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The Fiduciary Duties of Doctor in Clinical Trials (임상시험에서 의사의 선량한 관리자의 주의의무)

  • Lee, Jiyoun
    • The Korean Society of Law and Medicine
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    • v.21 no.2
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    • pp.163-207
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    • 2020
  • Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.

Development and Assessment of a Non-face-to-face Obesity-Management Program During the Pandemic (팬데믹 시기 비대면 비만관리 프로그램의 개발 및 평가)

  • Park, Eun Jin;Hwang, Tae-Yoon;Lee, Jung Jeung;Kim, Keonyeop
    • Journal of agricultural medicine and community health
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    • v.47 no.3
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    • pp.166-180
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    • 2022
  • Objective: This study evaluated the effects of a non-face-to-face obesity management program, implemented during the pandemic. Methods: The non-face-to-face obesity management program used the Intervention mapping protocol (IMP). The program was put into effect over the course of eight weeks, from September 14 to November 13, 2020 in 48 overweight and obese adults, who applied to participate through the Daegu Citizen Health Support Center. Results: IMP was first a needs assessment was conducted; second, goal setting for behavior change was established; third, evidence-based selection of arbitration method and performance strategy was performed; fourth, program design and validation; fifth, the program was run; and sixth, the results were evaluated. The average weight after participation in the program was reduced by 1.2kg, average WC decreased by 3cm, and average BMI decreased by 0.8kg/m2 (p<0.05). The results of the health behavior survey showed a positive improvement in lifestyle factors, including average daily intake calories, fruit intake, and time spent in walking exercise before and after participation in the program. A statistically significant difference was seen (p<0.05). The satisfaction level for program process evaluation was high, at 4.57±0.63 point. Conclusion: The non-face-to-face obesity management program was useful for obesity management for adults in communities, as it enables individual counseling by experts and active participation through self-body measurement and recording without restriction by time and place. However, the program had some restrictions on participation that may relate to the age of the subject, such as skill and comfort in using a mobile app.

Bone Density and Related Factors of Vegetarian and Non-vegetarian University Students in Seoul Area (서울지역 채식.비채식 대학생의 골밀도에 미치는 영향요인에 관한 연구)

  • Chung, Nam-Yong;Choi, Soon-Nam
    • Journal of the Korean Society of Food Culture
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    • v.21 no.1
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    • pp.86-98
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    • 2006
  • This study was conducted to investigate factors affecting bone density of food and nutrition vegetarian and non-vegetarian university students in Seoul area. Data for food habits, dietary and health-related behaviors were obtained by self administered questionnaires. BQI(bone quality index) of the subjects was measured by an Quantitative Ultrasound (QUS). The results are summarized as follows: The average height, weight, BMI and osteopenia percentage of the vegetarian and non-vegetarian male and female student were 172.61cm, 62.42kg, 20.98 and 24.2%; 175.38cm, 72.52kg, 23.71 and 16.7%; 160.47cm, 55.76kg, 21.66 and 55.9%; 161.77cm, 56.34kg, 21.53 and 37.6%, respectively. The BQI of the subjects were 101.73 and 107.43 in male student group, and 84.15, 89.64 in female student group, respectively. The BQI, Z-score value of bone density was significantly different in female group. Weight and BMI were positively related with BQI in male and female group. BQI was positively affected by nutrition supplement and negatively affected by seafood in vegetarian male student group. In vegetarian female student group, amount of meal was positively related with BQI and meal regularity was negatively related BQI. The result of this study revealed that the desirable food habits, dietary behaviors and health-related lifestyles may have a beneficial effect on bone density. They should have practically and systematically organized nutritional education on optimum body weight, good eating habits, weight bearing exercise and intakes of good quality nutrient for higher bone density level.

Comparative analysis of status of safety accidents and importance-performance analysis (IPA) about precautions of safety accidents by employment type of industry foodservices in Jeonbuk area (전북지역 산업체급식소 조리종사자의 고용형태에 따른 안전사고 실태 및 안전사고 예방관리에 대한 중요도와 수행도 분석)

  • So, Hee;Rho, Jeong Ok
    • Journal of Nutrition and Health
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    • v.50 no.4
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    • pp.402-414
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    • 2017
  • Purpose: The purpose of the study was to evaluate the status of safety accidents and importance-performance analysis (IPA) between regular and non-regular employees in industry foodservices. Methods: The participants were regular employees (n = 119) and non-regular employees (n = 163) in industry foodservices in the Jeonbuk area. Demographic characteristics, status of safety accidents, safety education, and importance and performance status were assessed using a self-administered questionnaire. Results: Approximately 66.4% of regular employees and 53.4% of non-regular employees experienced safety accidents (p < 0.05). Types of safety accidents of regular and non-regular employees were mostly burns, and causes were mostly from their own negligence. Approximately 98.3% of regular employees and 95.1% of non-regular employees experienced safety education. Approximately 88.9% of regular employees and 96.8% of non-regular employees received safety education from dietitians. Approximately 41.9% of regular employees and 50.0% of non-regular employees had difficulty applying the contents of safety education due to lack of time during work. As a result of IPA, regular and non-regular employees were aware of the importance of the following and performed them well: 'Clean the floor of the work place', 'Arrange in the work area', 'Wear safety shoes', 'Check for heater cord', and 'Safety cooking when using oil'. On the other hand, they were not aware of the importance of the following and performed them insufficiently: 'Check for the MSDS', 'Aware of chemical signs', 'Wear protection gloves etc.', 'Do stretching exercise', and 'Using ancillary tools'. Conclusion: Therefore, it is necessary to improve the consciousness of dietitians for effective application of safety education contents, development of contents, especially MSDS, and related things.

Permission of the Claim that Prohibits Military Aircraft Operation Nearby Residential Area - Supreme Court of Japan, Judgement Heisei 27th (Gyo hi) 512, 513, decided on Dec. 8, 2016 - (군사기지 인근주민의 군용기 비행금지 청구의 허용 여부 - 최고재(最高裁) 2016. 12. 8. 선고 평성(平成) 27년(행(行ヒ)) 제512, 513호 판결 -)

  • Kwon, Chang-Young
    • The Korean Journal of Air & Space Law and Policy
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    • v.33 no.1
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    • pp.45-79
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    • 2018
  • An increase of airplanes and military aircraft operation lead to significant demanding of residential claims by people who live in nearby airports and military bases due to noise, vibration and residential damages caused by aircraft operations. In recent years, a plaintiff has filed a lawsuit against the defendant, claiming the prohibition of using claimant's possessed land as a helicopter landing route, and the Daejeon High Court was in favour of the plaintiff. Although the Supreme Court later dismissed the Appeal Court decision, it is necessary to discuss the case of setting flight prohibited zone. In Japan, the airport noise lawsuits have been filed for a long time, mainly by environmental groups. Unlike the case that admitted residential damages caused by noise, the Yokohama District Court for the first time sentenced a judgment of the prohibition of the flight. This ruling was partially changed in the appellate court and some of the plaintiffs' claims were adopted. However, the Supreme Court of Japan finally rejected such decision from appeal and district courts. Atsugi Base is an army camp jointly used by the United States and Japan, and residents, live nearby, claim that they are suffering from mental damage such as physical abnormal, insomnia, and life disturbance because of the noise from airplane taking off and landing in the base. An administrative lawsuit was therefore preceded in the Yokohama District Court. The plaintiff requested the Japan Self-Defense Forces(hereinafter 'JSDF') and US military aircraft to be prohibited operating. The court firstly held the limitation of the flight operation from 10pm to 6am, except unavoidable circumstance. The case was appealed. The Supreme Court of Japan dismissed the original judgment on the flight claim of the JSDF aircraft, canceled the first judgment, and rejected the claims of the plaintiffs. The Supreme Court ruled that the exercise of the authority of the Minister of Defense is reasonable since the JSDF aircraft is operating public flight high zone. The court agreed that noise pollution is such an issue for the residents but there are countermeasures which can be taken by concerned parties. In Korea, the residents can sue against the United States or the Republic of Korea or the Ministry of National Defense for the prohibition of the aircraft operation. However, if they claim against US government regarding to the US military flight operation, the Korean court must issue a dismissal order as its jurisdiction exemption. According to the current case law, the Korean courts do not allow a claimant to appeal for the performance of obligation or an anonymous appeal against the Minister of National Defense for prohibiting flight of military aircraft. However, if the Administrative Appeals Act is amended and obligatory performance litigation is introduced, the claim to the Minister of National Defense can be permitted. In order to judge administrative case of the military aircraft operation, trade-off between interests of the residents and difficulties of the third parties should be measured in the court, if the Act is changed and such claims are granted. In this connection, the Minister of National Defense ought to prove and illuminate the profit from the military aircraft operation and it should be significantly greater than the benefits which neighboring residents will get from the prohibiting flight of military aircraft.

Dietary Habits, Body Weight Satisfaction and Eating Disorders according to the Body Mass Index of Female University Students in Kyungnam Province (경남 지역 일부 여대생의 비만도에 따른 식습관, 체중 만족도 및 섭식 장애에 관한 연구)

  • Park, Kyung-Ae
    • Journal of the East Asian Society of Dietary Life
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    • v.19 no.6
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    • pp.891-908
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    • 2009
  • This study was performed to investigate the dietary habits, body weight satisfaction and eating disorder tendencies of female university students in Kyungnam province. Anthropometric measurements, dietary habits, body weight satisfaction, food preferences, disordered eating, and nutrient intakes were assessed in 132 female students at Kaya University. The results were analyzed with $x^2$- and ANOVA tests using the SPSS package program. The average age of the subjects was 20.1 years and average body mass index (BMI) were $21.1\;kg/m^2$. According to BMI, the percentages of students who were underweight, normal weight and overweight by BMI were 21.2, 55.3, and 23.5, respectively. Duration of exercise was significantly different by BMI. Index scores for a mini dietary assessment were significantly higher in the normal and overweight groups than in the underweight group. Scores for sweet, salty, and meat preferences were highest and scores for bean and vegetable preferences were lowest, in the underweight group. Satisfaction for present body weight was lowest, and self-perception of body image and weight control experiences were highest in the overweight group. All subjects in the overweight group wanted to be slim, and those in the normal and underweight groups, preferred to be more slim despite their current body weight being in the normal or below normal range. The percentage of the subjects who were at risk for eating disorders (based on scores from the Eating Attitude Test-26, EAT-$26{\geqq}20$) was 11.3%. Scores for EAT-26 were higher in the overweight group than in the underweight and normal weight groups. Nutrient intakes were not different among the groups. Therefore, dietary habits, taste and food preferences, satisfaction for present body weight, and disordered eating were significantly different according to BMI. These results suggest that overweight female university students need help correcting disordered eating, and nutrition counseling should be established to aid desirable weight control methods. Those who are underweight and normal weight need help establishing proper perceptions of their normal body weight and body image as well as nutrition counseling for health.

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Anthropometric Measurement, Dietary Behaviors, Health-related Behaviors and Nutrient Intake According to Lifestyles of College Students (대학생의 라이프스타일 유형에 따른 신체계측, 식행동, 건강관련 생활습관 및 영양소 섭취상태에 관한 연구)

  • Cheong, Sun-Hee;Na, Young-Joo;Lee, Eun-Hee;Chang, Kyung-Ja
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.36 no.12
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    • pp.1560-1570
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    • 2007
  • The purpose of this study was to investigate the differences according to lifestyle in anthropometric measurement, dietary attitude, health-related behaviors and nutrient intake among the college students. The subjects were 994 nation-wide college students (male: 385, female: 609) and divided into 7 clusters (PEAO: passive economy/appearance-oriented type, NCPR: non-consumption/pursuit of relationship type, PTA: pursuit of traditional actuality type, PAT: pursuit of active health type, UO: utility-oriented type, POF: pursuit of open fashion type, PFR: pursuit of family relations type). A cross-sectional survey was conducted using a self administered questionnaire, and the data were collected via Internet or by mail. The nutrient intake data collected from food record were analyzed by the Computer Aided Nutritional Analysis Program. Data were analyzed by a SPSS 12.0 program. Average age of male and female college students were 23.7 years and 21.6 years, respectively. Most of the college students had poor eating habits. In particular, about 60% of the PEAO group has irregularity in meal time. The students in PAH and POF groups showed significantly higher consumption frequency of fruits, meat products and foods cooked with oil compared to the other groups. As for exercise, drinking and smoking, there were significant differences between PAH and the other groups. Asked for the reason for body weight control, 16.2% of NCPR group answered "for health", but 24.8% of PEAO group and 26.3% of POF group answered "for appearance". Calorie, vitamin A, vitamin $B_2$, calcium and iron intakes of all the groups were lower than the Korean DRIs. Female students in PTA group showed significantly lower vitamin $B_1$ and niacin intakes compared to the PFR group. Therefore, these results provide nation-wide information on health-related behaviors and nutrient intake according to lifestyles among Korean college students.