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BIOETHICS AND SAFETY ACT

Amended by Act No. 7150, Jan. 29, 2004

Amended by Act No. 7413, Mar. 24, 2005

Act No. 8366, Apr. 11, 2007

Act No. 8852, Feb. 29, 2008

Act No. 9100, jun.  5, 2008

Act No. 9386, Jan. 30, 2009

Act No. 9932, Jan. 18, 2010

Act No. 10605, Apr. 28, 2011

Act No. 11250, Feb.  1, 2012

 

Article 1 (Purpose)

The purpose of this Act is to ensure bioethics and biosafety, thereby contributing to the promotion of citizens' health and the improvement of their quality of life by preventing the violation of human dignity and values or the infliction of harm on human body in the course of researching on human beings and human materials or of handling embryos, genes, etc.

 

Article 2 (Definitions)

The terms used in this Act shall be defined as follows:

1. The term "human subjects research project" means a research project specified by Ordinance of the Minister of Health and Welfare, such as a research project physically involving a human being as a subject, a research project carried on through communication, physical contact or other means of interaction, a research project carried out by using information with which individuals can be identified;

2. The term "human subject of research" means a person who is the subject of a human subjects research project;

3. The term "embryo" means a fertilized human ovum or a group of cells divided during a period from the time such ovum is fertilized until the time all organs are embryologically formed;

4. The term "residual embryo" means an embryo remaining after embryos produced as a consequence of artificial insemination are used for pregnancy;

5. The term "residual ovum" means a human ovum left over after ova are used for artificial insemination;

6. The term "somatic-cell nuclear transplantation" means that a human somatic nucleus is transplanted into a human ovum with its own nucleus removed;

7. The term "parthenogenesis" means a process through which a human ovum is divided into cells aside from the process of fertilization;

8. The term "somatic-cell cloning embryo" means a group of cells produced by somatic-cell nuclear transplantation;

9. The term "parthenogenic embryo" means a group of cells produced by parthenogenesis;

10. The term "embryonic stem cell line" means a cell line derived from an embryo, somatic-cell cloning embryo, or parthenogenic embryo, which can constantly multiply in culturable conditions and can be divided into various cells;

11. The term "human material" means a component of the human body, such as a tissue, a cell, blood, or body fluid collected or extracted from the human body, or serum, plasma, chromosomes, DNA (Deoxyribonucleic Acid), RNA (Ribonucleic Acid), protein, etc. isolated from such component;

12. The term "human materials research project" means a research project on human materials through direct examination and analysis;

13. The term "human material bank" means an institution that extracts and preserves human materials or genetic information, relevant epidemiological information, and clinical information so as to directly use such derivatives or information or provide them to other persons;

14. The term "genetic information" means information obtained by analyzing the genetic characteristics of human materials of an individual;

15. The term "genetic test" means a test conducted to obtain genetic information from a human material for identifying an individual or for preventing, diagnosing, or treating a disease;

16. The term "gene therapy" means a series of procedures to alter genes for the purpose of preventing or treating a disease;

17. The term "personally identifiable information" means information with which an individual can be identified, such as the name, resident registration number, etc. of a human subject of research or the donor of an embryo, ovum, sperm, or human material (hereinafter referred to as "human subject of research or donor");

18. The term "personal information" means information about an individual, such as personally identifiable information, genetic information, or information about health;

19. The term "anonymization" means the deletion of personally identifiable information permanently or full or partial substitution of personally identifiable information with an identification code given by an institution involved.

 

Article 3 (Basic Principles)

(1) No activity regulated under this Act shall be conducted in any manner that violates the dignity and values of a human being, and priority shall be given to human rights and welfare of each human subject of research or donor.

(2) Self-determination of each human subject of research or donor shall be respected, and the voluntary consent of a human subject of research or donor shall be supported by adequate information.

(3) Privacy of each human subject of research or donor shall be protected, and personal information likely to lead to the invasion of privacy shall be protected as confidential information, except where the relevant party consents to disclosure or an Act expressly permits disclosure.

(4) Full consideration shall be given to the safety of each human subject of research or donor, and risks shall be minimized.

(5) An individual or group in vulnerable conditions shall be specially protected.

(6) International cooperation shall be promoted as necessary to ensure bioethics and biosafety, and a person conducting such activities shall endeavor to adopt universal norms.

 

Article 4 (Scope of Application)

(1) Except as expressly provided for in any other Act, bioethics and biosafety shall be governed by this Act.

(2) When it is intended to enact or amend any other Act providing for bioethics and biosafety, endeavors shall be made to ensure that such Act accords with this Act.

 

Article 5 (Responsibilities of State and Local Governments)

(1) The State and local governments shall formulate policies necessary to efficiently address bioethics and biosafety issues.

(2) The State and local governments shall formulate schemes to provide administrative and financial support to research and activities relating to bioethics and biosafety.

(3) The State and local governments shall ensure that educational institutions at various levels provide educational programs for bioethics and biosafety, develop educational programs, and assist such educational programs in developing good educational conditions for such purpose.

 

Article 6 (Designation of Bioethics Policy Research Centers)

(1) In order to conduct specialized surveys, research, education, etc. with respect to policies on bioethics, the Minister of Health and Welfare may designate an institution, organization, or facility as a bioethics policy research center, if he/she finds that the institution, organization, or facility is capable of conducting such activities.

(2) Matters necessary for the designation, operation, etc, of a bioethics policy research center under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare.

 

Article 7 (Establishment and Functions of National Bioethics Committee)

(1) In order to deliberate on the following matters regarding bioethics and biosafety, the National Bioethics Committee (hereinafter referred to as the "National Committee") shall be established as a presidential committee:

1. Establishment of basic national policies on bioethics and biosafety;

2. Affairs assigned to joint institutional bioethics committees under Article 12 (1) 3;

3. Exemption from the examination of a human subjects research project under Article 15 (2);

4. Making and preservation of records and disclosure of information under Article 19 (3);

5. Research for which it is permitted to use residual embryos under Article 29 (1) 3;

6. Categories, subject-matter, and the scope of research under Article 31 (2);

7. Research for which it is permitted to use embryonic stem cell lines under Article 35 (1) 3;

8. Exemption from the examination of research on human materials under Article 36 (2);

9. Restrictions on genetic test under Article 50 (1);

10. Other matters tabled by the chairperson of the National Committee deemed likely to substantially affect society in connection with bioethics and biosafety.

(2) The chairperson of the National Committee shall introduce a bill, submitted by at least one-third of current members with regard to a matter specified in any provision of paragraph (1) 1 through 9, to a meeting of the National Committee.

 

Article 8 (Composition of National Committee)

(1) The National Committee shall be comprised of at least 15 but not exceeding 18 members, including one chairperson and one vice chairperson.

(2) The chairperson shall be appointed or commissioned by the President of the Republic of Korea 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:

1. The Minister of Education, Science and Technology, the Minister of Justice, the Minister of Knowledge Economy, the Minister of Health and Welfare, and the Minister of Gender Equality and Family;

2. Up to seven persons commissioned by the President of the Republic of Korea from among persons who have abundant expertise and experience in research on bioscience, biomedical science, or social science;

3. Up to seven persons commissioned by the President of the Republic of Korea from among representatives from religions, academic circles of ethics, judicial circles, non-governmental organizations (referring to nonprofit non-governmental organizations defined in Article 2 of the Assistance for Non-Profit, Non-Governmental Organizations Act) or women.

(4) The term of office of a member specified in paragraphs (3) 2 and 3 shall be three years but may be renewed consecutively: Provided, That the term of office of a member newly commissioned to fill a vacancy shall coincide with the remaining term of his/her predecessor.

(5) The National Committee shall have two secretaries, comprised of the Minister of Education, Science and Technology and the Minister of Health and Welfare, and the Minister of Health and Welfare shall serve as the senior secretary.

 

Article 9 (Operation of National Committee)

(1) The National Committee may organize specialized committees for its efficient operation.

(2) The senior secretary shall take charge of administrative affairs of the National Committee.

(3) Meetings and activities of the National Committee shall be independent and generally open to the public.

(4) The National Committee may request parties to a case to make an appearance and make oral statements or submit information. A person so demanded shall comply with such request, unless justifiable grounds exist.

(5) Except as provided for in this Act, the organization and operation of the National Committee and special committees and other necessary matters shall be prescribed by Presidential Decree.

 

Article 10 (Establishment and Functions of Institutional Bioethics Committees)

(1) An institution specified in any of the following subparagraphs shall establish an institutional bioethics committee (hereinafter referred to as "institutional committee") so as to ensure bioethics and biosafety:

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

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

3. A medical institution designated under Article 22 (1) as specializing in producing embryos;

4. A research institute registered pursuant to Article 29 (2) as specializing in embryos;

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

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 biosafety.

(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 an institution or a joint institutional bioethics committee under Article 12 (1) to entrust the execution of affairs assigned to its institutional committee established pursuant to 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. Examination of 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;

(c) Matters regarding the safety of 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 biosafety in the relevant institution;

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

3. The following activities for bioethics and biosafety:

(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;

(c) Establishment of ethical guidelines for researchers.

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

 

Article 11 (Composition, Operation, etc. of Institutional Committees)

(1) An institutional committee shall be comprised of at least five members, including one chairperson, with mixed gender, and shall include at least one person who has sufficient experience and knowledge to evaluate social and ethical validity and at least one person from outside of the relevant institution.

(2) Members of an institutional committee shall be commissioned by the head of the relevant institution specified in any subparagraph of Article 10 (1), and the committee chairperson shall be elected by and from among the members.

(3) No member involved in a case of research, development, or use subject to examination shall participate in the examination of the relevant case of research, development, or use.

(4) If the head of an institution specified in any subparagraph of Article 10 (1) finds that a serious accident has occurred, or is likely to occur, to affect bioethics or biosafety, he/she shall convene a meeting of the competent institutional committee promptly for deliberation and shall report to the Minister of Health and Welfare on the results of the deliberation.

(5) The head of an institution specified in any subparagraph of Article 10 (1) shall ensure that the competent institutional committee maintains independence and shall provide administrative and financial support to the committee.

(6) An institution that has two or more institutional committees established pursuant to Article 10 (1) may integrate such institutional committees for efficient operation, as prescribed by Ordinance of the Ministry of Health and Welfare.

(7) Except as provided for in paragraphs (1) through (6), matters necessary for the organization and operation of an institutional committee shall be prescribed by Ordinance of the Ministry of Health and Welfare.

 

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

(1) In order to permit an institutional committee established pursuant to Article 10 (1) to execute the following affairs, the Minister of Health and Welfare may designate such institutional committee as a joint institutional bioethics committee that institutions or researchers may jointly use (hereinafter referred to as "joint committee"):

1. Affairs entrusted by an institution under an agreement made with the joint committee pursuant to Article 10 (2);

2. Affairs requested by a human subjects researcher or human materials researcher affiliated with any educational institution, research institute, or hospital;

3. Other affairs specified by Ordinance of the Ministry of Health and Welfare through deliberation by the National Committee.

(2) Where two or more institutions execute a joint research project and it is found inappropriate for the institutional committee of each institution involved in the research project to examine the project separately, the institutions involved may select one of their institutional committees to authorize it to exclusively examine the research project.

(3) Matters necessary for the designation, functions, and operation of a joint committee and the joint operation of an institutional committee under paragraphs (1) and (2) shall be prescribed by Ordinance of the Ministry of Health and Welfare.

 

Article 13 (Support, etc. to Institutional Committees)

(1) In order to appropriately supervise and support the operation of institutional committees, the Minister of Health and Welfare shall take charge of the following affairs:

1. Inspection of institutional committees;

2. Education of members of institutional committees;

3. Other affairs specified by Ordinance of the Ministry of Health and Welfare as necessary to supervise and support institutional committees.

(2) Matters necessary for inspection of institutional committees and support to education shall be prescribed by Ordinance of the Ministry of Health and Welfare.

 

Article 14 (Evaluation and Accreditation of Institutional Committees)

(1) The Minister of Health and Welfare may evaluate and accredit the organization, operation performance, etc. of each institutional committee on a regular basis.

(2) The Minister of Health and Welfare may publish the results of accreditation of an institutional committee accredited under paragraph (1) through a web-site or by other means.

(3) The head of a central administrative agency may subsidize an institution's budget or take a measure to restrict subsidization for research expenses, based on the results of accreditation under paragraph (1).

(4) If an institutional committee accredited under paragraph (1) falls under any of the following subparagraphs, the Minister of Health and Welfare may revoke its accreditation: Provided, That the Minister of Health and Welfare shall revoke accreditation in cases falling under subparagraph 1:

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

2. If an institutional committee ceases to meet a standard for accreditation under paragraph (5) because of a significant change in the organization or operation of the institutional committee.

(5) Matters necessary for the standards for accreditation referred to in paragraph (1) and the period of validity of such accreditation shall be prescribed by Ordinance of the Ministry of Health and Welfare.

 

Article 15 (Examination of Research on Human Subjects)

(1) A person who intends to conduct research on human subjects shall prepare a research plan and submit it for examination by the competent institutional committee before commencing research on human subjects.

(2) Notwithstanding paragraph (1), a research project may be exempted from examination by the competent institutional committee, if a risk to human subjects of research and the general public is insignificant and the research project meets the standards prescribed by Ordinance of the Ministry of Health and Welfare through deliberation by the National Committee.

 

Article 16 (Consent to Research on Human Subjects)

(1) A human subjects researcher shall obtain written consent (including consent by an electronic document; hereinafter the same shall apply) with regard to the following matters from human subjects of research before commencing a human subjects research project:

1. Objectives of the human subjects research project;

2. Duration, procedure 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 project;

6. Provision of personal information;

7. Withdrawal of consent;

8. Other matters the competent institutional committee deems necessary.

(2) Notwithstanding paragraph (1), where a research project 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/her representative specified in any of the following subparagraphs shall consent thereto in writing. 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 no legal representative is appointed, 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), a research project may be exempted from obtaining written consent of a human subject of research, subject to approval from the competent institutional committee, if the research project satisfies all the following prerequisites. In such cases, a research project shall not be exempted from obtaining written consent of the representative under paragraph (2):

1. If it is determined 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/her pursuant to paragraphs (1) and (2).

 

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

(1) A human subjects researcher shall assess the physical and mental impact of a research project and the research environment on human subjects of research and prepare safety measures before commencing the research project, and if he/she finds that a research project in progress is likely to cause a serious harm to an individual or society, he/she shall immediately report thereon to the head of the institution, to which he/she belongs, and take appropriate measures therefor.

(2) No human subjects researcher shall delay medical treatment necessary to a human subject of research or deprive a human subject of research of an opportunity for diagnosis or prevention of a disease in the course of research relating to the diagnosis, treatment, or prevention of a disease.

 

Article 18 (Provision of Personal Information)

(1) When a human subject of research consents in writing to providing his/her personal information to a third party pursuant to Article 16 (1), the relevant human subjects researcher may provide his/her personal information to a third party, subject to examination thereof by the competent institutional committee.

(2) When a human sub

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