Baby Doe Regulations Research Articles

Federal regulations and neonatologists' views on care of seriously ill infants: changes over time.

The Baby Doe Regulations (BDR) regulate provision of life-sustaining treatment to seriously ill neonates. In 2020, the Trump administration expanded upon these through the Executive Order on Protecting Vulnerable Newborn and Infant Children (EO-PVNIC). Neonatologists were surveyed in 1988 to determine their opinions on the regulations. We sought to compare views of neonatologists from 1988 and 2021 in relation to three hypothetical cases and about the impact of the BDR and to evaluate perceptions of the EO-PVNIC. We modified and distributed the 1988 survey to members of the American Academy of Pediatrics Section on Neonatal Perinatal Medicine. We used Chi-squared tests to compare responses in 1988 to responses in 2021. We received 445 survey responses. Neonatologists today felt less compelled to provide aggressive care to the hypothetical patients, felt less constrained by the regulations, and were more likely to report that parental wishes would impact their actions. There have been shifts in neonatologists' perceptions of the Baby Doe Regulations toward less aggressive medical treatment for seriously ill neonates and more shared decision-making. Further research is required to identify how practices have been impacted over these decades. Neonatologists in the 1980s largely objected to the Baby Doe regulations, fearing the regulations would restrict their ability to provide optimal care to seriously ill neonates. Though still in place, current perceptions of these and newer regulations are unknown. Perspectives on the Baby Doe regulations have changed since their enactment and with the addition of newer, more restrictive regulations. Neonatologists today may favor less aggressive management in the face of poor prognosis. Neonatologists may also favor more shared decision-making now as compared to the past.

Educational Perspectives: Personal, Professional, and Practice—A Framework for Ethics Education

Health care professionals commonly encounter ethical issues in neonatology as part of their clinical practice. How they approach different situations that require ethical and legal consideration depends on the interaction among their personal values, their profession’s values and obligations, and the conduct of their profession’s practice as a whole. This relationship between the personal, the professional, and the practice provides a framework for learning about ethics and the law. In this article, this framework is used to present a sample curriculum on the Baby Doe regulations, which draws on several different educational strategies for teaching ethics.

If a Baby Doe Case Reached the Supreme Court Today: Legal Rights for Disabled and Premature Infants

This paper puts forth principles to solidify the theory that if a Baby Doe case were to appear before the Supreme Court today, the decision would indeed establish legal protections for disabled and very premature newborns. It begins by describing the early Baby Doe cases and subsequent enacted federal regulations, (often referred to as the “Baby Doe regulations”), and elucidate why the approach taken was truly a backwards approach, rather than a “rights-first approach”, the latter of which would successfully address the same problems it sought to solve, while being more acceptable by the legal and medical communities. Next, this paper analyzes the constitutional basis which exists for establishing legal protections for infants and an application of factors from prior disability cases. It explains the problem of the inaccurate use of the term “parental autonomy”, which would be rectified by instilling infant rights and applying an altered best interests approach. It then examines the states’ ability to uphold those rights and regulate parental choice. A tort theory basis is also provided to establish infant legal protections. The paper also explicitly distinguishes the sole case advanced as the best argument against newborn rights; affirms the importance of the massive Neonatal Intensive Care Unit (hereinafter, NICU), technology, and advancements in neonatal medicine since that case; and uses two actual and current NICU cases to do so. Lastly, the paper details additional dangers if infant rights are not legally protected.

The History of Ethical Decision Making in Neonatal Intensive Care

Neonatal ethics has focused on 2 questions: is withholding potentially live-saving treatment from neonates ethically justified? and if so, who has the authority to decide? This article details how these questions developed and provides a description of the possible answers. In the first section, we review a selection of seminal articles by noted authors in the fields of ethics, medicine, and law. The second section provides a detailed account of the development of the Baby Doe Regulations and the impact they had on neonatal ethics, with particular attention to the emergence of the Best Interest Standard as a guideline for decision making. In the last section, we review the landmark position statements by the American Academy of Pediatric (AAP), and the focus on evidence-based decision making. We conclude that forgoing life-saving treatment is ethically justified. However, this requires a rigorous evidence-based process and is limited by the Best Interest Standard. The second question is more difficult to answer, but we feel that in light of legal limitations, physicians acting as both the infant advocate and a proxy for the state, decide what falls in the range of acceptable treatment options, with the parents free to choose within that range.

The Legal Landscape at the Threshold of Viability for Extremely Premature Infants

One of the most difficult decisions that can confront a family is what medical treatment to seek for an extremely premature infant at the threshold of viability. The complexity of the treatment options, competing interests of healthcare providers and the family, consideration of the parents' values, and the sheer immensity of making decisions that affect such a new and fragile life all converge on parents when making such decisions. Overlying this are the legal context and the healthcare professionals and institutions that often may have more direct control and impact on those decisions than the parents. In the United States, the law since the so-called baby doe regulations has not provided much in the way of consistent guidance. Federal attempts to miciomanage the decision-making process and draw bright lines have largely failed. Conflicts between the competing interests sometimes end up in court, and the law is developing state by state with widely varying results. Parental consent to treatment of their infants is at the crux of these conflicts. Part I of this article discusses the evolving legal landscape of decision making for treatment of infants at the threshold of viability. Part II will address informed consent and the fundamental role nurses can play in creating a collaborative decision-making process that respects the best interests of tlie infant and the family.

The Legal Landscape at the Threshold of Viability for Extremely Premature Infants

This is the second of a 2-part article exploring the legal landscape overlying the difficult decisions that can confront a family with an extremely premature infant at the threshold of viability. In Part I, recent legal regulations and litigation were analyzed to show that the baby doe regulations are largely inert and that recent litigation arises out of state laws and regulations. Part II takes up the analysis to show that the common thread through all these conflicts, and the subsequent litigation, is a failure to obtain parental consent for the course of treatment at issue. The author argues that the central focus of all parties seeking to minimize legal risks in these situations must be on creating a transparent decision-making process that includes the parents from the onset. Nurses play a pivotal role in that process and are supported broadly by the professional guidelines of the American Nurses Association, the Association of Women's Health Obstetric and Neonatal Nurses, the National Association of Neonatal Nurses, the American Academy of Pediatrics, and the Principles of Family-Centered Neonatal Care.

Parents and Professionals in the NICU: Communication within the Context of Ethical Decision Making—An Integrative Review

Communication between parents and professionals in the NICU is a necessary part of collaborative decision making in the provision of family-centered care. Decisions with ethical components, those regarding treatment plans or neonatal research enrollment, need to be made conjointly with parents and health care professionals. This article reviews the present state of knowledge of how parents' input can be facilitated in regard to decisions made about their children. Research studies involving decisions made with ethical components in the NICU since the advent of the Baby Doe regulations reveal parents' frustration with communication practices, their need for control of information, and the trust in their children's health care providers that is required to best facilitate their input into ethical decisions made about their children.

The Legal Landscape at the Threshold of Viability for Extremely Premature Infants

One of the most difficult decisions that can confront a family is what medical treatment to seek for an extremely premature infant at the threshold of viability. The complexity of the treatment options, competing interests of healthcare providers and the family, consideration of the parents' values, and the sheer immensity of making decisions that affect such a new and fragile life all converge on parents when making such decisions. Overlying this are the legal context and the healthcare professionals and institutions that often may have more direct control and impact on those decisions than the parents. In the United States, the law since the so-called baby doe regulations has not provided much in the way of consistent guidance. Federal attempts to micromanage the decision-making process and draw bright lines have largely failed. Conflicts between the competing interests sometimes end up in court, and the law is developing state by state with widely varying results. Parental consent to treatment of their infants is at the crux of these conflicts. Part I of this article discusses the evolving legal landscape of decision making for treatment of infants at the threshold of viability. Part II will address informed consent and the fundamental role nurses can play in creating a collaborative decision-making process that respects the best interests of the infant and the family.

FUTILE CARE AND THE NEONATE

The concept of futile care is controversial and difficult to define. Efforts to prolong life, once considered an outcome of healing, may now be viewed by some as harmful acts of prolonging suffering. This article reviews a number of cases representing this challenging ethical dilemma, such as Baby K and MacDonald v. Milleville. The Baby Doe regulations, the Emergency Medical Treatment and Labor Act (EMTALA), and the Born-Alive Protection Act of 2001, also are discussed to provide an improved understanding of the legal framework that impacts ethical decision making. Nurses at the bedside must be equipped with the ethical knowledge and communication skills necessary to care for patients and families facing the ethical dilemma of futile care. An increased focus on neonatal palliative care is suggested to provide infants, families, and staff with the necessary tools to work through this painful process.

Futility considerations in the neonatal intensive care unit

The purpose of this article is to summarize and comment on the history of medical decision making in the neonatal intensive care nursery, emphasizing considerations of futility. Several epochs will be described, with shifting roles of health care providers, the infant's family, and proxies for society at large. Futility has been an issue in the intensive care of newborn infants throughout the last 35 years. Long before the Baby Doe regulations and the formation of ethics committees, neonatologists tried to determine which care measures were indicated. Given the frequency of severe malformations, birth asphyxia, and extreme prematurity, it has been a common event for the responsible physician to ask himself: will this treatment be beneficial or merely futile? As the therapeutic armamentarium became more powerful and complex, the choices from among a possible array of interventions became increasingly difficult. The autonomy of parents as decision makers was increasingly affirmed. In the 1980s, the federal government, the courts, and frequent malpractice suits set boundaries on medical decision making. In the 1990s, third party payors became increasingly assertive in limiting resource expenditure. These legal and societal mandates are frequently at variance with one another. Thus the issue of medical futility, as it applies to neonates in the United States, must be considered unresolved.

At Law: Baby Ryan and Virtual Futility

Perhaps someday the courts will accept a definition of that will establish when further care is inappropriate and tell physicians, patients, and their families who has the authority to discontinue such care. Yet, for the third time in recent years, a high-visibility case about futility has failed to produce a definitive legal ruling. Instead, the case provided a new twist on the so-called Baby Doe regulations promulgated during the Reagan administration. A Tale of Two Cities Ryan Nguyen (pronounced Win) was born six weeks premature on 27 October 1994, asphyxiated and with barely a heartbeat. His physicians at Sacred Heart Hospital in Spokane, Washington, soon diagnosed severe medical problems including brain damage, an intestinal blockage, and kidneys that produced water but did not remove toxins from his system. After several weeks of sustaining Ryan through intravenous feedings and dialysis, the physicians concluded that he was almost certain to die even if he could be kept on dialysis for two years and then given a kidney transplant. Unable to provide such services, they consulted the kidney specialists at the Children's Hospital and Medical Center in Seattle. This program was unwilling to treat Ryan because, in the words of University of Washington professor Ellis D. Avner, dialysis would not only be inappropriate but would be immoral since it would prolong agony with likelihood of a good outcome. But Nghia and Darla Nguyen refused to accept the recommendation that their son be allowed to die. When they met with Ryan's physicians on 17 November they came armed with the name of another physician, at the Oregon Health Sciences University, from whom they wanted a second opinion. Four days later, the Sacred Heart neonatologist had a phone conversation with Mr. Nguyen about the report they had body received from Portland: Ryan would not be eligible for dialysis there either. Rather than come in for a recommended consultation with the Sacred Heart physicians, on 22 November the Nguyens sought and obtained an emergency order from Commissioner David Thorne of the Spokane County Superior Court directing the hospital to whatever immediate steps [are] necessary to stabilize and maintain the life of Ryan Nguyen, including dialysis of the kidney functions.(1) Why take this extraordinary legal step? The Nguyens' attorney says the hospital had removed Ryan from dialysis and refused to put him back. Sacred Heart's health care ethicist Johnny Cox contends, however, that the hospital was providing all treatment needed to maintain Ryan pending the consultation with outside experts, and that the physicians still expected to work with the parents in finding a solution. Perhaps, he speculates, Sacred Heart's statement that it was not capable of providing the long-term dialysis then thought to be needed by Ryan, along with the recommendation of comfort measures only, left the Nguyens with the misimpression that the hospital planned to act unilaterally, without seeking court appointment of a guardian to replace them as decisionmakers for Ryan. As a result of media attention to the case, physicians at Legacy Emanuel Children's Hospital in Portland contacted Sacred Heart and offered to accept Ryan for treatment. On 13 December, Ryan's parents and guardian ad litem agreed to the transfer, and his fate moved out of the courts and back into the medical arena. Three days later, the physicians at Legacy Emanuel performed surgery to clear Ryan's blocked intestines. Since then he has made normal progress in recovering from the surgery and switching to nutrition by mouth, and by the end of January 1995, his physicians were prepared to send him home. Having not required dialysis since shortly after arriving in Portland, he is not expected to need a kidney transplant as an infant. Finally, despite the seizures he experienced early in life and a CAT scan that was interpreted as showing irreversible brain injury, he seems free of any permanent neurological deficit and shows age-appropriate development; his CAT scan at Legacy Emanuel reveals no structural problems. …

Evidence-Based Ethics and the Care of Premature Infants

Despite the success of newborn intensive care, a vexing ethical question remains: Which preterm infants are so malformed, sick or immature that newborn intensive care should not be administered? In an attempt to answer this question, this article examines current clinical practices and the persisting effects of the controversial Baby Doe regulations. The scientific evidence for current practices is critically analyzed in relation to fundamental ethical issues for marginally viable patients of any age. A variety of strategies--some highly provocative--is proposed and discussed to facilitate better-informed, better-justified, more broadly acceptable, and more fiscally responsible ethical decisions in the care of preterm infants.

170 CONJOINED TWINS – WHO LIVES? WHO DIES? WHO DECIDES?

We recently cared for a set of thoracopagus conjoined twins that shared a complex 6 chamber heart and liver. This was the 10th reported case and attracted international attention on medical and ethical issues. No conjoined twin with a shared heart has survived longer than 3 months. Our infants were ventilator dependent since birth. The father was a substance abuser with a criminal record. After careful review and ethical consultation, we recommended extubation and humane care without surgical separation. Despite our pleas, the parents insisted on surgery. At 7 weeks of age, successful separation was accomplished with the sacrifice of one twin. At 7 months of age, she remains ventilator dependent with a medical bill exceeding 1.5 million dollars. Baby Doe regulations mandated treatment for the most seriously ill newborn. Is the U.S. health system geared to rescue rather than prevention? Do we continue to investigate the uninvestigated and try to achieve the unachievable? In a society which values individual freedom, do parents have the right to choose for their children regardless of costs and suffering? Can this surgery be considered an amputation? Is the sacrifice of one twin justifiable homicide? Faced with many unimmunized children as well as an expanding AIDS and aging population, could this money have been spent more wisely? In the emerging era of health care reform, who will have the ultimate decision to ration care? Exceptional cases as this will have to be scrutinized closely. The patient's welfare and physicians quest for knowledge must complement and not oppose each other.

Caring for the dying child.

In this paper we discuss the nutritional needs of terminally ill children. We delineate the physical, psychological, and developmental characteristics of children that differentiate them from adults vis a vis the nutritional aspects of their care. We highlight the special role of parents and suggest guidelines for dealing with the common nutritional needs of the dying child. We discuss ethical issues emphasizing the Baby Doe regulations, decision making for minors, and the benefits and burdens associated with permanently unconscious children.

Compelled compassion: government intervention in the treatment of critically ill newborns

Life-and-Death Decisions in the Midst of Uncertainty.- Conflict, Compromise, and Symbolism: The Politics of the Debate.- A Legal Analysis of the Child Abuse Amendments of 1984.- Hard Cases Make Bad Law: The Legacy of the Controversy.- Parental Perspectives on Treatment-Nontreatment Decisions Involving Newborns with Spina Bifida.- Rationing Medicine in the Neonatal Intensive Care Unit (NICU).- and Me: A Personal Journey.- and Forgoing Life-Sustaining Treatment: Compassion, Discrimination, or Medical Neglect?.- Neonatologists, Pediatricians, and the Supreme Court Criticize the Baby Doe Regulations.- The Impact of the Child Abuse Amendments on Nursing Staff and Their Care of Handicapped Newborns.- Infant Care Review Committees in the Aftermath of Doe.- Decision Making in the Neonatal Intensive Care Unit: The Impact of the 1984 Child Abuse Amendments.- Appendix: Chronology of Events Related to Passage of the 1984 Child Abuse Amendments.- Biographies.

Limiting Treatment for Extremely Premature, Low-Birth-Weight Infants (500 to 750 g)

Despite impressive recent advances in neonatology, outcomes for extremely premature, very-low-birth-weight infants (500 to 750 g) remain uneven. In a situation of inherent uncertainty, treating patients vigorously could do violence to the moral principles of nonmaleficence and (distributive) justice. Equally, failing to treat patients vigorously because of concerns about nonmaleficence and (distributive) justice could violate the principle of patient-centered beneficence. Compounding this dilemma is the legacy of the "Baby Doe Regulations." International perspectives on this particular quandary are provided. We assert that at Stanford (Calif) University the "individualized prognostic strategy" rather than the "wait until certainty" approach prevails. Four concluding questions are posed: Why is prevention not encouraged more than after-the-fact heroic intervention? Is it possible to develop a more rational view of stopping aggressive therapy once having started? Can we ignore the finitude of our medical resources? Is there a need to redefine the nature of autonomy?

Baby Doe regulations and medical judgment

The potential for conflict between social policy and medical judgment can be examined in relation to the ‘Baby Doe’ regulations issued by the U.S. Federal Government in 1984. These regulations identify the circumstances in which medical treatment may be withheld from handicapped infants. This article reports on a national survey of perinatal social workers which compared their responses to the answers of physicians to similar questions published earlier. These social workers failed to express a conflict between sound medical judgment and the federal regulations when confronted with three hypothetical cases. The same was true in the published study of physicians but that was erroneously interpreted as providing evidence of a conflict between medical judgment and federal regulations. On some general opinion statements, the social workers were similar to physicians in their criticism of these regulations but on others they were equivocal. While the majority of responses of social workers to other questions about these regulations was rather similar to the responses of physicians, the social workers were found to be more inclined than physicians to express the view that these regulations were needed to protect the rights of handicapped infants and the view that the physician's practice had been changed as a result of these regulations.

New Jersey's "Granny Doe" squad: arguments about mechanisms for protection of vulnerable patients.

A state government official in New Jersey has written to administrators of the state's nursing homes outlining what he understands to be certain implications of the Conroy, Peter and Farrell decisions of the New Jersey Supreme Court. These include mandatory reporting to and investigation by his office of virtually all cases of contemplated withholding or withdrawal of life-sustaining treatment, even decisions not to hospitalize or dialyze. This directive has aroused health professionals and advocates for patient privacy. The resulting urgent effort to fashion an acceptable alternative to decisional review by government agents is reminiscent of the process which was sparked by the federal government's promulgation of the "Baby Doe regulations" some years ago. Now, as then, a consensus is being fashioned by a wide spectrum of participants. The likely candidate for an alternative to "Granny Doe squads" is, once again, some form or forms of the institutional ethics committee. Any acceptable proposals will have to satisfy the requirement of public confidence in the face of a perception that elderly nursing home patients are particularly vulnerable to "abuse." They should, in the view of these participants in the debate, also acknowledge relevant differences among nursing homes and enhance, rather than discourage, the exercise of responsibility by nursing home leaders and staff members.

Institutional ethics committees: a survey of children's hospitals.

Institutional ethics committees first gained national prominence after the 1976 Karen Ann Quinlin decision by the New Jersey Supreme Court. However, it wasn't until the Federal Government promulgated the Baby Doe regulations in 1983 that significant movement occurred toward implementing such committees. Currently, statistics show that the number of ethics committees are increasing in health care institutions across the country. However, the majority of studies have focused on adult institutions. The membership of ethics committees and the objectives under which the committees function are usually addressed by the studies. Very little attention has been given to the nursing representation on the institutional ethics committee and the unique role played by nurses in the deliberation of ethical decision-making. It is the intent of this research to shed some light on the availability and functions of ethics committees within children's hospitals. Attention has also been given to the nurses' involvement on such committees. Additionally, the study takes a separate look at nursing ethics committees, their function within an institution, and the availability of ethics education for nurses. The study offers information not previously acknowledged in past studies of ethics committees. The study also opens up to consideration the unique concerns of nurses and their roles in ethical decision-making.

Selective nontreatment of handicapped newborns: how do we decide?

The selective nontreatment of handicapped newborns is an issue that has been of prominent legal debate since the 1982 Department of Health and Human Services "Baby Doe Regulations." It is also an issue of great ethical debate. This article analyzes the dilemma using the principle of nonmaleficence. In addition, the related constructs of ordinary versus extraordinary care, the qualifications of personhood, and the quality of life versus sanctity of life are explained. Nonmaleficence is discussed in terms of the ethical decision-making impact upon the child, the family, health care professionals, and society.