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)

In this open peer commentary, we concur with the three target articles’ analysis and positions on abortion in the special issue on Roe v. Wade as the exercise of reproductive liberty essential for the bioethical commitment to patient autonomy and self-determination. Our proposed OPC augments that analysis by explicating more fully the concept crucial to Roe of fetal personhood. We explain that the development and use of predictive reproductive technologies over the fifty years since Roe has changed the literal image, (...) and thereby the epistemological landscape, through which a prospective parent comes to know the fetus. The logic of Roe required a legal and ethical denial of fetal personhood to prioritize maternal autonomy over claims to fetal moral personhood. Our claim is that such a denial may be more complicated today. The fetal person genetic testing and reproductive imaging now presents to prospective parents has become an increasingly individualized, distinct medicalized picture of a developing person with which a parent can either identify or differentiate. In contrast, the fetal person of Roe was an abstract and vague figure stripped of most human particulars, a pregnancy rather than the specific individualized human entity reproductive technology now presents as a person to prospective parents. We discuss the implications of this shift and call for a more capacious analysis of reproductive ethics that works towards both reproductive and disability justice. (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)

Advancements in fetal assessment and therapeutic intervention in medical practice and clinical research call for corresponding progress in regulatory and ethical guidance. In “A new ethical framewo...