English law is unambiguous that legal personality, and with it all legal rights and protections, is assigned at birth. This rule is regarded as a bright line that is easily and consistently applied. The time has come, however, for the rule to be revisited. This article demonstrates that advances in fetal surgery and (anticipated) artificial wombs do not marry with traditional conceptions of birth and being alive in law. These technologies introduce the possibility of ex utero gestation, and/or temporary existence (...) ex utero, and consequently developing human beings that are novel to the law. Importantly, therefore, the concepts of birth and born alive no longer distinguish between human beings deserving of legal protection in the way originally intended. Thus, there is a need for reform, for a new approach to determining the legal significance of birth and what being legally alive actually encompasses. Investigating the law of birth is of crucial importance, because of the implications of affording or denying the subjects of new reproductive technologies rights and protections. A determination of the legal status of the subject of fetal surgery or an artificial womb will determine what can and cannot be done to each entity. Moreover, the status afforded to these entities will drastically impact on the freedoms of pregnant women. (shrink)

BackgroundBreakthroughs in animal studies make the topic of human application of ectogenesis for medical and non-medical purposes more relevant than ever before. While current data do not yet demonstrate a reasonable expectation of clinical benefit soon, several groups are investigating the feasibility of artificial uteri for extracorporeal human gestation.Main textThis paper offers the first comprehensive and up to date discussion of the most important pros and cons of human ectogenesis in light of clinical application, along with an examination of crucial (...) ethical (and legal) issues that continued research into, and the clinical translation of, ectogenesis gives rise to. The expected benefits include advancing prenatal medicine, improving neonatal intensive care, and providing a novel pathway towards biological parenthood. This comes with important future challenges. Prior to human application, important questions have to be considered concerning translational research, experimental use of human fetuses and appropriate safety testing. Key questions are identified regarding risks to ectogenesis’ subjects, and the physical impact on the pregnant person when transfer from the uterus to the artificial womb is required. Critical issues concerning proportionality have to be considered, also in terms of equity of access, relative to the envisaged application of ectogenesis. The advent of ectogenesis also comes with crucial issues surrounding abortion, extended fetal viability and moral status of the fetus.ConclusionsThe development of human ectogenesis will have numerous implications for clinical practice. Prior to human testing, close consideration should be given to whether (and how) ectogenesis can be introduced as a continuation of existing neonatal care, with due attention to both safety risks to the fetus and pressures on pregnant persons to undergo experimental and/or invasive procedures. Equally important is the societal debate about the acceptable applications of ectogenesis and how access to these usages should be prioritized. It should be anticipated that clinical availability of ectogenesis, possibly first as a way to save extremely premature fetuses, may spark demand for non-medical purposes, like avoiding physical and social burdens of pregnancy. (shrink)

In his article “Research Priorities and the Future of Pregnancy” in this issue of CQ, Timothy Murphy evaluates some of the arguments I advanced in an earlier publication, “The Moral Imperative for Ectogenesis.

Abstract:Open neural tube defects or myelomeningoceles are a common congenital condition caused by failure of closure of the neural tube early in gestation, leading to a number of neurologic sequelae including paralysis, hindbrain herniation, hydrocephalus and neurogenic bowel and bladder dysfunction. Traditionally, the condition was treated by closure of the defect postnatally but a recently completed randomized controlled trial of prenatal versus postnatal closure demonstrated improved neurologic outcomes in the prenatal closure group. Fetal surgery, or more precisely maternal-fetal surgery, raises (...) a number of ethical issues that we address including who the patient is, informed consent, surgical innovation and equipoise as well maternal assumption of risk. As the procedure becomes more widely adopted into practice, we suggest close monitoring of new fetal surgery centers, in order to ensure that the positive results of the trial are maintained without increased risk to both the mother and fetus. (shrink)

Video recording is widely available in modern operating rooms. Here, I argue that, if patient consent and suitable technology are in place, video recording of surgery is an ethical duty. I develop this as aduty to protect,arguing for professional and institutional duties, as distinguished forduties of rescue.A professional duty to protect is described in mental healthcare. Practitioners have to take reasonable steps to prevent serious, foreseeable harm to their clients and others, even if that entails a non-consensual breach of confidentiality. (...) I argue surgeons have a similar duty to patients which means that, provided the patient consents, surgery should be routinely videoed. This avoids non-consensual breaches of patient confidentiality and is aligned with stated professional obligations.An institutional duty to protect means institutions have to take reasonable steps to prevent serious, foreseeable harm at the hands of their surgeons. Rulli and Millum highlighted how institutions can meet their duty using a more consequentialist approach that balances wider interests.To test the force and scope of such duties, I examine potential impacts of routine videoing on aspects of autonomy, justice, beneficence and non-maleficence. I find routine videoing can benefit areas including safety, candour, consent and fairness in access (to surgical careers and expertise). Countervailing claims, for example, on liability, confidentiality and privacy can be resisted—such that where consent and the technology are in place, routine videoing meets aduty of easy protection. In other words, its use should be standard of care. (shrink)

New fetal therapies offer important prospects for improving health. However, having to consider both the fetus and the pregnant woman makes the risk–benefit analysis of fetal therapy trials challenging. Regulatory guidance is limited, and proposed ethical frameworks are overly restrictive or permissive. We propose a new ethical framework for fetal therapy research. First, we argue that considering only biomedical benefits fails to capture all relevant interests. Thus, we endorse expanding the considered benefits to include evidence-based psychosocial effects of fetal therapies. (...) Second, we reject the commonly proposed categorical risk and/or benefit thresholds for assessing fetal therapy research. Instead, we propose that the individual risks for the pregnant woman and the fetus should be justified by the benefits for them and the study’s social value. Studies that meet this overall proportionality criterion but have mildly unfavorable risk–benefit ratios for pregnant women and/or fetuses may be acceptable. (shrink)

Many pregnant women use pregnancy related mHealth applications, encompassing a variety of pregnancy apps and wearables. These are mostly directed at supporting a healthier fetal development. In this article we argue that the increasing dominance of PRmHealth stands in want of empirical knowledge affirming its beneficence in terms of improved pregnancy outcomes. This is a crucial ethical issue, especially in the light of concerns about increasing pressures and growing responsibilities ascribed to pregnant women, which may, in turn, be reinforced by (...) PRmHealth. A point can be made that it would be ethically askew if PRmHealth does not lead to improved pregnancy outcomes, while at the same time increasing maternal duties to closely monitor fetal development. We conclude that more research is needed to get a view on the benefits and burdens of PRmHealth in order to ethically assess whether the latter are proportionate to the former. If not, there is a case in saying that endorsement of PRmHealth is overdemanding. (shrink)