On the Handling of a Fetus Involved in Clinical Research

Introducing the Concept of “the Fetus as a Research Subject”

Abstract

    Even though interventions for pregnant women affect the fetus in the womb in various manners, many of these effects are not well understood. This makes medical research on fetuses necessary. However, in Japan and other countries, the discussion on how to involve fetuses in research is insufficient. Therefore, in this paper, we will 1) confirm the status of involving fetuses in research as per the current ethical guidelines for research in Japan and other countries; 2) categorize the types of research which may involve fetuses; and 3) identify studies where the fetus should have been considered the subject. We confirmed that at least some of the studies should have considered the fetus as the subject. We further discussed 4) the practical implications of considering the fetus as the research subject and determined that the concept of “fetus as the research subject” can be introduced where intervention for pregnant women is performed for the health of the fetus itself and where intervention is performed for the fetus itself. However, we have shown that there are various problems to be considered in such cases.