BIOETHICS AND SAFETY ACT

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BIOETHICS AND SAFETY ACT — 법갈피

Article 8(Composition of National Committee) #

(1) The National Committee shall be comprised of at least 16 and not more than 20 members, including one chairperson and one vice chairperson. <Amended by Act No. 11690, Mar. 23, 2013>

(2) The chairperson shall be appointed or commissioned by the President from among members, and the vice chairperson shall be elected by and from among members.

(3) The National Committee shall be comprised of the following members: <Amended by Act No. 11690, Mar. 23, 2013; Act No. 12844, Nov. 19, 2014; Act No. 14839, Jul. 26, 2017>

1. The Minister of Education, the Minister of Science and ICT, the Minister of Justice, the Minister of Trade, Industry and Energy, the Minister of Health and Welfare, and the Minister of Gender Equality and Family;

2. Not more than seven persons commissioned by the President from among persons who have abundant expertise and experience in research on biological science, medical science, or social science;

3. Not more than seven persons commissioned by the President from among representatives of representatives of religious circles, ethical circles, judicial circles, civic groups (referring to nonprofit, non-governmental organizations defined in Article 2 of the Assistance for Non-Profit, Non-Governmental Organizations Act) or women’s organizations.

(4) Each member specified in paragraph (3) 2 and 3 shall hold office for a term of three years and may be appointed consecutively for further terms: Provided, That the term of office of a member newly commissioned to fill a vacancy shall be the remaining term of his or her predecessor.

(5) The National Committee shall have two secretaries, who are the Minister of Science and ICT and the Minister of Health and Welfare; and the Minister of Health and Welfare shall also serve as senior secretary. <Amended by Act No. 11690, Mar. 23, 2013; Act No. 14839, Jul. 26, 2017>

(6) In order to support the affairs, including the management of administrative affairs, of the National Committee, the Minister of Health and Welfare may designate a specialized institution related to bioethics and safety, so that the institution serves as a secretariat, as prescribed by Ordinance of the Ministry of Health and Welfare. <Newly Inserted by Act No. 12447, Mar. 18, 2014>

Article 10(Establishment and Functions of Institutional Bioethics Committee) #

(1) Any of the following institutions shall establish an institutional bioethics committee (hereinafter referred to as "institutional committee") so as to ensure bioethics and safety:

1. An educational institution, research institute, hospital, or similar institution, to which a person who conducts human subjects research(hereinafter referred to as "human subjects researcher") belongs;

2. An educational institution, research institute, hospital, or similar institution, to which a person who conducts human materials research (hereinafter referred to as "human materials researcher") belongs;

3. An embryo-producing medical institution designated pursuant to Article 22 (1);

4. An embryo research institute registered pursuant to Article 29 (2);

5. A research institute for somatic-cell cloning embryos, etc. registered pursuant to Article 31 (3);

6. A Human Material Bank with permission from the Minister of Health and Welfare under Article 41 (1);

7. Other institutions specified by Ordinance of the Ministry of Health and Welfare as institutions likely to substantially affect society in connection with bioethics and safety.

(2) Notwithstanding paragraph (1), an institution shall be deemed to have an institutional committee, if it has entered into an agreement with the institutional committee of any other institution or a public institutional bioethics committee under Article 12 (1), to entrust the affairs assigned to its institutional committee specified in paragraph (3) and Article 11 (4), as prescribed by Ordinance of the Ministry of Health and Welfare.

(3) An institutional committee shall take charge of the following affairs:

1. Deliberation on the following matters:

(a) Ethical and scientific validity of a research plan;

(b) Whether consent has been duly obtained from human subjects of research or donors;

(d) Measures for protecting personal information of human subjects of research or donors;

(e) Other matters regarding bioethics and safety in the relevant institution;

2. Inspection and supervision of the progress and outcomes of research conducted by the relevant institution;

3. The following activities for bioethics and safety:

(a) Education of researchers and employees of the relevant institution;

(b) Formulation of measures for protecting human subjects of research or donors in a vulnerable position;

(4) An institution that has established an institutional committee pursuant to paragraph (1) shall register the institutional committee with the Minister of Health and Welfare.

(5) Details necessary for functions of an institutional committee and the registration under paragraphs (3) and (4) shall be prescribed by Ordinance of the Ministry of Health and Welfare.

Article 16(Consent to Human Subjects Research) #

(1) A human subjects researcher shall obtain written consent (including consent given in an electronic document; hereinafter the same shall apply) regarding the following matters from human subjects of research before commencing human subjects research:

1. The objectives of the human subjects research;

2. The duration, procedures for, and methods of participation of human subjects of research;

3. Foreseen risks and benefits to human subjects of research;

4. Protection of personal information;

5. Compensation for losses incurred through participation in the research ;

6. Provision of personal information;

7. Withdrawal of consent;

8. Other matters the competent institutional committee deems necessary.

(2) Notwithstanding paragraph (1), where research is to involve a person incapable of, or incompetent for, giving consent as a human subject of research, as specified by Ordinance of the Ministry of Health and Welfare, his or her representative specified in the following shall give written consent thereto. A representative's consent in such cases must not be contrary to the intention of the relevant human subject of research:

1. The legal representative;

2. If there is no legal representative, the spouse or a lineal ascendant or descendant shall act as an agent for such person in the abovementioned order; but if there are two or more lineal ascendants or descendants, the representative for such person shall be appointed under agreement by and between such ascendants or descendants, or the oldest person among them shall act as the representative for such person if they fail to reach an agreement.

(3) Notwithstanding paragraph (1), research may be exempted from obtaining written consent of a human subject of research, subject to approval from the institutional committee, if the research satisfies all the following prerequisites. In such cases, research shall not be exempted from obtaining written consent of the representative under paragraph (2):

1. If it is deemed that obtaining consent from a human subject of research is impracticable in the course of research or is likely to seriously affect the validity of research;

2. If there is no ground to find that a human subject of research will decline consent or the risk to a human subject of research is very low even if the project is exempted from consent.

(4) A human subjects researcher shall fully explain the matters specified in paragraph (1) to a person having the right to consent before obtaining written consent from him or her pursuant to paragraphs (1) and (2).

Article 37(Consent to Human Materials Research) #

(1) A human materials researcher shall obtain written consent regarding the following matters from donors of a human material before commencing the human materials research:

1. The objectives of the human materials research;

2. Protection and disposal of personal information;

3. Storage and disposal of human materials;

4. Provisions of human materials and genetic information obtained from human materials (hereinafter referred to as "human materials, etc.");

5. Withdrawal of consent, treatment of human materials, etc. if consent is withdrawn, rights of donors of a human material, change of the objectives, and other matters specified by Ordinance of the Ministry of Health and Welfare.

(2) Article 16 (2) shall apply mutatis mutandis to the consent of a representative in cases where the donor of a human material is incapable of, or incompetent for, giving consent. In such cases, "human subject of research" shall be construed as "donor of a human material". <Newly Inserted by Act No. 15888, Dec. 11, 2018>

(3) Notwithstanding paragraphs (1) and (2), if a human materials researcher conducts research with a human material provided by a person who is not a human materials researcher but collected the human material, the human materials researcher shall be deemed to have obtained written consent pursuant to paragraph (1) at the time the person who collected the human material obtained written consent from the donor (including the representative prescribed in Article 16 (2), which applies mutatis mutandis under paragraph (2); hereafter in this Article and Article 38 the same shall apply) of the human material regarding matters specified in paragraph (1). <Amended by Act No. 15888, Dec. 11, 2018>

(4) Article 16 (3) shall apply mutatis mutandis to the exemption of written consent for human materials research. In such cases, "human subject of research" shall be construed as "donor of a human material".

(5) A human materials researcher shall fully explain the matters specified in paragraph (1) to the donor of a human material before obtaining written consent under paragraphs (1) and (2) from him or her. <Amended by Act No. 15888, Dec. 11, 2018>

(6) Details necessary for the form, etc. of the written consent under paragraphs (1) and (2) shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 15888, Dec. 11, 2018>

Article 42-2(Provision of Residual Samples) #

(1) Notwithstanding Article 42, a Human Material Bank can be provided from a medical institution (referring to any medical institution established under the Medical Service Act; hereafter in this Article the same shall apply) with any human material remaining after the medical institution has used for the purpose of treatment or diagnosis (hereinafter referred to as "residual sample") only for research purposes in compliance with the manner and procedures provided in paragraphs (2) through (6). In such cases, medical institutions shall not collect any human material in excess of the volume necessary for treatment or diagnosis for the purpose of providing residual samples.

(2) A medical institution that intends to provide residual samples for Human Material Banks shall give the donor written notice stating the following information before the medical institution collects the human materials it intends to provide. In such cases, the medical institution shall also explain the information referred to in subparagraph 1 orally to the donor:

1. The fact that the residual samples can be provided to Human Material Banks unless the donor expresses his or her opposition;

2. The manner and procedures in which the donor expresses his or her opposition under subparagraph 1;

3. The method of anonymizing the residual samples;

4. Matters about the storage, management, disposal, and use of the residual samples;

5. Other matters prescribed by Ordinance of the Ministry of Health and Welfare.

(3) In receipt of written notice under paragraph (2), a donor who intends to oppose to the provision of residual samples, shall express his or her opposition in writing form signed or sealed by himself or herself or in other manners prescribed by Ordinance of the Ministry of Health and Welfare. In such cases, a refusal to accept written notice given under paragraph (2) shall be construed as expression of opposition under the former part.

(4) A medical institution shall not provide Human Material Banks with any residual samples to which the donor has expressed his or her opposition under paragraph (3).

(5) A medical institution shall determine the purposes and objects for which residual samples are provided and the method of anonymizing such residual samples, and shall obtain approval from its institutional committee in advance, before providing the residual samples.

(6) A medical institution shall anonymize residual samples when it provides such samples for Human Material Banks under paragraph (1).

(7) Provision of residual samples by medical institutions under paragraph (1) shall be free of charge: Provided, That if any expenses are incurred by a medical institution in storing and providing residual samples, the medical institution may request reimbursement of the expenses from Human Materials Banks, as prescribed by Ordinance of the Ministry of Health and Welfare.

(8) Upon provision of a residual sample, a medical institution shall prepare and keep records on the provision of the residual sample, as prescribed by Ordinance of the Ministry of Health and Welfare.

(9) Article 43 shall apply mutatis mutandis to the provision of residual samples by Human Material Banks. In such cases, "human material, etc." shall be construed as "residual sample".

(10) Details necessary for the methods and procedures of written notice pursuant to paragraph (2), the method and procedure for expressing opposition under paragraph (3), and items and procedures for approval granted by the institutional committee pursuant to paragraph (5), etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare.

[This Article Newly Inserted by Act No. 16372, Apr. 23, 2019]

Article 49(Genetic Testing Institutions) #

(1) A person who intends to conduct genetic shall secure such facilities, human resources, etc. required depending on genetic test items as prescribed by Ordinance of the Ministry of Health and Welfare and shall report on his or her business to the Minister of Health and Welfare: Provided, That the foregoing shall not apply to a State agency that intends to conduct genetic tests. <Amended on Dec. 29, 2020>

(2) A change to any important matter specified by Presidential Decree, among matters reported pursuant to paragraph (1), shall be also reported.

(3) Upon receipt of a report under paragraphs (1) and (2), the Minister of Health and Welfare shall review the details of the report and accept it if it complies with this Act. <Amended on Dec. 29, 2020>

(4) Where a genetic testing institution that has reported pursuant to paragraph (1) (hereinafter referred to as "genetic testing institution") intends to suspend or close its business operations for genetic testing, it shall report thereon to the Minister of Health and Welfare, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended on Dec. 29, 2020>

(5) Where a genetic testing institution has reported on its business closure to the head of the competent tax office pursuant to Article 8 of the Value-Added Tax Act or where the head of the competent tax office has canceled the business registration of a genetic testing institution, the Minister of Health and Welfare may ex officio cancel records of the reporting of the genetic testing institution. <Amended by Act No. 15188, Dec. 12, 2017>

(6) Where necessary to cancel the reported matters ex officio under paragraph (5), the Minister of Health and Welfare may request the head of the competent tax office to furnish information on whether the genetic testing institution has closed its business operations. In this case, the head of the competent tax office in receipt of the request shall provide the requested information in accordance with Article 36 (1) of the Electronic Government Act. <Newly Inserted by Act No. 15188, Dec. 12, 2017>

Article 49-2(Evaluation and Certification of Genetic Testing Institutions) #

(1) The head of a genetic testing institution shall undergo a skill evaluation, as prescribed by Ordinance of the Ministry of Health and Welfare, and the Minister of Health and Welfare may disclose the results thereof.

(2) The head of a genetic testing institution who intends to conduct a test under Article 50 (3) 2 (hereinafter referred to as "directly conducted genetic test for consumers") shall be equipped with facilities, human resources, etc. prescribed by Ordinance of the Ministry of Health and Welfare, and shall obtain certification from the Minister of Health and Welfare for the inspection capabilities of the relevant institution, such as the level of skills of each test item, the analysis, interpretation, and transmission of test results, measures to protect persons subject to test and personal information, etc. In such cases, the certified institution may not undergo an evaluation of skills under paragraph (1) during the effective period of certification.

(3) The period of validity of certification under paragraph (2) shall be three years from the date of certification, and where a person intends to continue to maintain such certification even after the period of validity of certification expires, he or she shall obtain re-certification.

(4) Where a genetic testing institution certified pursuant to paragraph (2) falls under any of the following cases, the Minister of Health and Welfare may revoke its certification: Provided, That where it falls under subparagraph 1, the Minister of Health and Welfare shall revoke its certification:

1. If an institutional committee obtains accreditation by fraud or other improper means;

2. Where it fails to meet the standards for certification under paragraph (2) due to important changes in facilities, human resources, equipment, etc. in the testing capacity of a genetic testing institution;

3. Where it has performed a directly implemented genetic test for consumers, other than the certified items, implemented directly for consumers;

4. Where he or she has conducted a direct genetic test directly implemented to consumers by means of significantly misleading the test subjects, such as divulging personal information of the test subjects or distorting the effectiveness of the test, etc.;

5. Where he or she has conducted a directly implemented genetic test for consumers in violation of the standards prescribed by Ordinance of the Ministry of Health and Welfare.

(5) Matters necessary for the criteria and procedures for evaluation, certification, re-certification, and revocation of certification under paragraphs (1) through (4) shall be prescribed by Ordinance of the Ministry of Health and Welfare.

[This Article Newly Inserted on Dec. 29, 2020]

Article 51(Consent to Genetic Testing) #

(1) When a genetic testing institution directly collects or requests collection of test materials to be used for genetic testing, it shall obtain written consent from the testee regarding the following, before collecting the test material: Provided, That if a testee has a disability, heed shall be given to the person's particular conditions in seeking for consent:

1. The objectives of the genetic test;

2. Management of test material;

3. Withdrawal of consent, the protection of rights and information of the testee, and other matters specified by Ordinance of the Ministry of Health and Welfare.

(2) If a genetic testing institution intends to provide a test material to a human material researcher or a Human Material Bank, it shall obtain written consent from the testee regarding the following in addition to the consent under paragraph (1):

1. Protection and disposal of personal information;

2. Storage, management, and disposal of the test material;

3. Provision of the test material;

4. Withdrawal of consent, treatment of the test material when consent is withdrawn, rights of the testee, and other matters specified by Ordinance of the Ministry of Health and Welfare.

(3) When any person, other than a genetic testing institution, collects a test material and requests a genetic testing institution to conduct a genetic test thereon, he or she shall present written consent obtained from the testee to the genetic testing institution pursuant to paragraph (1) and shall take measures for protecting personal information, as prescribed by Ordinance of the Ministry of Health and Welfare.

(4) Article 16 (2) shall apply mutatis mutandis to consent by an agent where a testee is incompetent or quasi-incompetent to consent. In such cases, "human subject of research" shall be construed as "testee", and "research" as "testing", respectively.

(5) Consent is not required for genetic testing in either of the following cases:

1. Where it is urgently or specially required to identify a corpse or an unconscious person;

2. Where it is provided in any other statute.

(6) A person who intends to obtain written consent pursuant to paragraphs (1) through (4) shall, in advance, give sufficient explanation the objectives and methods of the genetic test and the expected results and significance of the genetic test, to the testee or his or her legal representative.

(7) The method for consenting to a genetic test, the exemption from consent, and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare.

Article 55(Orders for Disposal or Improvement) #

(1) The Minister of Health and Welfare may order an institution subject to supervision or any of its employees and a person who registers, provides, or uses an embryonic stem cell line pursuant to Articles 33 through 35, to dispose of the following materials. In such cases, Articles 25 (5), 39 (4), and 53 (6) shall apply mutatis mutandis to the procedures and methods for the disposal: <Amended on Dec. 29, 2020; Feb. 20, 2024>

1. An embryo, somatic-cell cloning embryo, embryonic stem cell line, or eggs collected, produced, stored, used for research, or provided in violation of Articles 22 (1) through (3), 23, 24 (1), 25 (3) (including cases to which the aforesaid paragraph shall apply mutatis mutandis pursuant to Article 32 (2)), 26 (1), 27 (1) through (3), 29 (1) and (2), 30 (1) through (3), 31 (1), (3), and (4), 33 (1), 34 (1) and (3), and 35 (2);

2. Materials and human materials subject to test, etc. collected, produced, conserved, researched, or provided for inspection, in violation of Articles 39 (1), 41 (1), 41 (1), 43 (2), 47 (1), the former part of Article 47 (2), and (5), 48 (1), 49 (1) and (2), the former part of Article 49-2 (2), Articles 50 (1) through (3), 51 (1), (2), and (4), and 53 (1) through (3), in violation of Articles 39 (1), 41 (1), 41 (1), 43 (2), 47 (2), 47 (1), the former part of Article 47 (2), and (5), 48 (1), 49 (1) and (2), 49 (1) and (2), the former part of Article 49-2 (2), 50 (1) through (3), 51 (1), (2) and (4), and 53 (1) through (3).

(2) Where the Minister of Health and Welfare deems that an institution subject to supervision causes or is likely to cause or is likely to cause serious harm to bioethics or safety when collecting, producing, preserving, preserving, researching, providing, or producing embryos or generating embryos because it fails to meet the standards, etc. prescribed in Article 22 (2), 29 (2), 31 (3), 41 (4), 49 (1), or the former part of Article 49-2 (2), the Minister of Health and Welfare may order the institution subject to supervision to improve its facilities or prohibit the use of all or part of its facilities. <Amended on Dec. 29, 2020>

Article 68(Penalty Provisions) #

Any of the following persons shall be punished by imprisonment with labor for not more than one year or by a fine not exceeding 20 million won: <Amended on Apr. 23, 2019; Dec. 29, 2020>

1. A person who collects and stores eggs or sperm or produces embryos therefrom through fertilization without being designated as an embryo-producing medical institution, in violation of Article 22 (1) through (3);

2. A person who fails to dispose of embryos, in violation of Article 25 (3) (including cases to which the aforesaid paragraph shall apply mutatis mutandis pursuant to Article 32 (2));

3. A person who provides residual embryos or eggs for monetary compensation, in violation of Article 26 (1);

4. A person who fails to report relevant details to the Minister of Health and Welfare, in violation of Article 26 (3);

5. A person who conducts research on residual embryos without registering as an embryo research institute, in violation of Article 29 (2);

6. A person who conducts research on embryos without obtaining approval of the relevant plan therefor, in violation of Article 30 (1) (including cases to which the aforesaid paragraph shall apply mutatis mutandis pursuant to Article 31 (5));

7. A person who produces, or conducts research on, somatic-cell cloning embryos, etc. without registering with the Minister of Health and Welfare, in violation of Article 31 (3);

8. A person who establishes a Human Material Bank without permission, in violation of Article 41 (1);

9. A person who directly collects a human material or requests another person to collect a human material, without written consent, in violation of Article 42 (1);

9-2. A person who provides a Human Material Bank with any residual sample without giving the donor written notice required under Article 42-2 (2);

9-3. A person who provides a Human Material Bank with a residual sample collected from a donor who expressed his or her opposition, in violation of Article 42-2 (4);

10. A person who practices a gene therapy without reporting thereon, in violation of Article 48 (1);

11. A person who conducts a genetic test without filing a report, in violation of the main clause of Article 49 (1);

12. A person who makes a misrepresentation or an exaggerated advertisement regarding genetic tests, in violation of Article 50 (4);

13. A person who collects a material to be used for a genetic test without written consent to the genetic test, in violation of Article 51 (1), (2), or (4), or a person who requests a genetic testing institution to conduct a genetic test without presenting written consent or without taking measures for protecting personal information, in violation of Article 51 (3).

Article 70(Administrative Fines) #

(1) Any of the following persons shall be subject to an administrative fine not exceeding five million won: <Amended on Apr. 23, 2019; Dec. 29, 2020>

1. A person who fails to establish an institutional committee, in violation of Article 10 (1);

2. A person who provides or uses an embryonic stem cell line without registering, in violation of Article 33 (1);

3. A person who uses an embryonic stem cell line, in violation of Article 35 (1);

4. A person who provides a human material, etc. to any other researcher without anonymizing the human material, etc., in violation of Article 38 (2);

5. A person who fails to dispose of, treat, or transfer a human material as referred to in the main clause of Article 39 (1) or Article 39 (3) (including cases to which any of the aforesaid paragraphs shall apply mutatis mutandis pursuant to Article 42-3 (2) and Article 44 (3));

6. A person who fails to report as required in Article 41 (2);

6-2. A person who provides a residual sample for a Human Material Bank without anonymizing the residual sample, in violation of Article 42-2 (6);

6-3. A person who provides a residual sample for any other person without anonymizing the residual sample, in violation of Article 42-2 (9);

6-4. A person who fails to establish personal information protection guidelines, including schemes for anonymizing residual samples or fails to designate a manager in charge of the management and security of personal information, in violation of Article 42-3 (4);

7. A person who fails to establish personal information protection guidelines, including schemes for anonymizing human materials, etc., or fails to designate a manager in charge of the management and security of personal information, in violation of Article 44 (4);

8. Deleted; <Dec. 29, 2020>

9. Deleted; <Dec. 29, 2020>

10. A person who fails to undergo an evaluation of skilled crafts, in violation of Article 49-2 (1);

11. An institution subject to supervision or its employee that fails to comply with an order issued, an inspection conducted, or an inquiry, etc. made by the Minister of Health and Welfare, without good cause, in violation of Article 54 (3).

(2) Any of the following persons shall be subject to an administrative fine not exceeding three million won:

1. A person who fails to report with the Minister of Health and Welfare, in violation of Article 22 (4) or (5) or 29 (3);

2. A person who fails to transfer relevant documents, in violation of Article 22 (6).

(3) Any of the following persons shall be subject to an administrative fine not exceeding two million won: <Amended on Apr. 23, 2019; Dec. 29, 2020>

1. A person who fails to register with the Minister of Health and Welfare, in violation of Article 10 (4);

2. A person who fails to report with the Minister of Health and Welfare, in violation of Article 11 (4);

3. A person who provides an embryonic stem cell line for consideration, in violation of Article 34 (3);

4. A person who provides a human material, etc. for consideration, in violation of Article 38 (3);

5. A person who fails to report as required under Article 41 (3);

5-2. A person who provides a residual sample for consideration, in violation of Article 42-2 (7);

6. A person who conducts research on gene therapy without deliberation by the institutional committee, in violation of the former part of Article 47 (2);

7. A person who fails to report as required under Article 49 (2) or (4).

(4) Administrative fines specified in paragraphs (1) through (3) shall be imposed and collected by the Minister of Health and Welfare, as prescribed by Presidential Decree.

BIOETHICS AND SAFETY ACT

Article 1(Purpose) #

Article 2(Definitions) #

Article 3(Basic Principles) #

Article 4(Scope of Application) #

Article 5(Responsibilities of the State and Local Governments) #

Article 6(Designation of Bioethics Policy Research Centers) #

Article 7(Establishment and Functions of National Bioethics Committee) #

Article 8(Composition of National Committee) #

Article 9(Operation of National Committee) #

Article 10(Establishment and Functions of Institutional Bioethics Committee) #

Article 11(Composition and Operation of Institutional Committees) #

Article 12(Designation of Public Institutional Bioethics Committees and Joint Operation of Institutional Committees) #

Article 13(Support to Institutional Committees) #

Article 14(Evaluation and Accreditation of Institutional Committees) #

Article 15(Deliberation on Human Subjects Research) #

Article 16(Consent to Human Subjects Research) #

Article 17(Safety Measures for Human Subjects of Research) #

Article 18(Provision of Personal Information) #

Article 19(Records Storage and Disclosure of Information) #

Article 20(Prohibition of Human Cloning) #

Article 21(Prohibition on Implantation between Different Species) #

Article 22(Designation of Embryo-Producing Medical Institutions) #

Article 23(Obligations regarding Production of Embryos) #

Article 24(Consent to Production of Embryos) #

Article 25(Storage and Disposal of Embryos) #

Article 26(Provision of Residual Embryos or Eggs) #

Article 27(Protection of Donors of Reproductive Cells) #

Article 28(Obligations of Embryo-Producing Medical Institutions) #

Article 29(Residual Embryos Research) #

Article 30(Approval of Embryo Research Plans) #

Article 31(Research on Somatic-Cell Cloning Embryos) #

Article 32(Obligations of Embryo Research Institutes) #

Article 33(Registration of Embryonic Stem Cell Lines) #

Article 34(Provision of Embryonic Stem Cell Lines) #

Article 35(Use of Embryonic Stem Cell Lines) #

Article 36(Deliberation on Human Materials Research) #

Article 37(Consent to Human Materials Research) #

Article 38(Provision of Human Materials) #

Article 39(Storage and Disposal of Human Materials) #

Article 40(Obligations of Human Materials Researchers) #

Article 41(Permission for, and Reporting of, Human Material Banks) #

Article 42(Consent to Collection of Human Materials) #

Article 42-2(Provision of Residual Samples) #

Article 42-3(Management of Residual Samples) #

Article 43(Provision of Human Materials) #

Article 44(Obligations of Human Material Banks) #

Article 45(Support to Human Material Banks) #

Article 46(Prohibition of Discrimination Based on Genetic Information) #

Article 47(Gene Therapy and Research) #

Article 48(Gene Therapy Institutions) #

Article 49(Genetic Testing Institutions) #

Article 49-2(Evaluation and Certification of Genetic Testing Institutions) #

Article 49-3(Genetic Testing Education) #

Article 50(Restrictions on Genetic Tests) #

Article 51(Consent to Genetic Testing) #

Article 52(Records Storage and Disclosure of Information) #

Article 53(Provision and Disposal of Materials for Testing) #

Article 54(Reporting and Inspection) #

Article 55(Orders for Disposal or Improvement) #

Article 56(Revocation of Registration and Suspension of Operation) #

Article 56-2(Closure of Facilities) #

Article 57(Hearings) #

Article 58(Penalty Surcharges) #

Article 59(Fees) #

Article 60(National Fund Support) #

Article 61(Delegation and Entrustment) #

Article 62(Legal Fiction as Public Officials in Application of Penalty Provisions) #

Article 63(Prohibition of Confidential Information) #

Article 64(Penalty Provisions) #

Article 65(Penalty Provisions) #

Article 66(Penalty Provisions) #

Article 67(Penalty Provisions) #

Article 68(Penalty Provisions) #

Article 69(Joint Penalty Provisions) #

Article 70(Administrative Fines) #