-Young-Rhan UM, PhD, RN Associate Professor, Soonchunhyang University, Korea Email: firstname.lastname@example.org
Reports of success in cloning cows and deriving stem cell from human embryo made Korean people realize more of the bioethical considerations on scientific research. This paper describes the current situation and disputes over scientific research using human embryos in Korea. This paper introduces the ethical recommendations by the Korean Bioethics Advisory Commission and analyzes its ethical imperatives through comparing recommendations of other countries. To realize "respect for embryos" as a major moral imperative, research goals, permissible period after fertilization, and storage or discard of embryos should be considered. There are several guidelines regarding human embryo research in Korea. One is "The ethical guidelines on assisted reproduction medicine" by the Korean Society of OBGY, in 1999. Another is "The guidelines on the safety of biotechnology research" that were suggested by the Ministry of Health and Welfare (MHW) in 2000.
The third is by the Korean Bioethics Advisory Commission (KBAC). The KBAC was established November 2000, and it was continued until November 2001. The KBAC consisted of twenty members who are professionals in humanity, religion, biotechnology, medicine, and nongovernmental organizations. On May 18, 2001, the KBAC published a set of recommendations for biotechnological research and application, including scientific experiments with human embryos. Four days later on May 22, the KBAC had a public hearing in order to finalize its recommendations. Since then, public reaction and debate over the ethical aspects of human embryo research have been actively shown because this recommendations specified considerations of human embryo research in detail more than the above two guidelines. The KBAC recommendations might have influenced the bill drafting from the MHW for the legislative process of the National Assembly in the year of 2002.
The Korean government is trying to legislate a bill governing human cloning and other biotechnology. Both the MHW and the Ministry of Science and Technology have each drafted a bioethics bill. However, the Office for Government Policy Coordination decided to provide the MHW with the authority to introduce the bill. This decision is interpreted as the Korean government weighing respect for human life more than advances in biotechnology. However, the bill could not be established because the two ministries had failed to reach an agreement on the proposal for the bill by November 8, 2002.
Now, briefly, I am going to summarize the regulations for scientific research using human embryos, as proposed in the bill drafted by the MHW. The bill draft included human cloning, use of human embryos, genetic tests, protection and use of human genetic information, and genetic treatment. The draft bill permitted using spare embryos after infertility treatment that are less than 14 days old, and after a preservation period of five years. Human embryos can be used for the purpose of research to develop infertility treatment methods and contraceptive techniques, stem cell research for disease treatment, and other research for disease prevention, diagnosis, and treatment under permission of the National Bioethics Advisory Commission. The bill prohibited creating human embryos using somatic cell nuclear transfer into oocytes, hybridizing between humans and animals, and selling ova and sperm.
The bill included somatic cell nuclear transfer into oocytes only if the president permitted transfer after the National Bioethics Advisory Commission examined it. This exception evoked hot discussion from both parties of pros and cons about using human embryos.
The bill draft included some ethical requirements for human embryo research. First, a researcher should get written consent from donors of embryos or germ cells. An informed consent must include the purpose of creating embryos, preservation period of embryos, decision to or not use spare embryos except for pregnancy, the discarding of spare embryos, and revocation of consent and protection of individual rights and privacy.
Second, the government should establish a commission to oversee public as well as private research involving human embryos. Finally, the role of IRB should be strengthened in order to evaluate ethical and scientific validity of research proposals, identify informed consent from germ cell donors and research subjects, protect safety and privacy of germ cell donors and research subjects, and to assure liability regulations for victims.
Legal actions: The bill stated that if a violation occurs, the institute, the responsible person, and the participant would face criminal or administrative actions. For example, a researcher who tries human reproductive cloning should be sentenced to ten years' penal servitude.
Ethical principles: The bill draft stated in the very first clause that its purpose was to assure respect for human dignity and value.
Legal status of human embryo: Generally, the status of human embryos have been regarded as a simple cell mass, a potential human being, or a person having full human status from the moment of its creation. In the bill, the human embryo was defined as "a split cell mass from fertilization before all organs are formed embryologically." However, in the case of preservation and discard of human embryos, the wording of the bill suggests that the embryo should be respected as a potential being.
Leaders of churches and women's organizations objected to the permission of scientific research on spare embryos. They object to any type of embryo research. A Catholic priest who is a member of a Catholic Bioethics Committee criticized the proposal concerning Bioethics and Safety for trying to enhance biotechnology while avoiding blame, rather than dealing with ethics about human life and safety. He strongly blamed the exception clause of somatic cell nucleus transferal into an oocyte.
Scientists and economists supported creating human embryos for research purposes only and permitting therapeutic cloning. When therapeutic cloning is prohibited legally, they worry that health care in Korea may become dominated by other countries in the future. Some scientists worry that the prohibition will impact negatively on the advancement of basic scientific research in the field of cell differentiation and development of early embryos.
The Ministry of Science and Technology insisted strongly that therapeutic cloning, including hybridization between humans and animals, should be permitted. This assertion conflicted with the bill draft, and made the bill draft fail to pass legislation in this year 2002.
The bill could not deny the benefits of human embryonic research but also had a burden to preserve the dignity of human life. The bill could have provided embryos with a degree of protection. However, it faced objections from both religious leaders and scientists.
In order to resolve the conflict, the bill would do well to have a discussion that leads to mutual agreement from both sides (about defining the status of human embryo).
In order to actualize the bill, the standards for proper handling of human embryos during and after infertility treatment should be established.
I think a kind of institute needs to be established as an intermediary between the MHW and researchers. The institute would consist of professionals in embryology and reproductive medicine as an intermediary between the MHW and researchers and could advise researchers and commissions on ways to deal with human embryos. In the present draft bill, there is only IRB between the ministry and researchers.