• The Korean Society of Law and Medicine
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• v.20 no.2
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• pp.173-206
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• 2019

This research examines the characteristic of regulation on Japanese clinical research in recent years. First, Japan has had a severe punishment policy on research misconduct like Korea, but, in recent days, Japan has changed the direction of research ethics policy from restriction to research publicness securement by educational training, in addition, Act of Clinical Research, effected April 2018, has recruited excellent researchers, and then integrated clinical research and medicine clinical trial through raising transparency of funding and integrating ethics screening by mandating announcement on funding information of clinical research. Second, Japan has integrated and organized ethics guideline from dual system that consists of ethics guideline on dynamic research(here after, referred to as 「dynamic guideline」) and ethics guideline on clinical research(here after, referred to as 「clinical guideline」) to ethics guideline on medical research aimed at human(here after, referred to as 「integrated guideline」), thus, it complements repetition and deficit of ethics guideline needed in clinical research and dynamic research, and it has risk evaluation system for protecting human subjects, and also it clarifies the concept of 「invasiveness」, a preliminary consideration of evaluation. 「Evaluation issue of risk and profit」, common contents of international regulation related clinical research, is the method to check whether the research is designed appropriately or not, this is the method for Institutional Review Board to decide whether the risk on human subjects could be justified, and also this is the important standard for future human subjects to participate in clinical trial. Therefore, it is meaningful to define 「invasiveness」 concept, a preliminary consideration of risk evaluation for human subjects. This research examines Japanese clinical trial focusing on change of awareness on prevention of research misconduct, efficiency improvement of research through research screening and integration of human subjects, and clarification and extension of range of 「invasiveness」 concept, a preliminary of risk evaluation to protect human subjects.

• The Korean Journal of Air & Space Law and Policy
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• v.33 no.2
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• pp.345-366
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• 2018

Article 37 of the International Convention on Civil Aviation requires that rules should be adopted to keep in compliance with international standards and recommended practices established by ICAO. As SARPs are revised annually, each ICAO Member State needs to reflect the new content in its national aviation Acts in a timely manner. In recent years, data-driven international standards have been developed because of the important roles of aviation safety data and information-based legislation in accident prevention based on human factors. The Safety Management System and crew Fatigue Risk Management Systems were reviewed as examples of the result of data-driven rulemaking. The safety management system was adopted in 2013 with the introduction of Annex 19 and Chapter 5 of the relevant manual describes safety data collection and analysis systems. Through analysis of safety data and information, decision makers can make informed data-driven decisions. The Republic of Korea introduced Safety Management System in accordance with Article 58 of the Aviation Safety Act for all airlines, maintenance companies, and airport corporations. To support the SMS, both mandatory reporting and voluntary safety reporting systems need to be in place. Up until now, the standard of administrative penal dispensation for violations of the safety management system has been very weak. Various regulations have been developed and implemented in the United States and Europe for the proper legislation of the safety management system. In the wake of the crash of the Colgan aircraft, the US Aviation Safety Committee recommended the US Federal Aviation Administration to establish a system that can identify and manage pilot fatigue hazards. In 2010, a notice of proposed rulemaking was issued by the Federal Aviation Administration and in 2011, the final rule was passed. The legislation was applied to help differentiate risk based on flight according to factors such as the pilot's duty starting time, the availability of the auxiliary crew, and the class of the rest facility. Numerous amounts data and information were analyzed during the rulemaking process, and reflected in the resultant regulations. A cost-benefit analysis, based on the data of the previous 10 year period, was conducted before the final legislation was reached and it was concluded that the cost benefits are positive. The Republic of Korea also currently has a clause on aviation safety legislation related to crew fatigue risk, where an airline can choose either to conform to the traditional flight time limitation standard or fatigue risk management system. In the United States, specifically for the purpose of data-driven rulemaking, the Airline Rulemaking Committee was formed, and operates in this capacity. Considering the advantageous results of the ARC in the US, and the D4S in Europe, this is a system that should definitely be introduced in Korea as well. A cost-benefit analysis is necessary, and can serve to strengthen the resulting legislation. In order to improve the effectiveness of data-based legislation, it is necessary to have reinforcement of experts and through them prepare a more detailed checklist of relevant variables.

• 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 radiological science and technology
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• v.30 no.4
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• pp.313-320
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• 2007

There are the Medical Radiation Health and Safety Act(the Patient Radiation Health and Safety Act, the Radiologic Technologist Act), the Medical Laboratory Technologist Act, the Physical Therapy Practice Act, and the Dental Hygienist Act, etc in America. However, Korea has only one Act for a medical radiologic technologist(including radiation therapy technologist, nuclear medicine technologist), medical laboratory technologist, physical therapist, occupational therapy examiner, dental hygienist, and so on. It is the Medical Technologist Act. Therefore, the Medical Radiation Health and Safety Act for a radiologic technologist(including radiation therapy technologist, nuclear medicine technologist) has to be enacted independently in Korea. It is the purpose of this Act to provide for the appropriate certification of persons using radioactive materials, equipment emitting ionizing radiation on humans or performing medical imaging for diagnostic and therapeutic purposes. In Korea, the radiologic technologist is a "fusion technologist" who is a person other than a licensed practitioner as a radiographer, radiation therapist, nuclear medicine technologist, computed tomography technologist, magnetic resonance technologist, mammographer, sonographer, medical dosimetrist, quality management technologist, etc. This Act will have some provisions related to the definitions, reserved title, scope of practice, specialized technologist, application for licensure, radiologic technology council, renewal, continuing education, the radiation control advisory commission, etc. This Act will ensure that quality radiation therapy treatments are delivered and that quality diagnostic information is presented for interpretation, which will lead to accurate diagnosis, treatment and cure. Accurate diagnosis can be provided only when a personnel is properly educated in technique, equipment operation and radiation safety. In the end, this Act will protect the civil right to health. By regulating the personnel responsible for performing those procedures, this Act will mean improved care for patients-higher quality images, improved accuracy, and less exposure to radiation.

• Journal of Arbitration Studies
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• v.28 no.1
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• pp.125-151
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• 2018

Rapid industrial growth based on massive fossil fuel energy consumption has caused serious damages on natural environment and every aspects of human life. As demands for clean and pleasant living circumstance increases, conflicts and disputes around environmental problems have also been widespread. Given the 'environmental rights' is a relatively new legal concept, however, resolving environmental disputes through the traditional legal principles and litigation procedures could be restrictive and, in some sense. inefficient as well as expensive. With efforts to develop new legal principles on environmental disputes, the environmental dispute adjustment system has been introduced as an alternative dispute resolution to the traditional legal dispute procedures. The Korean Environmental Dispute Resolution Commission introduced as the environmental dispute adjustment system has been well established for the past twenty-seven years, given the steadily increasing numbers of applications to the Commission over environmental disputes. However, as most cases are still small in money terms and mainly subject to adjudication, the effectiveness and practical contribution of the Commission in the resolution of environmental disputes have in fact been limited. For the enhancement of the status and roles of the Commission as the prior instrument of the alternative dispute resolution(ADR) in environmental disputes, several suggestions could be considered as follows: First, mediation needs to be more activated than adjudication in order to meet the primary purpose of ADR that resolves environmental disputes according to free will of concerned parties. Second, the scope of mediation could be expanded to the areas including potential environmental damages. Third, the roles and responsibilities of the Environmental Dispute Resolution Commissions at both central and local levels need to be evenly distributed. Fourth, the mechanism and procedures of environmental dispute resolution should be standardized. Fifth, the status of the Environmental Dispute Resolution Commission could be elevated in rank by shifting its current affiliation from the Ministry of Environment to the Office of Prime Minister. Sixth, the organizational structure and human resources of the Commission need to be reinforced. Seventh, the current situation that tends to give priority to litigation procedures when an environment dispute is simultaneously pending in litigation and mediation should be eased and properly adjusted. Eighth, the adoption of mandatory mediation in advance to litigation needs to be discussed. Ninth, the legal authority of the Commission's decisions should be further guaranteed. If above suggestions are thoroughly reviewed and properly adopted, the roles, authority and power of the Environmental Dispute Resolution Commission would be increased in the era when environmental conflicts get widespread, requiring an effective alternative environmental dispute resolution mechanism.

• KDI Journal of Economic Policy
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• v.14 no.3
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• pp.23-48
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• 1992

The Korea's Consumer electronics industry has exhibited a spectacular growth in the last three decades, expanding into one of the most important industries in Korea in many respects. One interesting aspect of the industry is the dominant role played by the Big Three of the industry, Gumsung, Samsung, and Daewoo. Since 1984, the three companies have accounted for about 90% of the sales in key items such as color TV, VTRs, refrigerators, and washers. The Big Three not only dominated the manufacturing stage, but also the distribution stage of the industry through their networks of exclusive dealers that constitute the major part of the distribution market. In this study, we analyzed the effects of the exclusive dealing by the Big Three on the efficiency of the Korean economy. We find that exclusive dealing by the Big Three could seriously constrain competition in both the manufacturing and distribution stages of the industry. Exclusive dealing by the Big Three effectively forcecloses the market for most other manufacturers as well as deterring entry into the manufacturing stage by potential entrants. Further, it impedes the growth of distributors that achieve the economies of scale and scope and restricts competition by the Big Three. In contrast, we could find little evidence that exclusive dealing by the Big Three is pro-competitive or enhances welfare. As a remedy to this problem, we suggest that the Fair Trade Commission of Korea should regulate the exclusive dealing by the Big Three, thus opening the door for the growth of distributors that are not bound by an exclusive dealing relationship with any of the Big Three. Put differently, we urge the Korean Fair Trade Commission to apply the Article 23 (5) to the exclusive dealing by the Big Three. Article 23 (5) that states that unfair restrictive dealing is illegal has never been clarified by the FTC. We believe that our analysis could also serve as a basic for the clarification of the article in general.

• Journal of The Korean Association of Information Education
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• v.14 no.2
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• pp.261-271
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• 2010

NEIS (National Education Information SystTem) provides educational information to parents while students are not able to have the direct access to their own academic information. Students filed their request to the National Human Right Agency. The objective of this study is to investigate the feasibility of students direct access to their own information and how to do it. In detail, online survey was conducted from 3,300 students, teachers and parents who are the stake holders of student information service on NEIS regarding whether they are for it, if so how to do it. The result indicated that students, parents and teachers are all positive in that order. It is unexpected that teachers who need to input and are responsible for the accuracy and reliability for student information are also for it. Although the human right law suggests all students have the right to direct access to their own information, the order of operation can be from secondary school level if the operation can not be done all at the same time. The range of information provided through this service is in principle the same as what parents can access except the counseling information.

• 대한공업교육학회지
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• v.36 no.2
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• pp.239-256
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• 2011

The purpose of this study is to deduce the effective improvement plans of engineering education system and to provide the base materials by analyzing satisfaction and problems in the perception survey of stakeholders related in engineering education system including Engineering Education Accreditation System. Engineering education system improvement plans from the results of study are as follows. First, government and university should provide more financial support to the college in order to improve education environment such as laboratories and equipment. Second, in order to improve links among engineering education stakeholders, student-professor, student-faculty, and colleges should operate effective mentoring program and consultation plan. Third, according to service quality evaluation, colleges need to give rewards to distinguished faculties for their outstanding work and build up job training about services in order to enhance satisfaction of students and professors, Also, business related to Engineering Education Accreditation System should be simplified and needs to increase the number of workers exclusively responsible for this work. Forth, in order to enhance comprehension of learning outcome and outcome of Engineering Education Accreditation System, it is necessary to improve Engineering education innovation center's status, to establish active systematic promotion system and to operate engineering education evaluation expert committee such as 'Engineering education system evaluation council'. Fifth, because of the stakeholder's shortage of benefits and tiredness accumulation, the issue of effectiveness in engineering education institutions has raised controversy. Thus, engineering education institutions needs to take measure necessary. Moreover, engineering education improvements should be improved by reflecting opinions from professors, faculties and students who are practically planning, operating and participating engineering education programs.

• The Journal of the Korea Contents Association
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• v.18 no.5
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• pp.34-45
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• 2018

In Korea, there are a lot of regulation on gambling industry. Among them, the most unique regulation is the CAP system. The purpose of CAP system is to minimize the social side effects of gambling industry. For that, National Gambling Control Commission controls the maximum number of business premises of gambling companies. The CAP system is a means of preventing excessive expansion of the gambling industry. The CAP system has lasted since 2009. This study investigate how the CAP system influence the structure of gambling industry. In result, after the CAP system carried out, the growth rates of gambling industry are similar to those of national GDP. And before the CAP system, the HHI index and CR index were decreasing trend. However, after the CAP system, the HHI index and CR index were not decreasing. That means the structure of gambling industry has been stable and settled. And there were few variation among the gambling companies in sales. In conclution, the CAP system influenced the gambling industry to be stable. There were few competition among the gambling companies in Korea. And the structure of gambling industry has been settled.

• Journal of Navigation and Port Research
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• v.35 no.1
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• pp.31-38
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• 2011

With today's continuous increase of both seaborne trade and foreign crew boarding ships, it is necessary to study the standardization of Marine English with respect to Aids to Navigation(AtoN) for the safety of ships. After reviewing the organization of the standard council of the equipment and article of AtoN, the standardization of various types of AtoN was not capable of meeting by the only existing council's activities. For on-the-job progress, it was necessary for the subcommittee to be composed by types of AtoN. It is thus desirable to the integrated approach to the combination of the civil, the public, academic circles and research institutes, which harmonized the council's flexibility and professionalism in the composition of the members. Subjects, levels and targets in each course were presented from results of the study on the standardization scheme of Marine English related to AtoN. The ET steps were classified by the difficult degree to which the principles of interpretation and communication were applied. This study contributed to the scheme that was firstly established to solve the problem of the audiovisual English ET due to the lack of the professionalism of the existing marine affairs by presenting the standardization scheme of Marine English prior to the institutional reform related to AtoN.