Spring 2003 Vol. 10, Issue 2
The news that something has gone wrong in one's pregnancy will be devastating to a woman. Experts may refer to "a fetal anomaly," "a fetal patient," and discuss the possibility of experimental "maternal-fetal surgery," but these words cannot begin to capture the anguish and anxiety of the situation. Nor can the dreadful choices presented to a pregnant woman with a damaged fetus be fully conveyed by the term of "informed consent." Decisions to be made in such cases are emotionally charged and present excruciating moral dilemmas.
Such dilemmas have appeared in the developed world as part of the modernization and medical control of reproduction. The possibility of innovative, sophisticated technologies of maternalfetal surgery have only emerged in the wake of the reduction of infant mortality, the development of the medical specialty of obstetrics, and new technologies of fetal monitoring and ultrasonography. The ready availability of contraception and legal access to elective abortion has further complicated childbearing decisions. The landscape of family formation has been forever changed.
At the same time a new awareness of the maternal-fetus relationship has emerged in many fields from feminist theory, psychosocial research and evolutionary biology. Today it is clear that there can exist female ambivalence toward childbearing and the potential for different kinds of maternal-fetal conflict. Yet epidemics of infertility and other cultural developments that newly enhance the value of children have raised the stakes in women's reproductive decisions. Maternal satisfactions are newly appreciated and parental altruism can be seen as the mainstay of social and biological flourishing.
For both biological and cultural reasons women will invest enormous effort and energy in childbearing and child rearing. They have a strong drive to protect their offspring and can identify with the fetus as their own flesh and blood. Maternal bonding with a fetus can begin early and be strengthened by ultrasound images. Women's emancipation and freedom to choose can make their desires for children more intense. Fortunately, new respect for women's rights has been part of a general human rights movement that has also benefited other vulnerable groups such as infants, children, patients, prisoners and experimental subjects.
In this complex new cultural context Laurence B. McCullough, PhD, and Frank A. Chervenak, MD, have proposed an admirable ethical framework for dealing with the challenges presented by innovative fetal research 1. The authors attempt to give proper moral weight to the claims of the pregnant woman, the "fetal patient," and to the physician-investigators who want to further medical progress. The authors set forth ethical criteria for the initiation and assessment of clinical trials, selective criteria for inclusion of subjects, guidelines for the informed consent process, and justifications of the obligation of treating physicians to support clinical investigations that will benefit future patients.
In undertakings of innovative medical experiments, risks and benefits remain uncertain. The uncertainty along with the promise of benefits produces the need for clinical trials accompanied by thorny problems of informed consent. Constructing ethical criteria for experimental maternal-fetal surgery is a particularly complex challenge because two lives are involved and the stakes for a woman and her family are enormously high.
Looming in the background of the authors' proposed framework are continuing ethical conflicts over abortion and the moral status of the fetus at different stages of development. Other complicating debates exist concerning the medical and moral indications for starting and stopping experimental clinical trials. Fundamental difficulties in acquiring truly informed consent also have to be confronted. Without delving into the ongoing arguments and conflicts of bioethics, the general criteria proposed in McCullough and Chervenak's ethical framework seem sensible.
They propose that clinical trials can begin when 1) there exist reliable expectations that fetal interventions may be life-saving or prevent serious and irreversible disease, injury or handicap for the fetus; 2) the pregnant woman's risks of disease or injury for the present and future pregnancy is reliably expected to be low; and 3) among alternative designs for intervention, those with the least risk for the fetal patient will be chosen. In other words neither the welfare of the woman or the fetus can be disregarded or sacrificed for the other.
Of course there is always the problem remaining of who decides whether ethical criteria to initiate or stop clinical trials have been met. Who will measure the disagreement or agreement in the expert clinical community and by what methods? The authors recommend outside monitoring boards to prevent investigator bias and to protect subjects. Unfortunately, medical research enthusiasm and a desire to recruit subjects can produce subtle pressures upon subjects to agree to interventions. False hopes or therapeutic misconceptions have to be avoided. Potential coercion of women from all - investigators, treating physicians, husbands and families - must be guarded against by rigorous non-directed procedures for obtaining consent.
In order to further protect the autonomy of a woman's decision, the authors recommend (somewhat unrealistically?) that only neutral language be used. Thus no loaded words such as "father" or "mother" should be allowed. And in this approach the very worst four letter word to be avoided is b - - y. Of course pregnant women do not usually think of themselves as carrying a fetal patient, but as having something wrong with the baby. Still the authors insist that the woman must be clearly informed that "she is under no obligation to the fetal patient to enroll it in a clinical research project."
In the same neutral spirit, there should be no exclusion criteria regarding a woman's countenancing of elective abortion or the choice to produce an affected infant. Throughout the process the individual woman must be granted the power to give, or withdraw, the status of patient to the fetus. This acceptance of the individual woman's power to unilaterally confer or deny the status of patient to the fetus will disturb those who judge that human life has moral claims beginning with conception. But this aspect of the proposed ethical framework, along with the use of neutral language, can be seen as an effort to protect a woman from external pressures while making her decision.
Yet, even if external pressures are minimized, a woman will still confront inner moral struggles. In such a crisis women will have to make an incredibly difficult moral decision. Both positive and negative responses may be aroused in the process. Intense hopes can be invested in a pregnancy as well as anxiety and fear over future consequences. Morally socialized persons desire to do good and avoid evil; women will feel the ethical pull and pressure of conscience to do the right thing. In the case of a pregnant woman, there can be further strong desires to become a good mother and not harm her offspring. The prospect of regret and guilt over a decision can be sobering. The risk of unknown outcomes produces anxiety, even in normal pregnancies. Ironically, women's new freedom to determine their own maternal obligations produces its own burdens.
A woman's choice may be determined in great part by her perception or estimate of the probabilities that the experimental procedure can be of possible benefit for her fetus. If there is minimal or little benefit to be expected, then it seems too much to ask that a woman should volunteer herself and her fetus to risks of harm in order to further the good of future patients and medical progress. The primary moral obligation of parenthood is to protect one's own specific offspring. To offer one's fetus for a risky experimental procedure seems morally callous, even if abortion is ultimately to be elected. A personal sacrifice is one thing; sacrificing one's offspring another.
However, if there is some chance of actual benefit to the fetus, then the situation is different - involving a more tortuous decision. The risks to be taken may be more acceptable if both one's own fetus and future fetal patients may bene- fit. After all, the human species has only survived this far by continuing acts of maternal altruism. Consenting to innovative experimental fetal surgery may be one more gift that women can give to the next generation.
Sidney Callahan, PhD
Distinguished Professor of Moral Theology St. John's University, New York
Suggested reading
Brody BA. The Ethics of Biomedical Research: An International Perspective. New York: Oxford University Press, 1998.
Chervenak FA, McCullough LB. Ethical issues in obstetric ultrasonography. Clin Obstet Gynecol 1992;4:758-62.
Chervenak FA, McCullough LB. What is obstetric ethics? Clin Obstet Gynecol 1992;4:709-19.
Hardy SB. Mother Nature: A History of Mothers, Infants, and Natural Selection. New York. Pantheon Books, 1999.
Levine RJ. Ethics and Regulation of Clinical Research, 2nd ed Baltimore-Munich: Urban & Schwarzenberg, 1986.
Rothman BK. Recreating Motherhood: Ideology and Technology in a Patriarchal Society. New York: W.W. Norton & Company, 1989.
Reply
Sidney Callahan rightly points out that the abortion controversy is "looming in the background" of our proposed framework. Current "debates" about the morality of abortion have hit a dead end, because they have focused on whether or not the fetus has independent moral status, is a person, or has rights. There is no way to resolve these disputes, because there is no single, intellectually and morally authoritative perspective from which to resolve them. As a serious intellectual discipline, ethics in general and bioethics in particular should be willing to recognize conceptual failure when it repeatedly occurs. A distinct advantage of our framework is that it liberates the ethics of maternal-fetal research and medicine from intractable disputes about fetal rights. Indeed, our framework explicitly rejects the concept and language of fetal rights, in favor of the clinically applicable concept and language of the fetus as a patient.
Callahan correctly underscores the difficulty of reaching a reliable judgment that equipoise exists or should exist in the expert clinical community. It is certainly clear that new forms of surgical management - as distinct from innovative changes to existing techniques - should never be presumed to be clinically beneficial, despite the sometimes understandable enthusiasm of investigators who have developed them. Before they are tested, such expectations of benefit must properly be understood to be only theoretical. Moreover, as we pointed out, new forms of surgical management should always be tested in animal models as the first step toward establishing more than theoretical benefit. If animal models are promising, small, well-designed and thoroughly evaluated, experimental case series should be undertaken. These steps will ensure the collection of data that can then discipline enthusiasm and result in considered judgments about whether equipoise exists.
We agree with, and want to emphasize strongly, Callahan's point that a pregnant woman's decision to enroll herself and her fetal patient in maternal-fetal research involves serious "inner moral struggles," especially when there are nontrivial risks of fetal loss. Investigators and others involved in the consent process can help potential subjects think through their decision with care and thus manage their moral struggles. Pregnant women should - after they have developed a reliable understanding that the intervention involves research and what the research involves - be asked what is important to them in their decision about whether to enroll in the trial. They should also be encouraged to draw fully on their social supports, including spouse or partner, family, spiritual or religious advisers, and others whose judgment and wisdom they trust. Leaving pregnant women without an opportunity to reflect on their values and leaving them on their own to make a complex decision could result in such struggles becoming more difficult than they would be in the context of a compassionate and supportive informed consent process.
Frank A. Chervenak, MD
Department of Obstetrics and Gynecology New York Presbyterian Hospital Weil Medical College of Cornell University, New York
And
Laurence B. McCullough, PhD
Center for Medical Ethics and Health Policy Baylor College of Medicine, Houston, Texas
Footnotes
1("An ethical framework for fetal research," Lahey Clinic Medical Ethics, Winter 2003)
in collaboration with
Dartmouth-Hitchcock Medical Center
The opinions expressed in the journal, Lahey Clinic Medical Ethics,
belong to the individual contributors and do not represent the institutional position
of Lahey Clinic on any subject matters discussed.
