• 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.1
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• pp.261-284
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• 2018

The current international legal system does not provide a safeguard against the militarization and the weaponization of outer space. Although the term "peaceful use of outer space" in the 1967 Outer Space Treaty(OST) appears in official government statements or in multilateral space treaties, it is still without an authoritative definition in reviewing national practices. The ambiguous ban on weapons in Article IV of the OST allows countries to loophole on the deployment of other weapons other than nuclear weapons. Meanwhile "Draft Treaty on the Prevention of the Placement of Weapon in Outer Space and of the Threat or Use of Force against Outer Space Objects(PPWT)" to Conference on Disarmament (CD) commissioned by the UN General Assembly's Special Session jointly submitted by China and Russia in 2008 and later revised in 2014, attempting to define and prohibit the proliferation of weapons in outer space and provided definitions of prohibited weapons, are opposed by the US on the grounds that currently there is no arms race in outer space. Some experts support a hard law approach in which binding laws aimed at ultimately creating integrated and binding legal instruments in all aspects of the use of outer space should be adopted to regulate the military use of space. However as a temporary measure the soft law guidelines should be developed for the non liquiet, a situation where there is no applicable law. The soft law could be used to create support for the declaration of the treaties and to create international customary law. For example, the 1963 Declaration of Legal Principles Governing the Activities of States in the Exploration and Use of Outer Space that regulates the activities of the state in the exploration and use of the universe, and the 1992 Principles Relevant to the Use of Nuclear Power Sources in Outer Space will illustrated. While substantial portions of the former was codified later in the 1967 OST, the latter which, although written in somewhat mandatory terms, have been consistently complied with by states, have arguably become part of customary international law. On November 12, 1974, the General Assembly reaffirmed that the development of international law may be reflected inter alia, by declarations and resolutions of the General Assembly which may to that extent be taken into consideration by the International Court of Justice.

• The Korean Journal of Air & Space Law and Policy
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• v.33 no.1
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• pp.81-120
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• 2018

To promote the aviation safety reporting system that is operated to enhance aviation safety and to utilize related information, it should first be preceded by standards for non-punishment and data protection. It is because the purpose of collection and analysis of aviation safety related data through the aviation safety reporting system is to prevent recurrence of accidents by investigating their causes through collection and analysis of diverse types of information related to aviation safety. Both mandatory and voluntary reporting systems are in operation for aviation safety under the current Aviation Safety Act. It is said that they were introduced to survey causes for accidents and to prevent recurrences. In fact, however, it is hard to expect active implementation of the reporting system for aviation safety unless the reporters are firstly exempted from punishment. Therefore, the system should be improved so that it can satisfy its purpose and the purposes of data collection concerning aviation safety through examination of the purposes of the reporting system. One of the matters that needs to be considered to promote the reporting system should be the scope of aviation safety hindrances presupposed under the current institution. The voluntary aviation safety reporting system differs from the systems of ICAO or the key advanced countries, including the USA and the UK as it limits the target accidents subject to reporting to minor aviation safety hindrances only. That being said, improvements should be made by requiring mandatory reporting of aviation safety hindrances based on their severity while recognizing a greater variety of aviation safety concerns like international standards. Safety actions and sharing of information based on collection and analysis of diverse data related to aviation safety will greatly contribute to enhance aviation safety as the purposes of the reporting system are to explore causes for accidents and to prevent their recurrences. What is most important in this regard is strict data protection and non-punishment principles; compliance with them should be secured. We can hardly expect the successful operation of the system unless the reporter is exempted from punishment and the relevant data is protected as promotion of voluntary reporting is an essential factor for enhancing the safety culture. Otherwise, the current system may induce hiding of relevant facts or data to evade punishment. It is true that the regulation for enhancing safety tends to have limitations or blind spots; nevertheless, it should still be enforced strictly and completely. Technological progresses and mistakes of operators appear in different forms based on individual cases. The consequential damages may amount to a truly severe level. Therefore, we have studied and suggested to the methods of activiation and amendments on the aviation safety reporting system, which is referred for one of the proactive safety management systems. The proposed improvement of the reporting system and introduction of non-punishment for collection of aviation safety data for deploying a preemptive prevention system would serve as the backbone for enhancing aviation safety in Korea.

• The Korean Journal of Air & Space Law and Policy
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• v.1
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• pp.47-85
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• 1989

The Fundamental purpose of the Warsaw Convention was to establish uniform rules applicable to international air transportation. The emphasis on the benefits of uniformity was considered important in the beginning and continues to be important to the present. If the desire for uniformity is indeed the mortar which holds the Warsaw system together then it should be possible to agree on a worldwide liability limit. This liability limit would not be so unreasonable, that it would be impossible for nations to adhere to it. It would preclude any national supplemental compensation plan or Montreal Agreement type of requirement in any jurisdiction. The differentiation of liability limits by national requirement seems to be what is occurring. There is a plethora of mandated limits and Montreal Agreement type 'voluntary' limits. It is becoming difficult to find more than a few major States where an unmodified Warsaw Convention or Hague Protocol limitation is still in effect. If this is the real world in the 1980's, then let the treaty so reflect it. Upon reviewing the Warsaw Convention, its history and the several attempts to amend it, strengths become apparent. Hijackings of international flights have given rise to a number of lawsuits by passengers to recover damages for injuries suffered. This comment is concerned with the liability of an airline for injuries to its passengers resulting from aviation terrorism. In addition, analysis is focused on current airline security measures, particularly the pre-boarding screening system, and the duty of air carriers to prevent weapons from penetrating that system. An airline has a duty to exercise a high degree of care to protect its passengers from the threat of aviation terrorism. This duty would seemingly require the airline to exercise a high degree of care to prevent any passenger from smuggling a weapon or explosive device aboard its aircraft. In the case an unarmed hijacker who boards having no instrument in his possession with which to promote the hoax, a plaintiff-passenger would be hard-pressed to show that the airline was negligent in screening the hijacker prior to boarding. In light of the airline's duty to exercise a high degree of care to provide for the safety of all the passengers on board, an acquiescene to a hijacker's demands on the part of the air carrier could constitute a breach of duty only when it is clearly shown that the carrier's employees knew or plainly should have known that the hijacker was unarmed. A finding of willful misconduct on the part of an air carrier, which is a prerequisite to imposing unlimited liability, remains a question to be determined by a jury using the definition or standard of willful misconduct prevailing in the jurisdiction of the forum court. Through the willful misconduct provision of the Warsaw Convention, air carrier face the possibility of unlimited liability for failure to implement proper preventive precautions against terrorist. Courts, therefore, should broadly construe the willful misconduct provision of the Warsaw Convention in order to find unlimited liability for passenger injuries whenever air carrier security precautions are lacking. In this way, the courts can help ensure air carrier safety and prevention against terrorist attack. Air carriers, therefore, would have an incentive to increase, impose and maintain security precautions designed to thwart such potential terrorist attacks as in the case of Korean Air Lines Flight No.858 incident having a tremendous impact on the civil aviation community. The crash of a commercial airliner, with the attending tragic loss of life and massive destruction of property, always gives rise to shock and indignation. The general opinion is that the legal system could be sufficient, provided that the political will is there to use and apply it effectively. All agreed that the main responsibility for security has to be borne by the governments. I would like to remind all passengers that every discovery of the human spirit may be used for opposite ends; thus, aircraft can be used for air travel but also as targets of terrorism. A state that supports aviation terrorism is responsible for violation of International Aviation Law. Generally speaking, terrorism is a violation of international law. It violates the soverign rights of the states, and the human rights of the individuals. I think that aviation terrorism as becoming an ever more serious issue, has to be solved by internationally agreed and closely co-ordinated measures. We have to contribute more to the creation of a general consensus amongst all states about the need to combat the threat of aviation terrorism.

• Health Policy and Management
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• v.11 no.2
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• pp.141-168
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• 2001

Healthcare service organizations can apply the cost of quality(COQ) model as a method to evaluate a service quality improvement project such as Total Quality Management (TQM). COQ model has been used to quantify and evaluate the efficiency and effectiveness of TQM project through estimation between cost and benefit in intervention for a quality Improvement to provide satisfied services for a customer, and to identify a non value added process. For estimating cost of quality, We used activities and activity costs based on Activity Based Costing(ABC) system. These procedures let the researchers know whether the process is value-added by each activity, and identify a process to require improvement in TQM project. Through the series of procedures, health care organizations are service organizations can identify a problem in their quality improvement programs, solve the problem, and improve their quality of care for their costumers with optimized cost. The study subject was a quality improvement program of the department of radiology department in a hospital with n bed sizes in Metropolitan Statistical Area (MSA). The principal source of data for developing the COQ model was total cases of retaking shots for diagnoses during five months period from December of the 1998 to April of the 1999 in the department. First of the procedures, for estimating activity based cost of the department of diagnostic radiology, the researchers analyzed total department health insurance claims to identify activities and activity costs using one year period health insurance claims from September of the 1998 to August of the 1999. COQ model in this study applied Simpson & Multher's COQ(SM's COQ) model, and SM's COQ model divided cost of quality into failure cost with external and internal failure cost, and evaluation/prevention cost. The researchers identified contents for cost of quality, defined activities and activity costs for each content with the SM's COQ model, and finally made the formula for estimating activity costs relating to implementing service quality improvement program. The results from the formula for estimating cost of quality were following: 1. The reasons for retaking shots were largely classified into technique, appliances, patients, quality management, non-appliances, doctors, and unclassified. These classifications by reasons were allocated into each office doing re-taking shots. Therefore, total retaking shots categorized by reasons and offices, the researchers identified internal and external failure costs based on these categories. 2. The researchers have developed cost of quality (COQ) model, identified activities by content for cost of quality, assessed activity driving factors and activity contribution rate, and calculated total cost by each content for cost for quality, except for activity cost. 3. According to estimation of cost of quality for retaking shots in department of diagnostic radiology, the failure cost was ￦35,880, evaluation/preventive cost was ￦72,521, two times as much as failure cost. The proportion between internal failure cost and external failure cost in failure cost is similar. The study cannot identify trends on input cost and quality improving in cost of qualify over the time, because the study employs cross-sectional design. Even with this limitation, results of this study are much meaningful. This study shows possibility to evaluate value on the process of TQM subjects using activities and activity costs by ABC system, and this study can objectively evaluate quality improvement program through quantitative comparing input costs with marginal benefits in quality improvement.

• Journal of Internet Computing and Services
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• v.22 no.4
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• pp.83-98
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• 2021

The purpose of this study to find the factors influencing the fire alarms using IoT firefighting facility management system data of Seoul Fire & Disaster Headquarters, and to present academic implications for establishing an effective prevention system of fire situation. As the number of high and complex buildings increases and former bulidings are advanced, the fire detection facilities that can quickly respond to emergency situations are also increasing. However, if the accuracy of the fire situation is incorrectly detected and the accuracy is lowered, the inconvenience of the residents increases and the reliability decreases. Therefore, it is necessary to improve accuracy of the system through efficient inspection and the internal environment investigation of buildings. The purpose of this study is to find out that false detection may occur due to building characteristics such as usage or time, and to aim of emphasizing the need for efficient system inspection and controlling the internal environment. As a result, it is found that the size(total area) of the building had the greatest effect on the fire alarms, and the fire alarms increased as private buildings, R-type receivers, and a large number of failure or shutoff days. In addition, factors that influencing fire alarms were different depending on the main usage of the building. In terms of time, it was found to follow people's daily patterns during weekdays(9 am to 6 pm), and each peaked around 10 am and 2 pm. This study was claimed that it is necessary to investigate the building environment that caused the fire alarms, along with the system internal inspection. Also, it propose additional recording of building environment data in real-time for follow-up research and system enhancement.

• Journal of the Korean Institute of Landscape Architecture
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• v.49 no.5
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• pp.79-96
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• 2021

Green infrastructure planning represents landscape planning measures to reduce particulate matter. This study aimed to derive factors that may be used in planning green infrastructure for particulate matter reduction using text mining techniques. A range of analyses were carried out by focusing on keywords such as 'particulate matter reduction plan' and 'green infrastructure planning elements'. The analyses included Term Frequency-Inverse Document Frequency (TF-IDF) analysis, centrality analysis, related word analysis, and topic modeling analysis. These analyses were carried out via text mining by collecting information on previous related research, policy reports, and laws. Initially, TF-IDF analysis results were used to classify major keywords relating to particulate matter and green infrastructure into three groups: (1) environmental issues (e.g., particulate matter, environment, carbon, and atmosphere), target spaces (e.g., urban, park, and local green space), and application methods (e.g., analysis, planning, evaluation, development, ecological aspect, policy management, technology, and resilience). Second, the centrality analysis results were found to be similar to those of TF-IDF; it was confirmed that the central connectors to the major keywords were 'Green New Deal' and 'Vacant land'. The results from the analysis of related words verified that planning green infrastructure for particulate matter reduction required planning forests and ventilation corridors. Additionally, moisture must be considered for microclimate control. It was also confirmed that utilizing vacant space, establishing mixed forests, introducing particulate matter reduction technology, and understanding the system may be important for the effective planning of green infrastructure. Topic analysis was used to classify the planning elements of green infrastructure based on ecological, technological, and social functions. The planning elements of ecological function were classified into morphological (e.g., urban forest, green space, wall greening) and functional aspects (e.g., climate control, carbon storage and absorption, provision of habitats, and biodiversity for wildlife). The planning elements of technical function were classified into various themes, including the disaster prevention functions of green infrastructure, buffer effects, stormwater management, water purification, and energy reduction. The planning elements of the social function were classified into themes such as community function, improving the health of users, and scenery improvement. These results suggest that green infrastructure planning for particulate matter reduction requires approaches related to key concepts, such as resilience and sustainability. In particular, there is a need to apply green infrastructure planning elements in order to reduce exposure to particulate matter.

• Journal of agricultural medicine and community health
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• v.43 no.4
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• pp.258-269
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• 2018

Objectives: There was an outbreak of foodborne and waterborne disease among high school students at Okcheon in June, 2018. First attack occurred June $5^{th}$ but seven days later it was notified. The purpose of this investigation was to evaluate the pathogen of outbreak and cause of delayed notification. Methods: First, we did a questionnaire survey for 61 cases and 122 controls to find what symptoms they had and whether they ate foods or drank water from June $2^{nd}$ to June $12^{th}$. Second, we investigated the environment of cafeteria and drinking water. Third, we examined specimen of cases and environment to identify bacteria or virus. Results: Attack rate of this outbreak was 7.8%. Drinking water was strongly suspected as a source of infection in questionnaire survey but we could not find the exact time of exposure. Norovirus was identified in specimen of cases (2 students), drinking water (at main building and dormitory) and cafeteria (knife, dishtowel, hand of chef) Conclusions: We decided norovirus as the pathogen of this outbreak based on the clinical features of cases with diarrhea vomiting, abdominal pain and recovery within 2 or 3 days after onset, outbreak due to drinking water and microbiologic examination, And the cause of delayed notification might be the non-existence of the nurse teacher at that time and the lack of understanding of teachers on immediate notification under the outbreak. To prevent the delayed notification, notification system about outbreak of foodborne and waterborne disease in school is needed to be improved.

• 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.

• Journal of the Society of Disaster Information
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• v.19 no.2
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• pp.395-410
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• 2023

Purpose: The purpose of this study was to analyze the current state of drone terrorism response at such critical national facilities and derive improvements, especially to identify problems in laws and systems to effectively utilize the anti-drone system and present directions for improvement. Method: A qualitative research method was used for this study by analyzing a variety of issues not discussed in existing research papers and policy documents through in-depth interviews with subject matter experts. In-depth interviews were conducted based on 12 semi-structured interviews by selecting 16 experts in the field of anti-drone and terrorism in Korea. The interview contents were recorded with the prior consent of the study participants, transcribed back to the Korean file, and problems and improvement measures were derived through coding. For this, the threats and types were analyzed based on the cases of drone terrorism occurring abroad and measures to establish anti-drone system were researched from the perspective of laws and systems by evaluating the possibility of drone terrorism in the Republic of Korea. Result: As a result of the study, improvements to some of the problems that need to be preceded in order to effectively respond to drone terrorism at critical national facilities in the Republic of Korea, have been identified. First, terminologies related to critical national facilities and drone terrorism should be clearly defined and reflected in the Integrated Defense Act and the Terrorism Prevention Act. Second, the current concept of protection of critical national facilities should evolve from the current ground-oriented protection to a three-dimensional protection concept that considers air threats and the Integrated Defense Act should reflect a plan to effectively install the anti-drone system that can materialize the concept. Third, a special law against flying over critical national facilities should be enacted. To this end, legislation should be enacted to expand designated facilities subject to flight restrictions while minimizing the range of no fly zone, but the law should be revised so that the two wings of "drone industry development" and "protection of critical national facilities" can develop in a balanced manner. Fourth, illegal flight response system and related systems should be improved and reestablished. For example, it is necessary to prepare a unified manual for general matters, but thorough preparation should be made by customizing it according to the characteristics of each facility, expanding professional manpower, and enhancing response training. Conclusion: The focus of this study is to present directions for policy and technology development to establish an anti-drone system that can effectively respond to drone terrorism and illegal drones at critical national facilities going forward.