Research to improve the health of pregnant and fetal patients presents ethical challenges to clinical investigators, institutional review boards, funding agencies, and data safety and monitoring boards. The Common Rule sets out requirements that such research must satisfy but no ethical framework to guide their application. We provide such an ethical framework, based on the ethical concept of the fetus as a patient. We offer criteria for innovation and for Phase I and II and then for Phase III clinical trials (...) to improve the health of pregnant patients and of fetal patients and also criteria to responsibly manage the transition from investigation to clinical practice. Basing ethical criteria for research involving pregnant women on the ethical concept of the fetus as a patient insulates the proposed ethical framework and therefore research on pregnant women from the divisive and politicized concepts and discourses of personhood, fetal rights, and unborn child. (shrink)

There are limitations of obstetric estimation of neonatal outcome in extremely premature newborns. Predicting outcomes, survival, and morbidity are often uncertain, such as in cases of extreme prematurity, certain fetal anomalies, intrauterine growth restriction, and intrauterine infection. Informed consent, truth telling, the maternal–fetal conflict, decision making, and the fetus as a patient are the most important issues of obstetric and neonatal ethics. Because the boundary between utility and futility is not clear, the best interest of the mother, the fetus, and (...) the newborn will be subject of discussion every time. Here, we report a case of obstetric patient to discuss. (shrink)

Despite its prominence in the abortion debate and in public policy, the discourse of ‘unborn patient’ has not been subjected to critical scrutiny. We provide a critical analysis in three steps. First, we distinguish between the descriptive and normative meanings of ‘unborn child.’ There is a long history of the descriptive use of ‘unborn child.’ Second, we argue that the concept of an unborn child has normative content but that this content does not do the work that opponents of abortion (...) want it to do, namely, to establish the independent moral status of fetuses and their rights, the right to life in particular. Third, we argue that the normative content of ‘unborn child’ should be dependent moral status, not independent moral status. We conclude that the ethical concept of the fetus as a patient should replace the discourse of “unborn child” when that phrase is used normatively. (shrink)

Since it can sometimes seem necessary to undertake research that might affect a developing fetus, it would be useful to have a satisfactory ethical framework governing such efforts. Frank Chervenak...

The development of in vitro fertilisation (IVF) as a treatment for human infertilty was among the most controversial medical achievements of the modern era. In Ireland, the fate and status of supranumary (non-transferred) embryos derived from IVF brings challenges both for clinical practice and public health policy because there is no judicial or legislative framework in place to address the medical, scientific, or ethical uncertainties. Complex legal issues exist regarding informed consent and ownership of embryos, particularly the use of non-transferred (...) embryos if a couple separates or divorces. But since case law is only beginning to emerge from outside Ireland and because legislation on IVF and human embryo status is entirely absent here, this matter is poised to raise contractual, constitutional and property law issues at the highest level. Our analysis examines this medico-legal challenge in an Irish context, and summarises key decisions on this issue rendered from other jurisdictions. The contractual issues raised by the Roche case regarding informed consent and the implications the initial judgment may have for future disputes over embryos are also discussed. Our research also considers a putative Constitutional 'right to procreate' and the implications EU law may have for an Irish case concerning the fate of frozen embryos. Since current Medical Council guidelines are insufficient to ensure appropriate regulation of the advanced reproductive technologies in Ireland, the report of the Commission on Assisted Human Reproduction is most likely to influence embryo custody disputes. Public policy requires the establishment and implementation of a more comprehensive legislative framework within which assisted reproductive medical services are offered. (shrink)

Obstetric ultrasound has become a significant tool in obstetric practice, however, it has been argued that its increasing use may have adverse implications for women’s reproductive freedom. This study aimed to explore Australian obstetricians’ experiences and views of the use of obstetric ultrasound both in relation to clinical management of complicated pregnancy, and in situations where maternal and fetal health interests conflict.

Moral status ascribes equal obligations and rights to individuals on the basis of membership in a protected group. Substance change is an event that results in the origin or cessation of individuals who may be members of groups with equal moral status. In this paper, two substance changes that affect the moral status of human embryos are identified. The first substance change begins with fertilization and ends with the formation of the blastocyst, a biological individual with moral status comparable to (...) that ascribed to human organs. The second substance change begins at implantation and ends late in embryological development with the formation of the human body, an organism with moral status as a human being. The bioethical implications of each substance change are explored. The Two Substance Change theory is contrasted with continuity theories, which recognize no substance change in embryological development and with fertilization-only substance change theories. (shrink)

Background To determine whether fetal care paediatric and maternal–fetal medicine specialists harbour differing attitudes about pregnancy termination for congenital fetal conditions, their perceived responsibilities to pregnant women and fetuses, and the fetus as a patient and whether self-perceived primary responsibilities to fetuses and women and views about the fetus as a patient are associated with attitudes about clinical care.Methods Mail survey of 434 MFM and FCP specialists .Results MFMs were more likely than FCPs to disagree with these statements : ‘the (...) presence of a fetal abnormality is not an appropriate reason for a couple to consider pregnancy termination’ ; ‘the effects that a child born with disabilities might have on marital and family relationships is not an appropriate reason for a couple to consider pregnancy termination’ ; and ‘the cost of healthcare for the future child is not an appropriate reason for a couple to consider pregnancy termination’ . 65% MFMs versus 47% FCPs disagreed that their professional responsibility is to focus primarily on fetal well-being . Specialists did not differ regarding the fetus as a separate patient. Responses about self-perceived responsibility to focus on fetal well-being were associated with clinical practice attitudes.Conclusions Independent of demographic and sociopolitical characteristics, FCPs and MFMs possess divergent ethical sensitivities regarding pregnancy termination, pregnant women and fetuses, which may influence clinical care. (shrink)