2025 Volume 35 Issue 1 Pages 63-71
This study sought to develop a new framework for examining the ethics of fetal therapy research. In the history of research ethics, fetuses and pregnant women have essentially been regarded as objects to be protected, and there is a lack of a theoretical foundation for dealing with new medical technologies, such as fetal therapy. Consequently, most existing regulations are overly restrictive for fetal therapy research. To address this situation, various theoretical attempts have been made, and the key to this is the investigation of a new framework for a risk/benefit assessment. According to the two-patient model, the prevailing idea is that fetal therapy is aimed at benefiting the fetus, and the pregnant woman only bears the risk; both the risks and benefits are independent. A predominant argument justifies the conduct of fetal therapy research by assuming such a distribution of risk‒benefit and emphasizing the social benefits generated by the research. However, the arguments based on this two-patient model have fatal problems. First, imposing risks on pregnant women through research that does not benefit the pregnant population is contrary to the principle of justice, which is a cornerstone of the Belmont Report. Second, in the two-patient model, it was difficult to set an appropriate cap on the risk carried by pregnant women. To address these problems, we must depart from the idea that these two independent entities participate in fetal therapy and fetal therapy research. Rather, we should consider one single dyad that would be called the “fetus‒maternal complex.” Under such a complex model, the burden on pregnant women in fetal therapy research can be justified, and an appropriate cap on risk can be envisioned.
