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Transparency in neonatal intensive care.

Medical teams care for severely premature infants under conditions of emergency and uncertainty that make parental involvement very difficult. Parents can be invited into a decisional relationship with the team that enables them to assess more fully the meaning of their child's illness.

The classic case goes something like this: A 25-week, 750-gram infant is born to a young, distraught, university-educated couple. After long weeks of crises and complications, the parents request that the respirator be withdrawn from their infant so that his suffering may end. The caregiving team refuses to consider this request, out of concern about the Baby Doe regulations, or personal and professional commitment to life, or suspicion of the parents' motives. Some months later, one of two outcomes is most likely: either the infant dies despite aggressive support, or he is weaned from the respirator, suffering from serious lung disease, blindness, cerebral palsy, severe developmental disabilities, and other complications, eventually to go home with his still-angry parents.

This kind of case is the focus of much of the scholarly and popular literature addressing decisionmaking about premature infants.(1) But a new paradigm case has begun to emerge. In Case 2, a 25-week, 750-gram infant is born to a very young single mother of two who has had only one prenatal visit. She lives in an isolated rural community, or in a devastated inner-city neighborhood, and cannot easily visit the hospital often. After long weeks of crises and complications, the caregiving team comes to believe that it is in the infant's best interest to withdraw respiratory support and allow his suffering to end. The infant's mother refuses to give her permission for the withdrawal of treatment, stating that only God can end her son's life and that she is praying for a miracle. Some months later, one of two outcomes is most likely: either the infant dies despite aggressive support, or he survives with multiple severe handicaps and with caregiving needs that his mother is unable to meet. Eventually he leaves the hospital to enter a chronic care facility or to live in foster care.

Decisional Strategies and Parental Choice

Nancy Rhoden's 1986 article, "Treating Baby Doe: The Ethics of Uncertainty," describes American neonatologists as generally subscribing to a wait-until-certainty decisional philosophy regarding the treatment of premature infants.(2) This philosophy, illustrated in Case 1, prescribes aggressive treatment for all potentially viable premature infants "until death or irreversible coma seems almost certain." Rhoden ascribes its apparent popularity to a combination of legal fears, a vitalist emphasis on the preservation of life, and the desire to minimize prognostic uncertainty, and goes on to state,

Perhaps the most significant drawback is that this strategy denies the ethical complexity. Doctors who follow it, whether because of their own inclinations or legal concerns, will increasingly be governed by technology instead of employing it as a tool. The parents' role is likewise reduced to that of onlookers. . .so long as there is any uncertainty.

Rhoden proceeds to argue for the superiority of what she calls the "individualized prognostic strategy," in which treatment is begun and periodically reevaluated as more information is amassed about the infant's condition and prognosis. She reasons that, as practiced by British neonatologists, the individualized prognostic strategy results in fewer cases like Case 1, speculating that the real difference between typical American and British practices may be in the degree of certainty they seek. The degree of risk that justifies [a given decision] is a difficult ethical question. An individualized approach brings this question to the forefront of ethical deliberation, though it does not provide an answer. Yet raising the question is itself important.

On the basis of my discussions with neonatologists, my reading of the literature, and observational research conducted in one neonatal intensive care unit, I believe that many American neonatologists have now largely embraced the "individualized prognostic strategy."(3) Yet the shift from Case 1 to a more flexible, realistic medical decisionmaking strategy produces Case 2. Despite caregivers' willingness to propose treatment withdrawal, the outcome for the child is no different.

Caregivers' legal fears have begun to diminish as hospital administrations become more aware of the complex dimensions of treatment decisions for premature infants. Infant care review committees have also begun to share in this difficult decisional process.(4) Finally, although the information available to neonatologists improves and increases every day, at the same time prognostic certainty has come to be understood as an even more impossible goal.

Neonatologists are coming to terms with uncertainty certainty because they have no other choice, but they are no more comfortable with it than they ever were. They often are willing to accept less certainty, and they seldom hesitate to raise hard questions with patients. Nonetheless, neonatologists, like American caregivers generally, have failed to understand and to use informed consent as a "preventive" decisionmaking strategy, in neonatal intensive care or in other hospital settings.

I contend that improved informed consent practice can make a difference in the care of premature infants; I do not argue, however, that changes in informed consent will affect most infants' ultimate outcomes. Instead, rethinking informed consent in this setting should accoplish two things. First, it will require caregivers to articulate more fully the basis for their recommendations and decisions about the infants in their care, for themselves as well as for parents.(5) As a result, it can take on a second, preventive function, preparing parents better for their decisional role and thereby helping to reduce the emotional trauma of parental decisionmaking as well as minimizing delays in critical decisions on behalf of those infants who suffer the more serious complications of extreme prematurity.

Essentially, I wish to maintain that better informed consent practice will reduce the instances of Case 2 and other disagreements that arise from misunderstanding rather than solely from differences in values, because I believe that better informed consent practice will make parents more likely to accept the team's recommendations. This argument could easily appear to be paternalistic; after all, the purpose of informed consent is to enable autonomous decisionmaking based on the decisionmaker's own preferences and values, not to promote obedience to medical advice. Yet the basis of my claim is that only an adequate understanding of the team's recommedations can enable parents autonomously to dissent from them or assent to them, and that in the neonatal intensive care unit (NICU), because the parents' goals and the team's are often very close if not identical, agreement is substantially more likely than disagreement so long as the team employs the individualized prognostic strategy.(7) There will of course continue to be instances where, after truly effective communication and discussion, the goals and values of parents and those of the team continue to diverge. In such cases the team can be better assured that the parents' views are based on as full an assessment of the situation as the team can give them, and the parents can be better assured that they have been well-equipped to carry out their chosen course of action.

A Study of Decisionmaking and Communication in the NICU

Recognizing the complexities of decisionmaking and communication in medical care and the extent to which the conventional legal doctrine of informed consent has as yet failed to address them, I sought an opportunity to observe the informed consent process in a hospital setting. I conducted an observational study in an NICU during the summer and fall of 1988 and 1989. My goal was to gain a sense of the caregiving team's own process of decisionmaking about an infant as well as a sense of how the parents' process of decisionmaking relates to the team's.

During my first period of observation, I followed closely (with their consent) several families whose premature infants were born "in-house" and had more than minimal stays in the NICU. Next, over a two-month period I enrolled in my study all in-born infants of 32 weeks or less gestation and less than 2500 grams, but without additional anomalies. I obtained consent from their parents to record my observations of all significant discussion and decisionmaking about them, and I kept records of decisionmaking on rounds, telephone conversations between family members and nursing staff, and discussion between staff and parents during family members' visits to the NICU.

In the first phase of my study I followed four infants closely and talked with three sets of parents. One infant had an uncomplicated 12-day course in the NICU; the intern assigned to the child's care could not find time to talk with the mother until her permission was needed to transfer the baby to a local hospital nursery. Another child, born at 25 weeks' gestational age and 780 grams in weight, stayed in the unit for 40 days (the first time) and had multiple complications of extreme prematurity. Finally, a set of 25 1/2-week twins, 740 and 830 grams, had 35- and 50-day courses, respectively, with some complications and more "scares." During the second phase of my study, I followed 18 infants (including a set of triplets and two sets of twins) in 14 families. Sixteen of these infants stayed in the unit 10 days or less. One of the infants died; the rest were all transferred to a nursery providing less intensive care. The remaining two infants had stays of over 50 days. Only these two infants and the one who died were less than 28 weeks' gestational age. In this group, there were many complications of prematurity, but few were severe.(8) Clearly, the study group did extremely well overall, with a low incidence of serious complications, a high percentage of short, relatively uncomplicated NICU courses, and a sharp dividing line in weight and gestational age between the "healthy" cohort of premature infants and the few much smaller and much sicker infants.

With the assistance of Arlene Davis, RN,JD,I made timelines for each of the infants in the second phase of my observational study, recording the number of contacts between staff and parents on each successive day of the infant's NICU stay. When I examined these timelines and the content of the parent contacts, three things stood out.

First, the timelines were all very similar, with a large peak on days 1 and 2 of life, a smaller peak on the last days of the infant's stay, and sometimes small peaks in between, marking crises or surgeries. In between those times, when there was contact with parents it was usually minimal, often consisting of telephone updates from nursing staff.

Second, caregivers generally adhered explicitly to the individualized assessment strategy, telling parents, "The first 24 to 72 hours are the most critical for your child, and we'll know a lot more about how he's likely to do after that; meanwhile, we're doing everything possible." During these first days, therefore, while the caregiving team was gathering information about an infant, its parents were gathering information of a different sort, much of it from the nursing staff: information about the NICU environment, their infant's caregivers, their infant's physical appearance, the equipment being used, and general information about the course and problems of premature infants. Not until after this initial assessment period did caregivers discuss directly with parents the actual condition and prognosis of their infant and the proposed course of treatment.

During its period of assessment, the team is doing a range of things: gathering expert information and interpreting it; determining how much certainty is necessary and achieving the requisite level of certainty; and forecasting as far as is deemed necessary to provide for the child's short-term needs, against a backdrop of knowledge of the long-term concerns that will arise on discharge or transfer. When, at the end of this period, the team begins to talk specifically and in detail with the family, the opportunity has been lost for the team and the parents to reach this point together. Instead, the team's views are already formed, and the parents may receive the impression that their communication is a one-way information transfer only.

Third, despite their willingness to assess and reassess an infant's condition whenever necessary, caregivers still had deep ambivalence about the uncertainties of their enterprise. Wary of the pitfalls of both optimistic and pessimistic predictions to parents, they sought to avoid the appearance of certainty, emphasizing the individuality of every child.

This admirable avoidance of over-generalization can have paradoxical results. It can arrogate to the caregiving team even more authority than it would willingly claim for itself, because when there is virtually unlimited uncertainty about an infant there can be almost no effective information disclosure to parents, and there are no decisions to be made except by experts with expert experience and judgement. At the same time, however, resistance to overgeneralization can prevent the team from drawing appropriate conclusions from its own experience and lead it to be continually surprised by each infant's course, thus lengthening the time it takes to assess the infant's condition. For example, although during my observation I learned the concept of the "honeymoon period," during which an extremely premature infant often has an excellent clinical course for several days despite discouraging X rays and the virtual certainty of future deterioration, I also observed that caregivers would naturally prefer to forget that the honeymoon period might be responsible for an infant's promising clinical status. The resulting unwarranted optimism sometimes made it more difficult for the team to reassess the infant's condition promptly and accurately when its downhill course began.

My observations confirmed that, by conventional measures, informed consent policy and practice in the NICU was excellent. Parental permission was obtained for all major interventions, though it was sometimes by telephone or after the fact, and consent was obtained in writing for all surgical procedures. The team generally disclosed everything required by informed consent law, including the nature and consequences of the proposed procedure, its most significant risks, and medically reasonable alternatives.(9) Parents were given any additional information they asked for or were willing to accept, particularly by nursing staff.

I was continually impressed by the quality of the explanations given to parents regarding the physiological mechanisms of disease, and by the facility most parents gained with the indicators of their infants' illnesses. Yet I listened to, and learned from, many discussions with parents with a pervasive sense that something crucial was being left out of all of them. What I saw as missing was the link between information disclosure and parental understanding of the implications of that information, either immediately or in the long term. Because parents were being informed, but neither equipped for decision nor viewed as having a significant role in most decisions, they were not told, or did not know how to ask, what their child's condition meant. Those who did ask were usually told that prediction was difficult, if not impossible. Yet when treatment withdrawal was recommended, it was because the team had indeed made an assessment of the meaning and implications of the information it had about an infant.

As a result, when caregivers informed parents that their infant's prognosis was poor enough to begin considering the possibility that treatment withdrawal might be best, it always took the parents longer to grasp this than the team anticipated. The team was always genuinely concerned when parents seemed not to understand the situation or held unrealistic expectations, and did everything it believed possible to help them come to terms with their infant's poor prognosis; yet Case 2 scenarios were the most common serious decisionmaking dilemmas in which the team found itself, and were often the subjects of Infant Care Review Committee discussion.

There are many possible explanations for the parental overoptimism of Case 2: anger, grief, and guilt; lack of intellectual or emotional capacity to understand the relevant information; distrust of physicians combined with complete faith in their technology; or strong personal values or religious beliefs. Any or all of these might influence any given situation; most of them are either difficult to remedy or ought not to be challenged. One other explanation, however, identifies a problem that can and should be remedied: the above-described temporal gap between the understanding of the care-giving team and that of the parents.

Transparency Bridges the Gap

When caregivers employ the individualized prognostic strategy without realizing they are creating this temporal gap, they end up several days ahead of the parents in their grasp of an infant's condition and prognosis. Once the team's initial assessment of an infant is completed, it is presented to the parents, who must understand it intellectually as well as emotionally but who were not given the opportunity to share in the team's decisionmaking process.

Medical decisionmaking is not a mechanical enterprise nor a mathematical process. Personal factors such as the decisionmaker's own beliefs and views must necessarily enter into the assessment of information. The physician's assessment of an infant's condition and prognosis is both expert and personal; parents need and deserve a similar opportunity to develop a similar assessment of their child, an assessment that will be composed not only of parental feelings but of direct experience and knowledge. If Case 2 can ever have a better outcome, it will be when the temporal gap is narrowed and caregivers and parents become better decisionmaking partners. Even in situations where the outcome is happier than that of Case 2, a better decisionmaking relationship can lead to fewer misunderstandings and fewer surprises, both immediately and in the long term.

In a 1989 article Howard Brody suggests an informed consent model that he calls "transparency," and argues that it is better suited to primary than to tertiary care settings. He notes that informed consent literature and case law most often address the providing of risky and invasive procedures, where "the risks to the patient are significant, and the values placed on alternative forms of treatment are quite weighty," as is the case for treatments provided in tertiary settings.(10) These circumstances, he argues, call for the laundry list model of disclosure specified in conventional informed consent doctrine.

In emergent tertiary settings like the NICU, however, informed consent doctrine begins with the assumption that medically indicated treatment serves the patient's best interest.(11) Similarly, because the child's best interest is presumed to be the basis for parental decisionmaking, parental discretion may be questioned or limited in the NICU setting when it appears that an infant patient's best interest is not being served.(12) Although newborn infants have decisional autonomy in the formal sense that they have the right to have proxies (usually parents) make decisions on their behalf, they do not have formed preferences or life experiences upon which proxy decisionmakers can rely to give content and substance to this autonomy. Parents must instead make choices based on their perception of their infant's best interests, and although their values as parents enter into these determinations, to a large extent parents' best-interests determinations in the NICU setting are shaped by their understanding of medical information and the recommendations of their infants' caregivers. Moreover, states' power to intervene in instances of child abuse and neglect--including medical neglect as elaborated in the "Baby Doe" regulations--reinforces the already close relationship between parental decisionmaking and beneficence by rendering any great divergence between parental autonomy and medical beneficence unacceptable.(13)

As a result, conventional informed consent doctrine may appear not to require that parents of infants in the NICU receive much disclosure or that their treatment choices be honored. Once the initial decision to resuscitate a premature infant is made (a decision that is likely to involve the parents only if the infant is on the borderline of viability, e.g., 24 weeks and 500 grams, or is known to have major illness, injury, or anomaly), parents may be viewed by the team as having no real decisional role, at least until the end of the initial assessment period is reached or if treatment withdrawal is proposed. Parents cannot contribute technical expertise to the necessary decisions--perhaps they cannot even fully understand them--and their refusals of any necessary interventions will not be honored. The NICU team will inform them and educate them for many good reasons, but not for decisionmaking. By this reasoning, conventional informed consent practice is appropriate in the NICU, and by its standards, parental involvement in decisionmaking is largely superfluous until the question of the value of nontreatment arises.

Contrary to his claims for it, Brody's "transparency" model for informed consent in primary care is appropriate for, and perhaps indispensable to, the NICU setting. It has the capacity to take account of critical factors in the physician's reasoning that cannot be captured by the laundry list of conventional informed consent. On Brody's account, the transparency model has two requirements: "(1) the physician discloses the basis on which the proposed treatment, or alternative possible treatments, have been chosen; and (2) the patient is allowed to ask questions suggested by the disclosure of the physician's reasoning, and those questions are answered to the patient's satisfaction." The goal of informed consent under the transparency model is to render the physician's basic thinking transparent to the patient: "Essentially, the transparency standard requires the physician to engage in the typical patient-management thought process, only to do it out loud in language understandable to the patient."

Brody reasons that this model is appropriate for settings in which "risks to the patient are negligible and conflicts over patient values and the goals of treatment or nontreatment are of little consequence." The NICU is such a setting. Although the risks to NICU patients are very far from negligible, the risks of treatment may often be negligibly different in magnitude from the risks of nontreatment, since most state-of-the-art treatments for premature infants hold great potential for unavoidable iatrogenic injury. Moreover, unless and until life-and-death decisionmaking is at issue, there are likely to be relatively few major value conflicts between parents and caregivers. In almost all cases, both seek to preserve the lives of premature infants as free as possible from impairment. The transparency model would require disclosure to parents of the physician's reasoning process regardless of whether the parents are thought likely to disagree.

The transparency model is also suited to settings where "the full process of informed consent for treatment ... occur[s] over several ... visits rather than at one single point in time." In the NICU the decisional relationship must be built from the ground up during the course of an infant's hospitalization, and built to withstand potentially devastating choices. The team already recognizes that this process takes time and must occur over several NICU visits. The complexity of the problems of prematurity likewise requires several visits to absorb, so that parental understanding of proposed treatments may be built upon an underlying understanding of the illness.

Perhaps most important, the transparency standard places emphasis not on technical information but on the physician's reasoning--that is to say, on the meaning and implications of technical information. The goal is not to give parents a "mini-course in medical education,"(14) but to give them the information they need to understand the basis for the team's beliefs and recommendations about their infant. The transparency standard is ideally suited to this end, and would go far toward providing parents with the kind of understanding they want and need. The transparency standard would also provide the team with an occasion to be explicit about the basis of its members' reasoning about an infant, up to and including the basis for any treatment withdrawal recommendations. Discussion of the team's reasoning with the parents would accord to them a greater place in decisionmaking from the outset of their infant's care, and thus better equip both team and parents for a more significant parental decisionmaking role should that become necessary.

In addition, the transparency model may make it easier for caregiving teams to overcome the sometimes artificial segregation of emotional and intellectual issues in decisionmaking. Many NICUs now provide social work services, chaplains, counselors, and parent help groups to offer parents support in bonding with their infants and coping with grief reactions. Yet this emphasis on emotional and psychological issues can obscure the necessary connection between the emotions and the intellect that is suggested by the transparency model. Because it takes account not only of data but also of the physician's cumulative experience, "gut feelings," and reasoning process, and attempts to share those with parents, the transparency standard can make an essential connection between data and its meaning, for parents and caregivers alike.(15)

Defining the Consent Relationship

The birth of a premature infant is always a tragedy, always an emergency, almost always a surprise, and it almost always requires parents to begin a new relationship with new caregivers, often overcoming barriers of geography and time to do so. Prematurity is medically complex, and there is still a paucity of good data as to both the short- and long-term outcomes for premature infants. The tertiary care setting is radically unfamiliar and potentially overwhelming. Finally, the patient and the decisionmaker are not the same. The patient is so newly a person that its own personality, interests, and desires are either unformed or unascertainable, and its parents often are so newly parents that the role of decisionmaker on behalf of their infant may itself be unfamiliar.(16)

Informed consent is the exercise of the patient's moral and legal right to control over his or her bodily integrity. To exercise any right effectively the holder of the right must understand it fully; yet many patients do not enter the physician-patient relationship with the understanding that they have this right. The disparity of knowledge between physician and patient, the authority of the physician in medical settings, and the urgency of many medical situations combine to reinforce the still-common misconception that by going to the doctor, or, especially, by coming to the hospital, patients put themselves entirely into the hands of the physician.

When the patient is an infant, the parents' sense of handing their infant over to the hospital's control may be very strong. Under these circumstances the physician has the fiduciary duty to establish a consent relationship with parents, discussing explicitly and clearly the parents' role in the decisionmaking process, as a necessary prerequisite to informed consent.(17) Parents must be told explicitly and repeatedly that they are the decisionmaking for their infant, and that the team's job is to work together with them to make the choices that are best for their infant. All of the team's language must be collaborative in nature, questions must be regularly encouraged by all teams members, and the team's genuine desire for the parents' participation must be reinforced repeatedly.

The intensive care setting simply does not invite family involvement, and all the good will in the world cannot overcome the impression of unavailability conveyed momentarily during a busy time. It can be difficult for caregivers to remember what a forbidding place the NICU is, and some may find it paternalistic to remind parents continually that it's okay to be involved. Yet in my observations it was not uncommon for parents to ask suddenly, well into an infant's hospitalization, "You mean it's okay to ask questions?"

In primary care contexts, many physicians offer patients and their families a choice of different degrees of involvement in decisionmaking. Deciding beforehand what form the relationship between parents and physicians will take can be extremely helpful to parents, as it takes their role seriously and requires from them a decision as to what it will be. Parents should understand that they are expected and encouraged to develop their capacities to take a full role in decisions, and that they will be supported in so doing.(18)

From the team's perspective, more is at issue here than simply giving parents a better explanation of their role in decisionmaking; rather, the team's own understanding of that role bears examination. To welcome parents into a fuller decisional role means to share decisional authority with them, which requires caregivers to relinquish some of their power. It means taking more time with parents during the critical initial hours and days of an infant's illness, and it means engaging in discussion not only about medical facts but also about the nature of the relationship between the team and the parents--an unfamiliar sort of discussion for which there are no ready models.

In a sense, however, a model for this discussion is provided by the individualized prognostic strategy. What distinguishes this medical decisionmaking strategy from the wait-until-certainty approach is its desire to avoid two errors: not only the death of an infant who could have survived without severe handicaps, but also the survival of an infant with overwhelming disabilities.(19) To apply the transparency model to discussion of the decisional relationship: when the team acknowledges these two risks of error to parents, the values on which the decisional relationship are based become explicit. This enables the parents to embrace or part company with the team's values in a fuller understanding of the real meaning and implications of either disvalued outcome. Dealing with uncertainty is unquestionably the most difficult decisional task of medicine; yet it too is a task that is best shared with those for whom the decision matters most.

Patients and families who feel disenfranchised from decisionmaking sometimes have a tendency to make use of the ultimate decisional authority they are accorded to dig in their heels and assert their power to be listened to and obeyed. Nobody is going to withhold or withdraw treatment without their consent, so they refuse to give it. These parents have to be shown that their authority is recognized without resort to such drastic measures. Sharing the decisionmaking process with them from the beginning--even when they appear reluctant to participate--is the best way to demonstrate to them that they have a place in it, and the transparency standard can help them to use their authority wisely and with understanding.

Sometimes, assertive parents work hard to make themselves central to the decisionmaking process. This is easiest to do when they are able to visit frequently and to ask questions. Assertive parents are often the ones who concentrate on the ventilator settings, blood oxygen saturation monitor readings, and other numbers, in a way that the team may feel demonstrates a misunderstanding of their importance. One morning when I accompanied the team on bedside rounds there was a discussion of such a family, whose minute concern about the ventilator settings was beginning to present a problem; every change in settings was challenged vociferously. One of the residents remarked, "How can we blame them for focusing on the numbers? That's what we talk to them about; that's what we've taught them." Although the team's own understanding may always be more complete than the family's, parents can learn, through the transparency model, to place the numbers in perspective.

By the same token, the family that takes an adversarial, divide-and-conquer posture, quizzing team members individually, exposing contradictions and disagreements and then complaining about inconsistencies, sometimes meets with a defensive response from a team that perceives its authority being challenged. An alternative approach is to recognize that the family is struggling with the meaning and significance of uncertainty in their child's care; they have not been led to expect disagreements or differences of opinion or practice within the team, and naturally conclude that somebody must be wrong. Parents who have been welcomed into a decisional relationship with the team may be able to appreciate more fully the realities of clinical decisionmaking, and to take a more positive decisional role.

Transparency in the NICU

The transparency model's great strength in the NICU and other critical proxy decisionmaking contexts is that it enables parents to take some part in the team's decisional process, even when the decisions are largely technical, by sharing with them the team's reasoning. This undoubtedly also helps prepare parents for decisions in which they must have a more significant role. The transparency model's capacity to reduce the temporal gap in understanding between physicians and parents can help to bring reality to parents' expectations from the beginning, and establish shared responsibility for all decisions, so that the decision to withdraw treatment is not treated differently from all others. This should reduce the likelihood of Case 2.

Case 2 is admittedly rare, however. Caregivers may fear the "bad baby syndrome" more; that is, they may be concerned that their attempts to paint a realistic picture for parents will backfire when it is time to take a surviving infant home, so that the parents lower their expectations too far and fail to stimulate the child's intellectual and physical development. The individualized prognostic strategy ought to work to minimize this risk as well, because its central tenet is that each infant must be individually assessed and individually treated. Parents take part in decisions about their infant as an individual in the NICU and should leave with the beginnings of the capacity to do the same at home.

Physicians who undertake by means of the transparency model to share with parents the entire decisionmaking process, including their initial period of assessment, will need to devise communication strategies that vary according to the situation and the needs of the parties involved, in the same way that a good informed consent process varies. What this sharing should accomplish is simple but significant: parents should not lag very far behind the team in their sense of their infant's illness and of what may be expected in the future. They will have experienced the team's changing views in a way that allows them to appreciate the commitment to give good care and to gather accurate information, and they are likely to be somewhat better prepared for unexpected reverses, because they have been learning how to cope with the uncertainties inherent in their infant's illness from the very beginning.

The task of helping parents become full partners in decisionmaking--informing, teaching, advising, and supporting them in their choices about their infant's care rather than merely asking them to ratify decisions already made by the caregiving team--is especially challenging, and especially important, in complex, emotionally charged care settings like the NICU. Conventional informed consent doctrine seems unsuited to this task, and is radically different in emphasis and goals from the transparency model of sharing the physician's reasoning with parents. There is, however, an important connection between the two. Conventional informed consent doctrine requires that, as decisionmakers, parents receive all information material to their decisions. Material information is not just the information that is pivotal to a decision, or the information that would result in a different choice; rather, it is all of the information that the decisionmaker considers significant enough not to want to do without, regardless of whether the choice is ultimately changed thereby.(20)

Thus, even though many parental decisions may ultimately be ratifications of the team's recommendations, material information must be communicated to them for all decisions. The transparency standard gives a meaningful form to the materiality requirement, by focusing on giving parents an understanding of the physician's reasoning. In this important respect, transparency is a means whereby the physician can understand and implement the requirements of conventional informed consent doctrine in a way best calculated to bring about a meeting of the minds between caregivers and patients. In the NICU, as in any decisional setting, this is surely one of informed consent's most elusive and sought-after goals.


This paper has benefitted greatly from the thoughtful critical commentary of Larry R. Churchill, Alan W. Cross, Arlene Davis, Ernest N. Kraybill, Ellyn Pearson, and Wes Boyd.


(1.) The Baby Doe controversy aroused concerns about the undertreatment of infants born with anomalies. See, among others, Nancy King, "Federal and State Regulation of Neonatal DecisionMaking," in Euthanasia and the Newborn: Conflicts Regarding Saving Lives, ed. R.C. McMillan, H.T. Engelhardt, Jr., and S. Spicker (The Netherlands: D. Reidel, 1987), pp. 89-115. In turn, concerns were raised about the overtreatment of extremely premature infants: Robert Stinson and Peggy Stinson, "On the Death of a Baby," The Atlantic Monthly 244 (1979): 64-72. The principal focus of ethical inquiry in neonatal settings has therefore been the appropriateness of decisions to withhold treatment, rather than the parents' role in decisions.

(2.) Nancy Rhoden, "Treating Baby Doe: The Ethics of Uncertainty," Hastings Center Report 16, no. 4 (1986): 34-42.

(3.) The literature is vast. See especially Loretta Kopelman, T. Irons, and Arthur Kopelman, "Neonatologists Judge the Baby Doe Regulations," NEJM 318 (1988): 677-83; Kathleen Nolan et al., "Imperiled Newborns," Hastings Center Report 17, no. 6 (1987): 5-32; and sources cited therein.

(4.) Nancy King, "Ethics Committees: Talking the Captain through Troubled Waters," in The Physician as Captain of the Ship: A Critical Reappraisal, ed. N. King, L. Churchill, and A. Cross. (The Netherlands: D. Reidel, 1988), pp. 223-41.

(5.) Alexander Capron first argued that informed consent would "encourage self-scrutiny" by physicians in his seminal 1974 article on the goals of informed consent, "Informed Consent in Catastrophic Disease Research and Treatment," University of Pennsylvania Law Review 123 (1974): 340-438, at 371-74.

(6.) Informed consent's beneficent and preventive functions were recognized by some eighteenth-and nineteenth-century physicians and in some early malpractice cases. See Ruth Faden, Tom Beauchamp, and Nancy King, A History and Theory of Informed Consent (New York: Oxford University Press, 1986), pp.64-67. Modern recognition of the preventive function of informed consent is often cast in terms of Jay Katz's influential writings on the sharing of uncertainty in The Silent World of Doctor and Patient (New York: Free Press, 1984).

(7.) Cf. Raymond Duff and Alexander Campbell, "Moral and Ethical Dilemmas in the Special-Care Nursery," NEJM 289 (1973): 890-94; and Thomas Gutheil, Harold Bursztajn, and Archie Brodsky, "Malpractice Prevention through the Sharing of Uncertainty: Informed Consent and the Therapeutic Alliance," NEJM 311 (1984): 49-51.

(8.) There were three intraventricular hemorrhages, two patent ductus arteriosus ligations, one instance of necrotizing enterocolitis, and pulmonary interstitial emphysema in the infant who died. Only two infants received courses of steroids, one had a moderately serious bilirubin problem, and one had recurrent pneumothoraces.

(9.) The influential court decision in Canterbury v. Spence, 464 F.2d 772, 787-88 (D.C. Cir. 1972), provides as good a summary of the doctrinal requirements as any.

(10.) Howard Brody, "Transparency: Informed Consent in Primary Care," Hastings Center Report 19, no. 5 (1989):5-9.

(11.) The "emergency exception" to the informed consent requirement thus permits physicians to act in the patient's best interests when there is no time to obtain informed consent. Alan Meisel, "The 'Exceptions' to the Informed Consent Doctrine: Striking a Balance between Competing Values in Medical Decision-making," Wisconsin Law Review 1979 (1979): 413-88, at 434-38.

(12.) President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Deciding to Forego Life-Sustaining Treatment (Washington, D.C.: U.S. Government Printing Office, 1983), pp. 214-19.

(13.) DHHS, Child Abuse and Neglect Prevention and Treatment Program, Final Rule, Federal Register 50 (15 April 1985), 14878-901, to be codified at 45 CFR 1340 et seq.

(14.) Cobbs v. Grant, 8 Cal.3d 244-45, 104 Cal. Rptr. 505, 502 P. 2d 1 (1972).

(15.) Cf. Faden et al., History and Theory of Informed Consent, at ch. 9, "Understanding," esp. pp. 316-26.

(16.) President's Commission, Deciding to Forego Life-Sustaining Treatment, p. 209.

(17.) Faden et al., History and Theory of Informed Consent, pp. 300-302, 314-15.

(18.) For an excellent discussion see Cathy Jones, "Autonomy and Informed Consent in Medical Decisionmaking: Toward a New Self-Fulfilling Prophecy," Washington and Lee Law Review 47 (1990): 379-430.

(19.) Nancy Rhoden, "Treating Baby Doe," p. 40.

(20.) Alan Meisel, "The Expansion of Liability for Medical Accidents: From Negligence to Strict Liability by Way of Informed Consent," Nebraska Law Review 56 (1977): 51-152, at 95-98, 107-13.
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Title Annotation:includes related article
Author:King, Nancy M.P.
Publication:The Hastings Center Report
Date:May 1, 1992
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