Stem cell research in Korea.

Abstract

Last February, a group of Korean scientists led by W. S. Hwang and S. Y. Moon surprised the world by deriving a human embryonic stem cell line (SCNT hES-1) from a cloned blastocyst (“Evidence of a pluripotent human embryonic stem cell line derived from a cloned blastocyst,” Reports, 12 Mar., p. 1669; published online 12 Feb., 10.1126/science.1094515). This is the first example of success in what might be considered a first step to human “therapeutic cloning,” and it captured the attention of the world media. In response to the announcement, many have raised questions about the ethical and social environment of Korea with regard to such biotechnological investigations. In December 2003, the Korean National Assembly passed the “Bioethics and Biosafety Act,” which will go into effect in early 2005. According to the Act, human reproductive cloning and experiments such as fusion of human and animal embryos will be strictly banned [([1][1]), Articles 11 and 12]. However, therapeutic cloning will be permitted in very limited cases for the cure of serious diseases. Such experiments will have to undergo review by the National Bioethics Committee (NBC) [([1][1]), Article 22]. According to the Act, every researcher and research institution attempting such experiments must be registered with the responsible governmental agency [([1][1]), Article 23]. Since the Act is not yet in effect, the research done by Hwang et al. was done without any legal control or restriction. The Korean Bioethics Association ( ), a leading bioethics group in Korea, consisting of bioethicists, philosophers, jurists, and scientists, announced “The Seoul Declaration on Human Cloning” ([2][2]) in 1999, demanding the ban of human reproductive cloning and the study of the socio-ethical implications of cloning research. Many nongovernment organizations and religious groups in Korea agreed with and supported the declaration. We regret that Hwang and Moon did not wait until a social consensus about reproductive and therapeutic cloning was achieved in Korea before performing their research. Indeed, Hwang is Chairperson of the Bioethics Committee of the Korean Society for Molecular Biology, and Moon is President of the Stem Cell Research Center of Korea and a member of its Ethics Committee. They argue that their research protocol was approved by an institutional review board (IRB). However, we are not convinced that this controversial research should be done with the approval of only one IRB. We believe that it was premature to perform this research before these issues had been resolved. The Korean government is working to prepare regulations, guidelines, and review systems for biotechnology research in keeping with global standards ([3][3]). We hope that there will be no more ethically dubious research reports generated by Korean scientists before these systems are in place. 1. 1.[↵][4]Biosafety and Bioethics Act, passed 2003. 2. 2.[↵][5]1. The Korean Bioethics Association , J. Kor. Bioethics Assoc. 1(no. 1), 195 (2000). [OpenUrl][6] 3. 3.[↵][7]Korean Association of Institutional Review Boards, Guidelines for IRB Management, 10 Feb. 2003. # Response {#article-title-2} We recognize that our report changed the ethical, legal, and social implications of therapeutic cloning from a theoretical possibility to the first proof of principle that human embryonic stem cells can be derived from cloned blastocysts. Stem cell researchers and society at large must consider all the implications associated with therapeutic cloning. Conversations on this important topic must be all-inclusive. However, it is important to reiterate that the experiments included in our manuscript complied with all existing institutional and Korean regulations. In accordance with both Korean government regulation, as well as our own ethics, we neither have nor will conduct “human reproductive cloning and experiments such as fusion of human and animal embryos.” We concur that all human embryo experiments should be overseen by appropriate medical, scientific, and bioethical experts. In Korea, as in other countries, there is a great diversity of opinions regarding the newest scientific discoveries and when or if they should be translated into clinical research. The Korean Bioethics Association (KBA) is, in our opinion, not neutral and advocates restricting the pace of biomedical advancements, viewing new techniques as threats to society. For example, they have spoken publicly against the study of transgenic mouse models for human disease and preimplantation genetic diagnosis to help parents have healthy children. Although we respect the opinions of the KBA, we, as members of a leading Korean stem cell and cloning laboratory, are committed to discovering the medical potential of stem cells and to participating in conversations with ethical and religious groups regarding matters of bioethical concern. Our research team has always and will continue to comply with ethical regulations and any laws or guidelines promulgated by the Korean government. [1]: #ref-1 [2]: #ref-2 [3]: #ref-3 [4]: #xref-ref-1-1 View reference 1. in text [5]: #xref-ref-2-1 View reference 2. in text [6]: {openurl}?query=rft.jtitle%253DJ.%2BKor.%2BBioethics%2BAssoc.%26rft.volume%253D1%26rft.issue%253Dno.%2B1%26rft.spage%253D195%26rft.atitle%253DJ%2BKOR%2BBIOETHICS%2BASSOC%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [7]: #xref-ref-3-1 View reference 3. in text