The Ethical Concept of the Fetus as a Patient
Frank A. Chervenak, M.D
Laurence B. McCullough, Ph.D.
Ethics is an essential dimension of obstetrical practice (1,2,3). In this paper, we have developed a framework for clinical judgment and decision-making about the ethical dimensions of the obstetrician-patient relationship. We emphasize a preventive ethics approach that appreciates the potential for ethical conflict and adopts ethically justified strategies to prevent those conflicts from occurring. We first define ethics, medical ethics, and the fundamental ethical principles of medical ethics, beneficence and respect for autonomy. We then show how these two principles should interact in obstetric judgment and practice, with emphasis on the core concept of the fetus as a patient.
Medical Ethics and Ethical Principles:
Ethics is the disciplined study of morality. Medical ethics is disciplined study of morality in medicine and concerns the obligations of physicians and health care organizations to patients as well as the obligations of patients (4). It is important not to confuse medical ethics with the many sources of morality in a pluralistic society, which include law, the world's religions, ethnic and cultural traditions, families, the traditions and practices of medicine (including medical education and training), and personal experience. Medical ethics since the eighteenth century European and American Enlightenments has been secular (5). It makes no reference to God or revealed tradition, but to what rational discourse requires and produces. Therefore, ethical principles and virtues should be understood to apply to all physicians, regardless of their personal religious and spiritual beliefs (6). The traditions and practices of medicine constitute an important source of morality for physicians, because they are based on the obligation to protect and promote the health-related interests of the patient. This obligation tells physicians what morality in medicine ought to be, but in very general, abstract terms. Providing a more concrete, clinically applicable account of that obligation is the central task of medical ethics, using ethical principles (4).
The Ethical Principle of Beneficence:
The ethical principle of beneficence requires one to act in a way that is expected reliably to produce the greater balance of benefits over harms in the lives of others (6). To put this principle into clinical practice requires a reliable account of the benefits and harms relevant to the care of the patient and of how those goods and harms should be reasonably balanced against each other when not all of them can be achieved in a particular clinical situation, such as a request for an elective cesarean delivery (7). In medicine, the principle of beneficence requires the physician to act in a way that is reliably expected to produce the greater balance of clinical benefits over harms for the patient (4).
Beneficence-based clinical judgment has an ancient pedigree, with its first expression found in the Hippocratic Oath and accompanying texts (8). It makes an important claim: to interpret reliably the health-related interests of the patient from medicine's perspective. This perspective is provided by accumulated scientific research, clinical experience, and reasoned responses to uncertainty. It is thus not the function of the individual clinical perspective of any particular physician and therefore should not be based merely on the clinical impression or intuition of an individual physician. On the basis of this rigorous clinical perspective, which should be based on the best available evidence, beneficence-based clinical judgment identifies the benefits that can be achieved for the patient in clinical practice based on the competencies of medicine. The benefits that medicine is competent to seek for patients are the prevention and management of disease, injury, handicap, and unnecessary pain and suffering and the prevention of premature or unnecessary death. Pain and suffering become unnecessary when they do not result in achieving the other goods of medical care, e.g., allowing a woman to labor without effective analgesia (4).
Non-maleficence means that the physician should prevent causing harm and are best understood as expressing the limits of beneficence. This is also known as "Premium non nocere" or "first do no harm." This commonly invoked dogma is really a Latinized misinterpretation of the Hippocratic texts which emphasized beneficence while avoiding harm when approaching the limits of medicine (4). It is important to note that there is an inherent risk of paternalism in beneficence-based clinical judgment. By this we mean that beneficence-based clinical judgment, if it is, mistakenly considered to be the sole source of moral responsibility and therefore moral authority in medical care, invites the unwary physician to conclude that beneficence-based judgments can be imposed on the patient in violation of her autonomy. Paternalism is a dehumanizing response to the patient and, therefore, should be avoided in the practice of obstetrics.
The preventive ethics response to this inherent paternalism is for the physician to explain the diagnostic, therapeutic, and prognostic reasoning that leads to his or her clinical judgment about what is in the interest of the patient so that the patient can assess that judgment for herself. This general rule can be put into clinical practice in the following way. The physician should disclose and explain to the patient the major factors of this reasoning process, including matters of uncertainty. In neither medical law nor medical ethics does this require that the patient be provided with a complete medical education (9). The physician should then explain how and why other clinicians might reasonably differ from his or her clinical judgment. The physician should then present a well-reasoned response to this critique. The outcome of this process is that beneficence-based clinical judgments take on a rigor that they sometimes lack, and the process of their formulation includes explaining them to the patient. It should be apparent that beneficence-based clinical judgment will frequently result in the identification of a continuum of clinical strategies that protect and promote the patient's health-related interests, such as the choice of preventing and managing the complications of menopause. Awareness of this feature of beneficence-based clinical judgment provides an important preventive ethics antidote to paternalism by increasing the likelihood that one or more of these medically reasonable, evidence-based alternatives will be acceptable to the patient. All beneficence-based alternatives must be identified and explained to all patients, regardless of how the physician is paid, especially those that are well established in evidence-based obstetrics and gynecology.
One advantage for the physician in carrying out this approach to communicating with the patient would be, we believe, to increase the likelihood of compliance (10). This is an especially pertinent consideration in gynecologic practice, where the patient often must monitor herself for clinical changes (e.g., a woman at risk for ectopic pregnancy) and take an active role in preventive medicine (e.g., breast self-examination) as well as in obstetric practice (e.g., self-observation for unusual weight gain or bleeding). Another advantage would be to provide the patient with a better-informed opportunity to make a decision about whether to seek a second opinion. The approach outlined above should make such a decision less threatening to her physician, who has already shared with the patient the limitations on clinical judgment.
The Ethical Principle of Respect for Autonomy:
In contrast to the principle of beneficence, there has been increasing emphasis in the literature of medical ethics on the principle of respect for autonomy (6). This principle requires one always to acknowledge and carry out the value-based preferences of the adult, competent patient, unless there is compelling ethical justification for not doing so, e.g., prescribing antibiotics for viral respiratory infections. The pregnant patient increasingly brings to her medical care her own perspective on what is in her interest. The principle of respect for autonomy translates this fact into autonomy-based clinical judgment. Because each patient's perspective on her interests is a function of her values and beliefs, it is impossible to specify the benefits and harms of autonomy-based clinical judgment in advance. Indeed, it would be inappropriate for the physician to do so, because the definition of her benefits and harms and their balancing are the prerogative of the patient. Not surprisingly, autonomy-based clinical judgment is strongly anti-paternalistic in nature (4).
To understand the moral demands of this principle, we need an operationalized concept of autonomy to make it relevant to clinical practice. To do this, we identify three sequential autonomy-based behaviors on the part of the patient: 1) absorbing and retaining information about her condition and alternative diagnostic and therapeutic responses to it; 2) understanding that information (i.e., evaluating and rank-ordering those responses and appreciating that she could experience the risks of treatment; and 3) expressing a value-based preference. The physician has a role to play in each of these. They are, respectively, 1) to recognize the capacity of each patient to deal with medical information (and not to underestimate that capacity), provide information (i.e., disclose and explain all medically reasonable alternatives, i.e., supported in beneficence-based clinical judgment), and recognize the validity of the values and beliefs of the patient; 2) not to interfere with but, when necessary, to assist the patient in her evaluation and ranking of diagnostic and therapeutic alternatives for managing her condition; and 3) to elicit and implement the patient's value-based preference (4).
The obligations in United States law of the physician regarding informed consent were established in a series of cases during the twentieth century. In 1914, Schloendorff v. The Society of The New York Hospital established the concept of simple consent, ie, whether the patient says "yes" or "no" to medical intervention (9,11). To this day in the medical and bioethics literature, this decision is quoted: "Every human being of adult years and sound mind has the right to determine what shall be done with his body, and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages" (11). The legal requirement of consent further evolved to include disclosure of information sufficient to enable patients to make informed decisions about whether to say "yes" or "no" to medical intervention (9).
There are two standards in United States law for such disclosure. The professional community standard, adopted by the minority of states in the United States, defines adequate disclosure in the context of what the relevantly trained and experienced physician tells patients. The reasonable person standard, which has been adopted by most states, goes further and requires the physician to disclose "material" information, what any patient in the patient's condition needs to know and the lay person of average sophistication should not be expected to know. This reasonable person has emerged as the ethical standard, and we therefore urge obstetricians to adopt it. On this standard, the physician should disclose to the patient her or the fetus's diagnosis (including differential diagnosis when that is all that is known), the medically reasonable alternatives to diagnose and manage the patient's condition, and the short-term and long-term benefits and risks of each alternative.
The Ethical Concept of the Fetus as a Patient:
There are obviously beneficence-based and autonomy-based obligations to the pregnant patient: the physician's perspective on the pregnant woman's health-related interests provides the basis for the physician's beneficence-based obligations to her, whereas her own perspective on those interests provides the basis for the physician's autonomy-based obligations to her. Because of an insufficiently developed central nervous system, the fetus cannot meaningfully be said to possess values and beliefs. Thus, there is no basis for saying that a fetus has a perspective on its interests. There can therefore be no autonomy-based obligations to any fetus. Hence, the language of fetal rights has no meaning and therefore no application to the fetus in obstetric clinical judgment and practice despite its popularity in public and political discourse in the United States and other countries. Obviously, the physician has a perspective on the fetus's health-related interests, and the physician can have beneficence-based obligations to the fetus, but only when the fetus is a patient. Because of its importance for obstetric clinical judgment and practice, the topic of the fetus as a patient requires detailed consideration (4).
The ethical concept of the fetus as a patient is essential to obstetric clinical judgment and practice. Developments in fetal diagnosis and management strategies to optimize fetal outcome have become widely accepted, encouraging the development of this concept. This concept has considerable clinical significance because, when the fetus is a patient, directive counseling, that is, recommending a form of management, for fetal benefit is appropriate, and when the fetus is not a patient, nondirective counseling that is, offering but not recommending a form of management for fetal benefit is appropriate. However, there can be uncertainty about when the fetus is a patient. One approach to resolving this uncertainty would be to argue that the fetus is or is not a patient in virtue of personhood, or some other form of independent moral status. We now show that this approach fails to resolve the uncertainty, and we therefore defend an alternative approach that does resolve the uncertainty.
The Independent Moral Status of the Fetus:
One prominent approach for establishing whether or not the fetus is a patient has involved attempts to show whether or not the fetus has independent moral status. This is the approach to the moral status of the fetus taken in Roman Catholic moral theology. This is the first sense of the concept of the fetus as a patient. Independent moral status for the fetus means that one or more characteristics that the fetus possesses in and of itself and, therefore, independently of the pregnant woman or any other factor, generate and therefore ground obligations to the fetus on the part of the pregnant woman and her physician.
Many fetal characteristics have been nominated for this role, including moment of conception, implantation, central nervous system development, quickening, and the moment of birth. It should come as no surprise that there is considerable variation among ethical arguments about when the fetus acquires independent moral status. Some take the view that the fetus has independent moral status from the moment of conception or implantation. Others believe that independent moral status is acquired in degrees, thus resulting in "graded" moral status. Still others hold, at least by implication, that the fetus never has independent moral status so long as it is in utero (12,13).
Despite an ever-expanding theological and philosophical literature on this subject, there has been no closure on a single authoritative account of the independent moral status of the fetus. This is an unsurprising outcome because, given the absence of a single method that would be authoritative for all of the markedly diverse theological and philosophical schools of thought involved in this endless debate, closure is impossible. For closure ever to be possible, debates about such a final authority within and between theological and philosophical traditions would have to be resolved in a way satisfactory to all, an inconceivable intellectual and cultural event. In its first sense, that of the independent moral status of the fetus, the fetus as a patient has no stable or clinically applicable meaning. We therefore abandon these futile attempts to understand the fetus as a patient in terms of independent moral status of the fetus and turn to an alternative approach that makes it possible to identify ethically distinct senses of the fetus as a patient and their clinical implications for directive and nondirective counseling.
The Dependent Moral Status of the Fetus:
Our analysis of this second sense of the concept of the fetus as a patient begins with the recognition that being a patient does not require that one possess independent moral status. Rather, being a patient means that one can benefit from the applications of the clinical skills of the physician. Put more precisely, a human being without independent moral status is properly regarded as a patient when two conditions are met: that a human being 1) is presented to the physician, and 2) there exist clinical interventions that are reliably expected to be efficacious, in that they are reliably expected to result in a greater balance of clinical benefits over harms for the human being in question (14). This is the second sense of the concept of the fetus as a patient, what we call the dependent moral status of the fetus.
The authors have argued elsewhere that beneficence-based obligations to the fetus exist when the fetus is reliably expected later to achieve independent moral status as a child and person (4). That is, the fetus is a patient when the fetus is presented for medical interventions, whether diagnostic or therapeutic, that reasonably can be expected to result in a greater balance of goods over harms for the child and person the fetus can later become during early childhood. The ethical significance of the concept of the fetus as a patient, therefore, depends on links that can be established between the fetus and its later achieving independent moral status.
The Viable Fetal Patient:
One such link is viability. Viability , however, must be understood in terms of both biological and technological factors. It is only by virtue of both factors that a viable fetus can exist ex utero and thus achieve independent moral status. When a fetus is viable, that is, when it is of sufficient maturity so that it can survive into the neonatal period and achieve independent moral status given the availability of the requisite technological support, and when it is presented to the physician, the fetus is a patient. Viability exists as a function of biomedical and technological capacities, which are different in different parts of the world. As a consequence, there is, at the present time, no worldwide, uniform gestational age to define viability. In the United States, we believe, viability presently occurs at approximately 24 weeks of gestational age (15).
When the fetus is a patient, directive counseling for fetal benefit is ethically justified. In clinical practice, directive counseling for fetal benefit involves one or more of the following: recommending against termination of pregnancy; recommending against non-aggressive management; or recommending aggressive management. Aggressive obstetric management includes interventions such as fetal surveillance, tocolysis, cesarean delivery, or delivery in a tertiary care center when indicated. Non-aggressive obstetric management excludes such interventions. Directive counseling for fetal benefit, however, must take account of the presence and severity of fetal anomalies, extreme prematurity, and obligations to the pregnant woman.
It is very important to appreciate in obstetric clinical judgment and practice that the strength of directive counseling for fetal benefit varies according to the presence and severity of anomalies. As a rule, the more severe the fetal anomaly, the less directive counseling should be for fetal benefit. In particular, when lethal anomalies such as anencephaly can be diagnosed with certainty, there are no beneficence-based obligations to provide aggressive management. Such fetuses are dying patients, and the counseling, therefore, should be nondirective in recommending between non-aggressive management and termination of pregnancy, but directive in recommending against aggressive management for the sake of maternal benefit (16). By contrast, third-trimester abortion for Down Syndrome or achondroplasia is not ethically justifiable, because the future child with high probability will have the capacity to grow and develop as a human being (17,18).
Directive counseling for fetal benefit in cases of extreme prematurity of viable fetuses is appropriate. In particular, this is the case for what we term just-viable fetuses, those with a gestational age of 24 to 26 weeks, for which there are significant rates of survival but high rates of mortality and morbidity. These rates of morbidity and mortality can be increased by non-aggressive obstetric management, whereas aggressive obstetric management may favorably influence outcome. Thus, it appears that there are substantial beneficence-based obligations to just-viable fetuses to provide aggressive obstetric management. This is all the more the case in pregnancies beyond 26 weeks of gestational age. Therefore, directive counseling for fetal benefit is justified in all cases of extreme prematurity of viable fetuses, considered by itself. Of course, such directive counseling is appropriate only when it is based on documented efficacy of aggressive obstetric management for each fetal indication. For example, such efficacy has not been demonstrated for routine cesarean delivery to manage extreme prematurity.
Any directive counseling for fetal benefit must occur in the context of balancing beneficence-based obligations to the fetus against beneficence-based and autonomy-based obligations to the pregnant woman. Any such balancing must recognize that a pregnant woman is obligated only to take reasonable risks of medical interventions that are reliably expected to benefit the viable fetus or child later. A unique feature of obstetric ethics is that the pregnant woman's autonomy influences whether, in a particular case, the viable fetus ought to be regarded as presented to the physician.
Obviously, any strategy for directive counseling for fetal benefit that takes account of obligations to the pregnant woman must be open to the possibility of conflict between the physician's recommendation and a pregnant woman's autonomous decision to the contrary. Such conflict is best managed preventively through the informed consent process as an ongoing dialogue throughout a woman's pregnancy, augmented as necessary by negotiation and respectful persuasion (19).
The Pre-viable Fetal Patient:
The only possible link between the pre-viable fetus and the child it can become is the pregnant woman's autonomy. This is because technological factors cannot result in the pre-viable fetus becoming a child. The link, therefore, between a fetus and the child it can become when the fetus is pre-viable can be established only by the pregnant woman's decision to confer the status of being a patient on her pre-viable fetus. The pre-viable fetus, therefore, has no claim to the status of being a patient independently of the pregnant woman's autonomy. The pregnant woman is free to withhold, confer, or, having once conferred, withdraw the status of being a patient on or from her pre-viable fetus according to her own values and beliefs. The pre-viable fetus is presented to the physician as a function of the pregnant woman's autonomy (4).
For pregnancies in which the woman is uncertain about whether to confer such status, the authors propose that the fetus be provisionally regarded as a patient. This justifies directive counseling against behavior that can harm a fetus in significant and irreversible ways, e.g., substance abuse, especially alcohol, until the woman settles on whether to confer the status of being a patient on the fetus.
In particular, nondirective counseling is appropriate in cases of what we term near-viable fetuses, that is, those that are 22 to 23 weeks of gestational age, for which there are anecdotal reports of survival (15,20). In our view, aggressive obstetric and neonatal management should be regarded as clinical investigation (i.e., a form of medical experimentation), not a standard of care. There is no obligation on the part of a pregnant woman to confer the status of being a patient on a near-viable fetus because the efficacy of aggressive obstetric and neonatal management has yet to be proven.
The In Vitro Embryo as a Patient:
A subset of pre-viable fetuses as patients concerns the in vitro embryo. It might seem that the in vitro embryo is a patient because such an embryo is presented to the physician. However, for beneficence-based obligations to a human being to exist, medical interventions must be reliably expected to be efficacious. Recall that, in terms of beneficence, whether the fetus is a patient depends on links that can be established between the fetus and its eventual independent moral status. Therefore, the reasonableness of medical interventions on the in vitro embryo depends on whether that embryo later becomes viable. Otherwise, no benefit of such intervention can meaningfully be said to result. An in vitro embryo, therefore, becomes viable only when it survives in vitro cell division, transfer, implantation, and subsequent gestation to such a time that it becomes viable. The process of achieving viability occurs only in vivo and is therefore entirely dependent on the woman's decision regarding the status of the fetus(es) as a patient, should assisted conception successfully result in the gestation of the pre-viable fetus(es). Whether an in vitro embryo will become a viable fetus, and whether medical intervention on such an embryo will benefit the fetus, are both functions of the pregnant woman's autonomous decision to withhold, confer, or, having once conferred, withdraw the moral status of being a patient on the pre-viable fetus(es) that might result from assisted conception.
It therefore is appropriate to regard the in vitro embryo as a pre-viable fetus rather than as a viable fetus. As a consequence, any in vitro embryo(s) should be regarded as a patient only when the woman into whose reproductive tract the embryo(s) will be transferred confers that status. Thus, counseling about preimplantation diagnosis should be nondirective. Preimplantation diagnostic counseling should be nondirective because the woman may elect not to implant abnormal embryos. These embryos are not patients, and so there is no basis for directive counseling. Information should be presented about prognosis for a successful pregnancy and the possibility of confronting a decision about selective reduction, depending on the number of embryos transferred. Counseling about how many in vitro embryos should be transferred should be rigorously evidence-based (21).
In this paper, we have provided an ethical framework for obstetric clinical judgment and practice, with particular emphasis on the ethical concept of the fetus as a patient. Implementing this ethical framework on a daily basis is essential to creating and sustaining the physician-patient relationship in obstetrics. This framework emphasizes preventive ethics, i.e., an appreciation that the potential for ethical conflict is built into clinical practice and the use of such clinical tools as informed consent and negotiation to prevent such conflict from occurring. This framework comprehensively appeals to the ethical principles of beneficence and respect for autonomy and shows how they shape the ethical concept of the fetus as a patient, which is an essential ethical concept for obstetrical practice. We believe that this ethical framework is not limited to medical ethics or obstetric practice in the United States, but apply in other countries as well.