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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

 Article 1 (Purpose)
The purpose of this Decree is to prescribe the matters delegated by the Bioethics and Safety Act and other matters necessary for the implementation thereof.
 Article 2 (Meetings of the National Bioethics Committee)
(1) The chairperson of the National Bioethics Committee (hereinafter referred to as the “National Committee”) under Article 7 (1) of the Bioethics and Safety Act (hereinafter referred to as the “Act”) shall convene a meeting, 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 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 National Committee)
Where a member mentioned in Article 8 (3) 2 and 3 of the Act falls under any of the followings, the President may dismiss the relevant member:
1. Where a member becomes unable to conduct his/her duties due to mental or physical disability;
2. Where a member commits a misdeed in connection with his/her duties;
3. Where a member is recognized to be unsuitable to be a member due to neglect of duties, injury to dignity and other grounds;
4. Where a member himself/herself expresses that he/she has difficulties in conducting his/her duties.
[This Act 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 research involving human subjects, policies on bioethics and safety, and other matters not subject to deliberation of any other specialized committee;
2. Specialized Committee on Embryos: Deliberation on matters concerning the production and maintenance of embryos, the use and research of residual embryos, residual ova, somatic-cell cloning embryos, etc. (referring to somatic-cell cloning embryos, etc. under Article 20 (1) of the Act), or the use of embryonic stem cell lines;
3. Specialized Committee on Human Biological Materials: Deliberation and exemption therefrom on a research of human materials, and deliberation on matters concerning human material banks;
4. Specialized Committee on Genes: Deliberation on matters concerning genetic tests, gene therapy, etc.;
5. Specialized Committee on the Protection of Human Subject of Research: Deliberation on matters concerning the protection of human subject of research, the affairs of institutional bioethics committees under Article 10 (1) of the Act (hereinafter referred to as “institutional committees”), 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 area 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 according to 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 exceeding seven members, including one chairperson and one vice-chairperson.
(2) The members of each specialized committee shall be persons falling under any of the following subparagraphs, and shall include at least one of the following persons, respectively: <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 Civil 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 life science, medical science, or social science;
3. Persons commissioned by the Minister of Health and Welfare, from among those engaged in judicial circles, ethical circles, religious circles, non-governmental organizations (referring to non-profit, non-governmental organizations defined in Article 2 of the Assistance for Non-Profit, Non-Governmental Organizations Act), or women’s circles.
(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/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/her opinions.
 Article 5-2 (Dismissal of Members of Specialized Committees)
Where a member mentioned in Article 4 (2) 1 through 3 falls under any of the followings, the Minister of Health and Welfare may dismiss the relevant member:
1. Where a member becomes unable to conduct his/her duties due to mental or physical disability;
2. Where a member commits a misdeed in connection with his/her duties;
3. Where a member is recognized to be unsuitable to be a member due to neglect of duties, injury to dignity and other grounds;
4. Where a member himself/herself expresses that he/she has difficulties in conducting his/her duties.
[This Act Newly Inserted by Presidential Decree No. 26703, Dec. 10, 2015]
 Article 6 (Allowances and Traveling 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, etc.)
If necessary for deliberating on any agenda item, the National Committee or specialized committees may request relevant agencies, organizations, etc. to present relevant materials or opinions.
 Article 8 (Holding, etc. 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, agencies, organizations, etc. to conduct investigations or research.
 Article 9 (Detailed Rules on Operation)
Except as expressly provided for 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 Institutional Committees, etc.)
(1) Standards for accreditation of institutional committees under Article 14 (1) of the Act shall include the following:
1. Propriety of deliberations by institutional committees on matters falling under any item 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 the members of institutional committees;
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 institutional committees, and the expertise of staff members supporting the operation thereof, both of which are necessary for smooth operation of institutional committees;
7. Whether to prepare standard operation guidelines for institutional committees 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, on the basis of the result of evaluation.
(3) Except as expressly provided for in this Decree, necessary matters concerning the details of standards for the evaluation and accreditation of institutional committees, 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(Restriction on Frequency of Ova Extractions)
(1) The frequency of ova extractions under Article 27 (3) of the Act shall be three times in a lifetime, and ova extractions shall be conducted at an interval of at least six months.
(2) Where there occurred side effects of ova extraction, ova may be re-extracted more than six months since the side effects have been completely cured.
 Article 12 (Subject Rare or Incurable Diseases of Residual Embryos Research)
(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 announced by the Minister of Health and Welfare, following deliberation by the National Committee, which are deemed necessary for research on residual embryos for public health.
 Article 13 (Such Matters of Plans for Research on Embryos as Require Approval for their Alternation)
“Important matters specified in Presidential Decree” in the latter part of Article 30 (1) of the Act means any of the following:
1. Purposes of or period for research;
2. Quantity of residual embryos necessary for research;
3. Medical institution for producing embryos which provides residual embryos;
4. The person in chare of research.
 Article 14 (Restriction on Acts of Somatic-cell Nuclear Transplantation or Acts of Parthenogenesis)
(1) Research permitted to conduct acts of somatic-cell nuclear transplantation or acts of parthenogenesis pursuant to Article 31 (2) of the Act shall meet all the following requirements:
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 collected from removed ovaries;
3. Research using somatic-cell cloning embryos or parthenogenesis embryos in vitro before the primitive streak appears genetically.
(2) With intent to provide residual oocytes to persons planning to conduct research under paragraph (1), medical institutions for producing embryos shall obtain written consent from their donors: Provided, That where with intent to provide oocytes under paragraph (1) 2 (e), the practitioners collecting the relevant oocytes shall obtain written consent from their donors.
 Article 15 (Such Matters of Plans for Research on Use of Embryonic Stem Cell Lines as Require Approval for their Alternation)
“Important matters specified in Presidential Decree” in the latter part of Article 35 (2) of the Act means any of the following:
1. Purposes of or period for research;
2. The person in chare of research;
3. Matters affecting the scientific and ethical validity of research for the use of embryonic stem cell lines.
 Article 16 (Permission for Establishment of Human Material Banks)
(1) A person who intends to obtain permission for establishment of a human material bank 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 human material bank shall, as prescribed by Ordinance of the Ministry of Health and Welfare, submit a written application for permission for establishment of a human material bank to the Minister of Health and Welfare, along with documents determined by the said Ordinance.
(3) Where the Minister of Health of Welfare intends to grant permission for establishment of a human material bank, he/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 Human Material Banks)
“Important matters specified in Presidential Decree” in Article 41 (3) of the Act means any of the following:
1. Location of the human material bank;
2. Head of the human material bank;
3. Name of the human material bank;
4. Facilities, apparatus, and human resources of the human material bank.
 Article 18 (Changes Subject to Reporting by Gene Therapy Institutions)
“Important matters specified in Presidential Decree” in the latter part of Article 48 (1) of the Act means any of the following:
1. Location of the gene therapy institution;
2. Head of the institution;
3. Name of the institution;
4. Subject diseases or treatment items of gene therapies.
 Article 19 (Changes Subject to Reporting by Genetic Testing Institutions)
“Important matters specified in Presidential Decree” in Article 49 (2) of the Act means any of the following:
1. Location of the genetic testing institution;
2. Head of the institution;
3. Name of the institution;
4. Items of genetic testing;
5. 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 Testing 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/she shall give written notice of the payment of the penalty surcharge specifying the kind 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 twenty 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) The collecting agency which has received penalty surcharges pursuant to paragraph (2) shall issue the receipts to the payers, and shall notify the Minister of Health and Welfare of the fact of receipts of the penalty surcharges without delay.
 Article 23(Subsidies from National Treasury)
Institutions, organizations, or employees thereof, 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. Persons engaged in 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 Outsourcing)
(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 institutional committees under Article 10 of the Act;
2. Designation of medical institutions for producing embryos under Article 22 (1) of the Act, acceptance of reports on any changed matters under paragraph (4) of the same Article, and acceptance of reports on temporary business closure or permanent business closure of such medical institutions under paragraph (5) of the same Article;
3. Registration of embryo research institutes under Article 29 (2) of the Act, and acceptance of reports on permanent business closure thereof under paragraph (3) of the same Article;
4. Registration of research institutes for somatic-cell cloning embryos 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 human material banks under Article 41 (1) of the Act, and acceptance of report on the change, temporary business closure, or permanent business closure thereof under paragraph (3) of the same Article;
9. Acceptance of reports or reports for 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 for change under paragraph (2) of the same Article, and acceptance of reports on temporary business closure or permanent business closure under paragraph (4) of the same Article;
11. Orders, other necessary measures, entry for inspection, queries, or collection under Article 54 of the Act;
12. Orders for discard 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 under Article 57 of the Act;
16. Imposition and collection of penalty surcharges under Article 58 of the Act;
17. Collection of fees under Article 59 of the Act.
(2) Pursuant to Article 61 (2) of the Act, the Minister of Health and Welfare shall outsource the affairs falling under Articles 13 (1) 2, 14, and 49 (3) of the Act to the relevant institutions or organizations classified as follows:
1. Affairs concerning education on the members of institutional committees under Article 13 (1) 2 of the Act: Institutions or organizations deemed expert in affairs of education on the members of institutional committees and designated and publicly announced 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 institutional committees under Article 14 of the Act: Institutions or organizations deemed expert in affairs of evaluation and accreditation of institutional committees and designated and publicly announced 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 announced by the Minister of Health and Welfare, from among non-profit corporations under Article 32 of the Civil Act.
 Article 24-2 (Reexamination of Restrictions)
The Minister of Health and Welfare shall examine the validity of standards for imposing fines for negligence specified in 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 Fines for Negligence)
Standards for imposing fines for negligence under Article 70 of the Act shall be as specified in attached Table 4.
ADDENDA
Article 1 (Enforcement Date)
This Decree shall enter into force on February 2, 2013.
Article 2 (Relations with Other Statutes)
Citations of the former provisions of the Enforcement Decree of the Bioethics and Safety Act in any other statutes 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 former provisions.
Article 3 (Transitional Measures concerning Fines for Negligence)
The imposition of fines for negligence on offences committed before this Decree enters into force shall be governed by the former provisions thereof.
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 among Presidential Decrees amended pursuant to Article 5 of the Addenda, the amended parts of the Presidential Decrees promulgated before this Decree enters into force, but the enforcement dates of which have not arrived, shall enter into force on the dates the relevant Presidential Decrees enter into force, respectively.
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 16 Omitted.
ADDENDUM <Presidential Decree No. 26703, Dec. 10, 2015>
This Decree shall enter into force on the date of 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.)
Article 2 through 8 Omitted.
Article 9 (Transitional Measures for Amendment to Enforcement Decree of the Bioethics and Safety Act)
When applying standards for the imposition of fines on misconduct committed before this Decree enters into force.
Articles 10 through 12 Omitted.
ADDENDUM <Presidential Decree No. 27918, Feb. 28, 2017>
This Decree shall enter into force on the date of 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 among Presidential Decrees amended pursuant to Article 8 of the Addenda, the amended parts of the Presidential Decrees promulgated before this Decree enters into force, but the enforcement dates of which have not arrived, shall enter into force on the dates the relevant Presidential Decrees enter into force, respectively.
Articles 2 through 8 Omitted.