an environment of substantial medical uncertainty. Finally, I will look toward the future by suggesting a partial research agenda for addressing some of the concerns raised by these discussions. 1934-5798/09/$17.00 2009 – IOS Press and the authors. All rights reserved 70 S. Van McCrary / Neonatology and the specter of the law 2. Controversy about the Baby Doe rules in the pediatrics community The origins and evolution of the Baby Doe rules, and court decisions addressing relevant clinical cases, have been extensively chronicled elsewhere in the literature [1–7]. The cases triggering these rules arose in the early 1980s from two neonates with the following clinical presentations: tracheoesophageal fistula combined with trisomy 21, and meningomyelocele combined with microcephaly and hydrocephalus [1]. Essentially, the rules provide that non-treatment of neonates is justified only in three exceptional cases: first, if the “... infant is chronically and irreversibly comatose;” second, if provision of treatment “... would merely prolong dying, not be effective in ameliorating or correcting all the infant’s life-threatening conditions, or otherwise be futile in terms of the survival of the infant;” and third, if provision of treatment “... would be virtually futile in terms of survival of the infant and the treatment itself under such circumstances would be inhumane” [1,8]. Further, the Baby Doe rules provide that “appropriate nutrition, hydration, and medication must always be given” [1]. Following legal challenges to their original 1984 version, the Baby Doe rules have been modified and are now technically optional, but compliance is essentially required for institutions receiving certain types of federal funding; the rules are subject to enforcement by state child protective services [8–12]. An emerging issue during the past decade is the change in types of patients for whom the Baby Doe rules apply, and are most often controversial. Previously, the legal focus of the Baby Doe rules was on infants with genetic and chromosomal abnormalities; today, issues of extreme preterm birth dominate the difficult cases in most NICUs. This transition has heightened debate among neonatologists regarding the propriety of practice guidelines endorsed by the American Academy of Pediatrics (AAP). In 1996, the Committee on Bioethics of the AAP published its opinion about treatment decisions for critically ill infants in the wake of Baby Doe [13]. The Committee asserted that decision making for children of all ages should be individualized according to the best interests of the child as determined by parents or guardians; further, they argue that this position is fully consistent with the Baby Doe rules and that persons who disagree misunderstand these rules [13]. This position has been rejected by bioethics scholars, including Loretta Kopleman, who claim that a careful reading of the Baby Doe rules clearly removes a substantial amount of discretion from parents and physicians confronting treatment decisions for seriously impaired newborns; she further argues that this result was the intent of the Reagan administration when it proposed the original rules, and that regulatory matters affecting treatment for newborns are inevitably intertwined with the politics of abortion [1]. Kopleman notes that the sole quality-of-life criterion allowed by the AAP Committee is that treatment need not be provided when the infant is “chronically and irreversibly comatose.” She argues that this criterion is inadequate to enable a humane and reasonable determination of the best interests of the child as commonly understood [1]. Citing the Committee’s reliance on the concept of futility as a way to introduce a best interests standard, Kopelman meticulously picks apart this reasoning by comparing the actual language of the regulations to the AAP interpretations [1]. Specifically, it is most telling that the Committee seems to ignore the point that a clear reading of the Baby Doe rules demonstrates that futility may legally be invoked only when it refers to cases in which the infant will die with or without treatment [1]. Further, the rules also require that appropriate nutrition, hydration, and medication be provided, employing a restrictive interpretation of the word “appropriate” [1]. Kopleman and her colleagues have performed empirical research that supports her arguments. This survey of practicing neonatologists indicates that 76% of respondents believed that the Baby Doe rules were not necessary to protect the rights of handicapped infants and 60% believed that the rules interfered with parents’ right to determine what treatment was in the best interests of their children [14]. In analyzing hypothetical cases, up to 32% of respondents reported their judgments that maximal life-prolonging treatment was not in the best interests of the infants described, but that the Baby Doe rules required such treatment nevertheless [14]. Joel E. Frader, an eminent bioethicist and pediatrician, both supports Kopleman’s arguments and adds useful political context. Frader notes that the AAP leaders in 1984 “... felt that they had to support the ‘compromise’language of [the rules] out of fear of even more intrusive and controlling legislation” [2]. He also regards the language of the Committee’s opinion, suggesting that their views are consistent with the Baby Doe rules, as