No. 20327
Promulgation Date 2024-02-20
Ministry of Health and Welfare
ALL
CHAPTER I GENERAL PROVISIONS
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)
CHAPTER II NATIONAL BIOETHICS COMMITTEE AND INSTITUTIONAL BIOETHICS COMMITTEE
Section 1 National Bioethics Committee
Article 7 (Establishment and Functions of National Bioethics Committee)
Article 8 (Composition of National Committee)
Article 9 (Operation of National Committee)
Section 2 Institutional Bioethics 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)
CHAPTER III HUMAN SUBJECT RESEARCH AND PROTECTION OF HUMAN SUBJECTS OF RESEARCH
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)
CHAPTER IV EMBRYO, PRODUCTION AND RESEARCH
Section 1 Protection of Human Dignity and Identity
Article 20 (Prohibition of Human Cloning)
Article 21 (Prohibition on Implantation between Different Species)
Section 2 Embryo-Producing Medical Institutions
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)
Section 3 Residual Embryos Research
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)
Section 4 Embryonic Stem Cell Lines
Article 33 (Registration of Embryonic Stem Cell Lines)
Article 34 (Provision of Embryonic Stem Cell Lines)
Article 35 (Use of Embryonic Stem Cell Lines)
CHAPTER V HUMAN MATERIALS RESEARCH AND HUMAN MATERIAL BANKS
Section 1 Human Materials Research
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)
Section 2 Human Material Banks
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)
CHAPTER VI GENE THERAPY AND TESTING
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)
CHAPTER VII SUPERVISION
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)
CHAPTER VIII SUPPLEMENTARY PROVISIONS
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)
CHAPTER IX PENALTY PROVISIONS
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)
ADDENDA <Act No. 11250, Feb. 1, 2012>
ADDENDA <Act No. 11690, Mar. 23, 2013>
ADDENDUM <Act No. 12447, Mar. 18, 2014>
ADDENDA <Act No. 12844, Nov. 19, 2014>
ADDENDUM <Act No. 13651, Dec. 29, 2015>
ADDENDA <Act No. 14438, Dec. 20, 2016>
ADDENDA <Act No. 14839, Jul. 26, 2017>
ADDENDUM <Act No. 15188, Dec. 12, 2017>
ADDENDUM <Act No. 15888, Dec. 11, 2018>
ADDENDUM <Act No. 16372, Apr. 23, 2019>
ADDENDA <Act No. 17472, Aug. 11, 2020>
ADDENDA <Act No. 17783, Dec. 29, 2020>
ADDENDUM <Act No. 20327, Feb. 20, 2024>