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ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT

Wholly Amended by Presidential Decree No. 24329, Jan. 22, 2013

Amended by Presidential Decree No. 24454, Mar. 23, 2013

Presidential Decree No. 25050, Dec. 30, 2013

Presidential Decree No. 25751, Nov. 19, 2014

Presidential Decree No. 25840, Dec. 9, 2014

Presidential Decree No. 26703, Dec. 10, 2015

Presidential Decree No. 27751, Dec. 30, 2016

Presidential Decree No. 27918, Feb. 28, 2017

Presidential Decree No. 28211, Jul. 26, 2017

Presidential Decree No. 29950, Jul. 2, 2019

Presidential Decree No. 30141, Oct. 22, 2019

 Article 1 (Purpose)
The purpose of this Decree is to prescribe matters mandated by the Bioethics and Safety Act and other matters necessary for enforcing said Act.
 Article 2 (Meetings of the National Bioethics Committee)
(1) The chairperson of the National Bioethics Committee (hereinafter referred to as the “National Committee”) established under Article 7 (1) of the Bioethics and Safety Act (hereinafter referred to as the “Act”) shall convene a meeting of the National Committee, in any of the following cases:
1. Where the President requests the convocation of a meeting;
2. Where at least 1/3 of all incumbent members of the National Committee request the convocation of a meeting;
3. Where the chairperson of the National Committee deems it necessary to convene a meeting.
(2) Where convening a meeting, the chairperson of the National Committee shall notify the members of the National Committee of the date, time, venue, and agenda items of a meeting until seven days before it is held: Provided, That where there exists any inevitable cause, such as an urgent matter for deliberation, the chairperson may give notice to the members of the National Committee until the day immediately before the meeting is held.
(3) Resolution by a meeting of the National Committee shall require the attendance of a majority of all incumbent members and consent from a majority of those present.
(4) If deemed necessary for deliberation, the chairperson of the National Committee may request the chairperson of a specialized committee under Article 3 or a member thereof to attend a meeting.
 Article 2-2 (Dismissal of Members of the National Committee)
Where a member referred to in Article 8 (3) 2 and 3 of the Act falls under any of the following, the President may dismiss the relevant member:
1. Where a member becomes unable to conduct his or her duties due to a mental or physical disability;
2. Where a member commits a misdeed in connection with his or her duties;
3. Where a member is recognized to be unsuitable to be a member due to neglect of duties, injury to dignity, or other grounds;
4. Where a member himself or herself expresses that he or she has difficulties in conducting his or her duties.
[This Article Newly Inserted by Presidential Decree No. 26703, Dec. 10, 2015]
 Article 3 (Establishment and Functions of Specialized Committees)
(1) The following specialized committees by field shall be established under the National Committee pursuant to Article 9 (1) of the Act:
1. Specialized Committee on Bioethics and Safety Policy: Deliberation on human subjects research projects, policies on bioethics and safety, and other matters not subject to deliberation by any other specialized committee;
2. Specialized Committee on Embryos: Deliberation on matters concerning the production and management of embryos, the use and research of surplus embryos, surplus oocytes, somatic-cell cloning embryos, etc. (referring to somatic-cell cloning embryos, etc. under Article 20 (1) of the Act), or the use, etc. of embryonic stem cell lines;
3. Specialized Committee on Human Materials: Deliberation on human materials research projects and exemption from such deliberation, and deliberation on matters concerning biobanks;
4. Specialized Committee on Genes: Deliberation on matters concerning genetic tests, gene therapies, etc.;
5. Specialized Committee on the Protection of Human Subjects of Research: Deliberation on matters concerning the protection of human subjects of research, the affairs of institutional review boards under Article 10 (1) of the Act (hereinafter referred to as “IRBs”), and the affairs of joint institutional bioethics committees under Article 12 of the Act;
6. Ad Hoc Specialized Committee: Deliberation on matters concerning any particular field by that committee established by the chairperson of the National Committee by a resolution thereof, which is to exist for a limited time only.
(2) Specialized committees shall deliberate on any matters referred to a meeting thereof by the National Committee based on their relevant fields or any matters they deem necessary to be referred to a meeting thereof; and the chairpersons thereof shall report the results of deliberation to the National Committee.
 Article 4 (Composition of Specialized Committees)
(1) Each specialized committee shall be comprised of at least five, but not more than seven members, including one chairperson and one vice-chairperson.
(2) The members of each specialized committee shall be appointed from among the following persons, and shall include at least one person referred to in each subparagraph: <Amended by Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 25751, Nov. 19, 2014; Presidential Decree No. 28211, Jul. 26, 2017>
1. Persons appointed by the Minister of Health and Welfare, on the recommendation of the relevant Minister, from among public officials in general service of Grade IV or higher or public officials belonging to the Senior Executive Service of the Ministry of Education, the Ministry of Science and ICT, the Ministry of Justice, the Ministry of Trade, Industry and Energy, the Ministry of Health and Welfare, or the Ministry of Gender Equality and Family;
2. Persons commissioned by the Minister of Health and Welfare, after consultation with the Minister of Science and ICT, from among those who have abundant professional knowledge and research experience in the field of biological science, medical science, or social science;
3. Persons commissioned by the Minister of Health and Welfare, from among those engaged in judicial circles, ethics circles, religious circles, civic groups (referring to non-profit, non-governmental organizations defined in Article 2 of the Assistance for Non-Profit, Non-Governmental Organizations Act), or women’s organizations.
(3) The chairperson of each specialized committee shall be elected from among and by the members thereof, and the vice-chairperson of each specialized committee shall be designated by the chairperson thereof.
(4) The members commissioned pursuant to paragraph (2) shall hold office for a term of three years and may be commissioned consecutively for future terms: Provided, That the term of office of the members who are public officials shall coincide with the term of their official positions.
(5) If a vacancy occurs in the office of a member, a member for filling a vacancy shall be commissioned, and the term of office of a newly commissioned member shall be the remainder of his or her predecessor’s term of office.
(6) Each specialized committee shall have one secretary, who shall be designated by the Minister of Health and Welfare from among the relevant public officials.
 Article 5 (Operation of Specialized Committees)
(1) The chairperson of the relevant specialized committee shall convene a meeting, in any of the following cases:
1. Where the chairperson of the National Committee requests the convocation of a meeting;
2. Where at least 1/3 of all incumbent members of the relevant specialized committee request the convocation of a meeting;
3. Where the chairperson of the relevant specialized committee deems it necessary to convene a meeting.
(2) If deemed necessary for deliberation, a specialized committee may request any relevant expert, etc. to make an appearance at the said committee to hear his or her opinions.
 Article 5-2 (Dismissal of Members of Specialized Committees)
Where a member referred to in Article 4 (2) 1 through 3 falls under any of the following, the Minister of Health and Welfare may dismiss the relevant member:
1. Where a member becomes unable to conduct his or her duties due to a mental or physical disability;
2. Where a member commits a misdeed in connection with his or her duties;
3. Where a member is recognized to be unsuitable to be a member due to neglect of duties, injury to dignity, or other grounds;
4. Where a member himself or herself expresses that he or she has difficulties in conducting his or her duties.
[This Article Newly Inserted by Presidential Decree No. 26703, Dec. 10, 2015]
 Article 6 (Allowances and Travel Expenses)
Allowances, traveling expenses, and other necessary expenses may be paid within the budget, to the members of the National Committee, the members of specialized committees, and relevant experts, etc. who appear at the National Committee or any specialized committee: Provided, That this shall not apply where public officials appear at the National Committee or any specialized committee in direct connection with affairs under their charge.
 Article 7 (Request for Cooperation of Relevant Agencies)
If necessary for deliberating on any agenda item, the National Committee or specialized committees may request relevant institutions, organizations, etc. to present relevant materials or opinions.
 Article 8 (Holding of Public Hearings)
If necessary for deliberating on any agenda item, the National Committee may hold a public hearing or discussion, or request relevant experts, institutions, organizations, etc. to conduct investigations or research.
 Article 9 (Operating Rules)
Except as provided in this Decree, matters concerning the composition and operation of the National Committee and specialized committees, and other necessary matters, shall be determined by the chairperson of the National Committee by a resolution thereof.
 Article 10 (Standards for Evaluation and Accreditation of IRBs)
(1) The standards for accreditation of IRBs under Article 14 (1) of the Act shall include the following:
1. Propriety of deliberations by IRBs on matters falling under the items of Article 10 (3) 1 of the Act;
2. Propriety of performance systems for inspection and supervision of the process and outcomes of research projects being conducted by the relevant institution under Article 10 (3) 2 of the Act;
3. Propriety of education provided for the researchers and employees of the relevant institution under Article 10 (3) 3 (a) of the Act, and education provided for the members of IRBs;
4. Formulation of measures for protecting human subjects of research in a vulnerable position, etc., under Article 10 (3) 3 (b) of the Act, and whether such measures are complied with;
5. Establishment of ethical guidelines for researchers under Article 10 (3) 3 (c) of the Act, and the propriety of such guidelines;
6. Independence of the composition of IRBs, and the expertise of staff members supporting the operation thereof, both of which are necessary for smooth operation of IRBs;
7. Whether to prepare standard operation guidelines for IRBs in relevant institutions, and the propriety of such guidelines;
8. Systems for the management of related records and documents, and the propriety of such systems.
(2) The valid term of accreditation shall be three years, but may be extended just for one year, depending on the result of evaluation.
(3) Except as provided in this Decree, necessary matters concerning the details of standards for the evaluation and accreditation of IRBs; the procedures and methods for evaluation, accreditation, and accreditation extension; the designs and indication methods of the accreditation mark; and other matters related thereto shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 11(Restrictions on Frequency of Oocytes Extractions)
(1) The frequency of oocytes extractions under Article 27 (3) of the Act shall be three times in a lifetime, and oocytes extractions shall be conducted at an interval of at least six months.
(2) Where there occurred side effects of oocytes extraction, oocytes may be re-extracted more than six months after the side effects are completely cured.
 Article 12 (Rare or Incurable Diseases for Which Research on Surplus Embryos Is Conducted)
(1) “Rare or incurable diseases specified by Presidential Decree” in Article 29 (1) 2 of the Act means the following: <Amended by Presidential Decree No. 27918, Feb. 28, 2017>
1. Rare diseases:
(a) Multiple sclerosis, Huntington’s disease, hereditary ataxia, amyotrophic lateral sclerosis, cerebral palsy, and spinal cord injury;
(b) Congenital immunodeficiency syndromes, aplastic anemia, and leukemia;
(c) Osteochondrodysplasia;
(d) Adrenoleukodystrophy, Metachromatic Leukodystrophy, and Krabbe's disease;
2. Incurable diseases:
(a) Myocardial infarction;
(b) Liver cirrhosis;
(c) Parkinson's disease, stroke, Alzheimer’s disease, and optic nerve damage;
(d) Diabetes mellitus;
(e) Acquired immunodeficiency syndrome.
(2) “Research specified by Presidential Decree” in Article 29 (1) 3 of the Act means research determined and publicly notified by the Minister of Health and Welfare, after deliberation by the National Committee, which is deemed necessary for research on surplus embryos for public health.
 Article 13 (Such Matters in Plans for Research on Embryos as Require Approval for Their Change)
“Important matter specified by Presidential Decree” in the latter part of Article 30 (1) of the Act means any of the following:
1. The purposes of or period for research;
2. The quantity of surplus embryos necessary for research;
3. The medical institution producing embryos which provides surplus embryos;
4. The person in charge of research.
 Article 14 (Restrictions on Somatic-Cell Nuclear Transplantation or Parthenogenesis)
(1) Research permitted to conduct somatic-cell nuclear transplantation or parthenogenesis pursuant to Article 31 (2) of the Act shall meet all the following requirements: <Amended by Presidential Decree No. 29950, Jul. 2, 2019>
1. Research for producing somatic-cell cloning embryos or parthenogenesis embryos and establishing embryonic stem cell lines by using them;
2. Research using any of the following oocytes:
(a) Oocytes cryopreserved for producing embryos, intended to be discarded due to any reason, such as success in pregnancy;
(b) Immature oocytes or abnormal oocytes, intended to be discarded because there is no plan to produce embryos;
(c) Oocytes used for in vitro fertilization, intended to be discarded due to failure in fertilization or abandonment of fertilization;
(d) Oocytes extracted for medical treatment of infertility, intended to be discarded because there is no appropriate donee;
(e) Oocytes extracted from removed ovaries;
3. Research using somatic-cell cloning embryos or parthenogenesis embryos in vitro before the primitive streak appears during embryonic development.
(2) With intent to provide surplus oocytes to persons planning to conduct research under paragraph (1), medical institutions producing embryos shall obtain written consent from their donors: Provided, That where with intent to provide oocytes under paragraph (1) 2 (e), the practitioners extracting the relevant oocytes shall obtain written consent from their donors.
 Article 15 (Such Matters in Plans for Research Projects Using Embryonic Stem Cell Lines as Require Approval for Their Change)
“Important matter specified by Presidential Decree” in the latter part of Article 35 (2) of the Act means any of the following:
1. The purposes of or period for research;
2. The person in charge of research;
3. Matters affecting the scientific and ethical validity of research projects using embryonic stem cell lines.
 Article 16 (Permission for Establishment of Biobanks)
(1) A person who intends to obtain permission for establishment of a biobank pursuant to Article 41 (1) of the Act shall be equipped with facilities, apparatus, and human resources specified in attached Table 1.
(2) A person who intends to obtain permission for establishment of a biobank shall, as prescribed by Ordinance of the Ministry of Health and Welfare, submit a written application for permission for establishment of a biobank to the Minister of Health and Welfare, along with documents determined by said Ordinance.
(3) Where the Minister of Health of Welfare intends to grant permission for establishment of a biobank, he or she shall issue a certificate of permission to the applicant, as prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 17 (Changes Subject to Reporting by Biobanks)
“Important matter specified by Presidential Decree” in Article 41 (3) of the Act means any of the following:
1. The location of the biobank;
2. The head of the biobank;
3. The name of the biobank;
4. The facilities, apparatus, and human resources of the biobank.
 Article 18 (Changes Subject to Reporting by Gene Therapy Institutions)
“Important matter specified by Presidential Decree” in the latter part of Article 48 (1) of the Act means any of the following:
1. The location of the gene therapy institution;
2. The head of the institution;
3. The name of the institution;
4. The diseases for which gene therapies are used or such therapy items.
 Article 19 (Changes Subject to Reporting by Genetic Testing Institutions)
“Important matter specified by Presidential Decree” in Article 49 (2) of the Act means any of the following:
1. The location of the genetic testing institution;
2. The head of the institution;
3. The name of the institution;
4. Genetic test items;
5. The facilities and human resources of the genetic testing institution.
 Article 20 (Prohibited or Restricted Genetic Tests)
“Genetic tests specified by Presidential Decree” in Article 50 (1) of the Act means tests prescribed in attached Table 2.
 Article 21 (Genetic Tests for Embryos or Fetuses)
“Hereditary diseases specified by Presidential Decree” in Article 50 (2) of the Act means diseases prescribed in attached Table 3.
 Article 22 (Imposition and Collection of Penalty Surcharges)
(1) Where the Minister of Health and Welfare intends to impose a penalty surcharge pursuant to Article 58 (1) of the Act, he or she shall give written notice of the payment of the penalty surcharge specifying the type of violation involved and the amount of such surcharge.
(2) A person who has been given notice pursuant to paragraph (1) shall pay the penalty surcharge to the collecting agency determined by the Minister of Health and Welfare within 20 days from the date of receipt of the notice: Provided, That where it is impossible to pay the penalty surcharge within the said period due to act of God or other inevitable cause, it shall be paid within seven days from the day such cause ceases to exist.
(3) Upon receiving penalty surcharges pursuant to paragraph (2), the collecting agency shall issue the receipts to the payers, and shall notify the Minister of Health and Welfare of the fact of receiving the penalty surcharges without delay.
 Article 23 (Subsidies from National Treasury)
Institutions or organizations, or their employees, entitled to receive a subsidy for research expenses pursuant to Article 60 of the Act shall be as follows:
1. Institutions or organizations performing activities of research or education on securing of bioethics and safety;
2. Bioethics policy research centers designated pursuant to Article 6 (1) of the Act;
3. Employees of any institution or organization referred to in subparagraph 1, who have performed research and education activities in any bioethics-related field for at least five years.
 Article 24 (Delegation and Entrustment of Authority)
(1) The Minister of Health and Welfare shall delegate the following authority to the head of the Korea Centers for Disease Control and Prevention pursuant to Article 61 (1) of the Act:
1. Registration of IRBs under Article 10 of the Act;
2. Designation of medical institutions producing embryos under Article 22 (1) of the Act, acceptance of reports on any changed matters under paragraph (4) of said Article, and acceptance of reports on suspension or closure of business operations of such medical institutions under paragraph (5) of said Article;
3. Registration of embryo research institutes under Article 29 (2) of the Act, and acceptance of reports on closure of business operations under paragraph (3) of said Article;
4. Registration of research institutes for somatic-cell cloning embryos, etc. under Article 31 (3) of the Act;
5. Registration of embryonic stem cell lines under Article 33 (1) of the Act;
6. Receipt of reports on the current status concerning provision of embryonic stem cell lines under Article 34 (2) of the Act;
7. Receipt of reports on details of approval for use of embryonic stem cell lines or reports on details of approval for change thereof under Article 35 (3) of the Act;
8. Permission for biobanks under Article 41 (1) of the Act, and acceptance of reports on the change or on suspension or closure of business operations under paragraph (3) of said Article;
9. Acceptance of reports or reports on change made by gene therapy institutions under Article 48 (1) of the Act;
10. Acceptance of reports made by genetic testing institutions under Article 49 (1) of the Act, acceptance of reports on change under paragraph (2) of said Article, and acceptance of reports on suspension or closure of business operations under paragraph (4) of said Article;
11. Orders, other necessary measures, entry for inspection, inquiries, or collection under Article 54 of the Act;
12. Orders for discarding under Article 55 (1) of the Act;
13. Orders for improvement of facilities or orders for prohibition of use of facilities under Article 55 (2) of the Act;
14. Orders for revocation of registration, etc., or orders for suspension of operation under Article 56 of the Act;
15. Holding hearings pursuant to Article 57 of the Act;
16. Imposing and collecting penalty surcharges under Article 58 of the Act;
17. Collecting fees under Article 59 of the Act.
(2) Pursuant to Article 61 (2) of the Act, the Minister of Health and Welfare shall entrust the affairs falling under Articles 13 (1) 2, 14, and 49 (3) of the Act to relevant institutions or organizations classified as follows:
1. Affairs concerning education on the members of IRBs under Article 13 (1) 2 of the Act: Institutions or organizations deemed expert in affairs of education on the members of IRBs, and designated and publicly notified by the Minister of Health and Welfare, from among non-profit corporations under Article 32 of the Civil Act;
2. Affairs concerning evaluation and accreditation of IRBs under Article 14 of the Act: Institutions or organizations deemed expert in affairs of evaluation and accreditation of IRBs, and designated and publicly notified by the Minister of Health and Welfare, from among non-profit corporations under Article 32 of the Civil Act;
3. Affairs concerning evaluation of accuracy of genetic tests under Article 49 (3) of the Act: Institutions or organizations deemed expert in affairs of evaluation of accuracy of genetic tests, and designated and publicly notified by the Minister of Health and Welfare, from among non-profit corporations under Article 32 of the Civil Act.
 Article 24-2 (Re-Examination of Regulation)
The Minister of Health and Welfare shall review the validity of the standards for imposing administrative fines under Article 25 and attached Table 4 every three years (referring to the period ending on the date immediately preceding January 1 of the third year), with January 1, 2014 as the reference date, and shall then take measures for improvement, etc. of such standards.
[This Article Newly Inserted by Presidential Decree No. 25050, Dec. 30, 2013]
 Article 25 (Standards for Imposing Administrative Fines)
Standards for imposing administrative fines prescribed in Article 70 of the Act shall be as prescribed in attached Table 4.
ADDENDA <Presidential Decree No. 24329, Jan. 22, 2013>
Article 1 (Enforcement Date)
This Decree shall enter into force on February 2, 2013.
Article 2 (Relationship to Other Statutes or Regulations)
Citations of the previous provisions of the Enforcement Decree of the Bioethics and Safety Act in any other statutes or regulations as at the time this Decree enters into force, if corresponding provisions exist in this Decree, shall be deemed citations of such corresponding provisions of this Decree in lieu of the previous provisions.
Article 3 (Transitional Measures concerning Administrative Fines)
The previous provisions shall apply to the imposition of administrative fines for violations committed before this Decree enters into force.
ADDENDA <Presidential Decree No. 24454, Mar. 23, 2013>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 4 Omitted.
ADDENDUM <Presidential Decree No. 25050, Dec. 30, 2013>
This Decree shall enter into force on January 1, 2014. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 25751, Nov. 19, 2014>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation: Provided, That the amendments to Presidential Decrees to be amended pursuant to Article 5 of the Addenda, which were promulgated before this Decree enters into force but the enforcement dates of which have yet to arrive, shall enter into force on the enforcement date of the relevant Presidential Decree.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 25840, Dec. 9, 2014>
Article 1 (Enforcement Date)
This Decree shall enter into force on January 1, 2015.
Articles 2 through 7 Omitted.
Article 8 (Transitional Measures for Amendment to the Enforcement Decree of the Bioethics and Safety Act)
In applying the standards for imposing administrative fines for violations committed before this Decree enters into force, the previous provisions shall apply notwithstanding the amended provisions of subparagraph 2 (a) and (b) of attached Table 4 of the Bioethics and Safety Act.
Articles 9 through 16 Omitted.
ADDENDUM <Presidential Decree No. 26703, Dec. 10, 2015>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 27751, Dec. 30, 2016>
Article 1 (Enforcement Date)
This Decree shall enter into force on January 1, 2017. (Proviso Omitted.)
Articles 2 through 8 Omitted.
Article 9 (Transitional Measures for Amendment to the Enforcement Decree of the Bioethics and Safety Act)
In applying the standards for imposing administrative fines for violations committed before this Decree enters into force, the previous provisions of subparagraph 2 (a), (f), (h), (i), and (k) of attached Table 4 shall apply notwithstanding the amended provisions of subparagraph 2 (a), (f), (h), (i), and (k) of attached Table 4.
Articles 10 through 12 Omitted.
ADDENDUM <Presidential Decree No. 27918, Feb. 28, 2017>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 28211, Jul. 26, 2017>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation: Provided, That the amendments to Presidential Decrees to be amended pursuant to Article 8 of the Addenda, which were promulgated before this Decree enters into force but the enforcement dates of which have yet to arrive, shall enter into force on the enforcement date of the relevant Presidential Decree.
Articles 2 through 8 Omitted.
ADDENDUM <Presidential Decree No. 29950, Jul. 2, 2019>
This Decree shall enter into on the date of its promulgation. (Proviso Omitted.)
ADDENDUM <Presidential Decree No. 30141, Oct. 22, 2019>
This Decree shall enter into force on October 24, 2019.