Article 1(Purpose) #
The purpose of this Rule is to prescribe matters entrusted by Bioethics and Safety Act and the Enforcement Decree thereof, and other matters necessary for enforcing them.
Article 2(Establishment of Institutional Bioethics Committees) #
According to article 9 (1) 7 of Bioethics and Safety Act (hereafter called ‘the Act’), the following institutions shall establish the Institutional Bioethics Committee (hereafter called an ‘Institutional Committee’):
1. Institutions which have filed a report to the Minister of Health, Welfare and Family Affairs according to article 24 (1) of the Act in order to obtain specimens directly and do genetic research on them (hereafter called a ‘Genetic Research Institution’); and
2. Nonprofit corporations that are established in order to study, develop or utilize life science and biotechnologies, and designated as specialized institutions by the Minister of Education, Science and Technology under article 16 (1) of Enforcement Decree of Technology Development Promotion Act.
Article 3(Institutional Committee Agreements with Other Institutions) #
An institution that “is below the standard set by the Ordinance of the Ministry for Health, Welfare, and Family Affairs” in article 9 (4) of the Act refers to the following:
1. The institution has employed no more than three researchers; or
2. It is significantly inefficient for the institution to hold Institutional Committee meetings at least four times a year, considering the number of research projects and results.
Article 3-2(Institutional Committee Evaluation and Result Disclosure) #
(1) The following matters need to be examined in evaluation of the Institutional Committee according to article 10-2 (2) of the Act:
1. The level of review conducted by the Institutional Committee;
2. Composition and operation of the Institutional Committee;
3. Training outcomes of the Institutional Committee members; and
4. Review standards developed by the Institutional Committee.
(2) Detailed criteria and procedures relating to the evaluation of each mater mentioned in paragraph (1) above shall be determined by the Minister of Health, Welfare and Family Affairs.
(3) Evaluation agencies which are entrusted with the task of evaluating Institutional Committees according to article 19-2 (2) of the Decree shall report evaluation results to the Minister of Health, Welfare and Family Affairs. And then he/she must immediately notify the relevant Institutional Committees of those results.
(4) The Minister of Health, Welfare and Family Affairs may publish the evaluation results under paragraph (3) above on the Ministry for Health, Welfare and Family Affairs website and, considering these results, determine whether and how much to support the Institutional Committees.
Article 3-3(Education of Institutional Committee members) #
(1) Medical colleges or educational institutions that are entrusted with the task of educating Institutional Committee members according to article 19-2 (2) of the Decree shall provide Institutional Committee members with training on research ethics, roles and responsibilities of the members, and review procedures and methods so as to improve their qualification.
(2) Medical colleges or educational institutions under paragraph (1) above shall store the records of training outcomes for five years after completion of each training program and submit them immediately upon the request of the Minister of Health, Welfare and Family Affairs.
Article 4(Designation of Embryo Producing Medical Institutions) #
(1) Any medical institution that wishes to be designated as an Embryo Producing Medical Institution according to article 14 (2) of the Act must have facilities, equipments and human resources listed in Schedule 1.
(2) Any institution that wishes to be designated as an Embryo Producing Medical Institution shall submit to the Director of Korea Centers for Disease Control and Prevention a Designation Application for Embryo Producing Medical Institution (Attachment 1) with the following documents:
1. A copy of Certificate of Report for Medical Institution Establishment or Establishment License of Medical Institution;
2. Documents outlining the current status of facilities and human resources;
3. Documents describing composition and operation of the Institutional Committee. If the institution has made an Institutional Committee Agreement with another institution, it shall also submit that agreement;
4. Documents outlining the method and number of artificial insemination treatments undertaken at the institution; and
5. Documents outlining the current status of storage and provision of spare embryos.
(3) When the Director of Korea Centers for Disease Control and Prevention designates an Embryo Producing Medical Institution, he/she shall issue a Designation Certificate for Embryo Producing Medical Institution (Attachment 2).
Article 5(Consenting to Embryo Production) #
(1) The form of consent that Embryo Producing Medical Institutions shall obtain under article 15 (1) of the Act as they collect sperm or oocytes in order to produce embryos is presented in Attachment 3.
(2) The form of consent that Embryo Producing Medical Institutions shall obtain from consenters to use spare embryos for purposes other than pregnancy under article 15 (2) 4 of the Act or to use spare embryos that have been stored for less than five years under article 17 of the Act is presented in Attachment 4.
(3) “Other necessary information set by the Ordinance of the Ministry for Health, Welfare, and Family Affairs” in article 15 (2) 5 of the Act refers to the followings: 1. Storage period and maintenance of sperm or oocytes;
2. Disposal of sperm or oocytes; and
3. Indication of whether or not consent is given to use sperm or oocytes for research purposes.
(4) Embryo Producing Medical Institutions shall store the written consents obtained under paragraphs (1) and (2) above for 10 years.
Article 5-2(Physical Examination of Oocyte Donors) #
(1) A physical examination that Embryo Producing Medical Institutions shall conduct on oocyte donors prior to oocyte collection under article 15-2 (1) of the Act is described in Schedule 1-2.
(2) “A person who is below the health standards set by the Ordinance of the Ministry of Health, Welfare and Family Affairs” in article 15-2 (2) of the Act refers to those who are found by the physical examination under paragraph (1) above to have syphilis, hepatitis, Acquired Immune Deficiency Syndrome and other diseases, or have abnormalities which make it impossible to collect oocytes from them.
(3) Embryo Producing Medical Institutions shall notify oocyte donors of the physical examination results under paragraph (1) above.
Article 5-3(Compensation for Oocyte Donors) #
(1) Pursuant to article 15-4 of the Act, the Embryo Producing Medical Institution may compensate oocyte donors for the following expenses to cover the actual costs:
1. Transportation;
2. Meals;
3. Accommodation; and
4. Compensation for the time spent for treatment and recovery
(2) The amount of expenses mentioned in subparagraphs 1 through 3 of paragraph (1) above shall be determined by Schedule 2 (section 2) of Public Official Remuneration Regulations.
(3) The head of the Embryo Producing Medical Institution shall determine specific standards to pay compensation under paragraph (1) 4 above after the review of the Institutional Committee.
(4) The head of the Embryo Producing Medical Institution shall report the amount of compensation paid under paragraph (1) above to the Institutional Committee.
Article 6(Procedure and Method of Embryo Disposal) #
(1) When Embryo Producing Medical Institutions intend to dispose of embryos according to article 16 (4) of the Act, they shall comply with the procedure and method described in article 13 of Wastes Control Act.
(2) When Embryo Producing Medical Institutions intend to dispose of embryos under paragraph (1) above, they shall complete an Embryo Disposal Register (Attachment 5) and store that document for five years.
Article 7(Embryo Research Institutions) #
(1) Anyone who wishes to be registered as an Embryo Research Institution under article 18 of the Act shall have facilities and human resources as described in Schedule 2.
(2) Anyone who wishes to be registered as an Embryo Research Institution shall submit to the Director of Korea Centers for Disease Control and Prevention a Registration Application for Embryo Research Institution (Attachment 6) with the following documents:
1. Bylaws and business plans if applicants are corporations. Medical corporations need not to submit those documents;
2. Business plans if applicants are not corporations. If they are medical professionals, they shall also submit copies of medical licenses;
3. Documents outlining composition and operation of Institutional Committees, or Institutional Committee Agreements; and
4. Documents stating current status of facilities and human resources.
(3) The public officials who have received the application under paragraph (2) above must check out the following documents through the administrative information sharing network under article 21 (1) of Act on Digitalization of Administrative Affairs. However, as for subparagraph 2 below, if applicants do not agree with it, the public officials shall have them submit a copy of that document.
1. A Certified Copy of Corporation Register if the applicants are corporations; or
2. Business License if the applicants are not corporations. The foregoing does not apply to medical professionals.
(4) When the Director of Korea Centers for Disease Control and Prevention registers an institution as an Embryo Research Institution, he/she shall issue a Registration Certificate of Embryo Research Institution (Attachment 7).
Article 8(Approval of Embryo Research Protocols) #
(1) When Embryo Research Institutions wish to obtain approval for embryo research protocols according to article 19 (1) of the Act, they shall submit to the Minister of Health, Welfare and Family Affairs an Approval Application of Embryo Research Protocol (Attachment 8) with the following documents:
1. Embryo research protocols including the purpose, method and duration of the research, names and CVs of principal investigators and researchers;
2. Documents showing the results of the Institutional Committee’s review about the embryo research protocols; and
3. Spare Embryo Utilization Plans including the number and collection methods of spare embryos to be used for the research.
(2) The Minister of Health, Welfare and Family Affairs may seek an advice from experts in the fields of life science, medicine or bio-ethics so as to review the documents submitted according to paragraph (1) above.
(3) When the Minister of Health, Welfare and Family Affairs approves embryo research protocols, he/she shal issue an Embryo Research Protocol Approval (Attachment 9).
Article 9(Approving Changes in Embryo Research Protocols) #
(1) When Embryo Research Institutions intend to change important items covered by article 12 of Enforcement Decree of Bioethics and Safety Act (hereafter called ‘the Decree’) in embryo research protocols approved pursuant to article 8 (3), they shall submit to the Minister of Health, Welfare and Family Affairs a Modification Approval Application for Embryo Research Protocol (Attachment 10) with the following documents:
1. The modified research protocol; and
2. A document showing the results of the Institutional Committee’s review about the modified research protocol.
(2) When the Minister of Health, Welfare and Family Affairs gives approval for modifying embryo research protocols, he/she shall issue a Modification Approval for Embryo Research Protocol (Attachment 11).
Article 10(Approval Criteria for Embryo Research Protocols) #
The criteria for approving embryo research protocols under article 19 (4) of the Act are as follows: 1. The research purpose is within the scope of permissible ones under the Act;
2. No other medical treatment is currently available or the Institutional Committee concluded, after reviewing scientific validity of the research, that the treatment to be investigated is expected to yield significantly outstanding results compared with other available treatments;
3. The number and types of spare embryos appropriate for the research purpose are clearly described;
4. Principal Investigators and researchers have appropriate qualification and experience in the relevant field;
5. The institution has appropriate facilities and equipments to conduct the study;
6. The proposed time period of research is sufficient to conduct the study;
7. The research protocol has been properly reviewed by the Institutional Committee; and
8. The schedule to collect spare embryos has been properly set up.
Article 11(Provision of Spare Embryos) #
(1) The amount of reimbursement that Embryo Producing Institutions may request of Embryo Research Institutions to cover the expenses of storing and providing spare embryos under article 20 (1) of the Act shall be the sum of the followings. Only the storing cost incurred after the end of the storage period of spare embryos can be reimbursed.
1. Maintenance and depreciation cost of equipments necessary for storing spare embryos such as a liquid nitrogen tank; and
2. Cost of supplies such as liquid nitrogen.
(2) When Embryo Research Institutions wish to receive spare embryos from Embryo Producing Medical Institutions as stipulated in article 20 (2) of the Act, they shall submit the following documents to the heads of the Embryo Producing Medical Institutions:
1. A copy of Embryo Research Protocol Approval under article 8 (3); and
2. A plan describing the purpose of use, number, and supply procedures of spare embryos.
(3) Embryo Producing Medical Institutions shall decide whether or not to provide spare embryos after the review of the Institutional Committee.
Article 12(Storage and Supply of Spare Embryos) #
(1) The Embryo Producing Medical Institution and Embryo Research Institution shall complete a Current Status of Storage and Supply for Spare Embryos (Attachment 12) concerning the current year’s storage and supply of spare embryos according to article 20 (3) of the Act and submit that document to the Minster of Health, Welfare and Family Affairs until the end of next February.
(2) Embryo Producing Medical Institutions shall grant registration numbers to stored spare embryos as decided by the Minister of Health, Welfare and Family Affairs.
Article 12-2(Registration of Stem Cell Lines) #
(1) Anyone who wishes to register stem cell lines under article 20-2 (1) of the Act shall submit to the Director of Korea Centers for Disease Control and Prevention a Registration Application for Stem Cell Lines (Attachment 12-2) with the following documents. However, in case of registering stem cell lines imported from overseas institutions designated and announced by the Director of Korea Centers for Disease Control and Prevention (hereafter called ‘overseas institutions’), those documents can be replaced by the documents issued by those overseas institutions, and as for the stem cell lines established before 1st January 2005, those documents other than that described in subparagraph 1 below can be waived:
1. A document describing characteristics of stem cell lines (Attachment 12-3);
2. A copy of the consent for research donation of spare embryos that have been used for establishment of stem cell lines; and
3. Records of using spare embryos (Attachment 12-4).
(2) The Director of Korea Centers for Disease Control and Prevention may seek an advice from experts in the fields of stem cell research or bio-ethics so as to review the documents submitted according to paragraph (1) above: and
(3) When the Director of Korea Centers for Disease Control and Prevention registers stem cell lines, he/she shall issue a Registration Certificate for Stem Cell Lines (Attachment 12-5).
Article 12-3(Registration Criteria for Stem Cell Lines) #
(1) Criteria for registering stem cell lines according to article 20-2 (1) of the Act are as follows:
1. Stem cell lines were established using methods and following consent procedures prescribed by the law; and
2. Identification, gene expression, and differentiation characteristics of stem cell lines have been scientifically validated.
(2) Notwithstanding paragraph (1) above, the stem cell lines mentioned below shall be regarded as satisfying criteria for registering stem cell lines:
1. The stem cell lines established before 1st January 2005 have met the requirement in paragraph (1) 2 above; or
2. The stem cell lines imported from overseas institutions.
Article 12-4(Institutional Committee Review on Provision of Stem cell Lines) #
When anyone who has established or imported stem cell lines wishes to provide those lines, the relevant Institutional Committee shall review the following matters according to article 20-3 (1) of the Act:
1. The review results of the Institutional Committee of the institution that wishes to use the stem cell lines; and
2. Whether or not the number and characteristics of stem cell lines to be provided are appropriate.
Article 12-5(Reporting Supply Status) #
Anyone who wishes to file a report of providing stem cell lines according to article 20-3 (2) of the Act shall submit a Current Supply Status of Stem Cell Lines (Attachment 12-6) to the Director of Korea Centers for Disease Control and Prevention until the next February.
Article 12-6(Cost for Providing Stem cell Lines) #
The amount of reimbursement that a provider of stem cell lines may request under article 20-3 (3) of the Act shall be the sum of the followings:
1. Maintenance and depreciation cost of equipments necessary for storing stem cell lines;
2. Cost of supplies necessary for provision and storage.
Article 12-7(Approving Research Protocol Involving Stem Cell Lines) #
When anyone wishes to use stem cell lines, the research protocol which includes the purpose and duration of using those lines shall be reviewed for its scientific and ethical validity by the Institutional Committee according to article 20-4 (2) of the Act.
Article 12-8(Approval Report of Research Protocol Protocols) #
Anyone who wishes to file a report of approval or modification approval of research protocols involving stem cell lines according to article 20-4 (3) of the Act shall submit to the Director of Korea Centers for Disease Control and Prevention an Approval Report of Research Protocol Involving Stem cell Lines (Attachment 12-7) or a Modification Approval Report of Research Protocol Involving Stem cell Lines (Attachment 12-8) with a document showing the results of the Institutional Committee’s review.
Article 13(Registration of SCNT Embryo Research Institutions) #
Anyone who wishes to produce or conduct research on SCNT(Somatic cell Nuclear Transfer) embryos according to article 23 (1) of the Act shall register with the Director of Korea Centers for Disease Control and Prevention, meeting facilities and human resources requirements outlined in Schedule 3.
(2) Anyone who wishes to register pursuant to paragraph (1) above shall submit to the Director of Korea Centers for Disease Control and Prevention a Registration Application for SCNT Embryo Research Institution (Attachment 13) with the documents mentioned in article 7 (2).
(3) The public officials who have received the application under paragraph (2) above must check out the following documents through the administrative information sharing network under article 21 (1) of Act on Digitalization of Administrative Affairs. However, as for subparagraph 2 below, if applicants do not agree with it, the public officials shall have them submit a copy of that document.
1. A Certified Copy of Corporation Register if the applicants are corporations; or
2. Business License if the applicants are not corporations. The foregoing does not apply to medical professionals.
(4) The Director of Korea Centers for Disease Control and Prevention shall issue a Registration Certificate of SCNT Embryo Research Institution (Attachment 14) to the persons who have registered according to paragraph (1) above.
Article 14(Reports of Genetic Testing Institution Institutions) #
(1) When anyone wishes to file a report according to article 24 (1) of the Act so as to conduct genetic tests or directly obtain specimens and do genetic research on them, he/she shall submit to the Director of Korea Centers for Disease Control and Prevention a Report of Genetic Testing/Research Institution (Attachment 15) with the following documents:
1. Bylaws and business plans if applicants are corporations. Medical corporations need not to submit those documents;
2. Business plans if applicants are not corporations. If they are medical professionals, they shall also submit copies of medical licenses;
3. Documents stating current status of facilities and human resources; and
4. Documents outlining composition and operation of Institutional Committees, or Institutional Committee Agreements.
(2) The public officials who have received the report under paragraph (1) above must check out the following documents through the administrative information sharing network under article 21 (1) of Act on Digitalization of Administrative Affairs. However, as for subparagraph 2 below, if applicants do not agree with it, the public officials shall have them submit a copy of that document:
1. A Certified Copy of Corporation Register if the applicants are corporations; or 2. Business License if the applicants are not corporations. The foregoing does not apply to medical professionals.
(3) The Director of Korea Centers for Disease Control and Prevention shall issue a Certificate of Report of Genetic Testing/Research Institution (Attachment 16) to the persons who have filed a report so as to conduct genetic tests (hereafter called a ‘Genetic Testing Institution’) or genetic research institutions under paragraph (1) above.
(4) When the heads of Genetic Testing/Research Institutions which have filed a report according to paragraph (1) above wish to change important items covered by article 13 of the Decree shall submit to the Director of Korea Centers for Disease Control and Prevention a Modification Report of Genetic Testing/Research Institution (Attachment 17) attaching the following documents within 30 days from the date when the cause of action arises:
1. An original copy of Certificate of Report for Genetic Testing/Research Institutions; and
2. Documents showing the modified items.
(5) When the Director of Korea Centers for Disease Control and Prevention has received the report of change under paragraph (4) above, he/she shall issue a Certificate of Reporting Changes of Genetic Testing/Research Institution (Attachment 18).
Article 15(Accuracy Evaluation of Genetic Tests) #
(1) To evaluate accuracy of genetic tests under article 24 (3) of the act, the following matters should be evaluated:
1. Accuracy of genetic test results;
2. Appropriateness of performance procedures of the Genetic Testing Institution;
3. Appropriateness of the facilities and equipments for conducting genetic tests; and
4. Appropriateness of human resources for conducting genetic tests.
(2) To evaluate accuracy of genetic tests under paragraph (1) above, the matter under paragraph (1) 1 above should be evaluated at least once a year, and the matters under subparagraphs 2 and 4 of paragraph (1) above should be evaluated at least once every two years by the institution designated by the Minister of Health, Welfare and Family Affairs. Such institution shall meet all the following requirements:
1. The institution has experience in evaluating the accuracy of genetic tests;
2. The institution has experts for evaluating the accuracy of genetic tests; and
3. The institution is a nonprofit corporation that received the establishment permit according to the Rules on Establishment and Oversight of Nonprofit Corporations under the Ministry for Health, Welfare and Family Affairs and its affiliated agencies. (3) Designation of institutions and the time, method and procedures of evaluating the accuracy of genetic tests under paragraph (2) above shall be announced by the Minister of Health, Welfare and Family Affairs.
Article 16(Permanent or Temporary Closure Report of Genetic Testing Institution) #
When a Genetic Testing Institution intends to cease operations, either permanently or temporarily, as stipulated in article 24(4) of the Act, it shall submit to the Director of Korea Centers for Disease Control and Prevention a Permanent or Temporary Closure Report of Genetic Testing Institution (Attachment 19) attaching the following documents within 30 days from the date when the cause of action arises:
1. A statement describing the reason for permanent or temporary closure;
2. A disposal plan of specimen, genes and genetic information; and
3. In case of permanent closure, an original copy of Certificate of Report for Genetic Testing Institution.
Article 17(Consenting to Genetic Tests) #
(1) “Other details stipulated by the Ordinance of the Ministry for Health, Welfare and Family Affairs” in article 26 (1) 5 of the Act refer to the followings:
1. Disposal or transfer of specimens in the event of permanent or temporary closure of the Genetic Testing Institution; and
2. The storage period and maintenance of records of genetic test results.
(2) The form of consent that Genetic Testing/Research Institutions shall obtain from test subjects or their legal guardians as stipulated in paragraphs (1) through (3) of article 26 of the Act is presented in Attachment 20.
(3) When anyone other than a Genetic Testing Institution refers genetic tests to a Genetic Testing Institution as stipulated in article 26 (2) of the Act, he/she shall delete personally identifiable information about test subjects including the name and birth date.
Article 18(Recording of Specimen Provision) #
When a Genetic Testing Institution, anyone conducting gene research, or anyone licensed to open a Gene Bank (hereafter called ‘Genetic Testing Institutions and others’) provides, or is provided with, specimens according to article 27 (3) of the Act, they shall complete a Specimen Maintenance Register as is shown in Attachment 21(hereafter called ‘Specimen Maintenance Register’. It also applies to articles 19 and 24).
Article 19(Disposal of Specimens) #
(1) When Genetic Testing Institutions and others are unable to store specimens due to permanent or temporary closure, or other unavoidable reasons as stipulated in article 28 (5) of the Act, they shall dispose of the specimens in compliance with the procedure and method described in article 13 of Wastes Control Act, or transfer them to Korea Centers for Disease Control and Prevention.
(2) When Genetic Testing Institutions and others transfer specimens to Korea Centers for Disease Control and Prevention, they shall also transfer records of genetic information including genes and personal information, and Specimen Maintenance Registers.
(3) When Genetic Testing Institutions and others dispose of specimens, they shall complete Specimen Maintenance Registers and keep them for five years.
Article 20(Filing and Accessing of Records) #
(1) Genetic Testing Institutions and others shall store the documents mentioned in subparagraphs 1 and 2 of article 29 (1) of the Act for 10 years, and the records mentioned in subparagraph 3 of the same paragraph for five years.
(2) When test subjects or their legal guardians request access or copies of records as stipulated in article 29 (3) of the Act, they shall submit to Genetic Testing Institutions and others an Application for Accessing and Obtaining Copies of Genetic Testing Records (Attachment 23). Legal guardians shall also submit a document showing that they are legal guardians of the test subjects.
Article 21(False Indications or Exaggerated Advertisements) #
The followings shall be regarded as false indications or exaggerated advertisements as stipulated in article 30 (3) of the Act:
1. Indications or advertisements that genetic tests have been scientifically and thoroughly proved. However, it does not apply to genetic tests to confirm identities;
2. Indications or advertisements stating or implying that the accuracy of genetic tests was evaluated by institutions designated for evaluating the accuracy of genetic tests as stipulated in article 15 (2), even though such evaluation was not conducted at all by the designated institutions;
3. Indications or advertisements made by a Genetic Testing Institution which is not a medical institution, implying that it can conduct tests directly to diagnose diseases without being requested by a medical institution to conduct such tests; or
4. Indications or advertisements implying that the genetic tests prohibited under article 25 (1) of the Act can be conducted.
Article 22(Gene Bank Licensing) #
(1) Anyone who wishes to receive licensing for establishment of a Gene Bank according to article 15 (2) of the Decree shall submit to the Director of Korea Centers for Disease Control and Prevention an Application for Gene Bank Licensing (Attachment 24) with the following documents:
1. Bylaws and business plans if applicants are corporations. Medical corporations need not to submit those documents;
2. Business plans if applicants are not corporations. If they are medical professionals, they shall also submit copies of medical licenses;
3. Documents stating current status of facilities and human resources;
4. Documents outlining composition and operation of Institutional Commitees, or Institutional Committee Agreements;
5. Documents describing current status of specimens, genes and genetic information being stored by the applicants; and
6. The guidelines for protecting personal information of test subjects.
(2) The public officials who have received the application under paragraph (1) above must check out the following documents through the administrative information sharing network under article 21 (1) of Act on Digitalization of Administrative Affairs. However, as for subparagraph 2 below, if applicants do not agree with it, the public officials shall have them submit a copy of that document:
1. A Certified Copy of Corporation Register if the applicants are corporations; or
2. Business License if the applicants are not corporations. The foregoing does not apply to medical professionals.
(3) When the Director of Korea Centers for Disease Control and Prevention permits establishment of a Gene Bank, he/she shall issue a Gene Bank Establishment Permit (Attachment 25) to the applicants.
Article 23(Modification Report of Gene Banks) #
(1) When the head of the Gene Bank intends to file a report of changes involving Gene Bank establishment permit as stipulated in article 32 (3) of the Act, he/she shall submit to the Director of Korea Centers for Disease Control and Prevention a Modification Report of Gene Bank Establishment Permit (Attachment 26) attaching the following documents within 30 days from the date when the cause of action arises:
1. An original copy of Gene Bank Establishment Permit; and
2. Documents showing the modified contents.
(2) When the Director of Korea Centers for Disease Control and Prevention has received the report of change under paragraph (1) above, he/she shall issue a Certificate of Reporting Changes of Gene Bank Establishment Permit (Attachment 27).
Article 24(Permanent or Temporary Closure Report of Gene Bank) #
When a Gene Bank intends to cease operations, either permanently or temporarily, as stipulated in article 32 (4) of the Act, it shall submit to the Director of Korea Centers for Disease Control and Prevention a Permanent or Temporary Closure Report of Gene Bank (Attachment 28) within 30 days from the date when the cause of action arises:
1. A statement describing the reason of permanent or temporary closure;
2. A disposal plan of specimens, genes and genetic information (hereafter called ‘genetic information and others’);
3. Specimen Maintenance Registers; and
4. In case of permanent closure, an original copy of Gene Bank Establishment Permit.
Article 25(Utilization Plan of Genetic Information and Others) #
The plan on how to use genetic information and others under article 33 (1) of the Act shall include the followings:
1. The purpose of using genetic information and others;
2. The research method using genetic information and others;
3. The number of genetic information and others the applicants want to be provided and the method of receiving them; and
4. Safeguards to protect personal information in using genetic information and others.
Article 26(Providing Genetic Information and Others) #
The cost of maintaining and providing genetic information and others under article 34 (2) of the Act is the sum of the followings:
1. Maintenance and depreciation cost of equipments necessary for storing, analyzing, and deriving genes from specimens, or storing genetic information and others; and
2. In case of storing cells, maintenance and depreciation costs of equipments of cell culture facilities and liquid nitrogen tanks, and cost of supplies such as liquid nitrogen.
Article 26-2(Management of Genetic Information and Others) #
(1) The head of the Gene Bank shall perform the followings in order to store and maintain genetic information and others according to article 35-2 (1) of the Act:
1. To establish and perform safeguards for protection of personal information in storing and maintaining genetic information and others;
2. To create and carry out Standard Operating Procedures necessary for storage and maintenance of genetic information and others; and
3. To provide staff with the training program necessary for storage and maintenance of genetic information and others.
(2) The security officers under article 35-2 (3) of the Act shall perform the duties as follows:
1. To file, store and maintain genetic information and others after granting identification marks, numbers or letters to them between collection and storage;
2. To store personally identifiable information including names, resident registration numbers and addresses separately from other genetic information after rendering them anonymous by using codes or ciphers. However, it does not apply when the Consenters agree with providing personal information; and
3. To carry out security measures including restricting entrance to storing facilities for genetic information and others.
(3) Other necessary details concerning storage and maintenance of genetic information and others shall be decided by the Minister of Health, Welfare and Family Affairs.
Article 27(Gene Therapy Institutions) #
(1) Anyone who wishes to file a report of Gene Therapy Institutions under article 37 (1) of the Act shall submit to the Director of Korea Centers for Disease Control and Prevention a Report of Gene Therapy Institution (Attachment 29) with the following documents:
1. Bylaws and business plans if applicants are corporations. Medical corporations need not to submit those documents;
2. Business plans if applicants are not corporations. If they are medical professionals, they shall also submit copies of medical licenses;
3. Documents describing the types of diseases or treatments targeted by gene therapy;
4. Documents outlining composition and operation of Institutional Committees, or Institutional Committee Agreements;
5. Documents stating current status of facilities and human resources; and
6. A copy of Certificate of Report for Medical Institution Establishment or Establishment License of Medical Institution.
(2) The public officials who have received the report under paragraph (1) above must check out the following documents through the administrative information sharing network under article 21 (1) of Act on Digitalization of Administrative Affairs. However, as for subparagraph 2 below, if applicants do not agree with it, the public officials shall have them submit a copy of that document:
1. A Certified Copy of Corporation Register if the applicants are corporations; or
2. Business License if the applicants are not corporations. The foregoing does not apply to medical professionals.
(3) When the Director of Korea Centers for Disease Control and Prevention has received the report under paragraph (1) above, he/she shall issue a Certificate of Report of Gene Therapy Institution (Attachment 30).
(4) When Gene Therapy Institutions which have filed a report according to paragraph (1) above wish to change important items covered by article 17 of the Decree, they shall submit to the Director of Korea Centers for Disease Control and Prevention a Modification Report of Gene Therapy Institution (Attachment 31) attaching the following documents within 30 days from the date when the cause of action arises:
1. An original copy of Certificate of Report for Gene Therapy Institution; and
2. Documents showing the modified items.
Article 28(Consenting to Gene Therapy) #
(1) “Other details stipulated in the Ordinance of the Ministry for Health, Welfare and Family Affairs” in article 37 (2) 3 of the Act refer to the followings:
1. Measures undertaken to ensure patient safety; and
2. Measures undertaken to protect patient personal information.
(2) The form of consent that Gene Therapy Institutions shall obtain from patients who will receive gene therapy under article 37 (3) of the Act is presented in Attachment 33.
Article 29(Report and Inspection) #
When the Minister of Health, Welfare and Family Affairs intends to order submission of reports or data as stipulated in article 38 (1) of the Act, he/she should specify the required reports or data and the deadline day.
Article 30(License Revocation and Facility Closure) #
Detailed criteria for imposing administrative actions under article 41 (2) of the Act are described in Schedule 4.
Article 31(Criteria for Calculating Fines) #
The amount of fines levied depending on the type and degree of the violations pursuant to article 43 (2) of the Act is presented in Schedule 5.
Article 32(Commission Fee) #
Commission fees under article 44 of the Act are presented in Schedule 6. Commission fees shall be paid by revenue stamps.
Article 33 #
[Deleted]