care resources.
6.2.2 Utilitarianism and Consequentialism
Based on the theories of the 19th century philosophers Jeremy Bentham and John Stuart Mill, utilitarianism states that the moral worth of an action is determined by its consequences.10 Moral decisions should seek to maximize the good; that is, given choices, one should choose that action that results in the greatest good for the greatest number of people. This is known as the principle of utility.
Utilitarian arguments are often used when decisions are made regarding the allocation of scarce resources in health care, such as the funding of expensive new technologies and the distribution of donated organs for transplant. One of the major criticisms of utilitarianism is that in theory it allows the interests of the majority to override what may be legitimate claims or rights of the minority. A utilitarian might argue that in pediatric neurosurgery, a resource-intensive subspecialty, funds could be more effectively utilized by diverting them to better prenatal care. Utilitariansim is a form of consequentialism, an ethical theory holding that the morality of an act is determined entirely by the consequences of that act.
6.2.3 Duty-Based Frameworks and Kantianism
In direct contradiction to consequentialist or utilitarian theory is the duty-based or “deontological” theory of moral reasoning. The work of the 18th century Prussian philosopher Immanuel Kant, Critique of Pure Reason, is the basis of duty-based ethical frameworks, and this moral framework is more popularly known as Kantianism. Kant’s “categorical imperative” states that one “…should act only according to that maxim which you can at the same time will that it become a universal law.”11 Thus, the moral worth of an action is based on whether it conforms to this rule of obligation. These obligations or imperatives can be derived from pure reason and are not dependent, according to Kant, on culture, tradition, or emotion. As an example, for Kant, truth telling is always morally obligatory, as one cannot construe a maxim in which lying would be considered universally acceptable. A major criticism of duty-based or Kantian moral theory is that it offers no solutions when duties or obligations conflict.
6.2.4 Communitarian Ethics
In contrast to the largely rights-based, individualistic theories summarized above, communitarianism seeks to make moral decisions based on communal values, goals, and traditions rather than individual rights and takes issue with more liberal theories that allow individual rights to trump the good of the community. The central question of communitarianism is “What is most conducive to a good society?” rather than “Is it harmful or does it violate autonomy?”12
6.2.5 Ethics of Care
Similar to communitarianism, an ethics-of-care framework does not seek to conform to set rules or moral theories. It highlights the role of relationships in making decisions and considers the values encountered in intimate personal relationships, such as love, compassion, fidelity, and sympathy, to be the most important factors in making decisions.13,14 Thus, in making a decision about aggressive care for a severely neurologically impaired child, factors such as the relationship of the child with other siblings and the impact of the child’s illness on the entire family or community would be considered.
6.2.6 Casuistry
Casuistry is a branch of applied ethics based largely on the reasoning applied in common law. Rather than applying a particular ethical theory or framework to a given problem, casuistry looks at morality by examining cases. The correct course of action is determined by comparing the case at hand to “pure” or “paradigm” cases and determining if a similar course of action as taken in the paradigm case is warranted.15,16 For example, for end-of-life issues, the case of Karen Quinlan could serve as the paradigm case.17 Thus, morality stems from a social consensus as dictated by previous actions, rather than a set of rules or theories.
6.3 Ethical Issues
Some of the more commonly encountered ethical situations in pediatric neurosurgery are presented below, with illustrative cases and an accompanying discussion.
6.3.1 Quality of Life and Futility
The Cases of Baby K and Baby Jane Doe
Baby K was born with anencephaly. At the insistence of her mother, Baby K was intubated and ventilated after delivery. The recommendation for a “do not resuscitate” order was rejected by the mother, and eventually Baby K was weaned from the ventilator. After attempts to transfer the baby to another institution were unsuccessful, she was transferred to a nursing home. Episodes of respiratory distress and apnea resulted in multiple readmissions and an eventual tracheostomy. Despite a court-appointed guardian’s recommendation for palliative measures only, the courts ultimately decided that the hospital was obligated to provide emergency treatment for respiratory distress. Baby K eventually died of a cardiac arrest at 2 years of age.
In 1983, Baby Jane Doe was born with an open neural tube defect. After being advised by physicians of a high risk for mental retardation and physical handicap, the parents of Jane Doe decided against surgical repair, despite the surgeon‘s recommendation that surgery be done, and asked that their child be provided nutrition and comfort measures only.
One of the more controversial topics in bioethics over the past 25 years has been medical futility and, stemming from this, quality of life—specifically, the following questions: Is there a threshold quality of life below which life cannot be considered worth living, and if so, who makes this decision if the patient is unable to do so? The cases of Baby K and Baby Jane Doe illustrate these concepts.
Futility has been described as comprising four separate types18: physiologic futility (the intervention will not have its intended physiologic effect); imminent demise futility (the patient will die regardless of the intervention); lethal condition futility (the patient will die, no matter what the treatment); and qualitative futility (treatment is futile because quality of life is so poor). Others define futility as being either quantitative (in the last 100 cases, the proposed treatment has not been successful) or qualitative (the treatment prolongs life but simply preserves unconsciousness and dependence on intensive medical care).19 Despite these attempts at defining futility, the American Medical Association Council on Ethical and Judicial Affairs summed up the reality of the situation when it stated that “futility cannot be meaningfully defined” and that “denial of treatment should be justified by openly stated ethical principles and acceptable standards of care.”20 In the end, no one definition of futility may be adequate for every ethical situation.
In pediatric neurosurgery, decisions regarding futility can often place physicians in conflict with parents or guardians when parents either insist on treatment that a surgeon feels is futile or refuse treatment that the surgeon feels is indicated and in the child’s best interests. Appeals to ethical principles do not necessarily resolve the conflict easily, as ethical principles can often conflict, especially with strongly held religious beliefs. A strict appeal to autonomy might dictate respecting the wishes of the parents even if a surgeon feels strongly that continued aggressive treatment or cessation of treatment may violate the principle of nonmaleficence.
When such conflict exists, it is important that neurosurgeons exercise care before deciding on a particular course. We suggest that the following steps be followed, as outlined by Brody and Halevy: (1) Parents or guardians should be involved in the decision-making process early on; (2) second opinions should be sought early and should be seen as a means of helping in the decision-making process; (3) when the conflict seems insurmountable, transfer of care to another physician should be considered; and (4) where available, institutional ethics consultation or review should be utilized.18 In rare circumstances, when conflicts cannot be resolved, legal remedies through the courts may need to be sought.
Quality of Life and Myelomeningocele—The Groningen Protocol
Euthanasia and physician-assisted suicide have been legal in the Netherlands since 1985. In 2005, pediatricians at the University Medical Center in Groningen, the Netherlands, outlined a protocol for euthanasia in newborns, commonly known as the Groningen Protocol.21 This protocol allows the use of lethal injection in newborns, with consideration of the following five criteria: (1) extremely poor quality of life (suffering) in terms of functional disability, pain, discomfort, poor prognosis, and hopelessness; (2) predicted lack of self-sufficiency; (3) predicted inability to communicate; (4) expected hospital dependency; (5) long life expectancy. In addition, parents are required to fully agree, and a team of physicians, at least one of whom is not involved in the care of the patient, must agree. All cases of infant euthanasia are reviewed by a district attorney, and if the above criteria are not met, a physician may be prosecuted.
During a 7-year period from 1997 to 2004, 22 newborns were felt to meet the above criteria and hence received a lethal injection. Interestingly, all 22 of these infants were felt to have “severe spina bifida.” Not surprisingly, the publication of the Groningen Protocol resulted in considerable controversy and debate. In 2010, Barry published a rebuttal to the assumptions made in the Groningen Protocol, using both ethical and evidence-based principles to argue that “active nonvoluntary euthanasia in neonates born with a myelomeningocele (MMC) must be condemned as unethical.”22 Barry argued that available evidence suggests that overall quality of life for persons with MMC is equal to that of age-matched controls.23 The authors of the protocol argued that euthanasia is justified in infants for whom a life of intolerable suffering is expected. Barry rightly pointed out that there is no evidence that persons living with MMC live with a severe degree of pain and suffering.
The motivation of the authors of the Groningen Protocol was to save affected infants from a life of intolerable suffering and hopelessness—in essence arguing that death is a better outcome than life in these children. Although we agree that there may be circumstances, given extreme amounts of pain, suffering, and cognitive dysfunction, in which death may be a more favorable alternative to the continuation of pain and suffering, with no hope for an acceptable quality of life, it is rare that this is the case in children born with MMC.
The debate surrounding the Groningen Protocol speaks to ethical issues that may never be resolved: What is an acceptable quality of life? Is there a threshold below which life cannot be considered worth living, and if so, who decides?
Quality of Life for the Caregiver
Although one should always act in the best interest of the patient, there are occasions when a surgical intervention may benefit the caregiver more than the child. Neurosurgeons working in developing countries commonly encounter examples of severe hydrocephalus and extreme macrocephaly resulting in significant developmental delay. Surgical treatment in these cases may not alter the long-term neurologic outcome of the child but greatly eases the burdens on caregivers.
6.3.2 Informed Consent and Assent
John is a 16-year-old boy with Ewing sarcoma metastatic to the brain. In addition to the initial treatment of his paraspinal sarcoma, he has undergone a posterior fossa craniotomy to partially resect a dura-based cerebellopontine angle metastasis, followed by radiation and chemotherapy. He presents again with worsening headache and a recurrence of his cerebellopontine angle metastasis, as well as a second metastasis in the right temporal lobe. Repeated surgery followed by stereotactic radiosurgery for residual tumor is recommended as an option, but it is recognized by all that the prognosis is grim.24 His parents wish to proceed with further treatment.
The day before surgery, John asks to speak with you. He states that he knows that it is unlikely he will survive and that he doesn’t want any more surgery, but he doesn’t want to disappoint his parents. He says, “If it were up to me, I would refuse to have another operation.”
Parents and guardians have traditionally been considered substitute decision makers for their children when decisions related to health care are made. Many jurisdictions in North America have a statutory age of consent that may correspond to the age of majority in that jurisdiction. The evolution of the process of obtaining informed consent from a patient has paralleled the development of the ethical concept of autonomy; in essence, a competent patient must be fully informed of the risks, benefits, and alternatives to a proposed intervention in order to exercise his or her right to make autonomous decisions. Young patients may not, for the most part, have the capacity to fully understand the consequences of medical decision making and are not considered to be fully autonomous individuals. Given this, we ask their parents or guardians to act as surrogate decision makers.
The basis for surrogate decision making can vary, depending on the particular child and the age of the child. Substitute decision making or substituted judgment, the basis for most surrogate decisions in adults, seeks to determine what individuals would decide for themselves were they able to make the decision on their own. For young children, clearly it is difficult to infer what decision they would make had they the capacity to decide. As such, most surrogate decision making for children is done by using either the “best interests” standard or the “reasonable parent” standard.
The best interests standard allows guardians to balance the potential benefits of therapy with the risks of such treatment, taking into account the natural history of the disease process, treated or untreated. In contrast, the rational parent standard allows surrogates to make decisions based on their own values as parents, as long as they are reasonable.25 The “reasonableness” of a decision can often be a legal determination.
When parents, as proxy decision makers for their children, act in a way that seems counter to the best interests of their children, physicians are not obligated to follow parental direction. Commonly encountered examples occur when parents decline life-saving treatment for their children on religious grounds. A substantial body of jurisprudence supports medical decision making based on the best interests of the child, rather than on the wishes of the parents: “Parents may be free to become martyrs themselves. But it does not follow that they are free, in identical circumstances, to make martyrs of their children.”26 Clearly, surgeons should do all they can to make decisions in concert with families but are under no obligation, legally and morally, to provide or withhold treatment when they feel it to be in the best interests of young patients unable to provide consent themselves.
Although most children below the statutory age of consent do not have the legal authority to provide informed consent, it has become increasingly common to include children, especially adolescents, in the decision-making process. This has become popularly known as obtaining “assent” to treatment.27 In a 1995 paper, the American Academy of Pediatrics Committee on Bioethics recommended that the concept of informed consent should be altered to one of “informed permission” from parents, and that when appropriate, assent to treatment should be obtained from the child.28 Obtaining assent from a child includes informing the child, in an age-appropriate manner, of the nature of the illness; explaining the likely course of action, including testing and therapy; and assessing the child’s understanding of the situation and willingness to proceed (or refuse) the proposed treatment. In some legal jurisdictions, there is no legal age of consent for medical decision making, and it is left to the physician to decide if a child has the capacity to make medical decisions.
Clearly, the assent process is different for a 16-year-old than for a 9-year-old or a 4-year-old. There is evidence to suggest that the decision-making abilities of children as young as 14 are similar to those of adults in response to hypothetical medical dilemmas.29 As the preceding case illustrates, adolescents may be able to make informed decisions regarding their health care before reaching the age of consent. This can be especially difficult for caregivers when those preferences are to refuse treatment.
6.3.3 End-of-Life Issues
A 13-year-old girl with a left frontal glioblastoma multiforme has undergone two separate resections as well as adjuvant radiation and chemotherapy. She presents with acute left-sided weakness, severe headache, and a computed tomographic (CT) scan showing progression of disease with hemorrhage into tumor that has invaded her contralateral hemisphere. The patient, her family, and caregivers decide on palliative measures only. The child’s severe headache and nausea are treated with patient-controlled analgesia and antinauseants. After appropriate supports are put in place, the girl eventually dies comfortably at home, surrounded by family and friends.
The death of a patient is an event pediatric neurosurgeons face more frequently than many other physicians, whether it results from malignant neoplasms, trauma, or complex congenital neurologic disorders. Although there are no published data specific to pediatric neurosurgical patients, evidence in the pediatric critical care and pediatric oncology literature suggests that there are widespread deficiencies in the provision of pediatric palliative care.
Most consensus guidelines regarding end-of-life care see “no ethical distinction between withholding or withdrawal of life-sustaining treatment”30 and suggest that physicians should “aggressively treat pain with analgesic drugs and, when needed, with heavy sedation, even if these treatments hasten death.” The attitudes of pediatric neurosurgeons toward the withdrawal of life-sustaining care are not known, but in a survey of pediatric critical care physicians and nurses,31–34 none of the physicians surveyed felt that withholding or withdrawing life-sustaining care from dying children was unethical. Despite this, a survey of parents of children who had died of cancer showed that 89% of the children suffered “a lot” or “a great deal” in their last month of life, usually from pain, fatigue, or dyspnea.35 This suggests that a greater awareness of the suffering and subsequent treatment of the suffering of dying children are needed. Pediatric neurosurgeons should play a leading role in ensuring that our patients with terminal illnesses die with the dignity and comfort they deserve.
6.3.4 Research and Children
A study on the transmission of hepatitis B took place at the Willowbrook School (an institution for developmentally challenged children) in 1966. In the study, new residents at the school were intentionally infected with hepatitis in order to study transmission among residents. At the time of the study, hepatitis B was endemic in the institution, and most residents contracted the virus during their stay. It is unclear what parents were told about the process, and toward the end of the study, it was suggested that children whose parents agreed to allow them to participate were given preferential placement in the school.
The evolution of bioethics in the 20th century occurred largely in response to concerns related to human subjects research. The Nuremberg and Helsinki Codes came in response to Nazi atrocities in the Second World War,7 and many credit Henry Beecher’s courageous paper on ethics and clinical research,36 which detailed the Willowbrook study highlighted above, with starting the process of ethics review of human subjects research. Today, virtually every university and many hospitals have REBs or IRBs to review research protocols before they start. Many journals require REB or IRB approval as a prerequisite for publication.
Emanuel et al outlined seven requirements for the ethical conduct of human subjects research37:
The research must be of value—that is, it has the potential to enhance health or knowledge.
It must be conducted such that the results are scientifically valid and methodologically rigorous.
Study populations and sites are chosen in a fair way—not based on vulnerability or privilege.
There must be a favorable risk–benefit ratio, with risks minimized and the potential for benefit to individuals and knowledge gained by society outweighing risks.
The research should be reviewed by unaffiliated individuals with the power to approve, amend, or terminate the research.
Participants must provide voluntary informed consent.
Subjects should have their privacy respected and have the ability to withdrawal from the trial.
Clinical research using children requires an even higher standard than research using competent adults, given that children are an especially vulnerable population. Although six of the seven requirements outlined by Emanuel et al can be applied to pediatric research, many children, by virtue of their age or capacity, are unable to provide informed consent. Issues of informed consent and pediatric patients have been referred to earlier, but there are distinct differences between consent for medical care, which is presumed to be of benefit to the patient, and consent to participate in clinical research, which may offer only the prospect of benefit and the potential for the assumption of risk without benefit.
Children are considered a potentially vulnerable population in research ethics. Kipnis outlines seven vulnerabilities in pediatric research subjects that should be considered by all investigators38:
They commonly lack the capacity to make mature decisions.
They are subject to the authority of others.
They (and their parents) may be deferential in ways that can mask dissent.
Their rights and interests may be socially undervalued.
They may have acute medical conditions requiring immediate attention that make informed consent impractical.
They may have serious medical conditions that cannot be effectively treated.
They (and their parents) may lack access to social benefits such as health care.
Outside the context of clinical research, the concept of informed permission from surrogate decision makers has evolved for making decisions regarding medical treatment. Parental permission for pediatric research is increasingly being thought of as necessary but not sufficient for the ethical conduct of such research.39 In addition to informed permission, the assent of the child involved in the research should be sought, when possible.37 Obtaining assent recognizes and respects the developing autonomy of the child. Assent, however, should be seen as a continuum, based on the developmental level of the child, “ranging from mere affirmation in the youngest child, to the equivalent of the informed consent process in the mature adolescent.”40
Current federal regulations in the United States allow IRBs to approve pediatric research if it conforms to one of three categories41:
Studies that offer participating children a prospect of direct benefit
Studies that do not offer a prospect of direct benefit but pose only minimal risk
Studies that do not offer a prospect of direct benefit and pose a minor increase over minimal risk
Minimal risk is defined as risk for harm or discomfort “ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”42 Current debate centers on what constitutes a minimal risk or a minor increase over minimal risk, as these could be considered subjective. Much work continues and needs to be done regarding the ethics of clinical research in the pediatric population. In the end, a balance between the need for important clinical research in pediatric neurosurgery and the protection of potentially vulnerable research subjects must be found.
6.4 Surgical Innovation
Historically, novel surgical procedures have developed and been adopted into practice by a process of trial and error, with dissemination among peers through the publication of case reports and series and presentations at specialty meetings. Unlike novel pharmaceutical agents, which must undergo a rigorous process of regulatory review (which almost always involves randomized controlled trials), a new operation can be adopted without any regulatory oversight.
There is widespread acceptance that novel surgical therapies need to undergo a more rigorous validation process before they are adopted into practice by the broader surgical community.43 The use of arthroscopic surgery for osteoarthritis of the knee is an example of a procedure in wide use that has been shown to be no better than medical management when studied in a randomized controlled fashion.44
The ethical principles of beneficence and nonmaleficence underpin the argument for more rigorous evaluation of novel surgical procedures. Even the simplest surgical procedure carries with it the potential risk for harm. If that procedure has not been shown to have a corresponding potential for benefit outweighing the risk for harm, than it is unethical for it to be widely adopted.
In response to these concerns, a group of methodologists and surgical clinicians known as the Balliol Collaboration developed a series of recommendations for the evaluation of surgical innovation, now known as the IDEAL recommendations.45 These recommendations outline a five-step process consisting of the following:
An innovative idea (I), with a procedure done in selected patients and disseminated through case reports
Development (D), involving the planned use of a procedure in a small group of patients, by a selected number of surgeons to refine and modify techniques
Exploration (E), involving wider use of the procedure in more centers, with mentoring and the systematic capture of data, including adverse outcomes
Assessment (A), involving full evaluation of the novel procedure, ideally through a randomized controlled trial, and finally
Long-term study (L), allowing the capture of rare late complications and long-term outcomes. Of note, review by an IRB or an REB is required for steps 2, 3, and 4 and, depending on the nature of the innovation, may need to be sought for step 1.
Although started well before the IDEAL recommendations were published, the Management of Myelomeningocele Study (MOMS) is an excellent example of using rigorous methodology and practice to evaluate the efficacy of a procedure before its acceptance into practice.46 Initial results of the fetal repair of MMC showed promise. However, because of concerns about premature adoption of the procedure as an acceptable standard of care, a decision was made by the pediatric neurosurgery community to halt expansion of the procedure to other North American centers and organize a randomized controlled trial. Pediatric neurosurgeons across North America agreed that no further fetal repair would be done outside the three study centers until its efficacy could be proven.
6.4.1 Fetal Surgery
The emergence of fetal intervention in the last two decades as a therapeutic option for lethal and nonlethal conditions diagnosed before delivery requires consideration of overlapping ethical issues. Most important of all is the balance between maternal risk and the benefit to her unborn fetus. Putting aside the psychological well-being of a mother who feels that her child’s health has improved, the mother does not derive any direct physical benefit. The question remains whether the mother is able to provide a truly objective informed consent in this situation. This problem was approached in MOMS through multiple sessions in which providers allowed the mother to hear the risks and benefits repeatedly and from different perspectives. A final step was an evaluation of the mother’s understanding by a social worker who was not a member of the actual treatment team. Inability to understand the issues presented was sufficient grounds to warrant exclusion from the study.
Dickens and Cook provide an excellent overview of some of the ethical and legal issues in fetal surgery.47 These include controversial and as yet unresolved issues, such as whether a fetus has any inherent moral status, the potential conflict between maternal and fetal health, and whether the state should have any interest or say in fetal life.
6.5 Conclusion
Pediatric neurosurgeons encounter ethical and moral dilemmas frequently. An awareness of these issues and the ethical principles that surround them can help neurosurgeons to make decisions regarding the optimal treatment of our most vulnerable patients. This chapter has served as an introduction to the basic concepts of bioethics, with an emphasis on their application to pediatric neurosurgery.
Pearls
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