The regulation of conditions on the permission of gene therapy research have been mitigated by partial amendments (Dec. 29, 2015) to prevent human dignity and harm on the human body, but since the research scope is narrowly defined, it is difficult to expand opportunities to treat rare or incurable diseases and there are concerns about the retrogression of technological competitiveness, and changes are needed in the regulatory methods and the creation and management of ethical research environment to make the research possible in accordance with the rapid development of biotechnology such as CRISPR technology.
Therefore, the amendment stipulates ethical compliance obligations following the previous deliberation and approval of a research plan for a person who intends to study gene therapy (a researcher) and aims to introduce the advisory application system of the National Committee to supplement the expertise of the deliberation on gene therapy research. The amendment also aims to prepare the grounds for the researcher's obligation to report and if necessary, the investigation and request of data by the National Committee in addition to the investigation and supervision on the IRB-centered research process and results, and aims to make research possible if the requirements of either subparagraph 1 or 2 are satisfied regardless of research methods by deleting the classification of research methods in Article 47 (1) and (2).
Additionally, a private genetic testing institution may conduct a direct test for 12 test items and six genetic tests by permitting the disease prevention-related direct-to-customer (DTC) service of non-medical institutions without requesting the test to a medical institution (the Bioethics and Safety Act was revised on Dec. 29, 2015, and enforced on Jun. 30, 2016), but there is no compulsory regulation on the test service quality control of the institutions that provide DTC gene tests, and thus, there is concern about public misunderstandings by testing institutions, recruitment agencies, etc. Therefore, it is necessary to improve the system such as strengthening the overall management of the DTC service performed by non-medical institutions.
For this purpose, the amendment requires non-medical genetic testing institutions to receive the certification for testing services from the Minister of Health and Welfare before providing services directly to consumers by making it mandatory to receive the certification of overall test services to improve the quality control and reliability of tests and testing institutions; and after receiving the certification, the amendment aims to impose regularly reporting obligations and to strengthen the follow-up management for the continuous quality management of certified testing institutions as the requirements for maintaining the certification of an institution (Article 47 (1) partially revised and (2) and (3) newly inserted, Article 49 (3) to (5) newly inserted and (6) partially revised, Article 49-2 newly inserted, and Article 54, Articles 56 to Article 58, Articles 67 and 70 partially revised).

Article 49-2 (Obligations of Education) (1) The head and employees of an institution that has been certified in accordance with Article 49 (3) and conducts genetic tests under Article 50 (3) 2 shall receive education on the safety of genetic tests (hereinafter referred to as "genetic testing education" in this Article).