1. Korean Regulations on Stem Cell Research and Their Problems Kyungsuk Choi School of Law, Ewha Womans University Interdisciplinary Study Program of Bioethics Policy

2. Is the Consent for the Research Use of Embryos an Informed Consent? Consent Form of the Use of Spare Embryos - According to Article 15- ② -4 of Bioethics and Safety Act, a written consent whether to “utilize the spare embryos for purposes other than pregnancy” must be obtained when Embryo Producing Medical Institutions produce embryos - On the basis of 15- ② -5, Enforcement Rule 5- ③ -3 requires Embryo Producing Medical Institutions to ask “whether or not consent is given to use sperm or oocytes for research purpose.” - When a donor gives a consent for the use of spare embryos, Consent Form of the Use of Spare Embryos must be filled out in addition to Consent Form of the Production of Embryos.

3. Is the Consent for the Research Use of Embryos an Informed Consent? Issue 1 - Is it valid that Embryo Producing Medical Institutions obtain a blanket consent because the concrete purpose of embryos research is not determined? - There is no space to explain for what purpose embryos are used and by whom. - I wonder if a consent for the research use of embryos is an informed consent.

4. Is the Consent for the Research Use of Embryos an Informed Consent? Issue 2 - What if a donor wants to give a consent for some of research purposes indicated by the Act? - Article 17 indicates purposes for which spare embryos may be utilized - “1. To conduct research aimed at developing contraception and infertility treatments; 2. To conduct research aimed at curing rare or incurable diseases including muscle dystrophy, as decided by the Presidential Decree; or 3. To conduct other research that is pursuant to subparagraphs 1 and 2 above, and approved by the Presidential Decree.

5. Is the Consent for the Research Use of Embryos an Informed Consent? Expediency is involved. - These problems show that expediency is involved in obtaining an informed consent. - I argue that researchers should obtain an informed consent, and - At least, a donor should be asked what purposes of research he/she gives a consent to.

6. Is the Consent for the Research Use of Oocytes an Informed Consent? More problematic in the use of oocytes - Some donors may allow to use their oocytes for SCNT embryonic research while some may not. - There is no regulation to have to explain what purposes spare oocytes may be utilized for.

7. Restriction of Oocytes available for SCNT Embryonic Research Restriction on SCNT - “No one shall conduct somatic cell nuclear transfer other than for the purpose of conducting research aimed at curing rare or currently incurable diseases, as described in Article 17- ②.” (Article 22- ① ) - “Research on somatic cell nuclear transfer will be permitted if it meets all the following requirements: 1. The research aims to produce SCNT embryos and then establish stem cell lines from those cloned embryos.” (Enforcement Decree 12.3- ① -1)

8. Restriction of Oocytes available for SCNT Embryonic Research Oocytes available for SCNT embryonic research - “2. Oocytes to be used for the research belong to the following categories; a. Oocytes that have been cryopreserved for reproductive purposes but are going to be disposed of for such reasons as completion of fertility treatment, b. Immature or abnormal oocytes that are going to be disposed of as they are not to be used for fertilization, c. Oocytes which have been used for in vitro fertilization but are going to be disposed of as they failed to fertilize or the patients gave up treatment”, -.

9. Restriction of Oocytes available for SCNT Embryonic Research Oocytes available for SCNT embryonic research “d. Oocytes that have been collected for infertility treatments but are going to be disposed of as there is no proper recipient for them, or e. Oocytes collected from surgically removed ovaries.”

10. Issues Relevant to Restriction of Oocytes Issue 1: Is it legally allowed to donate oocytes for research in general? - There is no regulation to prohibit the donation of oocytes for research in general. - The above regulation is applied to SCNT embryonic research.

11. Issues Relevant to Restriction of Oocytes Issue 2: Is it legally allowed to use so-called “fresh oocytes” for SCNT embryonic research? - In the above regulation, most of available oocytes are limited to spare ones. - However, there is an opinion that the above ‘c’ and ‘d’ allows the use of “fresh oocytes.” - In the case of ‘d,’ we have to take this regulation to be able to mean ‘Oocytes that have been collected for infertility treatments [and have not been frozen] but are going to be disposed of as there is no proper recipient for them.’

12. Issues Relevant to Restriction of Oocytes Issue 2: Is it legally allowed to use so-called “fresh oocytes” for SCNT embryonic research? - In the case of c, we have to take this regulation to be able to mean ‘Oocytes which are going to be disposed of as the patients gave up treatment, [although they have not been used for in vitro fertilization.]’ - The issue is whether we have to apply the phrase “have been used for in vitro fertilization” to the case in which the patients gave up treatment.

13. Issues Relevant to Restriction of Oocytes Issue 2: Is it legally allowed to use so-called “fresh oocytes” for SCNT embryonic research? - The intent of these phrases was to prevent the abuse of oocytes because they were made after Hwang’s scandle. - Although we may accept the above interpretation, it should be seriously reviewed why a donor changes her mind abruptly before her oocytes are frozen. - This debate is not purely a matter of literal interpretation, rather involved in our trust in scientists because we have experienced unethical procurement of oocytes for SCNT embryonic research.

14. Issues Relevant to Restriction of Oocytes Issue 2: Is it legally allowed to use so-called “fresh oocytes” for SCNT embryonic research? - I conclude that (1) cases considered in the above interpretation would be rare, and (2) such cases should be seriously reviewed to prevent the abuse of oocytes although the Act does not explicitly prohibit the use of “fresh oocytes.”

15. Issues Relevant to Restriction of Oocytes Is the Enforcement Decree consistent with the Act? - Some may argue that there is an inconsistency between the Enforcement Decree and the Act, - Because the Enforcement Decree imposes the limits on the use of “fresh oocytes” that are vey important for the success of the research although the Act allows SCNT embryonic research. - I argue that this prima facie conflict may be understood to be a kind of compromise between different ethical positions on SCNT embryonic research, - Because the Act and the above phrases in the Enforcement Decree were made at different periods.

16. Issues Relevant to Restriction of Oocytes Is the Enforcement Decree consistent with the Act? - Thus, Korea may be understood to have a compromised position on SCNT embryonic research, which allows the research with the very strict qualification in its purpose and the procurement of oocytes for the research.

17. Registration of Imported Embryonic Stem Cell Registration of Embryonic Stem Cell Line - “Anyone who has established or imported stem cell lines shall register those lines with the Minister of Health, Welfare and Family Affairs as provided in the Ordinance of the Ministry for Health, Welfare and Family Affairs before he/she provides them pursuant to Article 20.3 or uses them pursuant to Article 20.4.” (Article 20.2- ① ) - Thus, imported embryonic stem cell lines must be registered.

18. Registration of Imported Embryonic Stem Cell Issue: Why are imported embryonic stem cell lines registered? - Most Korean scientists disagree with the registration of imported embryonic stem cell lines. - This disagreement may lie in the obscurity in the purpose and benefit of the registration - (1) If the registration is for a stem cell bank, - The registration of imported embryonic stem cell lines is not justifiable. - Because such stem cell lines are not objects that a Korean bank should keep - There is an indefinite plan for a national stem cell bank.

19. Registration of Imported Embryonic Stem Cell Issue: Why are imported embryonic stem cell lines registered? - (2) If the registration is intend to limit Korean research and use of embryonic stem cells to cell lines that were ethically established with scientific validity, - It is justified that even imported embryonic stem cell lines must be registered for ethical and scientific validity in their use. - However, I wonder how the ethical validity of embryonic stem cell lines established abroad can be reviewed by the Korean government, let alone why the ethical and scientific validity must be reviewed through the registration, not through other procedures.

20. The Use of Embryonic Stem Cell Lines Limitation of the Use of Embryonic Stem Cell Lines - “The stem cell lines registered in accordance with Article 20.2 shall be used in vitro for the following research purposes: 1. Research to diagnose, prevent or treat diseases; 2. Basic research to study characteristics and differentiation of stem cells; or 3. Other research decided by the Presidential Decree after it has been reviewed by the National Committee.”(Article 20.4- ① )

21. The Use of Embryonic Stem Cell Lines Issue: Is the clinical trial with embryonic stem cells prohibited? - (1) If the use of embryonic stem cell lines includes clinical trials with the use of embryonic stem cells derived from cell lines, - The above regulation may be understood to prohibit the clinical trials with embryonic stem cells. - The intent of the above regulation may be the same as the above interpretation, - because it was expected that clinical trials with embryonic stem cells were not safe when the above regulation was added into the Act.

22. The Use of Embryonic Stem Cell Lines Issue: Is the clinical trial with embryonic stem cells prohibited? - At that time(2008), most embryonic stem cell lines were in the research grade, not in the clinical grade. - Another reason to support the above interpretation is that “research to diagnose, prevent or treat diseases” with the use of embryonic stem cell lines will be generally research to use stem cells derived from stem cell lines. - In addition, “stem cell lines” is just a term to refer to a group of stem cells although it is defined as “a population of cells that can be grown indefinitely and has the ability to differentiate into various types of cells if the culture conditions are met.”

23. The Use of Embryonic Stem Cell Lines Issue: Is the clinical trial with embryonic stem cells prohibited? - I wonder if stem cell lines are fundamentally different from stem cells in the perspective of safety and differentiation ability. - Because our worry is whether embryonic stem cells will grow to become a targeted type of a cell in clinical trials with stem cells. - Thus, the use of embryonic stem cell lines should be interpreted to include the use of embryonic stem cells within a human body.

24. The Use of Embryonic Stem Cell Lines ISSCR Guideline - ISSCR guideline does not regulate stem cell with the distinction of stem cell lines. - “Forms of research that involve the derivation of new human pluripotent cell lines by any means”(10.2a) and “Clinical research in which cells of totipotent or pluripotent human origin are transplanted into living human subjects”(10.2d) both should be reviewed by SCRO, not just by IRB.

25. The Use of Embryonic Stem Cell Lines Issue: Is the clinical trial with embryonic stem cells prohibited? - (2) If we interpret “the use of embryonic stem cell lines” to mean “the direct use of embryonic stem cells lines, that is, a population of cells that can be grown indefinitely and has the ability to differentiate into various types of cells if the culture conditions are met,” - The use of embryonic stem cells, that is, clinical trials with stem cells, is beyond the scope of the Act.

26. The Use of Embryonic Stem Cell Lines Issue: Is the clinical trial with embryonic stem cells prohibited? - The clinical trials with embryonic stem cells may be regulated, like clinical trials with adult stem cells, according to the Standard for the Control of Drug Clinical Trial and the Standard for the Approval of Biological Material for Treatment provided by Korean FDA, or - These trials may are object that the Evaluation Committee of New Medical Technology established by Medical Act can review like clinical trials with adult stem cells.

27. The Use of Embryonic Stem Cell Lines Clinical Trials with Embryonic Stem Cell by Cha Hospital - Now, a bill to revise the Act including the allowance of clinical trials with embryonic stem cells was presented to the National Assembly, reflection the debate. - However, Cha Hospital presented the protocol of clinical trial with the same embryonic stem cells that are under clinical trials in U.S.A. - The National Bioethics Committee provided an opinion that such trials be allowed despite the debate.

28. For Better Bioethics Policy Change of regulation model - As the debate on clinical trials with embryonic stem cells shows, it is not a good idea that scientific research is regulated in detail by an act. - Specific consideration had better be regulated by an enforcement rule or just guidelines autonomously established by scientists. Restoration of Trust in Scientist - As the issues of informed consent show, scientists should try to restore citizens’ trust.

29. For Better Bioethics Policy Public Dialogue - There should be lots of communication among scientists, ethicists, legal experts, the government and citizens. - Journalists as well as scholars should try to deliver accurate information to the public without any exaggeration and distortion. - Science education should try to provide educational program to establish self-regulatory model by scientists. - Scientists have to think that they themselves make law relevant to their profession.

30. Contact Information Thank you. Kyungsuk Choi: choiks@ewha.ac.krchoiks@ewha.ac.kr Bioethics Policy Research Center: bprc@bprc.re.krbprc@bprc.re.kr Bioethics Policy Library: bprl@bprc.re.krbprl@bprc.re.kr Center Homepage: www.bprc.re.kr