• The Korean Society of Law and Medicine
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• v.13 no.2
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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.

• The Korean Journal of Air & Space Law and Policy
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• v.35 no.3
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• pp.127-150
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• 2020

A Basic Plan for the Promotion of Space Development (hereinafter referred to as "basic plan"), which prescribes mid- and long-term policy objectives and basic direction-setting on space development every five years, is one of the matters to be deliberated by the National Space Committee. Confirmed February 2018 by the Committee, the 3rd Basic Plan has a unique matter, compared to the 2nd Basic Plan. It is to construct "Korean Positioning System(KPS)". Almost every country in the world including Korea has been relying on GPS. On the occasion of the shooting down of a Korean Air flight 007 by Soviet Russia, GPS Standard Positioning Service has been open to the world. Due to technical errors of GPS or conflict of interests between countries in international relations, however, the above Service can be interrupted at any time. Such cessation might bring extensive damage to the social, economic and security domains of every country. This is why some countries has been constructing an independent global or regional satellite navigation system: EU(Galileo), Russia(Glonass), India(NaVic), Japan(QZSS), and China(Beidou). So does South Korea. Once KPS is built, it is expected to make use of the system in various areas such as transportation, aviation, disaster, construction, defense, ocean, distribution, telecommunication, etc. For this, a pan-governmental governance is needed to be established. And this governance must be based on the law. Korea is richly experienced in developing and operating individually satellite itself, but it has little experience in the simultaneous development and operation of the satellites, ground, and users systems, such as KPS. Therefore we need to review overseas cases, in order to minimize trial and error. U.S. GPS is a classic example.

• Journal of Arbitration Studies
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• v.19 no.2
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• pp.95-126
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• 2009

One of the controversial issues in investor-state investment arbitration is the interpretation of "umbrella clause" that is found in most BIT and FTAs. This treaty clause requires on Contracting State of treaty to observe all investment obligations entered into with foreign investors from the other Contracting State. This clause did not receive in-depth attention until SGS v. Pakistan and SGS v. Philippines cases produced starkly different conclusions on the relations about treaty-based jurisdiction and contract-based jurisdiction. More recent decisions by other arbitral tribunals continue to show different approaches in their interpretation of umbrella clauses. Following the SGS v. Philippines decision, some recent decisions understand that all contracts are covered by umbrella clause, for example, in Siemens A.G. v. Argentina, LG&E Energy Corp. v. Argentina, Sempra Energy Int'l v. Argentina and Enron Corp. V. Argentina. However, other recent decisions have found a different approach that only certain kinds of public contracts are covered by umbrella clauses, for example, in El Paso Energy Int'l Co. v. Argentina, Pan American Energy LLC v. Argentina and CMS Gas Transmission Co. v. Argentina. With relation to the exhaustion of domestic remedies, most of tribunals have the position that the contractual remedy should not affect the jurisdiction of BIT tribunal. Even some tribunals considered that there is no need to exhaust contract remedies before bringing BIT arbitration, provoking suspicion of the validity of sanctity of contract in front of treaty obligation. The decision of the Annulment Committee In CMS case in 2007 was an extraordinarily surprising one and poured oil on the debate. The Committee composed of the three respected international lawyers, Gilbert Guillaume and Nabil Elaraby, both from the ICJ, and professor James Crawford, the Rapportuer of the International Law Commission on the Draft Articles on the Responsibility of States for Internationally Wrongful Acts, observed that the arbitral tribunal made critical errors of law, however, noting that it has limited power to review and overturn the award. The position of the Committee was a direct attack on ICSID system showing as an internal recognition of ICSID itself that the current system of investor-state arbitration is problematic. States are coming to limit the scope of umbrella clauses. For example, the 2004 U.S. Model BIT detailed definition of the type of contracts for which breach of contract claims may be submitted to arbitration, to increase certainty and predictability. Latin American countries, in particular, Argentina, are feeling collectively victims of these pro-investor interpretations of the ICSID tribunals. In fact, BIT between developed and developing countries are negotiated to protect foreign investment from developing countries. This general characteristic of BIT reflects naturally on the provisions making them extremely protective for foreign investors. Naturally, developing countries seek to interpret restrictively BIT provisions, whereas developed countries try to interpret more expansively. As most of cases arising out of alleged violation of BIT are administered in the ICSID, a forum under the auspices of the World Bank, these Latin American countries have been raising the legitimacy deficit of the ICSID. The Argentine cases have been provoking many legal issues of international law, predicting crisis almost coming in actual investor-state arbitration system. Some Latin American countries, such as Bolivia, Venezuela, Ecuador, Argentina, already showed their dissatisfaction with the ICSID system considering withdrawing from it to minimize the eventual investor-state dispute. Thus the disagreement over umbrella clauses in their interpretation is becoming interpreted as an historical reflection on the continued tension between developing and developed countries on foreign investment. There is an academic and political discussion on the possible return of the Calvo Doctrine in Latin America. The paper will comment on these problems related to the interpretation of umbrella clause. The paper analyses ICSID cases involving principally Latin American countries to identify the critical legal issues arising between developing and developed countries. And the paper discusses alternatives in improving actual investor-State investment arbitration; inter alia, the introduction of an appellate system and treaty interpretation rules.

• The Korean Journal of Archival Studies
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• no.18
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• pp.257-280
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• 2008

The purpose of this paper is reviewing the hot issue called 'draining away the presidential records' case occurred recently and finding the root cause why the state of affairs has been happened in Korea. Though the presidential records management law ensures the rights for the prior president to view his presidential records, the prior president has copied his presidential records produced while in office and moved to his private house at his retirement. He might have interpreted his right to his presidential records too broadly and done the 'draining away' them. There was a motive why the prior president did that at that time. The reason was because the National Archives didn't guarantee the services for right viewing the records to him who wanted to review his records from right after his retirement. The National Archives have judged the draining away the prior presidential records as illegal and accused a few public servants suspected to be responsible for the affairs. The formal accuser is the National Archives, but the actual accuser might be the current Presidential Secretariat. Whatever the results of juristic judgement are, the reason why the records management field should focus and treat this case importantly is that the collapse possibility of the protection wall needed essentially and critically to the Presidential records becomes very high. The root cause of this case might exist in the fact that the records and archives management organizations have not owned the political independence. But the National Archives has submitted the revised bill of the public records and archives management law which lower the position of the National Records Management Committee controlled under from the Prime Minister to the Ministry of Administration and Security. It might be hot concern that the records and archives management organizations have difficulty for keeping the political independence if the revision would be passed. Besides the political independence factor, the most important factor needed for the right records management is the establishing the professional specificity of records management. The specific action for the establishing professional specificity would be employing of specialists and introducing the open official appointment. But it was found from the reorganization after the governmental change that the professional specificity of the National Archives have been reduced. Although the policies introduced by the new government are worrying, it might be an inheritance from the prior government. If new government would build establish the institution for the political independence of the records and archives management organizations and expand the employment of the records management professions to the local government, these affairs can be not only the responsibilities but also the achievements of the new government.

• Journal of Arbitration Studies
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• v.29 no.2
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• pp.239-282
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• 2019

The importance of ADR(Alternative Dispute Resolution), which has the advantage of expertise, speed and neutrality due to the increase of arbitration cases due to domestic and foreign construction disputes, has emerged. Therefore, in order for the nation's arbitration system and the arbitration Organization to jump into the ranks of advanced international mediators, it is necessary to research the characteristics and advantages of these arbitration Organization through a study of prior domestic and foreign research and operation of international arbitration Organization. As a problem, First, education for the efficient promotion of arbitrators (compulsory education, maintenance education, specialized education, seminars, etc.). second, The effectiveness of arbitration in resolving construction disputes (hearing methods, composition of the tribunal, and speed). third, The issue of flexibility and diversity of arbitration solutions (the real problem of methodologies such as mediation and arbitration) needs to be drawn on the Arbitration laws and practical problems, such as laws, rules and guidelines. Therefore, Identify the problems presented in the preceding literature and diagnosis of the defects and problems of the KCAB by drawing features and benefits from the arbitration system operated by the international arbitration Institution. As an improvement, the results of an empirical analysis are derived for "arbitrator" simultaneously through a recognition survey. As a method of improvement, First, as an optimal combination of arbitration hearing and judgment in the settlement of construction disputes,(to improve speed). (1) A plan to improve the composition of the audit department according to the complexity, specificity, and magnification of the arbitration cases - (1)Methods to cope with the increased role of the non-lawyer(Specialist, technical expert). (2)Securing technical mediators for each specialized expert according to the large and special corporation arbitration cases. (2) Improving the method of writing by area of the arbitration guidelines, second, Introduction of the intensive hearing system for psychological efficiency and the institutional improvement plan (1) Problems of optimizing the arbitration decision hearing procedure and resolution of arbitration, and (2) Problems of the management of technical arbitrators of arbitration tribunals. (1)A plan to expand hearing work of technical arbitrator(Review on the introduction of the Assistant System as a member of the arbitration tribunals). (2)Improved use of alternative appraisers by tribunals(cost analysis and utilization of the specialized institution for calculating construction costs), Direct management of technical arbitrators : A Study on the Improvement of the Assessment Reliability of the Appraisal and the Appraisal Period. third, Improvement of expert committee system and new method, (1) Creating a non-executive technical committee : Special technology affairs, etc.(Major, supports pre-qualification of special events and coordinating work between parties). (2) Expanding the standing committee.(Added expert technicians : important, special, large affairs / pre-consultations, pre-coordination and mediation-arbitration). This has been shown to be an improvement. In addition, institutional differentiation to enhance the flexibility and diversity of arbitration. In addition, as an institutional differentiation to enhance the flexibility and diversity of arbitration, First, The options for "Med-Arb", "Arb-Med" and "Arb-Med-Arb" are selected. second, By revising the Agreement Act [Article 28, 2 (Agreement on Dispute Resolution)], which is to be amended by the National Parties, the revision of the arbitration settlement clause under the Act, to expand the method to resolve arbitration. third, 2017.6.28. Measures to strengthen the status role and activities of expert technical arbitrators under enforcement, such as the Act on Promotion of Interestments Industry and the Information of Enforcement Decree. Fourth, a measure to increase the role of expert technical Arbitrators by enacting laws on the promotion of the arbitration industry is needed. Especially, the establishment of the Act on Promotion of Intermediation Industry should be established as an international arbitration agency for the arbitration system. Therefore, it proposes a study of improvement and differentiation measures in the details and a policy, legal and institutional improvement and legislation.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.18 no.1
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• pp.3-9
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• 2007

Based on the broad and in-depth literature review, the dedicated members of the committee for the development of Korean attention-deficit hyperactivity disorder (ADHD) practice parameter develop the Korean practice parameter for ADHD. Members of the Korean Academy of child and Adolescent Psychiatry (KACAP) had reviewed the drafts through off-line and on-line access to the drafts. Feedbacks from the members of KACAP were carefully integrated into the current practice parameter. This article presents the state of the art knowledge regarding the assessment and the management of ADHD. Recommendations in the end of the practice parameter may help clinician to make decisions in clinical practice, but are not likely to override the clinician's decision in natural settings. Future directions to complement the limitation of the current practice parameter is suggested.

• Environmental Analysis Health and Toxicology
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• v.31
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• pp.1.1-1.13
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• 2016

Objectives To investigate the accuracy and scientific validity of the current very low risk factor for hereditary diseases in humans following exposures to ionizing radiation adopted by the United Nations Scientific Committee on the Effects of Atomic Radiation and the International Commission on Radiological Protection. The value is based on experiments on mice due to reportedly absent effects in the Japanese atomic bomb (A-bomb) survivors. Methods To review the published evidence for heritable effects after ionising radiation exposures particularly, but not restricted to, populations exposed to contamination from the Chernobyl accident and from atmospheric nuclear test fallout. To make a compilation of findings about early deaths, congenital malformations, Down's syndrome, cancer and other genetic effects observed in humans after the exposure of the parents. To also examine more closely the evidence from the Japanese A-bomb epidemiology and discuss its scientific validity. Results Nearly all types of hereditary defects were found at doses as low as one to 10 mSv. We discuss the clash between the current risk model and these observations on the basis of biological mechanism and assumptions about linear relationships between dose and effect in neonatal and foetal epidemiology. The evidence supports a dose response relationship which is non-linear and is either biphasic or supralinear (hogs-back) and largely either saturates or falls above 10 mSv. Conclusions We conclude that the current risk model for heritable effects of radiation is unsafe. The dose response relationship is non-linear with the greatest effects at the lowest doses. Using Chernobyl data we derive an excess relative risk for all malformations of 1.0 per 10 mSv cumulative dose. The safety of the Japanese A-bomb epidemiology is argued to be both scientifically and philosophically questionable owing to errors in the choice of control groups, omission of internal exposure effects and assumptions about linear dose response.

• The Journal of Korean Academic Society of Nursing Education
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• v.3 no.2
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• pp.207-213
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• 1997

Basic science teaching and clinical education should be integrated whenever appropriate, and the development of skills, values, and attitudes which are emphasized to the same extent as the acquisition of knowledge in nursing. Problem-based learning provides a students-centered learning environment and encourages an inquisitive style of learning. The purpose of this paper is to review and comment the role of tutors and students on problem-based learning. The use of problem-based learning places a high demand on faculty members' time and support. The role of tutors in Problem-based learning focuses primarily on issues of developing and teaching the curriculum and on organizational implementation and institutionalization. Tutors are an integral part of course planning. Tutors serve as a constant source of feedback on student needs and concerns to the course director and constitute an informal steering committee while the course is in progress. Tutors write cases, develop student evaluation methods, recommend resources, suggest modifications in lectures and laboratories. Students have a limited amount of time available to study what is traditionally defined as the core content of nursing. But, the role of students in Problem-based learning would be active, independent learners and problem-solvers rather than passive recipients of information. Students using a deep level approach attempt to integrate what they learn with what they already know, to understand the meaning underlying the material to be learned, and to look for explanations rather than facts. Students are encouraged, with appropriate guidance, to define their own learning goals, to select appropriate experiences to achieve these goals, and to be responsible for assessing their own learning progress. Problem-based learning is more flexible and meaningful, by encouraging student interaction, and by having a better emotional climate than the conventional learning.

• Journal of Digital Convergence
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• v.13 no.6
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• pp.133-139
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• 2015

The purpose of this study was to examine perceptions on the festival competitiveness of festival specialists. Though extant studies for improving competitiveness of local festival is continued, differences of competitive perception is shown. Thus this study used Q methodology in order to analyze local festival competitiveness perceptions by specialists. The Q sample was based on a review of related academic literature and newspaper, as well as interviews, while Q sample consisted of festival committee, public officers, related artists, art directors, event companies, and related professors. The analysis shows that meaningful three types of competitiveness perception. The results show that local festival competitiveness perception is source of local festival competitiveness. Theoretical and practical implication were discussed.

• Journal of Korean society of Dental Hygiene
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• v.19 no.6
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• pp.891-905
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• 2019

Objectives: The objective of this study was to examine the current state of dementia-related education for dental hygiene degree programs in Korea, as well as to develop a dementia-related curriculum for dental hygiene programs suitable for the social characteristics of Korea. Methods: The study was conducted between April and November 2018. First, the current state of dementia-related education for dental hygiene programs in colleges throughout Korea and dementia-related education for other health care-related fields were investigated. Based on the initial findings, the basic content of the preliminary curriculum was constructed. Second, based on the opinion of the dementia-related curriculum development committee comprising 10 professors of dental hygiene, the operations of dementia-related courses and relevant details were constructed. Third, these operations and relevant details were assessed and revised based on focus-group interviews. Fourth, the dementia-related curriculum was developed based on the study findings and literature review. Results: The name of the course in the developed curriculum was set as "Elderly Dental Hygiene and Practicum." The course was established as a "major elective," and was offered as two units with two instructional sessions of two hours each. The learning goal for this course was acquiring the methods for understanding and managing the characteristics of the elderly. A consensus was reached regarding conducting the theoretical and practical lessons on some of the dementia-related content. The dementia-related curriculum comprised 10 "required contents" which is to be conducted over three weeks of theoretical lessons and two weeks of practical lessons. Conclusions: With the growing elderly population, the development and operation of the curriculum for geriatric oral health interventions are warranted in dental hygiene education. However, continued discussions and improvements are needed on the extent of educational content, considering various dementia-related symptoms and general geriatric systemic diseases.