Like many other countries, South Korea has recognized the importance of biobanks as a tool for medical research and has engaged in two very important tasks to foster biobanking infrastructure: funding biobanks and setting up rules to protect the integrity of biobanks that share potentially sensitive personal information.
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References
1.
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.
2.
For critique on the inaugural legislation of the Bioethics and Biosafety Act from various ethical perspectives, seeJ.H.Kim, “An Analysis on ‘Bioethics and Biosafety Act,’”Journal of the Korea Bioethics Association5, no.1 (2004): 1–11; J.H.Kimet al., “A Critical Analysis of The ‘Bioethics & Biosafety Act,’”Korean Journal of Medical Ethics Education8, no.1 (2005): 21–33.
3.
Bioethics and Biosafety Act of Korea, Art. 1.
4.
Korean Constitutional Court, 2005HunMa346, May 27, 2010. The case was dismissed by the Korean Constitutional Court.
5.
Bioethics and Biosafety Act of 2005, Art. 5.
6.
M.Jhalani, “Protecting Egg Donors and Human Embryos — The Failure of the South Korean Bioethics and Biosafety Act,”Pacific Rim Law & Policy Journal17 (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,”Nature439, no.7073 (2006): 122–23. For those interested in learning more about this convoluted story, seeT.H.Kim, “How Could a Scientist Become a National Celebrity? Nationalism and Hwang Woo-Suk Scandal,”East Asian Science, Technology and Society2, no.1 (2008): 27–45.
7.
For a synopsis of the 2012 amendment and its critique, see e.g., S.H.Park, “Korean Regulations of Clinical Trials and Research with Human Subjects,”Biomedical Law & Ethics6, no.1 (2012): 1–18; H.S.Cho, “The System, Contents and Problems on New Bioethics and Safety Act,”Public Law Journal13, no. 4 (2012): 251–68; E.A.Kim, “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 Medicine12, no.1 (2011): 99–131.
8.
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: Article 3 (Basic Principles) (1) No activity regulated under this Act shall be conducted in any manner that violates the dignity and values of a human being, and priority shall be given to human rights and welfare of each human subject of research or donor. (2) Self-determination of each human subject of research or donor shall be respected, and the voluntary consent of a human subject of research or donor shall be supported by adequate information. (3) Privacy of each human subject of research or donor shall be protected, and personal information likely to lead to the invasion of privacy shall be protected as confidential information, except where the relevant party consents to disclosure or an Act expressly permits disclosure. (4) Full consideration shall be given to the safety of each human subject of research or donor, and risks shall be minimized. (5) An individual or group in vulnerable conditions shall be specially protected. (6) International cooperation shall be promoted as necessary to ensure bioethics and biosafety, and a person conducting such activities shall endeavor to adopt universal norms.
9.
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.
10.
B. M.Knoppers, “Biobanking: International Norms,”Journal of Law, Medicine & Ethics33, no. 1 (2005): 7-14.
11.
Bioethics and Biosafety Act of Korea, Chapter V, Section 1, Art. 36-40.
12.
Bioethics and Biosafety Act of Korea, Chapter V, Section 2, Art. 41-45.
13.
Bioethics and Biosafety Act of Korea, Art. 2, Item 17.
14.
Bioethics and Biosafety Act of Korea, Art. 2, Item 18.
15.
Bioethics and Biosafety Act of Korea, Art. 2, Item 14.
16.
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 B.M.Knoppers, “Biobanking: International Norms,”Journal of Law, Medicine & Ethics33, no. 1 (2005): 7-14.
17.
Bioethics and Biosafety Act of Korea, Art. 2, Item 19.
18.
Bioethics and Biosafety Act of Korea, Art. 10, Para. 1.
19.
Bioethics and Biosafety Act of Korea, Art. 13.
20.
Bioethics and Biosafety Act of Korea, Art. 14.
21.
Bioethics and Biosafety Act of Korea, Art. 10, Para. 3.
22.
Bioethics and Biosafety Act of Korea, Art. 3, Para 6.
23.
Y. J.Chang and S. Y.Kong, “Legal and Ethical Use of Biospecimens in Research Following Major Revision of the Bioethics and Safety Act,”Laboratory Medicine Online5, no. 3 (2015): 113–20.
24.
See, e.g., Korean Constitutional Court, 99HunMa513, 2004HunMa190, May 25, 2005. For a critique on the Korean Constitutional Court's decision in this regard, seeH.S.Jung, “Critical Analysis on the Korean Constitutional Court”s Decisions Concerning the Right to Informational Self-Determination,”Pusan National University Law Review56, no. 4 (2015): 1–31.
25.
Bioethics and Biosafety Act of Korea, Art. 37.
26.
Minister's Decree under the Bioethics and Biosafety Act of Korea, Schedule 34.
27.
Bioethics and Biosafety Act of Korea, Art. 37, Para. 3.
28.
Bioethics and Biosafety Act of Korea, Art. 70.
29.
Bioethics and Biosafety Act of Korea, Art. 39, Para. 1.
30.
Bioethics and Biosafety Act of Korea, Art. 39, Para. 1.
31.
Bioethics and Biosafety Act of Korea, Art. 36, Para. 1.
32.
Minister's Decree under the Bioethics and Biosafety Act of Korea, Art. 33, Para. 1.
33.
Bioethics and Biosafety Act of Korea, Art. 41, Para. 1, 2.
34.
At least 1 information manager and two biobank researchers must be hired by a biobank.
35.
Bioethics and Biosafety Act of Korea, Art. 41, Para. 4.
36.
Bioethics and Biosafety Act of Korea, Art. 45.
37.
Bioethics and Biosafety Act of Korea, Art. 42.
38.
Minister's Decree under the Bioethics and Biosafety Act of Korea, Schedule 41.
39.
C.Gradyet al., “Broad Consent for Research With Biological Samples: Workshop Conclusions,”American Journal of Bioethics15, no. 9 (2015): 34–42.
40.
Bioethics and Biosafety Act of Korea, Art. 44, Para. 4.
41.
Minister's Decree under the Bioethics and Biosafety Act of Korea, Art. 42, Para. 1.
42.
Minister's Decree under the Bioethics and Biosafety Act of Korea, Art. 42, Para. 2.
43.
Bioethics and Biosafety Act of Korea, Art. 43, Para. 2.
44.
Ministry of Health and Welfare of Korea, Standard Operation Guidelines for Biobanks (2013): at 91-92.
45.
Ministry of Health and Welfare of Korea, Standard Operation Guidelines for Biobanks (2013): at 92-96.
46.
Minister's Decree under the Bioethics and Biosafety Act of Korea, Art. 41, Para. 1.
47.
Bioethics and Biosafety Act of Korea, Art. 43, Para. 1.
48.
Bioethics and Biosafety Act of Korea, Art. 43, Para 4.
49.
Minister's Decree under the Bioethics and Biosafety Act of Korea, Art. 41, Para 3.
50.
Ministry of Health and Welfare of Korea, Standard Operation Guidelines for Biobanks (2013), at 100.
51.
Ministry of Health and Welfare of Korea, Standard Operation Guidelines for Biobanks (2013), at 99.
52.
Ministry of Health and Welfare of Korea, Standard Operation Guidelines for Biobanks (2013): at 99.
53.
S. Y.Choet al., “Opening of the National Biobank of Korea as the Infrastructure of Future Biomedical Science in Korea,”Osong Public Health and Research Perspectives3, no. 3 (2012): 177–84.
54.
Id.
55.
O.Parket al., “A Strategic Plan for the Second Phase (2013–2015) of the Korea Biobank Project,”Osong Public Health and Research Perspectives4, no. 2 (2013): 107–16.
56.
S.Y. Cho et al., supra note 53, at 180–181.
57.
J.E.Leeet al., “National Biobank of Korea: Quality Control Programs of Collected-Human Biospecimens,”Osong Public Health and Research Perspectives3, no. 3 (2012): 185–89.
E.g., M.Gymreket al., “Identifying Personal Genomes by Surname Inference,”Science339, no. 6117 (2013): 321–24.
62.
S. Y.Choet al., “Opening of the National Biobank of Korea as the Infrastructure of Future Biomedical Science in Korea,”Osong Public Health and Research Perspectives3, no. 3 (2012): 177–84, at 181. Requests for sharing serum samples came in a distant second with 8%, followed by plasma at 3%.
63.
C.Gradyet al., “Broad Consent for Research With Biological Samples: Workshop Conclusions,”American Journal of Bioethics15, no. 9 (2015): 34-42.
64.
E. A.Kim, “Significance and Limitation of Recent Changes in the Wholly Amended Bioethics and Safety Act for the Protection of the Human Research Participant,”Journal of the Korea Bioethics Association15, no. 2 (2014): 15-35.
65.
M. A.Rothstein, B. M.Knoppers, and H. L.Harrell, “Comparative Approaches to Biobanks and Privacy,”Journal of Law, Medicine and Ethics44, no. 1 (2016): 161-172.
“Credit card firms ordered to compensate consumers for data leak,”The Korea Herald, January 22, 2016, available at <http://www.koreaherald.com/view.php?ud=20160122000543> (last visited March 1, 2016) (the court awarded mere $83 to each victim of personal information breach).
68.
H. G.Koo and J. Y.Rha, “An Exploratory Study on Consumer Perception of Giving Consent for Personal Information,”Journal of Consumption Culture17 (2014): 151-181 (“Although the right to consent is not only the basic human right but also the property right, many consumers don't pay enough attention to the consent process and the terms of privacy policy…[m]any consumers don't read the terms of privacy policy…”)
69.
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.
