• 의료법학
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• 제13권2호
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• pp.79-113
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• 2012

This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

• 무역상무연구
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• 제21권
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• pp.129-151
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• 2003

Nowadays even if environment of international commercial transaction is changing quickly municipal law could not meet with such change accordingly. So far, however, efforts towards unification have prevailingly taken the form of binding instruments, such as non-national or supranational legislation, international conventions or international model laws. Among them, the UNIDROIT Principles with parties' autonomous and yet non-binding character do not only meet the substantive requirements of a true law merchant. In addition they also counter some of the main points of criticism against the modern lex mercatoria. As such the Principles constitute a cornerstone in the lex mercatoria debate and may become the heart of the new lex mercatoria. The purpose of this article is to ask whether there could be applied the Principles in international commerce. For the purpose it is to investigate when the Principles are applied in international commerce and how effectively the Principles are applied for the decision in international commercial disputes. Even though the Principles are used for reference by parties involved for the voluntary regulation of their contract, it is sufficiently expected that the Principles are to be a stepstone of uniform contract law in international commerce. Until now cases of appling the Principles are not satisfied with its expectation as a source of non-legislative means of unification or harmonization of law. Given the party's autonomy in the contract, this is among other things because business parties are strongly tend to observe their national laws in their international commerce. And also, even though there are a number of neutral and uniform regulations for international commercial contracts, parties do not often recognize their usefulness with being up to expectation. In order to explore the applicability of the Principles a number of cases of ICC International Court of Arbitration and others are quoted.

• 무역상무연구
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• 제57권
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• pp.35-60
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• 2013

The Incoterms which is one of the most useful international instrument for sale of goods provides when a contract goods deliver, risk passes and how costs are allocated between seller and buyer on the contract as long as they agree to use a rule of the Incoterms rules. The Incoterms rules have come into effective to use for an international or domestic trade of goods since January 2011, which have been modified several times since these established by ICC in 1936. The origin of Incoterms rules may had been appeared from English traditional FOB terms that had been affected to American regulations for the sale of goods. The Incoterms rules which had been started from the traditional English FOB terms and American FOB terms have been expanded other trade terms, such as CIF. Although FOB is based on the COD(Cash on Delivery), it is possible replaced COD to CAD(Cash against Delivery) through the use of Bill of Lading and Letter of Credit in the international sale of goods between seller and buyer according to the development of infrastructures on the international commercial transactions. This article exercises the process of transition of the Incoterms rules, being based on the English and American traditional FOB contract form through review literatures, judical precedents and provisions. Then this article provides some feasible alternatives to attempting to resolve some regulation problems of FCA, CPT, CIP, and D-rules in the Incoterms$^{(R)}$ 2010.

• 한국실내디자인학회논문집
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• 제22권1호
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• pp.211-221
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• 2013

As the result of investigating domestic interior design (interior architecture) field-related laws, it was found that interior design (interior architecture) is not recognized as in independent area due to weak classification standards by Korean standard industrial classification and job classification. Korean standard industrial classification is applied as a standard setting limits to applicable targets and industrial fields for laws related to general administration and industrial policy other than various statistic purposes. Also, the standard industrial classifications regarding the industry field determines the laws or applicable tax rates, government support and such according to the classification, and thus is very important. Moreover, interior architecture field is largely different from general architecture due to specialization and distinct characteristics, but due to the comprehensive concept of architecture industry regulations, it is considered the proper assessment for the professionalism is not conducted. Also, interior architecture field has irrational contradictions that is not independent with a clear definition and industry field classification not only in legal system and trade customs. Therefore, The following is proposed as the plan to strengthen the domestic/international competitiveness and system improvements for interior architecture. (1)interior design (interior architecture) must be amended as an industrial classification that can coexist with architecture. (2)interior design (interior architecture) must be amended as a job classification that can coexist with architecture. (3)Among the design tasks of an architect, approval for the design task field of interior architecture field must be legislated. -In architect design standard contract (the existing architecture design task scope and quality standard table) of a structure, among the tasks by request of the owner, (1)interior design tasks shall be legislated. It should be legislated so that interior design (interior architecture) majors can be included as well. (4)The task field of interior design that coexists with design must be amended. (5)National contract law - among contract method by negotiation, specialty item must be vitalized.

• Journal of Korea Trade
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• 제23권4호
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• pp.80-102
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• 2019

Purpose - This paper aims to articulate relationship about factors influencing FTA utilization by dividing them into company's external and internal factors and performing investigation on the relationship between FTA utilization and export performance. Design/methodology - This study verified factors influencing FTA utilization by dividing them into company's external and internal factors and performing investigation on the relationship between FTA utilization and export performance. Empirical analysis was performed by setting internal and external factors required for FTA utilization as variables. To achieve this, research model was established based on previous study, hypothesis was deduced, and statistical program were used to test the hypothesis. This study performed empirical analysis using statistical program of SPSS 18.0 and AMOS 18.0 for the research model. Findings - Empirical analysis was performed regarding the effect of the FTA utilization on export performance and previous study defined export performance as the company's increased economy benefits through export and increase in new transactions. Analysis was also performed for factors affecting the FTA utilization by the company and through management and response of external factors and internal factors it was confirmed that the FTA utilization by the company led to increase in the company's export performance as a result. This study proposes a method to achieve export performance based on this. Originality/value - Companies seeking to utilize the FTA sign the Contract for the International Sale of goods and there are many conditions to meet in order to receive trade preferences during the transaction process. Existing trade order and order in the FTA have to be followed. Country of origin can be seen as key in the FTA. The Rule of Origin becomes the most important evaluation standard in applying preferential tariff in the FTA. Such regulations can be seen as external factors which cannot be controlled by the company. Internal factors are capabilities owned before that can be controlled by the company. The study sought to test the variables regarding factors centered on such capability. This study verified factors influencing FTA utilization by dividing them into company's external and internal factors and performing investigation on the relationship between FTA utilization and export performance.

• 지능정보연구
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• 제28권4호
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• pp.41-59
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• 2022

군수물자의 적기 조달은 군의 작전능력 유지를 위해서 필수적이며, 계약업무는 적기 조달을 위한 첫 단추라고 할 수 있다. 또한 신속한 계약체결은 수요자의 여유로운 납기설정을 가능케 하며, 예산 집행의 가능성을 높여주기 때문에 예산의 조기집행과 이·불용 방지를 위해서도 계약 프로세스 개선이 필수적이다. 최근 빅데이터를 이용한 연구가 여러 분야에서 활발히 진행되고 있으며, 빅데이터를 이용한 프로세스 분석 및 개선 기법인 프로세스 마이닝 역시 민간에서 널리 활용되고 있다. 하지만 군 내 계약업무에 대한 분석은 업무 담당자의 경험과 단편적인 정보를 활용한 이·불용 문제사례별 원인 파악 및 대응적 모색과 같은 개별적 분석수준에 그치고 있다. 본 연구는 계약 프로세스 개선을 위해 공군 군수사령부 재정처가 2019년 11월부터 약 1년간 직접 계약한 총 560건의 계약업무에 관한 데이터를 가지고 프로세스 마이닝 기법을 이용하여 분석하였다. 분산된 데이터를 종합하여 프로세스 맵을 도출하고, 프로세스의 흐름, 수행시간 분석, 병목 분석 및 추가 세부분석을 실시했다. 분석결과 다수 계약 건에서 의뢰 후 재검토/수정이 반복 발생하고 있음을 발견할 수 있었다. 반복적인 재검토/수정은 원가계산 완료까지의 소요일수 지연에 크게 영향을 미치고 있으며, 이는 병목 지점 시각화를 통해서도 명확하게 드러났다. 재검토/수정은 계약의뢰가 많은 상위 5개 부서에서 60% 이상 발생하고, 의뢰가 집중되는 상반기에 주로 발생하는데 이는 소요부서의 계약의뢰 전 면밀한 사전검토가 필요함을 의미한다. 그리고 재정처의 계약업무는 법령에 따른 절차대로 수행되고 있었으나, 일부 업무의 순서조정이 필요함을 알 수 있었다. 본 연구는 군 내 계약업무 분석에 프로세스 마이닝을 이용한 첫 사례이다. 이를 기반으로 프로세스 마이닝을 군대 내 다양한 업무에 적용하기 위한 연구가 더욱 수행된다면, 각종 업무의 효율화를 이끌어 낼 수 있을 것으로 기대한다.

• Ocean and Polar Research
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• 제27권1호
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• pp.97-108
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• 2005

The International Seabed Authority (ISA) formally came into existence upon the entry into force of the UNCLOS on 16 November 1994. By adopting the Implementing Agreement in 1994, UNCLOS has the universality as a Magna Carta of International Ocean Regime, and the Deep Seabed Mining Regime could be operated as a unique one for the benefit of mankind. During last 10 years, ISA established the institutional framework successfully and made substantial and tangible progress in formulating the rules, regulations and procedures for the prospecting and exploration for polymetally nodules. Furthermore, RPI's obligations had been carried out completely, and the 7 RPI made contract with ISA to become a contractor who has an at least 15 you exclusive right for exploration in their allocated site. However, due to the uncertainty of commercial mining, the number of representatives from developing countries has been getting looser and looser and ISA has a problem of quorum of the Assembly. Land-based producers took a very strong opposite position to the contractors to make their loss in the minimum level. For the next decade, it might be prospected that ISA will focus on monitoring the contractor's activities, making rules, regulations and procedures for exploration on cobalt rich crust, sulphide and methane hydrate and implementing environment studies.

• 예술인문사회 융합 멀티미디어 논문지
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• 제6권7호
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• pp.219-228
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• 2016

본 연구는 방과후학교 민간위탁의 정책 변화과정을 조사하고, 향후 대안을 제시하는데 목적이 있다. 본 연구를 위해 정책관련 연구 자료와 관련 법규를 문헌조사 하였다. 조사결과 2004년부터 2008년은 교육부에서 방과후학교 운영계획을 수립하였으나 학교운영위원회의 심의(자문)를 통해 단위학교의 자율로 민간위탁이 진행되었고, 2008년부터 2015년은 교육부와 시도교육청에서 공동으로 제작한 '방과후학교 운영 가이드라인'에 제시된 표준화된 절차를 따르고 있었으며, 2016년 이후에는 방과후학교 민간위탁 시 계약법을 적용하도록 하는 등 정책 변화가 있었다. 2016년 이후의 정책 변화는 방과후학교 민간위탁의 투명성 확보 필요성과 함께 방과후학교 민간위탁 계약규모가 커지면서 계약법을 준수해야 하는 법적 필요성에 기인한다. 하지만 최저가 입찰방식으로 인해 방과후학교 교육의 질이 떨어질 수밖에 없다는 우려의 목소리도 함께 제기되고 있다. 정부에서는 기초금액에서 일정비율 이상을 인건비로 지급하도록 하여 지나친 가격경쟁을 방지하는 대안을 제시하였지만, 본 논문에서는 보다 근본적인 해결 방안으로 방과후학교 교육활동 및 시도의 특수성을 담아내는 시도의 조례를 제정하는 방안을 제시하였다.

• 한국건설관리학회논문집
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• 제25권4호
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• pp.34-44
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• 2024

국방 및 군사시설 프로젝트에서는 설계변경으로 인한 계약금액 조정은 공사 비용의 증가와 공사 기간의 연장 등에 직접 또는 간접적인 영향을 미친다. 또한, 이는 군과 계약 당사자 간 의견 차이와 갈등으로 이어지기도 한다. 본 사례연구는 서울과 경기도 남부지역에서 육군, 해군, 해병대, 공군의 국방 및 군사시설 사업을 통합 관리하는 경기남부시설단 추진사업을 분석한 것이다. 본 사례연구는 공사가 완료된 388건의 프로젝트 중 설계변경이 이루어진 103건을 표본으로 분석하였다. 이를 통해 프로젝트의 완결에서 발생하는 설계변경 비율 등에 대한 신뢰성을 확보하고자 하였다. 본 사례연구는 기획재정부 계약예규 공사계약 일반조건에서 규정하는 설계변경 발생 원인별로 표본을 분류하고, 각각의 원인별로 발생률에 따른 순위를 부여하였다. 또한, 각각의 설계변경 발생 원인별 세부 요인을 분석하고 시사점을 도출하여 설계변경 발생 원인에 대한 개선 방안을 제시하였다. 이러한, 사례연구는 군의 원천자료 접근에 제한성이 있는 특수성을 고려해 볼 때, 국방 및 군사시설 사업에서 설계변경을 최소화되도록 하는데 기여 할 것을 기대한다. 아울러, 설계변경에 따른 계약금액 조정 등에 관한 후속 연구 등에 실증적으로 유용할 것이다.

• 한국산학기술학회논문지
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• 제21권9호
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• pp.584-595
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• 2020

본 연구에서 사익편취규제제도가 특수관계인간 거래와 기업가치간의 관계에 미치는 영향을 분석하였다. 이를 위해 제도가 시행된 2014년 전·후 5개년(2009년~2013년과 2014년~2018년)동안 상장사들의 특수관계인간 거래와 기업가치간의 관계 변화를 살펴보았다. 특수관계인간 거래형태는 장기공급계약, 대여금, 신용공여이다. 총 6,534개 연도-기업 표본을 패널자료 회귀분석방법으로 분석하였다. 분석결과는 다음과 같다. 첫째, 규제제도는 특수관계인간 거래와 기업가치간의 관계에 영향을 미치는 것으로 나타났다. 전체기업 대상 분석결과 제도시행 이전에는 특수관계인간 거래와 기업가치간에 유의미한 영향관계를 확인할 수 없었다. 그러나 제도시행 이후에는 장기공급계약이 기업가치에 정(+)의 영향을 미치는 것으로 나타났다. 이는 제도시행으로 내부거래가 사익편취 목적이 완화되고 거래의 효율성과 투명성이 강화된 결과로 이해할 수 있었다. 둘째, 규제제도가 특수관계인간 거래와 기업가치간의 관계에 미치는 영향은 규제대상과 비규제대상 간에 차이가 있음을 알 수 있었다. 규제대상의 경우 제도시행 전에는 대여금과 신용공여가 기업가치에 유의미한 부(-)의 관계로 나타났지만, 제도시행 이후에는 유의미한 영향관계가 사라졌다. 사익편취 목적으로 수행되던 이들 거래가 제도시행으로 감시와 통제기능이 강화되면서 부정적인 영향관계가 완화된 것으로 이해되었다. 비규제대상에서는 제도시행 이전과 달리 장기공급계약이 제도시행 이후 기간에서 기업가치와 정(+)의 영향관계로 나타났다. 따라서 규제제도는 내부거래의 효율성과 투명성 강화 측면에서 규제대상보다 비규제대상에 더 크게 영향을 미친다는 것을 알 수 있었다.