ENFORCEMENT DECREE OF THE BRAIN RESEARCH PROMOTION ACT
Presidential Decree No. 15924, Nov. 6, 1998
Amended by Presidential Decree No. 16326, May 24, 1999
Presidential Decree No. 17115, Jan. 29, 2001
Presidential Decree No. 19513, Jun. 12, 2006
Presidential Decree No. 20740, Feb. 29, 2008
Presidential Decree No. 21214, Dec. 31, 2008
Presidential Decree No. 22075, Mar. 15, 2010
Presidential Decree No. 23224, Oct. 17, 2011
Presidential Decree No. 24423, Mar. 23, 2013
Presidential Decree No. 25751, Nov. 19, 2014
Presidential Decree No. 28210, Jul. 26, 2017
Presidential Decree No. 31168, Nov. 20, 2020
Presidential Decree No. 31895, Jul. 20, 2021
Presidential Decree No. 34425, Apr. 23, 2024
The purpose of this Decree is to provide for matters mandated by the Brain Research Promotion Act and matters necessary for the enforcement thereof. [This Article Wholly Amended on Oct. 17, 2017]
| Article 2 (Reporting on Outcomes of Implementation) |
| (1) | Pursuant to Article 5 (1) of the Brain Research Promotion Act (hereinafter referred to as the "Act"), the Minister of Education, the Minister of Science and ICT, the Minister of Trade, Industry and Energy and the Minister of Health and Welfare (hereinafter referred to as "head of a relevant central administrative agency") shall submit previous year’s outcomes of brain research promotion under the jurisdiction of each agency to the Minister of Science and ICT by the end of February each year. <Amended on Mar. 23, 2013; Nov. 19, 2014; Jul. 26, 2017> |
| (2) | The Minister of Science and ICT shall integrate the outcomes submitted under paragraph (1) with previous year’s outcomes and other performance of the Ministry of Science and ICT and report it to the Council for Comprehensive Biotechnology Policy established under Article 7 of the Biotechnology Support Act (hereinafter referred to as the "Council"). <Amended on Mar. 23, 2013; Jul. 26, 2017; Nov. 20, 2020> |
[This Article Wholly Amended on Oct. 17, 2017]
| Article 3 (Establishment of Master Plan for Brain Research Promotion) |
| (1) | Pursuant to Article 5 (1) of the Act, the head of each relevant central administrative agency shall submit a plan for promoting brain research under the jurisdiction of each agency to the Minister of Science and ICT by the end of February of the previous year before the start of the master plan for brain research promotion under Article 5 (2) of the Act (hereinafter referred to as "master plan"). <Amended on Mar. 23, 2013; Jul. 26, 2017> |
| (2) | The Minister of Science and ICT shall formulate a master plan every five years. <Amended on Mar. 23, 2013; Jul. 26, 2017> |
[This Article Wholly Amended on Oct. 17, 2017]
| Article 4 (Formulation of Implementation Plans for Brain Research Promotion) |
When the head of each relevant central administrative agency intends to consult with the Minister of Science and ICT on the formulation of an implementation plan for brain research promotion (hereinafter referred to as "implementation plan") under Article 6 (2) of the Act, he or she shall submit a draft implementation plan of the agency concerned to the Minister of Science and ICT by the end of February each year. <Amended on Mar. 23, 2013; Jul. 26, 2017> [This Article Wholly Amended on Oct. 17, 2017]
| Article 5 (Requests for Provision of Data) |
The Minister of Science and ICT may request heads of the relevant central administrative agencies to provide necessary data when preparing basic guidelines necessary for establishing implementation plans under Article 6 (3) of the Act. <Amended on Mar. 23, 2013; Jul. 26, 2017> [This Article Wholly Amended on Oct. 17, 2017]
| Article 6 Deleted. <Oct. 17, 2011> |
| Article 7 Deleted. <Oct. 17, 2011> |
| Article 8 Deleted. <Oct. 17, 2011> |
| Article 9 Deleted. <Oct. 17, 2011> |
| Article 10 (Organization and Operation of Working Committee for Brain Research) |
| (1) | The working committee for brain research established under Article 6-2 (1) of the Act (hereinafter referred to as "Working Committee") shall consist of up to 20 members, including one chairperson. |
| (2) | The Chairperson of the committee shall be assigned from among general or special officials belonging to the Senior Executive Service of the Ministry of Science and ICT, and committee members shall be assigned from among persons falling under each of the follows subparagraphs: <Amended on Mar. 23, 2013; Nov. 19, 2014; Jul. 26, 2017> |
| 1. | Each person respectively designated by the head of a relevant agency he or she belongs to from among Grade III public officials (including public officials in extraordinary civil service corresponding thereto), public officials in general or extraordinary civil service of the Senior Executive Service of the Ministry of Economy and Finance, the Ministry of Education, the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, and the Ministry of Health and Welfare; |
| 2. | A person commissioned by the Minister of Science and ICT, who has abundant knowledge and experience in brain research as a brain research expert working for academia, research institutes, or industries. |
| (3) | The term of office of Working Committee members shall be two years. |
| (4) | A member newly commissioned due to the resignation, etc. of a member referred to in paragraph (2) 2 shall serve for the remainder of his or her predecessor's term of office. |
| (5) | The chairperson of the Working Committee shall convene and preside over the meetings of the Working Committee. |
| (6) | A meeting of the Working Committee shall be held with a majority of all incumbent members present, and any resolution thereof shall be passed with the affirmative vote of a majority of those present at the meeting. |
| (7) | The Working Committee may organize and operate subcommittees under its jurisdiction to expertly review agenda concerning brain science, medical and pharmacological brain science, brain engineering fields. |
| (8) | Except as provided in paragraphs (1) through (7), matters necessary for the organization and operation of the Working Committee and subcommittees shall be determined by the chairperson of the Working Committee, following a resolution by the Working Committee. |
[This Article Wholly Amended on Oct. 17, 2017]
| Article 11 (Hearing of Opinions) |
The Working Committee may require related public officials or experts with specialized knowledge and experience in brain research to attend a meeting of the Working Committee and present their opinions, if deemed necessary in relation to matters to be deliberated on, etc.
[This Article Wholly Amended on Oct. 17, 2017]
Committee members, related public officials or experts who attend a meeting of the Working Committee may be reimbursed for allowances or actual expenses within budgetary limits: Provided, That the same shall not apply where a public official attends a meetings in direct relation to his or her duties.
[This Article Wholly Amended on Oct. 17, 2017]
| Article 13 (Entrustment of Affairs related to Education and Training) |
| (1) | The Minister of Science and ICT may, under Article 10-2 (2) of the Act, entrust affairs relating to education and training under paragraph (1) of that Article to the following institutes or organizations: |
| 2. | The following research institutes that perform affairs related to brain research: |
| 3. | An affiliated institution that performs affairs relating to brain research among affiliated institutions established under Article 3-2 of the Daegu Gyeongbuk Institute of Science and Technology Act.; |
| 6. | Other institutions or organizations related to brain research, which are deemed to be able to perform the affairs relating to education and training for brain research and publicly notified by the Minister of Science and ICT. |
| (2) | Where the Minister of Science and ICT entrusts affairs pursuant to paragraph (1), he or she shall publicly notify the name of an institution or organization entrusted with affairs and the affairs entrusted. |
[This Article Newly Inserted on Jul. 20, 2021
| Article 14 (Support for Joint Research) |
In order to facilitate a joint research on brain and its technology development among academia, research institutes and industries under Article 11 of the Act, the Minister of Science and ICT may encourage a joint procurement of research equipments and reagents and sharing of research facilities, and may provide support necessary for such activities. <Amended on Mar. 23, 2013; Jul. 26, 2017> [This Article Wholly Amended on Oct. 17, 2017]
| Article 15 (Support for Manufacturing New Technological Products) |
| (1) | In order to support the manufacturing of new technology products, which leads to commercialization of the brain research outcomes under the jurisdiction of each agency pursuant to Article 12 (1) of the Act, the Minister of Science and ICT and the heads of relevant central administrative agencies may request the heads of the relevant administrative agencies to take necessary measures, such as financial assistance and preferential purchase of the products, after deliberation by the Council. <Amended on Mar. 23, 2013; Jul. 26, 2017; Jun. 28, 2022> |
| (2) | Upon receipt of a request made under paragraph (1), the head of a relevant administrative agency shall comply with such request, except in extenuating circumstances. |
[This Article Wholly Amended on Oct. 17, 2017]
| Article 15-2 (Regulatory Improvement) |
| (1) | The Minister of Science and ICT may establish and operate a regulatory advisory group (hereafter referred to in this Article as the "regulatory advisory group") consisting of the following persons within the Working Committee in order to discover any regulation that needs improvement among the areas of regulation related to brain research and the brain industry and examine an improvement plan in accordance with Article 12-2 (2) of the Act: |
| 1. | A person commissioned by the Minister of Science and ICT from among experts in brain research and the brain industry affiliated with a university, research institute, hospital, enterprise, etc.; |
| 2. | A public official of the Ministry of Science and ICT who is designated by the Minister of Science and ICT. |
| (2) | The Minister of Science and ICT shall collect opinions from experts, interested parties, etc. on unnecessary regulation related to brain research and the brain industry through face-to-face surveys, questionnaires, or any other method, and notify the regulatory advisory group of the results. |
| (3) | The regulatory advisory group shall examine the results notified under paragraph (2) to identify unnecessary regulation that hinders the development of brain research and the brain industry and prepare an improvement plan. |
| (4) | When the regulatory advisory group identifies unnecessary regulation under paragraph (3) and prepares an improvement plan, it shall comprehensively consider the following matters: |
| 1. | Specificity, urgency, and feasibility of regulatory improvement; |
| 2. | Feasibility of achieving objectives through regulatory improvement; |
| 3. | Ripple effects as a result of regulatory improvement; |
| 4. | Other matters deemed necessary to identify unnecessary regulation and prepare an improvement plan. |
| (5) | The regulatory advisory group may make recommendations to the Minister of Science and ICT after deliberation by the Working Committee if it identifies unnecessary regulation pursuant to paragraph (3) and prepares an improvement plan. |
| (6) | The Minister of Science and ICT shall examine the improvement plan recommended under paragraph (5) and, if it is recognized that improvement is necessary, notify the head of the relevant central administrative agency of the improvement plan. |
| (7) | Except as provided in paragraphs (1) through (6), matters necessary for the establishment and operation of the regulatory advisory group shall be determined by the Minister of Science and ICT. |
[This Article Newly Inserted on Apr. 23, 2024]
[Previous Article 15-2 moved to Article 15-3 <Apr. 23, 2024>]
| Article 15-3 (Scope of Technical Information) |
The Minister of Science and ICT shall endeavor to collect the following information and disseminate it to relevant institutions pursuant to Article 13 (1) of the Act: | 1. | Information on technologies, industries, policies, and systems related to brain research and the brain industry at home and abroad; |
| 2. | Information on journals, papers, and patents related to brain research and the brain industry at home and abroad; |
| 3. | Information on standardization of technologies in brain research and the brain industry; |
| 4. | Other information deemed necessary by the Minister of Science and ICT to promote brain research and the brain industry. |
[This Article Newly Inserted on Jun. 28, 2022]
[Moved from Article 15-2 <Apr. 23, 2024>]
| Article 16 (Preparation of Guidelines for Clinical Trials and Testing for Approval) |
| (1) | In order to establish a clinical trials and testing system for the approval of products related to brain research under Article 15 of the Act, the Minister of Science and ICT and the heads of the relevant central administrative agencies shall prepare and implement guidelines for clinical trials and testing for approval, after deliberation by the Council: Provided, That the same shall not apply where any other Act and subordinate statutes prescribe otherwise. <Amended on Mar. 23, 2013; Jul. 26, 2017> |
| (2) | Guidelines for clinical trials and testing for approval referred to in paragraph (1) shall include the following: Provided, That the same shall not apply where guidelines cannot be formulated due to special characteristics of products related to brain research: |
| 1. | Animal tests and clinical trials of products produced or manufactured through brain research; |
| 2. | Matters concerning the analysis of components, purity, etc. of products produced or manufactured through brain research; |
| 3. | Other matters necessary for clinical trials and testing for the approval of products related to brain research. |
[This Article Wholly Amended on Oct. 17, 2017]
| Article 16-2 (Requirements for Designation of Brain Bank) |
The Minister of Science and ICT may designate an institution that meets all of the following requirements as a brain bank from among the institutions listed in Article 15-2 (1) of the Act in accordance with paragraph (2) of that Article: | 1. | Personnel requirements for each of the following: |
| (a) | It shall have at least one person in charge of the affairs of securing, preserving, managing, and utilizing brain research resources who holds a master's degree or higher in the field of biology under the national standard classification system for science and technology in Article 27 (1) of the Framework Act on Science and Technology; |
| (b) | It shall have at least one person in charge of the affairs of establishing and operating an information system for the operation and management of the brain bank; |
| 2. | Facility and equipment requirements for each of the following: |
| (a) | It shall have facilities and equipment to safely preserve and manage brain research resources donated by 100 donors or more; |
| (b) | It shall have an information system for the operation and management of the brain bank. |
[This Article Newly Inserted on Jun. 28, 2022]
| Article 16-3 (Procedures for Designation of Brain Bank) |
| (1) | A person who seeks to be designated as a brain bank pursuant to Article 15-2 (1) of the Act shall submit an application for designation as a brain bank in Form 1 to the Minister of Science and ICT along with the following documents: |
| 1. | Documents under the following classifications: |
| 2. | Documents proving that the requirements of Article 16-2 are met; |
| 4. | Business plan including the current status of brain research resources held; |
| 5. | Guidelines and code of ethics under the subparagraphs of Article 16-5; |
| 6. | Other documents prescribed and publicly notified by the Minister of Science and ICT for determining whether it is an institution suitable for performing the affairs under Article 15-3 (1) of the Act. |
| (2) | The Minister of Science and ICT shall notify the applicant within 30 days from the date of submission of the application for designation as a brain bank under paragraph (1) whether to grant the designation: Provided, that if there are unavoidable reasons, the period may be extended only once within the scope of 30 days. |
| (3) | The Minister of Science and ICT shall notify the applicant of the reasons if the period is extended pursuant to paragraph (2). |
| (4) | When the Minister of Science and ICT designates a brain bank pursuant to Article 15-2 (1) of the Act, the Minister shall issue a certificate of designation as a brain bank in Form 2 and publicly announce the following matters in the Official Gazette and on the website of the Ministry of Science and ICT: |
| 1. | The name and address of the designated institution; |
| 3. | The brain research resources held by the designated institution. |
[This Article Newly Inserted on Jun. 28, 2022]
| Article 16-4 (Designation of Changes to Brain Bank) |
| (1) | "Important matter prescribed by Presidential Decree" in Article 15-2 (3) of the Act means each of the following matters: |
| 1. | The name or address of the brain bank; |
| 2. | The head of the brain bank; |
| 3. | Personnel under subparagraph 1 of Article 16-2 or facilities and equipment under subparagraph 2 of that Article. |
| (2) | A brain bank that seeks to obtain changed designation pursuant to Article 15-2 (3) of the Act shall submit an application for designation of change to a brain bank in Form 3 to the Minister of Science and ICT within 30 days from the date the change occurs, along with the documents confirming the change to the brain bank. |
| (3) | When the Minister of Science and ICT grants changed designation pursuant to Article 15-2 (3) of the Act, he or she shall reissue a certificate of designation as a brain bank in Form 2, noting the change, and shall publicly announce the following matters in the Official Gazette and on the website of the Ministry of Science and ICT: |
| 1. | The name and address of the changed brain bank; |
| 2. | Date of designation of change; |
| 3. | Reason for designation of change. |
[This Article Newly Inserted on Jun. 28, 2022]
| Article 16-5 (Preparation of Management Guidelines) |
A brain bank shall prepare the following guidelines and codes of ethics to manage brain research resources in a bioethically safe manner:
| 1. | Guidelines for systematic management of warehousing and release and tracking of brain research resources; |
| 2. | Guidelines for managing the personal information of brain research donors; |
| 3. | Code of ethics on responsibilities and obligations of the brain bank and brain researchers. |
[This Article Newly Inserted on Jun. 28, 2022]
| Article 16-6 (Submission of Current Status of Operation of Brain Bank) |
Pursuant to Article 15-3 (3) of the Act, the head of a brain bank shall submit to the Minister of Science and ICT the status of operation of the brain bank for the previous year, including the following matters, by the end of February every year: | 1. | Current status of operation of the brain bank, including personnel, facilities, and equipment; |
| 2. | Current status of securing, preserving, managing, utilizing, and providing brain research resources. |
[This Article Newly Inserted on Jun. 28, 2022]
| Article 16-7 (Report on Temporary or Permanent Closure of Brain Bank) |
Where the head of a brain bank intends to close the brain bank temporarily or permanently, he or she shall submit to the Minister of Science and ICT a notification of temporary or permanent closure of a brain bank in Form 4 in accordance with Article 15-3 (4) of the Act along with the following documents: | 1. | Disposition plan for brain research resources under its control; |
| 2. | Brain research resources management register; |
| 3. | The original copy of the certificate of designation as a brain bank (only applicable to the permanent closure of its business). |
[This Article Newly Inserted on Jun. 28, 2022]
| Article 16-8 (Revocation of Designation of Brain Bank) |
The detailed criteria for revocation of designation and issuance of corrective orders under Article 15-4 (1) of the Act shall be as shown in the attached Table. | (2) | A person whose designation as a brain bank is revoked pursuant to Article 15-4 (1) of the Act shall return the certificate of designation as a brain bank to the Minister of Science and ICT without delay. |
| (3) | When the Minister of Science and ICT revokes the designation of a brain bank pursuant to Article 15-4 (1) of the Act, he or she shall publicly announce such fact in the Official Gazette and on the website of the Ministry of Science and ICT. |
[This Article Newly Inserted on Jun. 28, 2022]
| Article 17 (Preparation and Implementation of Experiment Guidelines) |
The Minister of Science and ICT and the heads of relevant central administrative agencies shall prepare and implement experiment guidelines specific to their agencies under Article 16 of the Act, after deliberation by the Council. <Amended on Mar. 23, 2013; Jul. 26, 2017> [This Article Wholly Amended on Oct. 17, 2017]
| Article 18 (Establishment of Government-Funded Research Institutes) |
| (1) | The establishment of a government-funded research institute under Article 17 (1) of the Act (hereinafter referred to as a "government-funded brain research institute") shall be governed by the Act on the Establishment, Operation and Promotion of Government-Funded Science and Technology Research Institutes. |
| (2) | Pursuant to Article 17 (1) of the Act, the Minister of Science and ICT may designate a government-funded brain research institute, from among those meet all of the following requirements, which is deemed suitable to perform the affairs under paragraph (3), taking into account relevant research outcomes: |
| 1. | It shall be any of the following institutes: |
| 2. | It shall have 15 or more employees (limited to full-time workers) conducting brain research; |
| 3. | It shall have facilities related to brain research with a total floor area of at least 1,500 square meters, including research labs and laboratories. |
| (3) | A government-funded brain research institute shall perform the following affairs: |
| 1. | Research and development in the field of brain; |
| 2. | Expansion of research infrastructure, including researchers, facilities, equipment, and information in the field of brain research; |
| 3. | Establishment of a collaboration system among academia, research institutes, and industry; |
| 4. | International collaboration, including international joint research related to the brain field; |
| 5. | Research related to the establishment of a comprehensive brain research information system under Article 13 (2) of the Act. |
| (4) | The head of a government-funded brain research institute shall formulate a detailed implementation plan and a fund operation plan for the affairs under each subparagraph of paragraph (3) every year and submit them to the Minister of Science and ICT. |
[This Article Newly Inserted on Jun. 28, 2022]
| Article 18-2 (Implementation of Rewards) |
| (1) | The Minister of Science and ICT may award prizes to any of the following universities, research institutes, enterprises, and individuals pursuant to Article 18 (2) of the Act: |
| 1. | Those that have contributed to the development of brain research by creating excellent research results; |
| 2. | Those who have contributed to the development of the brain industry by developing innovative technologies; |
| 3. | Those who have contributed to the development of brain research and the brain industry by promoting international cooperation and fostering human resources; |
| 4. | Other persons that have made significant contributions to the development of brain research and the brain industry. |
| (2) | The Minister of Science and ICT may receive recommendations from institutions, corporations, and organizations related to brain research and the brain industry when awarding prizes under paragraph (1). |
| (3) | Where the Minister of Science and ICT intends to award a prize pursuant to paragraph (1), he or she shall determine the details of the award, the method and procedure for selecting eligible persons, the criteria for the award, and other relevant matters and publicly announce them on the website of the Ministry of Science and ICT. |
[This Article Newly Inserted on Apr. 23, 2024]
| Article 19 (Re-Examination of Regulation) |
The Minister of Science and ICT shall examine the appropriateness of the following matters every three years, counting from January 1, 2023 (referring to the period that ends on the day before January 1st of every third year) and shall take measures, such as making improvements:
| 1. | Requirements for designation of a brain bank under Article 16-2; |
| 2. | Detailed criteria for revocation of designation of a brain bank and issuance of corrective orders under Article 16-8 (1) and the attached Table. |
[This Article Newly Inserted on Jun. 28, 2022]
ADDENDUM <Presidential Decree No. 15924, Nov. 6, 1998>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 16326, May 24, 1999>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 17115, Jan. 29, 2001>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 19513, Jun. 12, 2006>
Article 1 (Enforcement Date)
This Decree shall enter into force on July 1, 2006.
ADDENDA <Presidential Decree No. 20740, Feb. 29, 2008>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 21214, Dec. 31, 2008>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on March 19, 2010. (Proviso Omitted.)
ADDENDUM <Presidential Decree No. 23224, Oct. 17, 2011>
This Decree shall enter into force on October 22, 2011.
ADDENDA <Presidential Decree No. 24423, Mar. 23, 2013>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 25751, Nov. 19, 2014>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation: Provided, That among Presidential Decrees amended pursuant to Article 5 of the Addenda, the amendments of Presidential Decrees promulgated before this Decree enters into force but the date on which it enters into force has not arrived shall enters into force on the date the relevant Acts enters into force.
ADDENDA <Presidential Decree No. 28210, Jul. 26, 2017>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 31168, Nov. 20, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on November 20, 2020.
ADDENDUM <Presidential Decree No. 31895, Jul. 20, 2021>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 32728, Jun. 28, 2022>
This Decree shall enter into force on July 12, 2022: Provided, That the amended provisions of Articles 15-2 and 18 shall enter into force on June 29, 2022.
ADDENDUM <Presidential Decree No. 34425, Apr. 23, 2024>
This Decree shall enter into force on May 1, 2024.