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Organ prolongation in anencephalic infants: ethical & medical issues.

Organ Prolongation in Anencephalic Infants: Ethical & Medical Issues

Transplantation of neonatal solid organs is now capable of saving scores of fatally ill newborns, and the possibility for saving more is on the horizon as techniques and medications are perfected.

An unfortunate paradox exists, however: as neonatal transplant science advances, the already acute shortage of small organs will likely grow worse unless new sources of organs are identified. Today the most promising major pool for neonatal organs is anencephalic newborns. Our intent here is to assess the current controversy over using anencephalic infants as organ sources, and to present a rationale for limited respirator use while death of the anencephalic newborn is being determined for possible utilization of these neonates as organ sources.

Anencephalic Infants and


Anencephalic infants are severely impaired. Both cerebral hemispheres are missing, and there is little if any brain function above the brainstem.

Although most anencephalic infants are stillborn, between 25 and 45 percent are live births. Their brainstems do allow for some typical newborn activity. Most important, circulatory and respiratory functions are performed naturally. Such infants are not dead, then, according to currently accepted standards--common law using cardiopulmonary criteria or the newly enacted state laws reflecting the Uniform Determination of Death Act and including whole brain death.

Approximately 40 percent of these infants who are born alive survive at least twenty-four hours. Of these survivors, one of three will be living at the end of the third day and one of twenty will live to at least seven days. [1] Rarely have anencephalic infants lived to several months. Possibly these infants could live longer but aggressive treatment is routinely withheld. Standard treatment is "comfort care" because the condition is incompatible with a life of any self-awareness and an early death is inevitable.

Some two thousand anencephalic infants are born in this country annually, although most are stillborn. If a significant percentage of these infants born alive could be utilized as organ sources, a major supply of neonatal organs would become available. Theoretically, a single anencephalic infant with healthy thoracic and abdominal organs could supply vital organs to save the lives of two other infants (one needing a heart and another a liver) and enhance the lives of several others (who need kidneys, corneas, and various transplantable tissues.)

Use of these infants as organ sources following death determined by cardiovascular criteria is not new. This practice dates back to the early 1960s, and medical literature reports at least twenty-three renal transplants from anencephalic infants, with a success rate varying according to clinician and age of recipient. [2]

Reliable clinical data on the quality of organs and tissues from anencephalic infants is not yet available, but early indications suggest optimism. Surgeons from the Children's Hospital in Cincinnati who have had the greatest success with such kidney transplantation, have found that the kidneys are only three quarters the size of normal kidneys but assume normal weight rapidly after transplantation. Further, these surgeons report a 50 percent success rate in their kidney transplants, with one patient functioning well nine and a half years after transplantation. [3]

Widespread public interest in organ procurement from anencephalic infants is a recent phenomenon, however. It was prompted by the first successful heart transplant from an anencephalic newborn, Canadian baby Gabrielle, to Paul Holc, a newborn afflicted with hypoplastic left-heart syndrome.

Why the sudden public interest? First, the successful transplant of a heart to baby Paul illustrated the possibility of routine donation of various organs, including vital organs, from dead anencephalic infants. Second, cardiac transplant is more dramatic than renal transplant--the latter being the primary type of transplant previously reported. [4]

Recent Bioethical Discussion

Public awareness, however, has lagged behind that of physicians and ethicists. In the last three years, several projects have been actively considering organ procurement from anencephalic infants.

Hospital Protocols. Loma Linda University established an ad hoc committee in January 1986 to study and draft a protocol for organ prolongation in anencephalic infants. The publicly released December 1987 protocol relies on the practice of attaching the anencephalic newborn to a respirator for a maximum of a week while organ quality is ascertained and brain death determined. * Boston Children's Hospital physicians Joseph Vacanti, pediatric surgeon, and Michael Epstein, ethics committee chair, began work in 1986 on a similar protocol. It calls for the procurement of organs immediately after the birth of an anencephalic infant, but has not been implemented because such a procedure is currently illegal. * Washington University Medical Center, St. Louis, convened a committee of physicians, nurses, and ethicists to consider anencephalic infants as organ sources in January 1987. * Early in 1988, bioethicist John C. Fletcher was instrumental in establishing a task force at the University of Virginia Medical Center to make recommendations about the ethical, medical, and legal parameters of the use of anencephalic infants as sources for organs.

Professional and Policy Responses. The Child Neurology Society, in October 1987, set up a task force to determine the suitability of anencephalic newborns for organ procurement. The American Academy of Pediatrics and the American Academy of Neurology have undertaken similar studies. * California state senator Milton Marks convened a public hearing on "The Anencephalic as a Source for Pediatric Organ Transplants: A Question of Medical Ethics" in October 1986 to pursue the feasibility of altering state law on brain death to allow anencephalic infants to be declared "brain dead." The controversy generated appears to have quashed any immediate possibilities of such a change in the law being seriously considered by California legislators.

The discussion of anencephalic organ procurement is being pursued along two tracks. The primary intent of some researchers is to presume or effect a change in law that will make anencephalic infants an exception to the Uniform Determination of Death Acts, (such as the project at Boston Children's Hospital and the California legislative initiative). [5] The basic concern of other medical researchers is to develop methods for anencephalic organ procurement within the present law (such as the Loma Linda University protocol). Some researchers are active on both tracks.

An important substantive argument for the latter approach was articulated in 1986 by Fletcher, then staff ethicist at the National Institutes of Health, in collaboration with Michael Harrison, a fetologist, and law professor John Robertson. [6] Their proposal calls for a distinctive approach to anencephalic organ procurement: gradual "cooling" of the anencephalic newborn to save organs from ischemia (decreased organ perfusion). The authors cite the practice of doing all possible to save a donor's life until medical treatment is futile and then diverting effort to sustaining organ vitality. An analogy is drawn between this practice and the procedure of cooling the anencephalic infant to preserve viable organs until brain death occurs. The authors admit that cooling would have the unintended effect of hastening death, but they justify this procedure on two grounds: first, the accepted practice of giving hydration to a dying donor to preserve organs although this causes cerebral swelling and hastens death; and second, the principle of "double effect," which permits an unintended evil consequence to occur if the resulting good is proportionate.

While this procedure warrants further discussion, the argument is vulnerable to criticism. Even if a charge of active euthanasia could be refuted, a technical difficulty remains. The authors do not address the issue of hypothermia and its possible creation of a reversible "brain death" state. All brain death criteria state that patients cannot be hypothermic.

Means, Ends, and Anencephalic


Current statutes on brain death are legally binding and to be followed. Thus, organs may only be procured from humans who have been certified dead. However, this presupposition only sets the ground rules for considering three salient issues facing those who desire to see dead anencephalic infants used as organ sources: the ethics of using one human as a means for the good of another; the medical issue of determination of brain death; and the social questions of anencephalic infant research.

A high valuation of individual human life has been commonplace in Western society for centuries. Persons are ends in their own right, and are not to be used only as means to even the noblest of others' ends. This idea was most persuasively articulated by Immanuel Kant in the second form of his categorical imperative:

Act so that you treat humanity, whether in your own person or in that of another, always as an end and never as a means only. [7]

For the purposes of our argument the anencephalic infant will be considered as any other human being who is permanently unconscious and faces imminent death. [8] Does, then, respirator use with anencephalic infants for the purpose of obtaining organs involve using these newborns as a means only? No, this does not treat such infants as means only, but admittedly utilizes them as means primarily. This conclusion rests, finally, upon the minimal, fleeting life that such human beings face. In this regard, certain liberties are, and appropriately may be, taken--but surely are not mandatory--with such human beings.

An instructive comparison may be drawn from how we care for patients who are permanently unconscious. Such patients have been kept alive for years, even decades. [9] However, society increasingly recognizes the futility for all concerned in such a procedure. Accordingly, the American Medical Association's Ethical and Judicial Council ruled in 1986 that the withdrawal of artificial life support--specifically denoting nutrition and hydration--is "not unethical." [10] Such treatment, or nontreatment, is permissible because of the vegetative state of human life into which the patient has irreversibly passed.

Similarly, the anencephalic newborn regrettably possesses only a minimal degree of uniquely human existence, given the absolute lack of potential for possessing consciousness and the likelihood of imminent death. Standard treatment for anencephalic newborns, therefore, is "comfort care" only. These babies are fed and kept warm, but no specialized treatment is given to prevent early deaths.

A contemporary way of stating the ethical rationale for providing minimal care for anencephalic infants utilizes the language of "best interests": their "best interests" are not served through aggressive therapy, and therefore it may be forgone. However, as John Arras has insightfully noted, the best interests criterion for decisionmaking is itself limited. He takes best interests thinking to its logical conclusion by citing a worstcase example: a profoundly retarded, nonambulatory, deaf and blind newborn who will spend years in the corner of a neonatal intensive care unit. [11] Best interests criteria would logically lead to aggressive treatment because such an infant has never known a better life and presumably would desire to live. If the retarded newborn could think and speak, the infant's likely response would be: I'm fed, changed, and occasionally cuddled, and although life doesn't hold much I'll play out the meager hand I've been dealt. [12]

Helpful as a best interests standard may be in the great majority of cases, in instances such as anencephaly, this standard really begs the question of the grounds for decisionmaking. An anencephalic newborn could also be projected as possessing a "pro-life" sentiment, but an answer analogous to that of the profoundly retarded infant's reply is highly questionable: No distinctly human interests can be projected, and thus use of the language of best interests only underscores the marginality of anencephalic infants. The total inability to remedy their marginality as human beings justifies medicine's tradition of providing only custodial care.

The proposed use of a respirator to sustain an anencephalic infant until death for subsequent organ procurement builds on the underlying condition of these newborns, which has long been cited as the reason for withholding treatment. This underlying condition strains the helpfulness of both the ends/means distinction and best interests criteria. Both models of decisionmaking presuppose subjects who possess at least minimal capacities or potential capacities for distinctly human life, and anencephalic infants lack such a capacity or its potential. This does not mean that anencephalic infants may be used as a "means only," for these are human newborns. As such they must be treated with a certain dignity.

A Kantian-based ends/means criticism of any use of anencephalic infants as organ donors is widespread, but what Kant meant by persons as ends is debated by scholars. W.D. Ross contends that Kand did not have persons qua persons in mind, but rather persons as actual or potential possessors of "good will." If persons were genuinely self-subsistent ends, Kant's interpretation of "treating men as ends" as the positive "advancement of humanity" is meaningless. Although Ross laments Kant's ambiguity, he substantively agrees with Kant's positon: good will, not particular persons, possesses absolute value. [13]

Kantian scholar Patrick A.E. Hutchings takes strong exception to this philosophical move to make good will absolute over against concrete persons. According to Hutchings, rational being--not human life qua human life--is valuable as an end, a view in accord with the high priority Kant places on autonomous reason and the immediate context of Kant's statement on treating persons as ends.

Regardless of the interpretation of Kant's categorical imperative, it appears that he did not have nonself-aware humans in mind in his philosophizing. Therefore, to apply Kant's standard to anencephalic infants is beyond--not necessarily contrary to--his writings.

Kant's dictum has a powerful hold on popular thought, and it appropriately comes to mind in discussion of anencephalic organ procurement. But while important, the maxim is finally a myth--in the best sense of the term. [14] It is an ideal that supports our sense of exalted human worth and individual rights, but it has practical limitations. High valuation of individual life is weighty, but if we are more enamored with symbolic rather than actual personal life, the Kantian doctrine of infinite worth has surpassed its usefulness. Its emphasis on individual wellbeing must be balanced with the compelling utilitarian claims of a great number of persons who would be moral victims of a thoroughgoing Kantian ethic.

Moral Warrants for Respirator Use

An ethical justification for respirator use with anencephalic newborns may appeal to either a deontological or utilitarian position. In a deontological approach, the weighing of relevant and potentially competing duties is illuminating. Prima facie duties that may be important in this case are: respect for the vulnerable life of the anencephalic infant, concern for saving the life of a potential organ recipient, attention to the wishes of the anencephalic newborn's family, and regard for relevant legal statutes. In terms of proposed respirator use, attention to the family's wishes and compliance with the law are overriding duties, with the latter taking precedence if a choice must be made. (We do not see this as an appropriate case for civil disobedience.) Most commentators on anencephalic infants as organ sources would view both respect for the anencephalic infant and concern for the potential recipient as relevant duties, and hold that saving the recipient should be chosen if it does not violate respect for the life of the organ source. We believe that the duty to save a potential recipient's life can and does meet that requirement in the context of respirator use.

A sound utilitarian approach views these obligations in the context of the need to make a decision that will realize, or is intended to realize, the greatest possible good. The saving of human life is a laudable good to which medicine is dedicated. If potentially hundreds of infants needing vital transplant organs could be saved without displacing or violating equally valuable individual or societal goods, they should be saved. We believe that the good of procuring a significant number of needed vital organs from anencephalic infants can be realized without, on balance, harming other important goods. Societal welfare is thus maximized. This is true because the proposed use of a respirator with anencephalic infants is attentive to the aforementioned obligations, compatible with medical precedents for using some marginal human beings for the good of others, and is limited by certain ethical safeguards.

Medical Precedent

Usually a patient is treated in a manner solely conducive to the subject's--and not others'--best interests. However, there are recognized exceptions that have at least a loosely analogous relationship to limited respirator use with anencephalic infants:

Dying organ donor. A standard practice in medical centers is to give optimal care to the patient while viable life can be sustained, but to shift emphasis from prolongation of life to maintenance of organ vitality at an appropriate point in the organ donor's dying process. [15]

Pregnant patients approaching death. On more than one occasion women far along in their pregnancies have suffered traumatic accidents and while still alive have been placed on and/or kept on respirators for the sake of their fetuses. Typically, the women are subsequently determined to be brain dead, but their vital bodily functions are maintained by artificial life-support for the purpose of permitting the fetuses to develop to the point of viability at which time a cesarean section is performed. [16]

Dying neonates. Not infrequently an imminently dying baby is vigorously sustained by neonatal intensive care unit personnel for the sake of relatives who are traveling from a distance for a single chance to see and hold the child.

The contemplated use of a respirator and perhaps medications to sustain the vitality of an anencephalic newborn's organs while the baby dies is in the spirit of these examples of nonroutine treatment of patients. Further, these analogies suggest that the issue finally is not the diagnosis of anencephaly in and of itself, but the immediacy and inevitability of the death of a permanently unconscious subject.

Ethical Safeguards

Given the experimental nature of and personal sensitivities involved in using respirators with anencephalic infants, thorough moral justification of this procedure requires several qualifications:

Respirator time limitation. To preclude the anencephalic newborn from becoming an "organ farm," a limited number of days for respirator support should be set. This should allow sufficient time for medical tests and certification of brain death and for protection of the humanity of parents, medical personnel, and society.

Parental involvement. Much of the interest in organ donation stems from parents of anencephalic infants who desperately desire to see some good come from their personal tragedy. Full, documented, informed consent by parents is imperative.

Minimal additional discomfort. Limited and humane use of a respirator should cause little, if any, additional discomfort. The comfort of the anencephalic infant at all times is an important consideration, although the low level of existence is fully recognized.

Brain death. Under present law on brain death, organs may be produced from an anencephalic infant only after death is determined by the most accurate means available.

Research. Because little is known about the quality of organs or the causes of death in anencephalic neonates, careful collection and study of data within current governmental laws and regulations is incumbent on involved clinicians.

Though a coherent deontological argument for this procedure can be made, we believe that a utilitarian rationale is more fitting. Utility, however, is only advanced by attention to duties--such as respect for individual persons--that are fundamental in the strongest sense. Thus our underlying ethic is not a thorough-going consequentialism but appropriately is described as rule-utilitarian. The more important claim, though, is that on either ethical theory, attention to certain basic duties can lead to a justified use of anencephalic infants as organ sources under certain conditions.

Potentially, hundreds of fatally ill babies may be saved if organs from anencephalic newborns can be utilized, and this is no small gain. However, such a medical advance would pale indeed against the realization of some critics' fears for the future--a society preying upon and depriving the weak of minimally rewarding life so that others can be made whole. In such a scenario, good would not be maximized. To assure a humane end for medical advances, broad discussion of various points of view is essential at every step into the future.

Determination of Brain Death

Whereas the ends/means dilemma is the most troublesome ethical issue, the question of determination of brain death has emerged as the salient medical issue.

A protocol for organ prolongation in anencephalic infants currently being used at Loma Linda University Medical Center calls for a seven-day limit on respirator use while brain death is determined and organ quality is ascertained. A basic issue is whether brain death can be medically determined early enough to allow healthy, oxygenated organs to be produced from the newly dead anencephalic infant.

D. Alan Shewmon, a pediatric neurologist at UCLA, contends that "It is highly unlikely that these [anencephalic] babies will meet the current legal and medical criteria of death while on respirators." [17] This declaration could be interpreted in at least two different ways. First, it could be argued that anencephalic newborns attached to respirators will not die within a reasonable time limit. Significantly, Loma Linda University's protocol committee shelved its work for several months because of questions about whether a respirator-supported anencephalic newborn could with any likelihood be predicted to die within a reasonably short time. The fact that baby Gabrielle became brain dead within two days of being respirator supported was an important indication that respirators may not unduly prolong the dying process. As of this writing, a second out of four anencephalic infants maintained with respirator support at Children's Hospital in London, Ontario has become brain dead within a short time. Therefore, it appears that anencephalic newborns may die within a few days if attached to respirators.

A second issue raised by Shewmon's objection is whether determination of brain death in artificially sustained anencephalic infants is possible. We believe that such a determination can reliably be made, based on currently accepted criteria for determining brain death in children. No body of data now exists on determination of brain death in anencephalic infants because the need for determining such death is only recent; lack of data is not due to technical or conceptual difficulties in its collection.

Brain Death in Children

A variety of guidelines for establishing brain death both in adults and/or children have been developed: the Harvard Medical School criteria, the Medical Royal Colleges' study, the National Institute of Neurological Communicative Disorders and Stroke (NINCDS) study, the report of the President's Commission on bioethics, and the guidelines issued by a Special Task Force for the determination of brain death in children. [18] Recently, individual researchers have done much to refine the determination of brain death in children. [19]

Perhaps the most significant finding in current studies of pediatric brain death is the central importance of neurological (clinical) examination over neurodiagnostic (laboratory) testing. Research at Loma Linda University confirms the importance of clinical examination. In early studies of five young infants who were clinically brain dead and had EEG activity, all showed complete absence of cerebral blodd flow. [20] Thus the presence of EEG activity in infants and children does not preclude the diagnosis of brain death. In more recent studies, out of seventeen newborn infants less than one month of age clinically determined to be brain dead, nine were found to have EEG activity and five were found by dynamic brain scanning to have cerebral blood flow. In only four out of sixteen patients were both EEG studies and absence of cerebral blood flow confirmatory of the clinical diagnosis of brain death. [21]

In other studies of pediatric brain death in older children, only 80 percent of patients have electrocerebral silence at the time of initial recording. Further studies in clinically brain dead infants and children have shown that cerebral blood flow as measured by radionuclide scanning techniques may be present in contrast to adults where flow is almost universally absent. [22] Thus, in the newborn the presence of EEG activity or cerebral blood flow does not obviate the diagnosis of brain death.

The literature on brain death and research at Loma Linda on determination of brain death in newborns suggest that the recent Special Task Force guidelines can be extended to include the preterm and term infant and that the diagnosis of brain death can usually be determined solely on a clinical basis. In some patients, neurodiagnostic studies, such as EEG or cerebral blood flow estimations, may be helpful.

Determining Brain Death

Determinations of brain death then properly rely on clinical neurological examination, neurodiagnostic procedures, and observation of the patient over time. The purpose of the neurological examination is to document cessation of brainstem and any "cerebral" function, the purpose of ancillary neurodiagnostic studies is to confirm the clinical diagnostic of brain death, and the recommendation for observation over different time periods is to eliminate the possibility of a reversible process. How, then, does current knowledge apply to the unique situation of determining brain death in the anencephalic infant?

Neurological examination. The neurological examination of the anencephalic infant is different from wholebrain examination, and focuses primarily on the assessment of brainstem function. This is justifiable when considering anencephaly, despite the report of the consultants to the President's Commission in which the diagnosis of brain death requires irreversible cessation of all functions of the entire brain.

Studies by Pallis demonstrate that brainstem death is the essential feature in determining that function of the brain has irreversible ceased. In over 1,000 patients with coma and electrocerebral silence and without brainstem reflexes and respiratory function, cardiac arrest developed within several days in all patients. In 147 clinically similar patients who had EEG activity, the prognosis was identical. In contrast, sixteen patients who demonstrated brainstem function and no EEG activity survived. [23]

Determination of sustained apnea, the absence of spontaneous respiration, is perhaps the most important facet of the nerological examination for brain death confirmation. Testing must be done in a way that allows arterial carbon dioxide tensions to increase to levels sufficient to stimulate respiration, without impairing oxygenation or having adverse cardiovascular effects. [24]

Although the minimum carbon dioxide tension that will reliably stimulate respiration in a living patient (the apneic threshold) is unknown for anencephalic infants, use of the threshold concept is medically justifiable. Infants with brain malformations may possibly have altered, less sensitive brainstem responsiveness to changes in arterial carbon dioxide tensions. However, in brain dead patients, failure to breathe once the threshold is reached is due to the complete loss of function of these cells. not to altered function. Therefore, it is likely that the carbon dioxide threshold in anencephalic infants is similar to the rest of the infant population.

The assessment of cerebral response in comatose infants and children is usually accomplished by the use of a modified Glascow coma scale. [25] Eye opening, motor responses, and verbal responses are determined by examination with a worst possible score of three and best possible score fifteen. Brain dead infants and children usually have a score of three to four. This scoring system, based on clinical observation, can also be used in the anencephalic infant. It is likely that an anencephalic newborn who is not in a coma might not obtain as high a score as a normal newborn because of the cerebral and opthalmological defects. However, there is no clinical reason to believe that a comatose anencephalic infant being clinically evaluated for brain death should significantly differ in the determination of responsiveness compared to other newborns using this scoring system.

Neurodiagnostic testing. As previously noted, neurodiagnostic testing for the confirmation of brain death may only be helpful in approximately one-half to two-thirds of newborn infants. These findings, as well as recent studies of clinical brain death, lead us to believe that the diagnosis of brain death can be firmly declared on a clinical basis without a need for supportive neurodiagnostic testing. Further, the condition of anencephaly does not lend itself to laboratory testing.

Because of the severe cerebral malformation associated with anencephaly, it is unlikely that accurate recording of brain electrocortical activity could be accomplished. The atrophic brain structures are typically exposed with a very thin covering membrane, so standard paste-on scalp electrodes cannot be applied. If standard electrodes were used, environmental artifacts would make the likelihood of obtaining a readable, technically satisfactory tracing improbable. Insertion of sterile wire electrodes directly into the brain or adjacent scalp tissues is not appropriate.

Previous attempts to record EEG activity in anencephalic infants suggest that such procedures may not be valid in assessing neocortical viability. In one study of two full-term anencephalic infants, EEG activity was demonstrated yet studies of brain tissue at autopsy showed no evidence of functional nervous tissue above the midbrain (upper brainstem). [26] Thus, use of the EEG in the anencephalic newborn is technically not feasible nor valid for the laboratory confirmation of brain death in these infants.

Determination of cerebral blood flow in anencephalic infants similarly possesses many practical problems that suggest such techniques could not realistically be used. The vascular beds of the brain and scalp are abnormally developed, the cerebral hemispheres are absent, the major systemic arteries supplying the brain are both anomalous and atrophic, and the bony structures at the base of the skull are prominent. [27] These factors alone would obviate the use of current standard imaging techniques, because the structures to be studies are either absent or so malformed that results would be inconclusive. Thus, cerebral blood flow studies cannot be an integral part of the determination of brain death in anencephalic infants; neither are they necessary.

Duration of brain death examination. In adults and older children, twelve to twenty-four hours of observation without a change in the clinical examination is considered sufficient for final declaration of brain death. The recent Special Task Force guidlines for brain death determination in children recommend an observation period of twenty-four hours in children between two months and one year of age, and forty-eight hours in infants seven days to two months of age.

However, periods of observation have been recommended primarily to ensure that a reversible condition affecting cerebral and brainstem function is not present. The President's Commission sides with a functional definition of death: "In measuring functions, physicians are not concerned with mere activity in cells or groups of cells if much activity (metabolic, electrical, etc.) is not manifested in some way that has significance for the organism as a whole." [28] Because of the irreversible nature of the anencephalic infant's developmental malformation, a prolonged period of observation is neither clinically appropriate nor indicated. Thus, we believe that a period of observation of twenty-four to forty-eight hours in which there is no change in the anencephalic infant's neurological examination is sufficient to firmly establish clinical brain death.

Research on Anencephalic Infants

The humanitarian intent of parents who offer their anencephalic babies as potential organ sources and of physicians and medical centers that engage in transplantation is commendable. However, because of the increasingly severe shortage of transplantable neonatal organs, the need for basic knowledge of anencephalic newborns is great.

There is little data on their death--the cause, the effect of respirator use, and the realiability of early determination of brain death. Nor are we well versed as to the quality of organs and effect of involvement with anencephalic infants on attending health care personnel.

Although physicians and ethicists at some teaching hospitals have recognized the need for thorough research on anencephalic newborns as organ sources, the idea of doing human research on the weakest of the weak carries little intrinsic appeal. For such research to be acceptable, two issues must be addressed: first, the pure versus applied nature of the research, and second, its moral and regulatory permissibility.

At this time we do not see any need for pure research on anencephalic infants that would be totally separate from a humanitarian protocol. Good data on organ quality can be gained by procedures such as diagnostic ultrasound, blood sampling for arterial blood gases, chemistry profiles, hematologic studies, and urinalyses. Study of the visceral and neurological function of anencephalic infants may also be necessary.

The question of whether children should ever be the subjects of human research has been hotly debated. we contend that responsible research can and ought to be done with children. Further, in very limited circumstances, children may be subjects of research even when there may be no personal benefit to the child where the good of other children is intended. This position has been previously defended by Richard McCormick, who views the child subject as a most valuable individual in a larger social context for which we are all morally responsible:

[W]hen a particular experiment would involve no discernible risks, no notable pain, no notable inconvenience, and yet hold promise of considerable benefit, should not the child be constructed to wish this in the same way we presume he chooses his own life, because he ought to? I believe so. He ought to want this not because it is in any way for his own medical good, but because it is not in any realistic way to his harm, and represents a potentially great benefit for others. He ought to want these benefits for others. [29]

The current federal regulations for the protection of human subjects (published in 1983 by the Department of Heatlh and Human Services) also permits research on children "that does not hold out the prospect of direct benefit for the individual subject" under certain conditions. [30]

Because the Department of Health and Human Services regulations on Protections for Children are a recognized national standard, they are important for any contemplated research involving anencephalic infants. There are three key criteria in the published regulations: the risk to subjects is only a minor increase over minimal risk; the research is reasonable and of vital importance for understanding or ameliorating a serious problem affecting the health of children; and informed consent is obtained.

A research protocol for anencephalic newborns based on respirator use can meet the spirit and the letter of these regulations. First, a minor increase to minimal risk is most difficult to define. If risk means life threatening, the respirator is no threat in that it may only prolong life. If risk refers to additional pain, steps should be taken to see that any pain caused by respirator use is indeed only minimally beyond that which normally dying anencephalic infants may suffer.

Second, designing a humane protocol is reasonable and of great importance if medical science is to better understand--though not now prevent or ameliorate--anencephaly. The generalized knowledge to be gained about the condition itself is great. Clearly current research on anencephalic infants would be done primarily to benefit other children, although an ancillary benefit may be information on how "comfort care" may be made even more comforting for dying anencephalic newborns. Third, only fully informed parents--both mother and father when possible--will suffice. In light of the experimental nature of this procedure, only freely volunteering parents are acceptable.

The proposed use of a respirator with anencephalic newborns, in the end, may be ill-considered for several reasons. Alpha fetoprotein screening may be so effective that virtually no anencephalic infants will be brought to term; a low percentage of respirator-assisted anencephalic newborns may die; or society may decide that use of anencephalic newborns for organ procurement is inhumane. An alternative scenario is that hundreds of anencephalic babies may continue to be born despite screening; many of these infants may die on artificial life support; and both society and parents of anencephalic infants may rejoice that some good can come from the parents' personal tragedy.

Regardless of the future of organ procurement from anencephalic newborns, we believe that attaching volunteered, select anencephalic infants to respirators for determination of brain death is an ethically and medically appropriate step within the law toward meeting a severe shortage of neonatal organs.


[1] P.A. Baird and A.D. Sadovinich, "Survival in Infants with Anencephaly," Clinical Pediatrics 23 (1984), 268-71.

[2] W.E. Goodwin et al., "Human Renal Transplantation: Clinical Experiences with Six Cases of Renal Transplantation," Journal of Urology 89 (1963), 13-24; see also, Lester W. Martin et al., "Homotransplantation of Both Kidneys From an Anencephalic Monster to a 17-Pound Boy with Eagle-Barrett Syndrome" Surgery 66 (1969), 603-07; Kikuo Iitaka et al., "Transplantation of Cadaver Kidneys From Anencephalic Donors," Pediatrics 93 (1978), 216-20; Donald I. Moel and Khalid M.H. Butt, "Renal Transplantation in Children Less Than 2 Years of Age," Pediatrics 99 (1981), 535-39; Wolfgang Holzgreve et al., "Kidney Transplantation From Anencephalic Donors," New England Journal of Medicine 316:17 (1987), 1069-70.

[3] Iitaka et al., "Transplantation of Cadaver Kidneys From Anencephalic Donors."

[4] The first attempt to transplant an anencephalic heart occurred in 1966. See Adrian Kantrowitz et al., "Transplantation of the Heart in an Infant and an Adult," American Journal of Cardiology 22 (1968), 782.

[5] For an assessment of the opposing arguments on whether present statutory law on brain death should be altered to allow for immediate procurement of anencephalic infants' organs, see James W. Walters, "Should the Law be Changed?" Loma Linda University Ethics Center Update 3 (November 1987), 3-6.

[6] John C. Fletcher, John A. Robertson, and Michael R. Harrison, "Primates and Anencephalics as Sources for Pediatric Organ Transplant: Medical, Legal, and Ethical Issues," Fetal Therapy 1 (1986), 150-64.

[7] Immanuel Kant, Foundations of the Metaphysics of Morals, Lewis White Beck, trans., in Philosphical Writings, Ernst Behler, ed. (New York: The Continuum Publishing Co., 1986), 94.

[8] See James W. Walters, "The Moral Status of the Anencephalic Infant" (in press).

[9] See the helpful essay by Ronald E. Cranford, "The Persistent Vegetative State: The Medical Reality (Getting the Facts Straight)," Hastings Center Report 18 (February/March 1988), 27-32.

[10] American Medical Association Council on Ethical and Judicial Affairs, "Current Opinions of the Council on Ethical and Judicial Affairs of the American Medical Association--1986" 2.18 (Chicago: American Medical Association, 1986), 12-13.

[11] John Robertson, "Involuntary Euthanasia of Defective Newborns," Stanford Law Review 27 (1975), 254.

[12] John D. Arras, "Toward an Ethic of Ambiguity," Hastings Center Report 14 (April 1984), 25-33. This ethical analysis of the best-interests criterion is unsurpassed.

[13] Sir David Ross, Kant's Ethical Theory: A Commentary on the Grundlegung zur Metaphysik der Sitten (Oxford: Clarendon Press, 1954), 48-57.

[14] James W. Walters, "transplant of (Anencephalic Infants') Organs Can Save Lives," Los Angeles Times, December 10, 1987, editorial.

[15] Pittsburgh Transplant Foundation, "Post-Mortem Organ Procurement Protocol," 1038 J. Scaife Hall, Pittsburgh, PA 15261.

[16] Bruce Hilton, "Dead Mom's Fetus: Law Must Decide A Question of Life," San Francisco Examiner, June 22, 1986, B1, 5.

[17] Leslie S. Rothenberg and D. Alan Shewmon, "No Life Should Be Traded for Another," Los Angeles Times, December 10, 1987, editorial.

[18] Henry K. Beecher, "A Definition of Irreversible Coma. Report of the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death," Journal of the American Medical Association 205 (1968), 337-40; "Conference on Medical Royal Colleges and their Faculties in the UK: Diagnosis of Death," British Medical Journal 2 (November 13, 1976), 1187-88; "The NINCDS collaborative Study of Brain Death" (Washington DC: Government Printing Office, 1980); "guidelines for the Determination of Death: Report of the Medical consultants on the Diagnosis of Death to the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research," Neurology 32 (1982), 395-99; "Report of Special Task Force: Guidelines for the Determination of Brain Death in Children," Pediatrics 80 (1987), 298-301.

[19] Joseph J. Volpe," Commentary: Brain Death Determination in the Newborn," Pediatrics 80 (1987), 293-97; Stephen Ashwal and Sanford Schneider, "Brain Death in Children, I,Ii," Pediatric Neurology 3 (1987), 5-10, 69-78.

[20] Stephen Ashwal and Sanford Schneider, "Failure of Electroencephalography to Diagnose Brain Death in Comatose Patients," Annals of Neurology 6 (1979), 512-17.

[21] Ashwal and Schneider," Brain Death in the Newbord: Clinical, EEG and Blood Flow Determinations," Annals of Neurology, 1988 (in press).

[22] Ashwal and Schneider, "Brain Death in Children: I,II."

[23] Christopher Pallis, "ABC of Brainstem Death: The Arguments about the EEG," British Medical Journal 286 (January 22, 1983), 284-87.

[24] See Thomas W. Rowland et al., "Apnea Documentation for Determination of Brain Death in Children," Pediatrics 74 (1984), 505-08; K.M. Outwater and M.A. Rockoff, "Apnea Testing to Confirm Brain Death in Children," Critical Care Medicine 12 (1984), 357-58.

[25] Beth Drake, Stephen Ashwal, and Sanford Schneider, "Determination of Cerebral Death in the Pediatric Intensive Care Unit," Pediatrics 78 (1986), 107-12; Lawrence A. Lockman, "Coma in the Practice of Pediatric Neurology," in The Practice of Pediatric Neurology. Kenneth R. Swaiman and Francis S. Wright, eds., (St. Louis: C.V. Mosby Company, 1982), 143.

[26] V.W.D. Schenk et al., "Two Rhombencephalic Anencephalics: A Clinical-Pathological and Electroencephalographic Study," Brain 91 (1968), 497-506.

[27] F.S. Vogel, "The Anatomic Character of the Vascular Anomalies Associated with Anencephaly: With Consideration of Abnormal Angiogenesis in the Pathogenesis of the Cerebral Malformation," American Journal of Pathology 39 (1961), 169-83.

[28] President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral research, Defining Death: Medical, Legal and Ethical Issues in the Determination of Death (Washington: U.S. Government Printing Office, 1981), 28.

[29] Richard A. McCormick, "Proxy Consent in the Experimentation Situation," Perspectives in Biology and Medicine 18 (1974), 14.

[30] "Additional Protections for Children Involved as Subjects in Research," Code of Federal Regulations, 1983, Title 45, section 46.406, 407.

James W. Walters is associate professor of Christian ethics, School of Religion, Loma Linda University. Stephen Ashwal is a professor of pediatrics and neurology, School of MEdicine, Loma Linda University, Loma Linda, CA
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Title Annotation:includes related article on Loma Linda Hospital protocol
Author:Walters, James W.; Ashwal, Stephen
Publication:The Hastings Center Report
Date:Oct 1, 1988
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