Division of Bioethics is a new laboratory that was established in 2017.
New ethical, legal and social issues (ELSI) may occur when conducting advanced clinical research or clinical practice. In our laboratory, we study how and what decisions should be made by a nation, society, or individual when such issues arise.
1. The REC Education project
Currently, there are more than 1,800 institutional Research Ethics Committees (RECs) in Japan. Since 2010, cases of research fraud have come to light (e.g., the scandal around the Novartis drug Diovan) and improving the quality of reviews by REC has become the need of the hour. Therefore, Japanese ethical guidelines regarding medical studies involving humans now mandate that institutions with established RECs should offer education and training programs to REC members at least once a year. However, the guidelines do not make any provisions regarding the contents of programs and the way to deliver. As implementation of programs require manpower and economic resources, most institutions are unable to provide high-quality education and training. To address this situation, we launched the REC Education project with support from the Japan Agency for Medical Research and Development (AMED) from FY 2016.
Our programs have the following salient features:1)programs are animated, 2)in order to offer the learners how to review from their place, we created four characters: two experts in natural science and law, a lay member, and a secretariat, 3)each program has a subject of discussion, 4)an external expert committee evaluates each program prior to release, 5)each program is about 20 minutes long, 6)the programs are offered at no charge on the website,7)REC which successfully complete the program receive a certificate of completion.
Currently, we have more than 300 registered members. We constantly assess our programs through questionnaires to get user feedback on each program. We have consistently received high scores from our users. We are planning to produce totally 12 modules by the end of FY 2018.
2. Policy making of human-animal chimeric embryos research
In Japan, there are guidelines called “Guidelines on the Handling of Specified Embryos” based on the Act on Regulation of Human Cloning Techniques. In these guidelines, there are some limitation such as; 1) the production of animal-human chimeric embryos shall be carried out only for the purpose of basic research for the production of human cell-derived internal organs that can be transferred to human body, 2) animal-human chimeric embryos shall be carried out limited to a period until a primitive streak appears or 14 days from the date of the embryos being produced if such primitive streak does not appear, 3) chimeric embryos may not be transferred to human or animal uterus.
Following the recent great scientific achievements in this field, discussions have started in the the Ministry of Education, Culture, Sports, Science and Technology (MEXT) since 2013. Dr.Kamisato participated in these discussions as a member of the council and contributed for policy making.