• Title/Summary/Keyword: Regulation and Enforcement

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The Effect of Regulation on Recruitment Advertising for Clinical Trial Subjects in Korea (임상시험 대상자 모집 광고에 대한 정부의 규제 효과)

  • Kim, Hyun Jin;Sohn, Hyun Soon
    • Korean Journal of Clinical Pharmacy
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    • v.32 no.3
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    • pp.166-177
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    • 2022
  • Background: Recently clinical trials have expanded extensively in Korea; thus, ensuring the rights of subjects participating in clinical trials is imperative. Accordingly, national regulations on subject recruitment advertisement were enforced from October 25, 2018. In this study, the effect of this regulation was evaluated by analyzing the difference in the provision of information before and after enforcement of the regulation. Methods: Recruitment advertisements for clinical trial subjects 3 years before and after enforcement of the regulation were collated by the significance sampling approach. Print-based (newspapers, buses, and subways) and web-based (clinical trial center websites and online platforms) materials for recruitment in clinical trials of phase 1 to 4 for investigational drugs, medical devices, and oriental medicine were considered. Chi-square tests were conducted for inter-group comparisons. SPSS version 26 was employed for statistical analyses. Results: A total of 137 advertisements were collected comprising 60 pre- and 77 post-regulation enforcement. The overall rate of delivery of critical information in advertisements increased significantly from 47.5% before regulation to 93.2% after regulation enforcement. Particularly, details on expected adverse events augmented significantly (p<0.001). Benefits from participation in clinical trial reduced significantly from 88.3% to 70.1% (p<0.05). As the information provision amplified, the inclusion of professional terms increased. Conclusions: Enforcement of regulations has led to a surge in the amount of information and challenging terms contained in advertisements for recruiting subjects. Therefore, additional efforts are required by subjects to completely understand the information provided in the advertisements.

Nursing Consideration of the Infant Care Act and Suggestion on Its Enforcement Decree and Regulations (영유아보육법의 간호학적 고찰)

  • Kim Il-Ok;Kim Mi-Ye
    • Child Health Nursing Research
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    • v.10 no.3
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    • pp.361-366
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    • 2004
  • Purpose: This descriptive study was conducted to illuminate, from the nursing point of view, the infant care act, which was revised recently and to suggest a desirable direction of its enforcement decree and regulations. Method: This study was carried out through literature review and a collection of child care experts' opinions. Result: The most remarkable changes in infant care act and the suggestions for a desirable direction of its enforcement decree and regulations are as follows: It can be said that the law on 'health', 'nutrition' and 'safety' for a child care center was improved to the level of act from the level of enforcement regulation. In the enforcement regulation on the distribution of nurses in child care centers, it is desirable that nurse's aids are excluded. It is recommended that every child care center should have a nurse or a health care manager and/or an emergency caretaker. In the curriculum for child care, the subjects on child health care should be an essential subject, not elective. Conclusion: Child care act should be reformed under the discipline of first priority to child health. Every nurse and nursing professor should have interest and earnestness in child care and conduct related studies.

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Study for Reformation on Building Structure Regulation (건축구조 관련규제의 개선방안 연구)

  • Chung, Pyung-Rahn
    • Journal of Korean Association for Spatial Structures
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    • v.10 no.1
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    • pp.111-117
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    • 2010
  • This thesis draws institutional problem about safety of architectural structure through analysis of architectural structure regulation. The law of analysis target are building codes, enforcement ordinance of building codes, enforcement regulations of building codes, regulation for structure standards of building, building structure standards. The analysis showed there are imperfections in confirmed procedural application of structure safety and suggested reformation. It's necessary to make supplementary policies for the suitability of the term use and the structure safety certificate of compliance, establishing a special structure code.

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An Economic Analysis of the Enforcement of illegal Fishing in Traditional Fisheries Management (전통적 어업관리의 불법어업 감시·감독에 대한 경제학적 분석)

  • LEE, Sang-Go
    • Journal of Fisheries and Marine Sciences Education
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    • v.14 no.1
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    • pp.57-73
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    • 2002
  • Illegal fishing is often cited as a principal cause of the failure of fisheries management, expecially fishing efforts regulations in traditional fisheries management. Usually, illegal fishing problems are perceived to be equivalent to inadequate enforcement, and policy prescription then follow to strengthen enforcement programs. The purpose of this paper is to analyze the illegal fishing behavior relatively recent emphasis on fishing efforts regulations in traditional fisheries management. The analysis focuses on measuring, explaining and developing the effectiveness way of enforcement strategies responding to imperfectly managed fishing efforts regulations through illegal fishing behavior and avoid enforcement fishing efforts measures. A model of fishermen fishing behavior and profit-maximizing decision making is analyzed to determine optimal fishing at individual fisherman level in response to fishing efforts regulation. The results of economic analysis of the enforcement of illegal fishing in traditional fisheries management results are as follows: First, illegal fishing will occur only if enforcement effort is not so high as to remove the incentive to do so, and if the effectiveness of avoidance is not too great, nor its cost too low. Second, avoidance effort will occur at a level jointly proportional to the extent of illegal activity and of enforcement; for given levels of the latter, the desired avoidance effort increase with its effectiveness and decrease with its cost Third, to improve the effectiveness of enforcement, understanding avoidance behavior appears to be crucial to any efforts. Forth, enforcement and fishermen behavior interact depends strongly on characteristics of avoidance, specifically its cost and effectiveness. When avoidance is neither too cheap nor too effective, the interaction is regular. Fifth, in this case, at low levels of enforcement, fishers respond to increases in enforcement by increasing avoidance, but at higher enforcement levels, it becomes uneconomical to continue to do so, and avoidance decreases with enforcement. Sixth, illegal fishing activity decreases steadily with enforcement, so the fishery manager is able, in theory, to reduce illegal fishing toward zero by increasing enforcement. If, however, avoidance is very inexpensive and/or very efficient/ then the optimal level of avoidance will increase indefinitely with increasing enforcement. Finally, less fishery enforcement is required if fishermen have less incentive to overfish, and fishermen have less incentive to avoid fishery enforcement measures.

Comparison of Pharmacist and other Healthcare Professionals License Examination in Korea (국내 약사 및 의료인면허 국가시험 제도 비교)

  • Yoo, Bong Kyu
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.1
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    • pp.71-76
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    • 2013
  • Background (Purpose): The objective of this study was to investigate regulations on pharmacist and other healthcare professional license examination in Korea. Specific aim was focused on the implementation of new regulatory system governing pharmacist license examination particularly on naming of the subjects, method of the examination, and discrimination of pass or fail. Method: Laws and regulations of Korea on the examination system were retrieved from sources posted in Ministry of Government Legislation. Results: Two major regulatory differences were found between pharmacist and other healthcare professionals license examination systems. Firstly, the regulation on pharmacist license examination was ruled by the enforcement ordinance of parent law (Pharmacy Law) while it was ruled by enforcement regulation of parent law (Medical Law). Secondly, minimum grade requirement for pharmacist and other healthcare professionals was differently set up: 40% for each single subject in pharmacist and average of 40% for each group of several subjects in other healthcare professionals. Conclusion: Since pharmacist profession has drastically changed from drug-makers to drug-users during the recent decades, it is desirable to have the regulations on pharmacist license examination system amended in harmony with other laws and regulations of Korea and other major developed countries. Two-step examination for pharmacist license appears worthwhile to implement for balancing the two key functions of the pharmacist being drug-makers and drug-users.

The Procedure for Decision of Enforcement by the Arbitration Award and Its Problems (중재판정에 의한 집행판결의 절차와 그 문제점)

  • Kim Bong-Suk
    • Journal of Arbitration Studies
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    • v.13 no.1
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    • pp.169-205
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    • 2003
  • Arbitration means the procedure that a party inquires a third party arbitrator for a resolution on the dispute on certain matters of interest to follow through with the commitment of the arbitration, and a series of procedures performed by the arbitrator of the Korean Commercial Arbitration Board. Arbitration is implemented in accordance with the procedure determined by the Arbitration Act and Arbitration Regulations. In the event the parties reach to the reconciliation during the process of arbitration, the reconciliation is recorded in the form of arbitration award(decision), and in the event a reconciliation is not made, the arbitrator shall make the decision on the particular case. The arbitration award(decision) for reconciliation during the arbitration procedure (Article 31 of Arbitration Act, hereinafter referred to as the 'Act') or the mediation under the Arbitration Regulation of the Korean Commercial Arbitration Board (Article 18 of the Arbitration Regulations) shall have the same effectiveness with the decision rendered by a court that, in the event a party does not perform the obligation, the enforcement document is rendered under the Rules on Enforcement Document on Mediation Statement of various dispute resolution committees of the Supreme Court to carry out the compulsory enforcement. However, in the event that the party to take on the obligation to perform under the arbitration award (decision) rendered by the arbitrator (Article 32 of the Act) does not perform without due cause, a separate enforcement decision in accordance with the procedure determined under the Civil Enforcement Act shall be obtained since the arbitration award(decision) cannot be the basis of enforcement under the Civil Enforcement Act. And, in order to enforce the judgment compulsorily in accordance with the regulations under the Civil Enforcement Act under the foreign arbitration judgment (Article 39 of the A.1), it shall fulfill the requirement determined under the Civil Litigation Act (article 217 of Civil Litigation Act) and shall obtain a separate enforcement decision in accordance with the procedure determined under the Civil Enforcement Act (Article 26 and Article 27 of Civil Enforcement Act) since the arbitration judgment of foreign country shall not be based on enforcement under the Civil Enforcement Act. It may be the issue of legislation not to recognize the arbitration award(decision) as a source of enforcement right, and provide the compulsive enforcement by recognizing it for enforcement right after obtaining the enforcement document with the decision of a court, however, not recognizing the arbitration award(decision) as the source of enforcement right is against Clause 3 of Article 31 of the Act, provisions of Article 35, Article 38 and Article 39 that recognized the validity of arbitration as equal to the final judgment of a court, and the definition that the enforcement decision of a court shall require the in compulsory enforcement under Clause 1 of Article 37 of the Act which clearly is a conflict of principle as well. Anyhow, in order to enforce the arbitration award(decision) mandatorily, the party shall bring the litigation of enforcement decision claim to the court, and the court shall deliberate with the same procedure with general civil cases under the Civil Litigation Act. During the deliberation, the party obligated under the arbitration award(decision) intended to not to undertake the obligation and delay it raises the claim and suspend the enforcement of cancelling the arbitration award(decision) on the applicable arbitration decision within 3 months from the date of receiving the authentic copy of the arbitration award(decision) or the date of receiving the authentic copy of correction, interpretation or additional decision under the Regulation of Article 34 of the Act (Clause 3 of Article 36 of the Act). This legislation to delay the sentencing of the enforcement and then to sentence the enforcement decision brings the difficulties to a party to litigation costs and time for compulsory enforcement where there is a requirement of an urgency. With the most of cases for arbitration being the special field to make the decision only with the specialized knowledge that the arbitrator shall be the specialists who have appropriate knowledge of the system and render the most reasonable and fair decision for the arbitration. However, going through the second review by a court would be most important, irreparable and serious factor to interfere with the activation of the arbitration system. The only way to activate the arbitration system that failed to secure the practicality due to such a factor, is to revise the Arbitration Act and Arbitration Regulations so that the arbitration decision shall have the right to enforce under the Rules on Enforcement Document on Mediation Statement of various dispute resolution committees of the Supreme Court.

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Comparative study on the national quality regulation schemes of social services and implications to Korea - focusing on user centeredness, regulatory enforcement and system stability - (사회서비스 품질관리제도 구성요소와 국가비교 -이용자 중심성, 제도 실효성, 운영 안정성을 중심으로-)

  • Hwang, In-Mae;Lee, Dong Suk;Kim, Yong-Deug
    • Korean Journal of Social Welfare Studies
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    • v.45 no.2
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    • pp.203-232
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    • 2014
  • The purpose of this study is to compare the national quality regulation schemes among four countries, and to find out implications to Korean quality regulation system of social services. For this, this study fixed comparative criteria on national quality regulation schemes, and compared the quality regulation schemes of 4 countries such as England, United States, Singapore and Japan. By reviewing prior relevant studies, three criteria could be suggested.: the level of user centeredness, the effectiveness of regulatory enforcement and stability of operation system. All analysed nations share similarities in that they all eager to provide quality information to their service users and develop nationally acceptable quality standards of social services. On the contrary, differences are identified in the level of regulatory enforcement and establishment of independent body for national quality control. By these results, this study discussed the meaning of these findings and their implications on the development of Korean quality regulation system.

The Economic Analysis of the Determination of Optimal Management Measures and Level of Control in Fisheries Management (불완전 어업관리의 합리적 관리수단 및 규제수준의 결정에 관한 경제학적 분석)

  • 이상고;김도훈
    • The Journal of Fisheries Business Administration
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    • v.33 no.2
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    • pp.31-48
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    • 2002
  • This paper is aimed to analyze how to evaluate the choice of optimal management measures and level of control in fisheries management under the costly and imperfect management system by comparing with costless and perfect management system that is commonly assumed in the analysis of fisheries regulations. Fishermen would set the level of fishing efforts at the point where the marginal fishing profit for fishing effort is equal to the marginal level of fine under costly and imperfect management system. Therefore, under the case where the marginal fishing profit is higher than the marginal level of fine, the level of fishing efforts would be made at the point which is higher than the level of fishing efforts made under costless and perfect management system and is not a point where the economic profit is maximized in regulated fisheries. From this conclusion, the fishermens avoidance activities against regulations as well as the level of control in fisheries management substantially have an influence on the choice of fisheries management instruments. According to the analysis of optimal fisheries management policy, the economic profits in regulated fisheries are determined by the level of fisheries enforcement costs and total fishing profits, in which as enforcement costs increase the economic profits decrease. In addition, the economic profits vary in response to the level of control in avoidance activities. That is, as avoidance costs decrease, the economic profits increase. The determination of optimal level of control in fisheries management should be made at the point where the marginal regulation costs are equal to the marginal profits from regulated fisheries, in which marginal regulation costs are different according to the type of management measures. And the level of profits changes in response to different levels of avoidance activities. The management measure that can maximize the difference between the marginal regulation costs and marginal profits from regulated fisheries should be chosen as an optimal fisheries management instrument.

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Analytic Hierarchy Process for Prioritizing Radiation Safety Measures in Medical Institutions

  • Hyun Suk Kim;Heejeong Jeong;Hyungbin Moon;Sang Hyun Park
    • Journal of Radiation Protection and Research
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    • v.49 no.1
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    • pp.40-49
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    • 2024
  • Background: This study aimed to prioritize policy measures to improve radiation safety management in medical institutions using the analytic hierarchy process. Materials and Methods: It adopted three policy options-engineering, education, and enforcement-to categorize safety management measures, the so-called Harvey's 3Es. Then, the radiation safety management measures obtained from the current system and other studies were organized into action plan categories. Using the derived model, this study surveyed 33 stakeholders of radiation safety management in medical institutions and analyzed the importance of each measure. Results and Discussion: As a result, these stakeholders generally identified enforcement as the most important factor for improving the safety management system. The study also found that radiation safety officers and medical physicists perceived different measures as important, indicating clear differences in opinions among stakeholders, especially in improving quality assurance in radiation therapy. Hence, the process of coordination and consensus is likely to be critical in improving the radiation safety management system. Conclusion: Stakeholders in the medical field consider enforcement as the most critical factor in improving their safety management systems. Specifically, the most crucial among the six specific action plans was the "reinforcement of the organization and workforce for safety management," with a relative importance of 25.7%.

A Study on the Effectiveness of the Risk Assessment Regulations for Construction Works (건설공사 유해위험방지계획서제도의 효과분석에 관한 연구)

  • 안홍섭;노민래;이명구
    • Journal of the Korean Society of Safety
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    • v.16 no.4
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    • pp.134-139
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    • 2001
  • The Risk assessment regulation(RAR) is one of the essential articles of the Occupational safety and health law for the construction industry along with safety and health management expense and safety organization regulation. However, arguments regarding the working time of the safety assessment documents, the person in charge of documentation, weakness in legislative enforcement etc. are ongoing. Thus this study aims to analyze the effectiveness of RAR for the guidance of enhancing the effectiveness of RAR. The findings are; 1) the effectiveness of RAR is recognized, however the indirect effectiveness ie, enforcement of safety activities, previewing of drawings etc. are bigger than the direct effectiveness of accident prevention, 2) to enhance the effectiveness of RAR site inspection procedure has to be utilized, 3) further research for identifying and getting rid of negative factors in RAR is recommended.

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