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Administration of the Bioethics and Safety Act
The Bioethics and Safety Act, which seeks to make progress in biomedical technology sustainable by prohibiting human cloning and providing guidelines for embryo research and genetic tests, has been in effect since 2005. The Act was revised to include all human research in February 2012, and the revised Act has been enforced from February 2013.
The Division of Life Science Research Management enforces the Act by supervising embryo and somatic cell nuclear transfer (SCNT) research, and by registering fertility clinics, embryo research institutes, corporations performing genetic tests, gene therapy clinics, and institutional review boards (IRBs). We have sought to increase bioethics awareness in order to establish an infrastructure in which biomedical technology can progress without harming human dignity, improving national health and quality of life. To achieve this mission, we have continued to inspect fertility clinics, embryo research institutes, and genetic testing companies, and have developed appropriate guidelines.
The Act defines 6 types of authorized research institutes or clinics. These are: fertility clinics providing IVF services, embryo research institutes using surplus human embryos obtained from fertility clinics, SCNT (and parthenogenesis) embryo research institutes, corporations providing human genetic testing services, biobanks (previously gene banks) preserving and distributing human biospecimen, and gene therapy clinics. In 2014, we authorized 26 clinics/institutes/corporations after inspection or paper reviews of their facilities, equipment, employment practices, and institutional review boards. The numbers of registered clinics/institutes/corporations at the end of 2014 are shown below.