ELSI on the Clinical Research for Treating the Fetal-maternal Complex
- Biotechnology/Life Science
In this research project, we will investigate ethical, legal, and social issues (ELSI) as well as ethical ways of conducting responsible research and innovation (RRI) with regard to clinical research and development of maternal-fetal innovative interventions. Due to the technological underdevelopment and limitation of maternal-fetal medicine, ‘a fetus’ has long been inaccessible, and therefore, untreatable. Based on such an inaccessibility to a fetus, a research subject in the traditional clinical research ethics framework who ought to be protected from possible harms of research has been premised as an individual person. Accordingly, a sick fetus involved in clinical research, which is not a person yet, has not been considered as a research subject, and therefore was unable to expect the same level of protection as a person in research. However, recent development of the maternal-fetal medical technologies is coming to materialize a direct interventional approach to a fetus. As a consequence, a fetus which is going to experience experimental intervention in clinical research cannot expect a proper protection in the current research ethics framework as it is. Therefore, we will redefine a fetus in research as ‘a fetal-maternal complex’, and investigate to construc a new model framework including ethical guidelines and a legal basis for the protection of a fetal-maternal complex in research.
・R&D Period： October 2022 - March 2026 (in progress)
・Grant Number： JPMJRS22J2
Division Chair, Division of Bioethics and Healthcare Law, Institute for Cancer Control, National Cancer Center Japan