Abstract: Human embryonic stem cells have the potential to treat many physical and neurological disorders due to their unique ability to transform into any type of human cell. The process of deriving stem cells from human embryos, however, raises important ethical and regulatory issues. Embryonic stem cell research requires a steady source of human eggs to create embryos that are destroyed during stem cell extraction. International declarations and guidelines protect the two most vulnerable participants of embryonic stem cell research: women who donate eggs for research purposes and human embryos that are destroyed in the research.
In 2005, South Korea passed the Bioethics and Biosafety Act to regulate biotechnology research. In its current form, the Bioethics and Biosafety Act fails to adequately protect egg donors and human embryos. The Bioethics and Biosafety Act does not have adequate safeguards to protect egg donors, such as a requirement of voluntary consent and a requirement that egg donors understand the research and its potential risks. The Institutional Review Boards established by the Bioethics and Biosafety Act are not sufficiently removed from the research institution to guarantee that egg donors are not exploited. Additionally, this legislation fails to appropriately regulate the use of human embryos in scientific research as required by international guidelines. The Bioethics and Biosafety Act should include more detailed provisions dealing with the adequacy and quality of informed consent that is obtained from egg donors. Furthermore, Korea should amend its law to limit the use of human embryos in stem cell research so that the embryos are not unnecessarily destroyed.
To realize its goal of becoming the "world-best science nation," the Republic of Korea ("Korea") is investing tremendous money and resources into scientific research and development.1 Embryonic stem cell research is one specific area of study that the Korean government has encouraged and supported. In May 2006, the Korean government decided to invest 430 billion won,2 or $454 million, into stem cell research over the next decade.3 The money was allocated to support research on adult and embryonic stem cells as well as to strengthen the ethical infrastructure underlying stem cell research.4 Korea's strong support for stem cell research has required it to pass new legislation to guide this innovative, yet controversial, field. In 2003, Korea passed the Bioethics and Biosafety Act ("Bioethics Act") to deal with advances in biotechnology, particularly in stem cell research.5 The Bioethics Act came into effect at the beginning of 2005.6
No binding international standards currently govern embryonic stem cell research. In 1998, the United Nations ("UN") passed a resolution banning all forms of human cloning that are "incompatible with human dignity and the protection of human life."7 However, it is a non-binding declaration that was voted against by thirty-four member countries.8 Korea voted against the UN resolution and the Korean representative to the UN General Assembly made it clear that the resolution will not affect Korea's policy of allowing therapeutic cloning.9 As a result, the Korean Bioethics Act allows therapeutic cloning, yet places a ban on reproductive cloning.10 Reproductive cloning creates an embryo with the aim of producing a new, genetically identical individual, whereas therapeutic cloning produces embryos to be used in research.11 Thus, unlike reproductive cloning, therapeutic cloning has the potential to help patients by replacing or supplementing their damaged cells, tissues, or organs.12
Korea's continued support of therapeutic cloning and embryonic stem cell research arguably requires changes in the Bioethics Act to adequately protect egg donors and human embryos from exploitation and to bring the Act into compliance with international standards. Part II of this Comment provides a brief introduction to the Bioethics Act and addresses the highly publicized stem cell research scandal that took place in Korea after the Bioethics Act became law. …