Since the clinical advent of in vitro fertilization in the early 1980s, a wide range of ethical considerations and concerns regarding artificial womb technology (AWT) have been described. Recent advances in the development of extracorporeal neonatal life support through AWT have reignited ethical interest in this issue with a sense of urgency. An article in the prestigious American Journal of Bioethics reviews the ethical considerations and concerns regarding artificial womb technology and care of the fetal neonate or “fetonate”. The most imminent scenarios involve the existence of a physiologically improved method of neonatal care through AWT to provide life support to infants born so prematurely that, without this mode of therapy, the most likely outcomes are death or considerable disability. In contrast, the most remote scenarios refer to “complete ectogenesis”, i.e., human gestation that occurs completely outside the womb.
In the article, the researchers identify four domains of action depending on the infant’s stage of development:
Domain I: Fertilization and implantation (0 to 2 weeks)
Fertilization of a human egg outside the mother’s body and subsequent successful implantation was first performed in 1978 in the UK, resulting in the birth of the famous “test tube baby,” Louise Brown. In vitro fertilization (IVF) has since become the cornerstone of assisted reproductive technologies, and was involved in about 2% of births in the United States in 2018. After fertilization, the embryo is usually kept in the laboratory for three to five days before implanting it in the womb. However, in an experimental setting, continuous research efforts have led to the optimization of culture conditions that allow the culture of human embryos up to 14 days conceptional age or even longer.
Domain II: Embryological and early fetal development (2 to 21 weeks)
After two weeks, embryological development is defined by organogenesis and the formation of structures essential for life. At 11 weeks, the embryo is now known as a fetus and development is characterized mainly by the growth and maturation of the organ systems, which will continue until birth. The beginning of week 22 is generally considered the lowest threshold of viability, with little hope of survival. No clinical or experimental extra-uterine life support technology currently aims at intervention within domain II. Most professional and government guidelines in developed countries advocate palliative care at this stage.
Domain III: Peri-viability (22 to 25 weeks)
Over the next three weeks, recommendations change progressively due to increasing survival rates, and most guidelines recommend active care for infants born at 25 weeks. Despite increased survival rates due to aggressive resuscitation and improved neonatal clinical care, infants born at this stage often suffer severe somatic morbidity, long-term neurodevelopmental delay, and behavioral disability. The technological support currently available in domain III focuses primarily on cardiorespiratory resuscitation followed by mechanical ventilation. Experimental approaches, such as liquid ventilation and AWT, aim to delay the first gas exchange in premature lungs, with the intention of ensuring continued lung development and improving overall survival and clinical outcomes.
Domain IV: Vulnerable prematurity (26–34 weeks)
Infants born prematurely before 35 weeks gestational age have a substantially higher risk of infant respiratory distress syndrome. Fifty years ago, this syndrome was fatal, but now thanks to neonatal mechanical ventilation technology and surfactant replacement therapy, survival expectations for babies born at this stage have increased to 85%. Research focuses primarily on improving existing treatment modalities.
In summary, established and effective technological support exists for domains I and IV; is imperfect but clinically widespread for domain III; and is currently non-existent for domain II.
ETHICAL CONSIDERATIONS REGARDING ARTIFICIAL WOMB TECHNOLOGY AT EACH STAGE OF DEVELOPMENT
After presenting the technical possibilities for each stage, the authors of the aforementioned paper discuss the ethical considerations for each domain under four general headings: “Potential Benefits and Harms”; “Decision-Making Authority of Parents”; “Legal Status and Protections”; and “Fairness of Access”.
Ethical considerations of domain I
With regard to potential benefits and harms, three potential recipients of these must be considered: the embryos, parents and society.
With respect to embryos, the authors say that the key benefit of successful in utero transfer of an in vitro embryo is that it is given the chance to exist, to live. The most cited harm of IVF is the storage, discarding, and research use of un-implanted embryos. The moral and legal weight of this harm of denying further development to the initiated biological life depends on attributing personhood and its concomitant protections to the embryo. In our opinion, these aspects should not be attributed, but recognized. Other harms to the embryo caused by IVF are increased risk of ectopic pregnancy, birth defects, prematurity, low birth weight, and childhood cancer.
For parents, the most notable benefit attributed to IVF is increasing couples’ reproductive autonomy and fulfilling often very strong desires to have a child. However, IVF entails certain physical risks for the mother (e.g., ovarian hyperstimulation syndrome and complications related to egg retrieval, such as bleeding, infection, and organ damage) and it remains a high-cost, low-success procedure that can be psychologically and financially draining. In case of transfer of several zygotes, multiple pregnancy may occur, presenting its own set of potential harms to both mother and babies. Finally, the increased incidence of disability after IVF may pose a psychosocial burden for parents and family.
As regards society, when IVF is falsely perceived as an infallible procedure, it can generate the mistaken belief that delaying pregnancy has no consequences. Specific ethical issues arise when IVF is used to conceive at an advanced maternal age and with specific practices associated with IVF (e.g., pre-implantation diagnosis, gamete donation, surrogacy, and embryo reduction in case of multiple pregnancy).
Regarding the decision-making authority of parents, at present, contracts are signed between the parents before creating an embryo via IVF, clearly stating what should happen in case of parental disagreement and with the supernumerary frozen embryos. Some scholars have suggested that, in case of disagreement between parents, a “status quo approach” should be adopted in which change needs a stronger justification than allowing things to remain as they are.
With regard to the legal status of embryos, there are considerable differences between countries and states, based on differing definitions of life, personhood and patienthood that involve differences in the recognition of their dignity, custody and legal protection. As regards embryo research, in most jurisdictions, legal restrictions prohibit the culture of human embryos beyond 14 days of development. Nevertheless, there is currently a dispute over the possible extension of this legal limit. Thus, in 2021, the International Society for Stem Cell Research updated its guidelines and recommended that studies proposing to culture human embryos beyond two weeks be considered on a case-by-case basis and undergo several review stages to determine at what point the experiments should be halted (see HERE).
Finally, with respect to fairness of access, even though IVF is widely available in the developed world, the costs of the procedure remain high (average cost of $25,000 or more in the United States), which limits access to technology to those who can afford it or whose insurance covers it.
Ethical considerations of domain II
With regard to the potential benefits and harms, again a distinction is made between the embryo, fetus or fetonate, the mother and society.
With regard to the fetonate, early application of artificial womb technology would extend the window of opportunity for earlier and more impactful therapeutic interventions in congenital abnormalities and earlier rescue from pathological gestational states, which could improve outcomes.
Furthermore, complete ectogenesis has been hailed as an alternative to abortion or certain IVF practices, as radically earlier-in-gestation artificial womb technology could be used as an alternative to terminating a pregnancy or preventing an embryo from existing only in a frozen condition. However, these practices would in turn generate a whole set of different ethical and public policy questions.
With respect to the mother, complete ectogenesis would overcome many forms of infertility and avoid the use of surrogacy. In feminist literature, much of the discussion has focused on the potential of this futuristic technology to increase gender equality physically and socially, as it would allow biological motherhood without pregnancy-related health conditions or childbirth. However, despite being hailed by some authors as a “liberation from the biological yoke of pregnancy,” feminist literature has also pointed out that it could lead to the devaluation or even pathologization of pregnancy, and could diminish women’s experience of deriving meaning, empowerment, and self-realization from this unique aspect of female biology. The choice of pregnancy through ectogenesis (or, alternatively, through a natural pregnancy) could potentially be stigmatized ultimately.
Finally, regarding society, some authors have raised concerns related to the impact of complete ectogenesis technology on the “commodification of pregnancy, babies and motherhood” and the “disconnect between sexuality and procreation”. In addition, the possibility of allocating government funds to the development of complete ectogenesis within a context of limited resources will generate additional considerations.
With respect to fairness of access, if complete ectogenesis is ever possible, the combination of high cost and low availability will undoubtedly result in disparities in access and use and questions about which parents should have priority in the use of such technology.
Regarding the legal status of fetonates, it is expected that they would have full legal rights and protections. Complete ectogenesis, with all embryological and fetal development occurring outside the womb, would raise novel questions in this regard.
Ethical considerations of domain III
In terms of potential benefits and harms, again the distinction is made between the fetonate, parents and society.
Regarding the fetonate, the main population for which artificial womb technology would generate benefits are extremely premature infants born between 22 and 25 weeks of gestation, although the use of AWT could potentially also be contemplated to protect fetuses from pathological gestational states. The technology could also be used to improve the viability and safety of targeted, repeated prenatal therapy (fetal surgery, pharmaco-, gene or stem cell therapy). The main harm of artificial womb technology at this stage would be the risk of death or serious disability. Furthermore, the possible psychological and behavioral effects secondary to the lack of physical maternal-fetal bonding should be examined.
Regarding parents, the potential benefits of artificial womb technology are notably less thoroughly explored in the literature. In addition to hope for increased survival and reduced morbidity of their fetonate, benefits for parents could occur in scenarios where the pregnancy endangers the mother’s health, or when corrective procedures (medication, gene or stem cell therapy, surgery) could be performed without risk of maternal morbidity. A maternal burden of AWT is fetal delivery by cesarean section. Moreover, the lack of physical maternal-fetal bonding during the fetonate’s course of treatment may also have a psychological, emotional and behavioral effect on the mother.
Finally, with respect to society, artificial womb technology has the possibility of a potential economic benefit in the form of cost savings due to the reduction in comorbidities of extremely premature babies. Alternatively, AWT could increase costs by leading to longer stays in the neonatal intensive care unit (NICU) for babies who would not otherwise have survived.
Regarding the decision-making authority of parents, artificial womb technology will fundamentally change obstetric and neonatal decision-making paradigms in neonatal resuscitation. A multidisciplinary approach involving obstetricians, neonatologists and surgeons will be needed to guide clinical decision making. Nevertheless, the decision to undergo a cesarean section to transfer the fetus to AWT would in principle continue to fall under maternal autonomy. Once the fetonate switches to extrauterine support, decision-making would become a shared parental responsibility.
With regard to the legal status of the fetonate, the authors propose using the term “fetal neonate” or “fetonate”, since it would be a newborn in which the aim is to preserve the fetal physiology. It is expected that fetonates would have full rights and protections.
With regard to fairness of access, the existence of artificial womb technology exacerbate inequalities. With the need for continuous intensive clinical follow-up and treatment, it is anticipated that AWT will be costly. It is also expected to be a limited resource initially, raising questions about who should make allocation decisions and how.
Ethical considerations of domain IV
In terms of potential benefits and harms, a distinction is made between the premature newborn and the parents.
With respect to the infant, improved survival and better functional outcome in survivors are noted. However, babies can sometimes survive but with severe comorbidities that greatly diminish their quality of life. In such scenarios, ethicists have wondered whether these babies should have been allowed to die at or shortly after birth, rather than keeping them alive via resuscitation and ongoing invasive interventions. In current clinical care, if an infant is gravely ill at birth or has already suffered various forms of serious in utero injuries, the parents, along with the medical team, may limit the extent of resuscitation.
As for parents, they benefit when their children survive and experience better functional outcomes. In contrast, parents experience psychological distress and financial hardship if the surviving child has a severe disability.
With respect to the decision-making authority of parents, both ethically and legally, parents have considerable but restricted authority over the medical care their children will receive, exercised by providing or denying permission for specific interventions. The limits of this authority are clearer with respect to which interventions may be refused by notions of what would constitute medical negligence and are less clear with respect to requests for interventions deemed by medical judgment to be ‘futile’.
Regarding the legal status of infants born prematurely, there is currently a broad consensus that they have full legal rights and protection.
In terms of fairness of access, in highly developed countries, access to NICU care is much less limited than access to other forms of health care. However, within the NICU setting, disparities in the structure, process, and outcomes of care are a persistent concern.
Lucía Gómez Tatay
Bioethics Observatory – Institute of Life Sciences
Catholic University of Valencia