Medical Ethics and Bioethics: New Challenges in Perinatal Medicine

Limitations of Bioethics

The distinctive strength of bioethics is that is a pluralistic field. This strength is also a weakness. Like medical ethics, bioethics is neither transcultural, transnational nor transreligious.

Bioethics and Religious Beliefs and Traditions

In sometimes subtle, religious belief has been employed as the methodological basis of bioethics. Consider, for example, the “right to life” position on the morality of abortion.⁹ Advocates of this position typically assert that the fetus is an unborn child and has a right to life.

Such a view holds, in effect, that the fetus independently possesses the right to life on grounds that all should accept. It is plain that there are serious problems with this view.

First, the philosophical grounds for independent rights of the fetus are endless dispute.¹⁰ Second, in the Judeo-Christian tradition with its emphasis on stewardship over life as a gift from God, there is no independent right to life on the part of human beings.

By attending to these problems, we are in a position to see that advocates of the right to life position must either claim grounds for the independent rights of the fetus that are beyond dispute or acknowledge that the Judeo-Christian tradition would frame matters in very different ways. Namely, in terms of our dependence on God, the fetus’ theologically dependent moral status.^11,12

There is yet another problem: “right to life” does not refer to a single right but, in our view, to at least three. These are¹ the right not to be killed unjustly,² the right not to have technological, and other basic life supports discontinued unjustly, and³ the right to have all such basic life supports continued for as long as it is reasonable to do so. These rights, however, make different demands upon the pregnant woman. For example, the first version seems limited by very few exceptions, whereas the third version must admit to many exceptions. The right to life movement thus suffers from a lack of clarity about the concept of a right to life and its clinical, ethical, and legal implications.

Another problem with basing bioethics on theological grounds is the use of theological concepts as if they are secular philosophical concepts. This problem is illustrated in the work of Evans and Fletcher, who appeal, for example, to a “graded” moral status of the fetus as the basis for their evaluation of selective termination of multifetal pregnancies.¹³ The source for this concept, as is plain from their reliance on a key reference,¹⁴ is the history of Christian theology. Evans and Fletcher do not appeal to secular philosophical foundations for independent moral status of the fetus. Gynecologic and obstetric ethics rely crucially on theological bases should be clearly defined as such and its limited applicability in a pluralistic society.¹⁵

In summary, making religious beliefs the methodological basis of obstetric ethics imposes serious limitations on bioethics, because of an appeal to foundations that cannot be expected to be accepted in a pluralistic society. This is because bioethics based on religious belief requires all to accept¹ the existence of a deity or some equivalent transcendent reality and² a particular interpretation within a particular faith community. Key theological concepts that are employed in debates about ethical issues in obstetrics, such as the right to life, are equivocal. Approaches to bioethics that rely on theological foundations are flawed.

Despite these shortcomings, religious beliefs provide an important reference point for bioethics. Religious beliefs can be a major source of influence on the values and beliefs of physicians and patients. The role of religious beliefs in the formation of what we term the physician’s “private conscience” will be crucial for the discussion of abortion. The importance of religious beliefs for the values and beliefs of patients cannot be emphasized enough. The obligation of the physician to respect the integrity of the patient’s religious beliefs helps to underscore the concrete meaning and application of the ethical principle of respect for autonomy. The crucial role of religious beliefs in clinical practice has only recently received attention in bioethics.^1,16

Bioethics and the Law

The law has been employed prominently as a basis of bioethics. This is not surprising, given the high frequency of malpractice suits. There is thus a tendency on the part of some physicians in obstetric practice to equate ethical conduct, with what the law permits and unethical conduct, with what the law prohibits. In the literature, there has been a strong association between bioethics and the law. Elias and Annas argue on the basis of court opinions and hold that all obstetric ethics can be summarized in a single legal rule: respect for the liberty and rights of the pregnant woman.¹⁷

The problem with taking the law as the basis of obstetric ethics are several. Firstly, the law is primarily reactive. That is, the law—both the common law, written by courts and statutory law, enacted by legislatures—responds to civil complaints of issues that attract significant public attention. The law addresses those complaints, with a view to resolving them. This preventive dimension of the law is mainly negative in character, that is, providing incentives to avoid legally culpable action. This preventive dimension of law has led to a considerable emphasis on “defensive” medical practice. Such practice increasingly focuses the concern of the physician on protecting him or herself, rather than protecting the interests of patients. A truly preventive posture would focus primarily on the latter, thus emphasizing the prevention of ethical conflict in obstetric practice as a primary consideration. The clinical strategies of preventive ethics are essential to obstetric practice.

Secondly, the law is incomplete. For example, some state courts have issued court orders for cesarean delivery for fetal distress of placenta previa.¹⁸ However, no court has addressed, or is likely to address, a pregnant woman’s disinclination to maintain an excellent record of conduct during her pregnancy.

Thirdly, the law is largely silent on the virtues that physicians in obstetric practice ought to cultivate. Fourth, the law is subject to internal conflict. On the one hand, statutory governing publicly funded health care seems to obligate physicians to do less for their patients. On the contrary, the common law of malpractice seems to obligate physicians to do more.

In summary, making the law the basis of bioethics imposes serious limitations because it burdens bioethics unnecessarily by putting it at risk of being reactive. The law is also incomplete, and inconsistent.

Nevertheless, there are some areas in which the law is settled, for example, informed consent for invasive procedures on competent patients. Well-established law commands respect in a democratic society. To think, therefore, that obstetric ethics is intellectually autonomous from matters of settled law involves serious misconceptions in obstetric ethics. For example, to articulate ethical principles or “conditions” for ethically justified invasive clinical research in normal pregnant women without situating those principles within the settled body of statutory and regulatory law protecting human research subjects, as some have done,¹⁹ involves this misconception.

Despite the shortcoming, the law does provide two valuable reference points for bioethics. Firstly, in the discussion above of the principle of respect for autonomy, we saw that the law is crucial for understanding one dimension of the ethical principle of respect for autonomy, namely, autonomy as self-determination.

Secondly, in the law, the physician-patient relationship is understood to be a fiduciary relationship. Such a relationship presupposes, the virtues of self-effacement, self-sacrifice, compassion, and integrity. The law cannot, however, provide an ethical account of those virtues and so the law must be supplemented by philosophy. In the absence of those virtues, the physician-patient relationship is merely contractual, to which sort of relationship the law is just barely adequate, because the legal relationship in a contract is minimal, lacking the fuller legal dimensions of a fiduciary relationship.

Embryo and the Fetus and Concepts of Medical Ethics

To talk of the embryo and the fetus as a patient is to use the concepts of medical ethics. This is because protecting and promoting the interests of the patient have constituted the foundation for medical ethics since the days of the Hippocratic Oath.³⁶

In the ancient version of the Oath, the physician swore to do what would benefit the sick, while preventing harm to them.³⁶ In the technical language of ethics, the Oath should be understood in terms of beneficence-based ethical obligations to patients: the physician is to act in such a way as to produce a greater balance of “goods” over “harms,” as goods and harms are understood from a clinical perspective.^37,38 Over the centuries, the definition of these goods and harms has been clarified on the basis of what medicine as a profession can claim as competencies. The authors believe that the goods that medicine is competent to achieve are the prevention of premature death and the prevention, cure, or at least management of disease, injury, handicap, and unnecessary pain and suffering.^20,26 Pain and suffering are sometimes a necessary price to be paid in the attempt to achieve the other goods of medicine. Acting on these goods provides concrete meaning to the fundamental ethical obligation of protecting and promoting the interests of patients.

Beneficence-based clinical judgment and ethical obligations were the whole of medical ethics until recently. Under United States common law and ethics, medical ethics has increasingly come to acknowledge the importance of the patient’s perspective on her interests.^20,39 The patient is able to form her own judgments about her interests on the basis of her own values and express those judgments in value-based preferences. The ethical principle of respect for autonomy translates this fact into autonomy-based ethical obligations: to acknowledge the integrity of the patient’s values in her life, elicit the patient’s value-based preferences, and to assist the patient to put her preference(s) into effect.

Following a well-established and respected ethical theory,⁴⁰ the authors take the view that autonomy-based obligations are theoretically equally weighted with beneficence-based obligations.^20,37 Beneficence-based and autonomy-based obligations are prima facie: the former cannot be thought automatically to over-ride the latter, nor vice versa.^{20,37,38,41,42}

The concepts of autonomy-based clinical judgment and ethical obligations and of beneficence-based clinical judgment and ethical obligations provide a framework in terms of which the concept of the fetus as a patient can be articulated and its clinical implications identified in terms of concrete ethical obligations of the physician to the fetus and to the pregnant woman.^19,35,41

The Ethical Concept of the Embryo and the Fetus as a Patient

One prominent approach to understanding the concept of the embryo and the fetus as a patient has involved attempts to show whether or not the fetus has independent moral status.^13,14,42-50 Independent moral status for the embryo and the fetus would mean that one or more of the characteristics possessed either in, or of the fetus itself and, therefore, independently of the pregnant woman or any other factor, generate and therefore, ground obligations to the embryo and the fetus on the part of the pregnant woman and her physician.

A wide range of intrinsic characteristics has been considered for this role.^10,11,51 Given the variability of proposed characteristics, there are many views about when the fetus does or does not acquire independent moral status. Some take the view that the fetus possesses independent moral status from the moment of conception or implantation.^9,52,53 Others believe that the embryo and the fetus acquire independent moral status in degrees, thus resulting in “graded” moral status.^14,17,13 Still others hold, at least implicitly, that the embryo and the fetus never have independent moral status so long as it is in utero.¹⁷

Despite a voluminous philosophical and theological literature on this subject, there has been no agreement on a single authoritative account of the independent moral status of the embryo and the fetus.^54,55 This outcome should surprise no one, given the absence of a single methodology that would be authoritative for all of the markedly diverse theological and philosophical schools of thought involved in this centuries-old debate. In the absence of such a methodology, agreement on the independent moral status of the embryo and the fetus should not be expected. For agreement ever to be possible, intramural and transmural debates about such a final authority within and between theological and philosophical traditions would have to be resolved. This is an inconceivable event. It is best, therefore, to set aside futile attempts to understand the embryo and the fetus as a patient in terms of whether or not the embryo and the fetus possesses independent moral status and turn to an alternative approach. This approach makes it possible to identify ethically distinct senses of the embryo and the fetus as a patient and their clinical implications. We need to ask not “Does the embryo and the fetus have independent moral status?” but, as Warnock puts it, “How ought we to treat the fetus?”^55,56

This alternative approach starts with the recognition that being a patient does not require independent moral status.⁴⁹ Instead, being a patient means that one can benefit from the application of the skills of the physician. A human being without independent moral status is properly regarded as a patient when a human being is presented to the physician for the purpose of applying interventions that are reliably expected to result in a greater balance of goods over harms in the future of the human being in question.^20,35

An individual is a patient when a physician has beneficence-based ethical obligations to that individual. There have been some discussions about the fetus as a patient.^57,58 More recently, the senses in which beneficence-based approaches illuminate the concept of the embryo and the fetus as a patient have been identified.^20,35

Because the independent moral status of the fetus cannot be established, there can be no autonomy-based obligations to the fetus. To clarify the concept of the fetus as a patient, it is, therefore, appropriate to turn to an account of when there are beneficence-based obligations to the fetus.

The authors have argued elsewhere that beneficence-based obligations to the fetus exist when the fetus can achieve independent moral status, which occurs in early childhood.²⁰ That is, the fetus is a patient when medical interventions, reasonably can be expected to result in a greater balance of goods over harms in the future of the fetus, when there is independent moral status. The ethical significance of the concept of the fetus as a patient depends on links that can be established between the fetus and the ability to later achieve its independent moral status.

The Viable Embryo and the Fetus as a Patient

One such link is viability. Viability, however, cannot be understood as an intrinsic property of the fetus because viability must be understood in terms of both biological and technological factors.^55,59,60 Both factors are required for a viable fetus to exist ex utero and thus later achieve its independent moral status. These two factors do not exist as a function of the autonomy of the pregnant woman. When a fetus is viable, i.e., when it is of sufficient maturity so that it can survive into the neonatal period and later achieve independent moral status, the fetus is a patient.^20,61 Any beneficence-based obligation to the viable fetus must be negotiated with beneficence-based and autonomy-based obligations to the pregnant woman.⁴¹

Viability thus exists partly as a function of biomedical capacities, which are different in different parts of the world. As a consequence, there can be no worldwide uniform gestational age to define viability. In the United States, the authors believe that viability presently occurs at approximately 23–24 weeks of gestational age, while in the recent data from Sweden, it is 22 gestational weeks.^61-63

The Previable the Embryo and the Fetus as a Patient

The only possible link between the previable fetus and its ability to later achieve independent moral status is the pregnant women’s autonomy, which provides the sole basis for the second ethical sense of the fetus as a patient. Technological factors alone cannot result in the previable embryo and fetus later achieving independent moral status. This is simply what previable means. A link, therefore, between a previable embryo and fetus and the later achievement of its independent moral status can be established only by the pregnant woman’s decision to confer the status of being a patient on her previable fetus. The previable fetus has no claim to the status of being a patient independently of the pregnant woman’s autonomy. It follows that the pregnant woman is free to withhold, confer, or having once conferred, withdraw the status of being a patient on or from her previable fetus. The previable embryo and fetus is a patient solely as a function of the pregnant woman’s autonomy.^16,20,62

A subset of the second sense of the fetus as a patient includes in vitro embryos. Simply being presented to a physician does not make the in vitro embryo a patient. This is because, in terms of beneficence, whether the fetus is a patient depends also on links that can be established between the fetus and its future i.e., later achieving its 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 results.

This process of achieving viability occurs in vivo and is therefore entirely dependent on the woman’s decision regarding the status of the fetus(es) as a patient. Whether an in vitro embryo will benefit the fetus are both functions of the pregnant woman’s decision to withhold, confer, or having once conferred, withdraw the moral status of being a patient on or from the previable fetus(es) that might result from assisted conception. It is, therefore, appropriate to regard the in vitro embryo as a previable. 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 such status.^16,20

In summary, the viable fetus is a patient. The previable fetus including the in vitro embryo is a patient solely as a function of the exercise of the woman’s autonomy.

An Ethical Standard of Care for Fetal Therapy

Whether invasive fetal therapy can be judged to be a standard of care on ethical grounds depends on the clinical implications of the concept of the fetus as a patient. Such fetal therapy must reliably be thought of on the basis of documented clinical experience to benefit the child that the fetus can become. Recall that the ethical content of this concept is to be understood in terms of whether clinical intervention on the embryo and the fetus are reliably thought to be efficacious.

Satisfying this condition establishes an ethical standard of care for fetal therapy in its initial, beneficence-based sense. This ethical concept of standard of care, however, cannot be completely understood until its autonomy-based dimensions are considered.

The pregnant woman is under no ethical obligation to confer the status of being a patient on her previable fetus simply because there exists a fetal therapy. Whether such therapy is to be judged as an ethical standard of care for her fetus is also a function of the pregnant woman’s autonomy. Thus, the satisfaction of beneficence and autonomy-based conditions is necessary for fetal therapy to be reliably judged to be an ethical standard of care for fetuses.

The same is true for fetal therapy on the viable fetus. However, as noted above, beneficence-based obligations to the fetus must be negotiated with beneficence-based and autonomy-based obligations to the pregnant woman. This is because of a factual consideration—fetal therapy necessarily involves physical and perhaps, mental health risks to the pregnant woman—and an ethical consideration—she is ethically obliged only to accept reasonable risks to herself in order to attempt to benefit her fetus.^20,41

This helps to distinguish an ethical from a legal standard of care for fetal therapy. An ethical standard must take account not only of beneficence-based considerations applied to the embryo and the fetus but also of both beneficence-based and autonomy-based considerations applied to the pregnant woman. A legal standard of care tends only to focus on efficacy and safety, which are beneficence-based considerations applied to both the fetus and, perhaps, the pregnant woman. The legal standard of care tends to ignore autonomy-based considerations. This constitutes the fundamental difference between a legal and an ethical standard of care for fetal therapy.

Therapy and Experimental Therapy for the Viable Fetal Patient

There is no simple algorithm by which a pregnant woman or her physician can reach the judgment that she is obliged to accept risk to herself on behalf of her viable fetus. In the authors’ view, such an ethical obligation—which should not be equated automatically with a legal obligation—exists when three criteria are satisfied. The first criterion concerns the outcome of the procedure for the fetus and the child it can become. The other two criteria concern risks of harm for the viable fetus and the child it can become as well as the pregnant woman. The three criteria are the following:

• When invasive therapy of the viable embryo and fetus has a very high probability of being life-saving or preventing serious and irreversible disease, injury, or handicap for the embryo and the fetus and for the child the embryo and the fetus can become;

• When such therapy involves low mortality risk and low or manageable risk of serious disease, injury, or handicap to the viable fetus and the child it can become; and

• When the mortality risk to the pregnant woman is very low, and when the risk of disease, injury, or handicap to the pregnant woman is low or manageable.^20,35

The justifications for these criteria are both beneficence- and autonomy-based. When the first two criteria are satisfied, there is a clear and substantial benefit to the viable fetal patient. When the third criterion is satisfied there is no clear and substantial net harm to the pregnant woman. Given the expected net benefit to the viable fetal patient and the low risk of harm to the pregnant woman, the latter are risks she should reasonably be expected to accept.^20,41 This moral fact shapes how she should exercise her autonomy in response to her beneficence-based fiduciary ethical obligations to her fetus.

Under beneficence and autonomy-based clinical judgment, therefore, treatment of the viable fetal patient is warranted when these three criteria are satisfied. The burden of ethical proof rests with those who would propose further ethical obligations when one or more of these three criteria cannot be satisfied.

When the pregnant woman is ethically obliged to accept fetal therapy of her viable fetal patient, such management is ethical, though not necessarily legal, judged to be a justified ethical standard of care. Any forms of fetal therapy for which an ethical obligation (as defined above) on the part of the pregnant woman to accept them cannot be established must be regarded as experimental. For example, open abdominal fetal surgery involves significant risks to the fetus and risks that no pregnant woman can be understood, at this time. To be obliged to accept on behalf of an attempt to benefit her viable fetus, all such surgery must, on ethical grounds, be regarded as experimental.

In the case of a viable fetal patient, the physician is ethically justified in recommending fetal therapy. There is a vital role in this process for the exercise of the woman’s autonomy in assessing the risks and benefits to herself and to her fetus. These matters should be explained carefully to the pregnant woman. The benefits and risks of both invasive and noninvasive fetal therapy should be explained without bias to the pregnant woman. She should be given time to reflect, consult with those close to her or other physicians, and reach her own decision.

How should the physician respond if the pregnant woman rejects fetal therapy of a viable fetus that satisfies an ethically justified standard of care? Certainly, informed consent as an ongoing dialogue with the pregnant woman should be the first response. In undertaking a further response—negotiation, the physician should acknowledge and take consider the pregnant woman’s assessment of the risks and benefits of fetal therapy to herself and her fetus. It may be justified to go beyond negotiation to respectful persuasion, and perhaps even to an ethics committee, as part of a preventive ethics clinical strategy.⁶⁴

Whether a resort should be made to legal intervention is a matter of considerable dispute in the literature on the intrapartum management of pregnancy.^65-67 Given the newness of much fetal therapy, especially invasive fetal therapy, and the fact that few forms of such therapy satisfy all three criteria for an ethical standard of care, this is an uncertain area to respond to. It is also unlikely whether resorting to legal intervention bodes well for the future development of new experimental forms of fetal therapy.

Experimental therapy for the viable fetus can be offered to the pregnant woman. That is, unlike the case of “standard of care” therapy, there is no ethical justification to recommend experimental fetal therapy because there is no clear net benefit to the fetus or there is a clear net harm to the pregnant woman. Moreover, experimental therapy can be offered with ethical confidence only if there is a formal, scientifically sound protocol for the research and that protocol has been approved by the appropriate institutional review process. Obviously, discussion of experimental fetal therapy with the pregnant woman should be rigorously nondirective.^20,68

Therapy and Experimental Therapy for the Previable Embryo and Fetal Patient

There are two subgroups of previable fetuses. The first comprises those upon whom the pregnant woman has conferred the status of being a patient. When she has done so and the three criteria for an ethical standard of fetal therapy are also satisfied, then it is ethically justified to recommend fetal therapy. When one or more of the three criteria are not satisfied, fetal therapy should be regarded as experimental and should only be offered, not recommended to the pregnant woman.

When the pregnant woman withholds or withdraws the status of being a patient from her previable embryo and fetus, all counseling should be nondirective, even when the three criteria for an ethically justified standard of care for fetal therapy are met.^20,68 This is because there is no ethical obligation on the part of the pregnant woman or the physician to regard the previable embryo and fetus as a patient. It follows that any discussion of experimental fetal therapy must be strictly nondirective.