This piece of legislation is also translated as “The Bioethics and Safety Act.” In this article, “The Bioethics and Biosafety Act” is used instead, which is a more accurate representation of the contents of the law.Google Scholar

For critique on the inaugural legislation of the Bioethics and Biosafety Act from various ethical perspectives, see Kim, J.H., “An Analysis on ‘Bioethics and Biosafety Act,’” Journal of the Korea Bioethics Association 5, no.1 (2004): 1–11; Kim, J.H. et al., “A Critical Analysis of The ‘Bioethics & Biosafety Act,’” Korean Journal of Medical Ethics Education 8, no.1 (2005): 21–33.Google Scholar

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Jhalani, M., “Protecting Egg Donors and Human Embryos — The Failure of the South Korean Bioethics and Biosafety Act,” Pacific Rim Law & Policy Journal 17 (2008): 707–34. Prof. Hwang also participated in fabricating an article on stem cells published in Nature, which was later retracted. D. Cyranoski, “Verdict: Hwang's Human Stem Cells Were All Fakes,” Nature 439, no.7073 (2006): 122–23. For those interested in learning more about this convoluted story, see Kim, T.H., “How Could a Scientist Become a National Celebrity? Nationalism and Hwang Woo-Suk Scandal,” East Asian Science, Technology and Society 2, no.1 (2008): 27–45.Google Scholar

For a synopsis of the 2012 amendment and its critique, see e.g., Park, S.H., “Korean Regulations of Clinical Trials and Research with Human Subjects,” Biomedical Law & Ethics 6, no.1 (2012): 1–18; Cho, H.S., “The System, Contents and Problems on New Bioethics and Safety Act,” Public Law Journal 13, no. 4 (2012): 251–68; Kim, E.A., “A Study on the Proposed Amendment Bill of Bioethics and Safety Law: Focusing on the Meaning of Significant Contents Related to the Clinical Research,” Korean Society of Law and Medicine 12, no.1 (2011): 99–131.Google Scholar

The Bioethics and Biosafety Act of 2012 makes it manifestly clear that now protection of human research subjects is one of its most important goals. For example, Art. 3, which was inserted in 2012, reads as follows:Google Scholar

While Korea's regulatory framework for biobanking is pretty robust, there is one unmistakable idiosyncrasy about the law. Cord blood is governed under a separate piece of legislation. For reasons that are not entirely clear from a policy perspective, cord blood samples are regulated by the Cord Blood Management and Research Act.Google Scholar

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The Bioethics and Biosafety Act of Korea actually employs the term “anonymization” categorically to include both of the two methods of de-identification. This article, however, will use the term “de-identification” categorically, and reserve the word “anonymization” for the irreversible removal of personally identifiable information. Such usage was advocated in Knoppers, B.M., “Biobanking: International Norms,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 7-14.Google Scholar

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At least 1 information manager and two biobank researchers must be hired by a biobank.Google Scholar

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For example, the maximum sentence for implanting a cloned human embryo is 10 years in prison. The maximum sentence for fertilizing an egg for a purpose other than actual pregnancy is 3 years in prison. The maximum sentence for collecting human egg or sperm without written consent is 2 years in prison.Google Scholar