• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.125-144
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• 2016

All forms of Clinical trial should be fully equipped with protection systems for experimental subjects considering their uncertainty and various risks. Existing laws have some regulations in pharmaceutical affairs act and medical device act. Nonetheless, there is a limit to protect the subjects considering law objective to perform administration of medicine. Furthermore, the clinical trial on minor has no direct regulations in pharmaceutical affairs act, but prescribes certain portion in clinical trial assessment guideline on infants or medicine clinical trial management standard, however there is a limit because that is just recommendation not having legal effectiveness. The legislative solution would be possible for legal problems of clinical trial on minor by examining treatment system on minor in organ transplant act and clinical trial on minor in other foreign laws stronger than usual medical practice in terms of degree of human body invasion. I suppose that the control system of clinical trial being done focusing on the pharmaceutical affairs act, medical device act and other guidelines in existing laws system should be resolved by legislating 'trial subject protection law', in addition, this would be well balanced in organ transplant act on protection system of minor organ donors. Furthermore, the judgement on the consent ability and spontaneity in clinical trial on minor should be judged considering maturity and mentality of minor by clinical trial institutional review board based on legislative solution mentioned above.

• Journal of Digital Convergence
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• v.18 no.3
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• pp.383-393
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• 2020

The purpose of this study is to investigate the condition of the production facilities of severely impaired products for two years from 2017 to 2018, and to suggest ways to improve the preferential purchase system for the severely disabled comparison with previous study. As of June 2018, 267 out of 544 sites were research and analyzed. As a result, first, the average number of severely disabled workers is 16.51, and the total number of workers, disabled workers who participated in direct production, and non-disabled workers showed the trend of increase in 2018. Second, the average monthly wage of workers with disabilities participating in direct production increased slightly from 790,977 won in 2017 to 829,810 won in 2018. Third, Analysis of changes in sales of production facilities before and after designations showed that overall sales of production facilities increased after designations and after designations. Improvement measures include preferential purchase rate improvement and support for production facilities and purchasing public institutions, classification of roles of performance organizations, Clarification of the role of priority purchasing promotion committee for products produced by people with severe disabilities, complementing the minimum wage exclusion system.

• Journal of the Korean Data Analysis Society
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• v.20 no.6
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• pp.2993-3002
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• 2018

This case study introduces the process of developing the technology rating evaluation model for investment. The technology evaluation rating model for investment is a project that the Financial Services Commission and the Ministry of Commerce, Industry and Energy collaborated to expand the scope of technology finance from loan to investment. The technology evaluation model for investment was developed with the aim of predicting high growth companies. The model consists of a statistical model and an expert model. Here, statistical models were modeled by using logistic regression analysis. Expert models gathered opinions of experts and identified the weight of each evaluation item and set the model. The rating system of the model is composed of 10 grades. The distribution of the model was consistent with KTRS grade distribution. Interestingly, the emphasis is on technology and marketability. In the technology valuation grade model for the goddess, there is a considerable difference from the emphasis on managerial competence or business performance.

• Korean Journal of Heritage: History & Science
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• v.51 no.3
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• pp.54-71
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• 2018

This year marks the 40th anniversary of the first inscription of 12 UNESCO World Heritage sites in 1978. Based on an overview of the implementation of the 'Convention Concerning the Protection of the World Cultural and Natural Heritage', this article examines the current issues of the inscription of cultural heritage over the past 40 years. In particular, this paper focuses on the case study of 'Sacred Island of Okinoshima and Munakata Region' nominated by Japan, which was inscribed on the World Heritage List at the 41st World Heritage Committee in 2017. Also, it demonstrates the recent trend and investigates the issues of imbalances in the evaluation and the decisions among relevant actors in the nomination process of World Heritage. Furthermore, this article attempts to derive feasible implications and lessons, and to generate heritage discourse by examining Japan's management in 'heritage diplomacy' of the World Heritage Convention, which is rapidly changing in the course of its nearly half a century of implementation. In conclusion, the research is expected to provide Korea with strategic guidance marking the 30th anniversary of its entry into the Convention, and to steer the future direction for the inscription and conservation of cultural heritage.

• The Journal of KAIRB
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• v.4 no.2
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

• Korea Trade Review
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• v.42 no.2
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• pp.205-225
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• 2017

The study attempts to verify the case related to the notice of payment refusal by issuing bank regarding discrepancy in transport document under L/C(Letter of Credit) transaction. Considering the high portion of trade between Korea and China, Korean companies and banks in L/C transaction should be careful about many unpredictable situations. The case of this study is that Chinese seller(beneficiary) initiated a civil suit against Industrial Bank of Korea to Chinese court and Chinese courts in the first and second trials judged that the notice of payment refusal by Industrial bank of Korea doesn't satisfy Article 16, (c) (ii) (iii) in UCP 600. However, Industrial Bank of Korea implements the judgement even though the judgement is highly biased to Chinese seller. Considering the judgement by Chinese courts, the study suggests some countermeasures to Korean companies and banks which opened L/C. First, the issuing bank should describe the contents of discrepancy specifically based on Article 16, (c) in UCP 600. Second, it is necessary to insert a clause regarding governing law in the L/C contract like sales contract. Third, considering the biased judgement by Chinese court and difficulty in execution of foreign judgement in China, it is recommended to using arbitration as a method of dispute resolution such as ICLOCA and DOCDEX Rules which are international system operated by international instruments because it has legal effects to parties in L/C contracts if the issuing bank inserts arbitration clause in L/C.

• The Korean Society of Law and Medicine
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• v.17 no.1
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• pp.209-279
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• 2016

The Korean Mental Health Act was amended 2016 overall. This paper examines and evaluates the old Korean Mental Health Act since 1995 and the new Korean Mental Health Promotion Act 2016 from the Perspective of Human Rights and Inclusion of Persons with Psychosocial Disabilities. The persons with mental disabilities was separated and ruled out from society by the enactment of the Mental Health Act in 1995 and five times amendment. That has been justified and institutionally supported by medical viewpoint. The medical approach which reconsider the persons with mental disabilities as patients conceal that the aims of the involuntary admission in Mental Hospital are protection of society and the relief of the family member's duty of support for person with mental disabilities. This is institutionally supported in the 1995 Korean Mental Health Act by involuntary admission through the consent of family members as protectors. According to the old Act, the family members as protectors are authorized to consent to involuntary admission of persons with mental disabilities. Also, the psychiatrist that diagnoses the person with mental disabilities and evaluates the need for treatment by admission is not impartial in this decision. Family members as protectors may want to lighten their burden of support for the person with mental disabilities in their home by admitting them into a mental hospital, and the psychiatrist in the mental hospital can be improperly influenced by demand of hospital management. Additionally, Article 24 of the Korean Mental Health Act for the Involuntary Admission by the Consent of Family Members as Protector might violate personal liberty, as guaranteed in the Korean Constitution. The Mental Health Promotion Law was amended to reduce the scope of the persons with mental illness which are subject to forced hospitalization and to demand that a second diagnosis is made by another psychiatrist and screening by the committee concerning the legitimacy of admission in the process of the involuntary admission by the consent of family members as a method of protection. The amended Mental Health Promotion Law will contribute to reducing the number of the involuntary admissions and the inclusion of persons with mental disabilities. But if persons with mental disabilities are not providing some kind of service to the community, the amended Mental Health Promotion Law does not work for Inclusion of them.

• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.3-35
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• 2021

Inmitten der Flut der privaten und öffentlichen Information gilt die riesige Informationsmenge als Schlüsselressource im Zeitalter der 4. industriellen Revolution, repräsentiert durch Big-Data. Das Interesse an diesen wächst weltweit. Es gibt eine aktive Diskussion darüber, wie man Daten sichert und akkumuliert und wie man die gesammelten Daten sicher und effektiv nutzt. Gesundheitsdaten werden vor allem als die wertvollste Ressource bewertet, für die Big-DataTechnologie eingesetzt wird. Um Gesundheitsdaten sinnvoll zu nutzen, müssen verteilte Gesundheitsdaten integriert und den Benutzern in einer Form zur Verfügung gestellt werden, die für Forschung oder Inspektion verwendet werden kann. In einer Situation, in der große Länder um den Aufbau bzw. die Führung der Datenwirtschaft konkurrieren, wurden im August 2020 auch in Südkorea die sog. „3-Daten-Gesetze" geändert, die das Datenschutzgesetz(DSG) enthälten. Das DSG führte das Konzept der pseudonymen Informationen ein und baute eine Rechtsgrundlage für deren Verwendung auf. Als Folgemaßnahme kündigte die, Kommission für den Schutz personenbezogener Daten(Personal Information Protection Commission: PIPC)' die „Richtlinien für die Bahandlung mit pseudonymen Informationen" und, Ministerium für Gesundheit und Wohlfahrt' die „Richtlinien für die Verwendung von Gesundheitsdaten" an. Gesundheitsdaten stehen direkt in Zusammenhang mit Leben und Körper des Menschen und damit enthalten viele sensible Daten. Es handelt sich also um ein System, das aus einer vorsichtigeren und konservativeren Sicht unter der Voraussetzung verwendet werden kann, personenbezogene Daten sicherer zu schützen. Um die Hauptinhalte der „Richtlinien für Verwendung von Gesundheitsdaten" zu analysieren, überprüften wir zunächst die Hauptinhalte des überarbeiteten DSG. Danach durch die Analyse der wesentlichen Inhalte der „Richtlinien für Verwendung von Gesundheitsdaten" wurden Probleme wie Konflikte mit anderen Gesetzen und Verbesserungsmaßnahmen überprüft.

• Journal of Korean Society of Archives and Records Management
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• v.4 no.2
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• pp.118-162
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• 2004

Archival description in archives has an important role in document control and reference service. Archives has made an effort to do archival description. But we have some differences and problems about a theory and practical processes comparing with advanced countries. The serious difference in a theory is that a function classification, maintenance of an original order, arrangement of multi-level description are not reflected in practical process. they are arranged in shelves after they are arranged by registration order in a unit of a volume like an arrangement of book. In addition, there are problems in history of agency change or control of index. So these can cause inconvenience for users. For improving, in this study we introduced the meaning and importance of arrangement of description, the situation and problem of arrangement of description in The National Archives, and a description guideline in other foreign countries. The next is an example for ISAD(G). This paper has chapter 8, the chapter 1 is introduction, the chapter 2 is the meaning and importance of arrangement of description, excluding the chapter 8 is conclusion we can say like this from the chapter 3 to the chapter 7. In the chapter 3, we explain GOVT we are using now and description element category in situation and problem of arrangement of description in Archives. In the chapter 4, this is about guideline from Archives in U.S.A, England and Australia. 1. Lifecycle Date Requirement Guide from NARA is introduced and of the description field, the way of the description about just one title element is introduced. 2. This is about the guideline of the description from Public Record Office. That name is National Archives Cataloguing Guidelines Introduction. We are saying "PROCAT" from this guideline and the seven procedure of description. 3. This is about Commomon Record Series from National Archives of Australia. we studied Registration & description procedures for CRS system. In the chapter 5, This is about the example which applied ISAD to. Archives introduce description of documents produced from Appeals Commission in the Ministry of Government Administration. In the chapter 6, 7. These are about the problems we pointed after using ISAD, naming for the document at procedure section in every institution, the lack of description fields category, the sort or classification of the kind or form, the reference or identified number, the absence description rule about the details, function classification, multi-level description, input format, arrangement of book shelf, authority control. The plan for improving are that problems. The best way for arrangement and description in Archives is to examine the standard, guideline, manual from archives in the advanced countries. So we suggested we need many research and study about this in the academic field.

• Journal of Food Hygiene and Safety
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• v.33 no.1
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• pp.1-11
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• 2018

It is ten years since the Good Agricultural Practices (GAP) certification system was implemented in Korea, and the government aims to acquire GAP certification up to 25% of the total agricultural areas by 2022. As of the end of 2017, 6.3% of the total cultivated area and 8.1% of the total farm households were certified, which is slower than expected. The purpose of this study was to investigate the causes of the GAP accreditation through the surveys and on site inspections of the GAP certified farmers and to propose the development plans according to the problems analysis of the current system in order to expand the GAP certification. Certified farmers recognized the need for agricultural safety and hygiene, but there were a lot of nonconformities regarding practical practices. This is due to the ambiguity of the certification standards and the wrong ways in the training method for the producers. GAP certification is slow to expand to farmers and low consumer awareness is considered a structural problem of GAP certification system, and improvement measures are needed accordingly. It is necessary to convert the state-led GAP certification system into a state-led private certification system. It is necessary for the government to focus on policy, research and follow-up management. In addition, it is necessary to establish a separate organization in the form of a contribution organization for the certification, education, and public relations. In addition, long-term plan must be established and systematically carried out. It is necessary to integrate too many certification agencies compared to the farming scale of Korea, and it is necessary to realize the application fee for realizing the financial independence of the certification body and correct certification work. In addition, inspector qualification standards should be strengthened and training system should be improved to nurture high quality inspectors. Simplified certification standards based on statutes need to be subdivided into practical action plans. In order to improve the GAP certification system, it is necessary to have a discussion through a committee composed of specialists from industry and academia, and it will be possible to contribute to the safety of the food of the people through the production of safe by drawing concrete development plans.