Presentation Title: “The issue of consent in fetal-maternal research for fetal therapy”

Abstract:

Currently, it is becoming increasingly possible to treat a fetus in a mother's womb when prenatal treatment is desirable. A fetus is expected to get a direct clinical benefit from a therapy. But many fetal therapies are classified as research because they have not been established (therefore, hereafter they are referred to as fetal-maternal research). So, who are the subjects in fetal-maternal research? A fetus is the direct subject of the research, but not a person. On the other hand, a pregnant woman is not the direct subject. But she is a person who is involved in research because her inseparability from the fetus, and therefore her autonomy must be respected. Her autonomy is not exactly the same before and after pregnancy, because the existence of a fetus influences on it. Thus, fetal-maternal research cannot be adequately framed by the traditional framework of the researcher-subject relationship. The issue of consent by a research subject also requires a different way of thinking. Assuming both a fetus and a pregnant woman are subjects in research, the researcher has conflicting ethical responsibility for both subjects at the same time. Furthermore, the ethical responsibility that a pregnant woman herself bears her fetus will also be questioned. In this study, by referring to the "Belmont Report," "Research Involving Children," and "Research on the Fetus" written by the National Commission, we will aim to revise the traditional concept of “consent” in research so as to make it suitable for fetal- maternal research. We will first clarify whose consent should be obtained. As in pediatric research, a proxy consent and alike from parents or guardians for a fetus may also be required in fetal-maternal research. However, unlike in pediatric research, consent of a pregnant woman to participate in research must also be obtained. As clinical benefits and risks to a pregnant woman and a fetus are inevitably being in conflict, consents of a pregnant woman for herself and for her fetus must be compromised. In addition, family members, such as a husband, may need to be involved in the consent process to participate in research. This is because consent to participate in fetal-maternal research implies a decision about whether to establish a new family relationship that includes a fetus as a "soon-to-be-born" child, which differs from ordinal research. Second, we examine the complex risk-benefit assessment which is a premise for consent. With respect to a fetus, the clinical benefits and risks may be balanced. In contrast, there is no direct clinical benefit for a pregnant woman, who must accept a physical risk unnecessary for herself. On this point, it is also different from pediatric research. Further we argue how we should reassess and redefine the consent given by a pregnant woman in fetal-maternal research which involves unconventional internal risk-benefit tensions and how the consent in fetal-maternal research may depart from the traditional concept of consent. In conclusion, consent in fetal-maternal research would be given with an expectation that the benefits of increasing the possibility of establishing a new family relationship that includes the fetus as a child would outweigh her own physical risks. In other words, her consent in fetal-maternal research implies her active choice to transform herself and her family, through choosing to let her fetus exist or not, and thus to become parents or not.