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...

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...

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...

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...

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)

At no time in recent decades has more attention been paid to ethical issues in pregnancy. Particularly riveting—and alarming, to many—was the passage of Senate Bill 8, a Texas law banning abortion...

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...

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...

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)