In assessing the ethics of fetal therapy trials, we agree with Hendriks et al. that we should not just consider biomedical benefits, but also psychosocial benefits. Specifically, we argue th...

For ages, medicine has had poor access to the fetus inside the mother's womb. But in relatively recent years, the human body has become transparent. The latest breakthroughs of technology have made it possible, from the very beginning of pregnancy, to consider the fetus as an individual who can be examined and sampled. His or her physician may now establish a diagnosis and prognosis and prescribe a treatment in the same way as in traditional medicine.

For ages, medicine has had poor access to the fetus inside the mother's womb. But in relatively recent years, the human body has become transparent. The latest breakthroughs of technology have made it possible, from the very beginning of pregnancy, to consider the fetus as an individual who can be examined and sampled. His or her physician may now establish a diagnosis and prognosis and prescribe a treatment in the same way as in traditional medicine.

Health-related Quality of Life measures have recently been attacked from two directions, both of which criticize the preference-based method of evaluating health states they typically incorporate. One attack, based on work by Daniel Kahneman and others, argues that ‘experience’ is a better basis for evaluation. The other, inspired by Amartya Sen, argues that ‘capability’ should be the guiding concept. In addition, opinion differs as to whether health evaluation measures are best derived from consultations with the general public, with patients, or (...) with health professionals. And there is disagreement about whether these opinions should be solicited individually and aggregated, or derived instead from a process of collective deliberation. These distinctions yield a wide variety of possible approaches, with potentially differing policy implications. We consider some areas of disagreement between some of these approaches. We show that many of the perspectives seem to capture something important, such that it may be a mistake to reject any of them. Instead we suggest that some of the existing ‘instruments’ designed to measure HR QoLs may in fact successfully already combine these attributes, and with further refinement such instruments may be able to provide a reasonable reconciliation between the perspectives. (shrink)

Interventions performed on a pregnant woman's body can affect the fetus in multiple ways. Such effects can be harmful to beneficial to the fetus. Unfortunately, the effects of new drugs and compoun...

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)

Fetal surgery has been practised for some decades now. However, it remains a highly complex area, both medically and ethically. This paper shows how the routine use of ultrasound has been a catalyst for fetal surgery, in creating new needs and new incentives for intervention. Some of the needs met by fetal surgery are those of parents and clinicians who experience stress while waiting for the birth of a fetus with known anomalies. The paper suggests that the role of technology (...) and visualisation techniques in creating and meeting such new needs is ethically problematic. It then addresses the idea that fetal surgery should be restricted to interventions that are life-saving for the fetus, arguing that this restriction is unduly paternalistic. Fetal surgery poses challenges for an autonomy-based system of ethics. However, it is risky to circumvent these challenges by restricting the choices open to pregnant women, even when these choices appear excessively altruistic. (shrink)

Women in North America have many childbirth options. However, they must make these choices within a complex culture of birthing discourse characterized by competing knowledges and claims regarding the “ideal birth” as medicalized, natural, or woman centered. We interviewed 21 childless women and 22 new mothers to explore their perceptions of choice and birthing. The women’s interviews indicated that their birthing choices are reflective of tensions embedded in normative femininity; conflicting ideas relating to purity, dignity, and the messiness of birth; (...) and contradictions about women’s bodies as heteronormative sites of pleasure and sexuality on one hand and of asexual, selfless sources of maternal nurturance on the other. Finally, the women’s views reflected understandings of moral and normative constructs about selflessness as a core attribute of femininity and motherhood, particularly in terms of enduring pain as the “proper” means of accomplishing the rite of passage to motherhood. Although all the women described tensions between femininity and motherhood, childless women were more likely than mothers to be worried about achieving ideal, heteronormative sexuality and femininity. Likewise, women who have not yet had children and women who have experienced unplanned C-sections were more likely than those who experienced vaginal births to express that C-section births fail to fully accomplish women’s rite of passage to motherhood. (shrink)

When surgery is performed on pregnant women forthe sake of the fetus (MFS or maternal fetalsurgery), it is often discussed in terms of thefetus alone. This usage exemplifies whatphilosophers call the fallacy of abstraction: considering a concept as if it were separablefrom another concept whose meaning isessentially related to it. In light of theirpotential separability, research on pregnantwomen raises the possibility of conflictsbetween the interests of the woman and those ofthe fetus. Such research should meet therequirement of equipoise, i.e., a (...) state ofgenuine uncertainty about the risks andbenefits of alternative interventions ornoninterventions. While illustrating thefallacy of abstraction in discussions of MFS,we review the rationale for explicitacknowledgment of the essential tie betweenfetus and pregnant woman. Next we examinewhether it is possible to meet the requirementof equipoise in research on MFS, focusing on afetal condition called myelomeningocele. Weshow how issues related to equipoise innonpregnant populations appear also in debatesregarding MFS. We also examine evidence insupport of claims that the requirement ofequipoise has been satisfied with respect to``the fetal patient'' while considering risks andbenefits to gestating women only marginally ornot at all. After delineating challenges andpossibilities for equipoise in MFS research, weconclude with a suggestion for avoiding thefallacy of abstraction and achieving equipoiseso that research on MFS may be ethicallyconducted. (shrink)

This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception about the nature of clinical research and the status of research subjects. Second, given that it is not clear who the research subject/s in MFS is/are, if clinical equipoise is to be used as a (...) criterion to test the ethical appropriateness of RCT, its meaning should be unambiguous. Third, because of the multidisciplinary character of MFS, it is not clear who should be in equipoise. As a result, we lack an adequate criterion for the ethical review of MFS protocols. In our account, which is based on Chervenak and McCullough's seminal work in the field of obstetric ethics, equipoise is abandoned. and RCT involving MFS can be ethically initiated when a multidisciplinary ethics review board (ERB), having an evidence-based assessment of the risks involved, is convinced that the value of answering the research hypothesis, for the sake of the health interests of future pregnant women carrying fetuses with certain congenital birth defects, justifies the actual risks research participants might suffer within a set limit of low/manageable. (shrink)

Much has changed in maternal-fetal medicine since the early 2000s, when the previous ethical frameworks for fetal therapy trials were established. We applaud Hendriks and colleagues for taking on t...

The 21st-century translational science campaign could lead to an increase in first-in-human trials. As tests of investigational interventions move from the laboratory to human research, scientists, officials, and review committees should address ongoing concerns about the ethics of FIH trials. In this article, I describe three ethical considerations relevant to all FIH trials: the requirement for adequate preclinical research; study design safeguards; and choice of subject population. I also examine specific ethical considerations relevant to the three subject populations involved in (...) FIH research. I recommend a variety of actions that could increase subject protection and the value of the information generated in FIH trials. (shrink)

Translational science is a 21st century mission. Government officials and industry leaders are making huge investments in an attempt to transform more basic science discoveries into therapeutic applications. Scientists and policymakers express great excitement about the medical advances that could come with the current bench-to-bedside campaign.A key step in translational science is the move from animal and other preclinical studies to initial human testing. Researchers ability to predict human effects is limited, and first-in-human tests present significant uncertainty. Participants in this (...) form of research face risks and can experience serious, even lethal, harm. Well-known incidents involving Jolee Mohr and Jesse Gelsinger, as well as subjects in the 2006 study of the investigational agent TGN1412, show the dangers that can arise in early human research.The bench-to-bedside campaign will need many volunteers to participate in early human testing. Investigators and regulators must not allow the policy enthusiasm for translational science to overshadow the commitment to protect human subjects. Participants in exploratory research are diverse and as a group lack characteristics usually associated with vulnerable populations, such as impaired decisional ability or economic or educational disadvantage. (shrink)

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)

Assessing the risk-benefit ratio has always been considered key in designing clinical trials. These benefits can be diverse and may include social value and psychological benefits. When it comes to...

As members of the fetal surgery advisory board at a large tertiary care center, we read with great interest Hendriks’ et al. target article proposing a new ethical framework for fetal therap...

The history of maternal-fetal therapy is a complex and compelling one. It can be argued that the science and ethics underpinning this field evolved together, with emerging technology spurring on th...

Furthermore, adults with decision-making capacity, including pregnant women, can currently accept interventions with moderate net risks for themselves in other settings (e.g., open f...

Health‐related Quality of Life measures have recently been attacked from two directions, both of which criticize the preference‐based method of evaluating health states they typically incorporate. One attack, based on work by Daniel Kahneman and others, argues that ‘experience’ is a better basis for evaluation. The other, inspired by Amartya Sen, argues that ‘capability’ should be the guiding concept. In addition, opinion differs as to whether health evaluation measures are best derived from consultations with the general public, with patients, or (...) with health professionals. And there is disagreement about whether these opinions should be solicited individually and aggregated, or derived instead from a process of collective deliberation. These distinctions yield a wide variety of possible approaches, with potentially differing policy implications. We consider some areas of disagreement between some of these approaches. We show that many of the perspectives seem to capture something important, such that it may be a mistake to reject any of them. Instead we suggest that some of the existing ‘instruments’ designed to measure HR QoLs may in fact successfully already combine these attributes, and with further refinement such instruments may be able to provide a reasonable reconciliation between the perspectives. (shrink)