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The Overview of Regulating Biomedical Research Using Human Biological Samples in Korea
Baik, Su Jin 이화여자대학교 생명의료법연구소 2011 BIOMEDICAL LAW & ETHICS Vol.5 No.2
The regulation of biomedical research is important to protect human subjects from potential harm and risks during research. It is necessary to regulate research using human biological samples as well as biomedical research. Especially human biological samples include potential identifiable information and data. Regulating human biological samples is similar to regulations for other biomedical research, because human biological samples are including identifiable information or data. The number of studies using human biological samples has increased greatly. And the rapid development of genetic science and technology has stimulated the increase. The same situation is found in Korea. The process of research has to include critical ethical issues regarding human materials. Therefore, these research issues need to be regulated by adequate requirements. In Korea, The Bioethics and Safety Act was enacted in January. 2004, enforced the next year, and revised several times these after. However, it is restricted to the field of research using embryos and genetic information. The scope of the law has been limited to the regulation of biomedical research using human material. Recently, the government proposed an amendment to the Bioethics and Safety Act. The proposed draft of the amendment intends to meet international guidelines.