![]() But, many concerning issues have already been raised.Ģ.1. According to the representatives from the Japanese Ministry, this legal update does not raise special ethical or legal concerns because “there is technically zero risk of producing a new organism mixing human and animal elements under the research” ( The Japan Times, 2019).Īt this moment, the real consequences of this new regulation in actual researchis still uncertain. Therefore, Japanese researchers are now authorized to create HNH chimeras with human brain cells, to transfer the product into an uterus and to let it develop for a period of time that can surpass 14 days, in order to obtain human organs. This solution is substantially different from the previous one, which only allowed the resulting being to develop until the 14 th day. All these elements must be assessed in order to establish for how long can the study last. Moreover, according with the current Japanese regulation, there is no fixed time limit for the development of the resulting entity it depends on the study’s objective, the type of animal used, and the organ to be produced. Based on these findings, the practice is now allowed. The new regulation is based in a study carried out by the Japan’s Ministry of Education, Culture, Sports, Science and Technology, that concluded to be very unlikely that animals provided with some brain cells could acquire human brain functions ( Zimmer, 2019). The prior prohibition was based on the belief that “producing a brain derived from human cells in an animal body may have an effect on animal behavior, and should be regulated even at stages before individuals are generated” ( Mizuno et al., 2015). One of the most significant changes is the newly-allowed creation of chimeras with human brain cells, in contrast with the previous regulation that expressly banned the use of these particular cells. In order to accomplish that aim, practices that used to be banned in Japan are now allowed. The most recent Japanese regulation, issued on Ma( Ministry of Education, Culture, Sports, Science and Technology, 2019), came to largely flexibilize this research in order to facilitate the creation of human organs inside HNH chimeras ( Cyranoski, 2019 Sawai et al., 2019 Zimmer, 2019). ![]() However, this issue has recently got more complex. ![]() According to the 2001 Guidelines for Handling of a Specified Embryo ( Ministry of Education, Culture, Sports, Science and Technology, 2001), human-animal chimeric embryos can only be created for basic research regarding the creation of organs to be transplanted into humans the referred embryos are not allowed to develop after the 14 th day, that is, when the primitive streak comes around and they cannot be transferred into a human or animal uterus. ![]() Since some years ago, Japan allows research involving the creation of human/non-human (HNH) chimeric embryos introducing human cells in non-human (NH) animals,subject to certain conditions ( Mizuno et al., 2015). In the end, the paper will conclude that in spite of the legal and ethical hazards that this new regulation might carry, it should be allowed under strict scrutiny. Subsequently, it will analyze the new concerning issues brought on by the 2019 amendment: the use of human brain cells, the transfer of the chimera to an uterus and its development for more than 14 days, and the possibility of using animals which present close similarities with humans. This paper will start by addressing traditional topics involving this practice: the use of non-human animals in research, the use of human stem cells in scientific experimentation and the creation of human/non-human chimeras. However, many concerning issues have already been identified. At this moment, the real consequences of this new regulation in actual research are still uncertain. The amended rules allow the creation of chimeras with human brain cells, and the subsequent transfer of the resulting creature to an uterus, where it can develop for more than 14 days, eventually until term. In March 2019 Japan modified its norms regarding research with human/non-human chimeras.
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