• 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.

• Journal of the Korean Society of Marine Environment & Safety
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• v.28 no.1
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• pp.1-9
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• 2022

The effect of sediments in a waste dumping area on marine organisms was evaluated using sediment toxicity tests with a benthic amphipod (Monocorophium acherusicum) and bioluminescent bacterium (Vibrio fischeri) in accordance with the Korean Standard Method for Marine Wastes (KSMMW). Nine sites in the East Sea-Byeong, East Sea-Jeong, and Yellow Sea-Byeong areas were sampled from 2016 to 2019. The test results showed that the relative average survival rate (benthic amphipods) and relative luminescence inhibition rate (luminescent bacteria) were below 30%, which were judged to be "non-toxic." However, in the t-test, a total of 12 benthic amphipod samples (6, 1, 1, and 4 in 2016, 2017, 2018, and 2019, respectively) were significantly different (p<0.05) from the control samples. To identify the source of toxicity on benthic amphipods, a simple linear regression analysis was performed between the levels of eight heavy metals (Cr, As, Ni, Cd, Cu, Pb, Zn, and Hg) in sediments and the relative average survival rate. The results indicated that Cr had the highest contribution to the toxicity of benthic amphipods (p = 0.000, R2 = 0.355). In addition, Cr was detected at the highest concentration at the DB-85 station and exceeded the Marine Environment Standards every year. Although the sediments were determined as "not toxic" according to the ecotoxicity criteria of the KSMMW, the results of the statistical significance tests and toxicity identification evaluation indicated that the toxic effect was not acceptable. Therefore, revising the criteria for determining the toxic effect by deriving a reference value through quantitative risk assessment using species sensitivity distribution curves is necessary in the future.

• Journal of the Korean Society of Marine Environment & Safety
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• v.29 no.7
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• pp.802-811
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• 2023

Marine spatial planning (MSP) is a crucial element for rational allocation and sustainable use of marine areas. Particularly, Fishing Activity Protected Areas constitute essential zones accounting for 45.6% designated for sustainable fishing activities. However, the current assessment of these zones does not adequately consider future demands and potential values, necessitating appropriate evaluation methods and predictive tools for long-term planning. In this study, we selected key fish species (Scomber japonicus, Trichiurus lepturus, Engraulis japonicus, and Larimichthys polyactis) within the Fishing Activity Protected Area to predict their distribution and compare it with the current designated zones for evaluating the ability of the prediction tool. Employing the Intergovernmental Panel on Climate Change (IPCC) 6th Assessment Report scenarios (SSP1-2.6 and SSP5-8.5), we used species distribution models (such as MaxEnt) to assess the movement and distribution changes of these species owing to future variations. The results indicated a 30-50% increase in the distribution area of S. japonicus, T. lepturus, and L. polyactis, whereas the distribution area of E. japonicus decreased by approximately 6-11%. Based on these results, a species richness map for the four key species was created. Within the marine spatial planning boundaries, the overlap between areas rated "high" in species richness and the Fishing Activity Protected Area was approximately 15%, increasing to 21% under the RCP 2.6 scenario and 34% under the RCP 8.5 scenario. These findings can serve as scientific evidence for future evaluations of use zones or changes in reserve areas. The current and predicted distributions of species owing to climate change can address the limitations of current use zone evaluations and contribute to the development of plans for sustainable and beneficial use of marine resources.

• The Korean Society of Law and Medicine
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• v.25 no.1
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• pp.87-115
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• 2024

In Korea, exposure to stress has been accompanied by mental pain in the process of achieving many growth along with rapid development, various social problems, and the frequency of emergency hospitalization is increasing.. In the case of mentally ill patients, "unwanted hospitalization" is a problem, and police and 119 paramedics try to suppress the body of mentally ill patients, and many problems are exposed This is because the constituent requirements of the provisions of emergency hospitalization under the Mental Health and Welfare Act do not reflect reality, and each institution has a different position on one mentally ill person, and emergency hospitalization does not proceed smoothly or leads to friction between related organizations, and the safety of the mentally ill or others is not secured. Emergency hospitalization is defined as "a person who finds a person who is presumed to be mentally ill and is at high risk of harming his or her health or safety or others," and if the situation is so urgent that he or she cannot afford time to go through the hospitalization procedure to decide on his or her own hospitalization, he or she can request emergency hospitalization with the consent of a doctor and a police officer. In this case, 119 paramedics are escorted to a psychiatric institution. This provision of emergency hospitalization poses many problems in the process of transferring to psychiatric institutions. If a police officer or 119 paramedics in charge of practice use "physical force" during the emergency hospitalization process, side effects will inevitably occur, and professional negligence can be a problem. Specifically, when exercising physical force, the minimum necessary physical restraint based on laws and regulations and proportional principles is required, and the lack of the duty of care of 119 paramedics or police officers under the laws and regulations will eventually be resolved by applying other laws and regulations. Accordingly, it will be an opportunity for mentally ill patients to be transferred to psychiatric institutions in a safe environment by changing the subject of emergency hospitalization provisions under the Mental Health Welfare Act, defining and prescribing the use of physical protection guards as the enforcement regulations of the Mental Health Act, setting the duty of care for 119 paramedics and police officers, and creating an environment for transportation so that mentally ill patients can be treated safely.

• Journal of Life Science
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• v.34 no.8
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• pp.567-575
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• 2024

New breeding techniques (NBT) recognize specific DNA sequences and remove, modify, or insert DNA at a desired location, and can be used to treat genetic diseases in humans or to improve the traits of livestock or crops. In this study, we conducted a comparative analysis of various agricultural traits and assessed the safety of gene transferability in third-generation genome-editing rice (OsCKq1-G₃) with T and G nucleotide insertions developed using the CRISPR/Cas9 SDN-1 method, in comparison to its parental line (Oryza sativa L., cv Ilmi). The analyzed traits included heading date, culm length, panicle length, tiller number, yield, germination rate, viviparous germination rate, shattering, after wintering seed viability, the presence of toxins and allergens. The target trait, heading date, exhibited a high significant difference of approximately 5 days. Culm length, panicle length, tiller number, yield showed no significant differences compared to the parental line. No T-DNA bands indicating gene transfer were detected. In the third generation of genome-edited rice, the T-DNA was confirmed to be eliminated as successive generations advanced through self-pollination. Through the analysis of germination rate, viviparous germination rate, shattering, and after wintering viability, we confirmed that the genome-editing rice has no potential for weediness. The ORF and amino acid sequences of the genome-editing rice did not reveal any toxins and allergens. The results of this study can be utilized as important data for the environmental risk assessment of genome-editing rice.

• KSCE Journal of Civil and Environmental Engineering Research
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• v.44 no.3
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• pp.407-416
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• 2024

Over the past 20 years, there has been a rapid increase in the number and size of subway stations and underground structures worldwide, and the importance of safety for subway users has also continuously grown. Subway stations, due to their structural characteristics, have limited visibility and escape routes in disaster situations, posing a high risk of human casualties and economic losses. Therefore, an analysis of disaster vulnerabilities is essential not only for existing subway systems but also for deep underground facilities like GTX. This paper presents a case study applying a betweenness centrality-based disaster vulnerability analysis framework to the case of Gwanggyo Central Station. The analysis of Gwanggyo Central Station's base model and various disaster scenarios revealed that the betweenness centrality distribution is symmetrical, following the symmetrical spatial structure of the station, with high centrality concentrated in the central areas of basement levels one and two. These areas exhibited values more than 220% above the average, indicating a high likelihood of bottleneck phenomena during evacuation in disaster situations. To mitigate this vulnerability, scenarios were proposed to distribute evacuation flows concentrated in the central areas, enhancing the usability of peripheral areas as evacuation routes by connecting staircases continuously. This modification, when considered, showed a decrease in centrality concentration, confirming that the proposed addition of evacuation paths could effectively contribute to dispersing the flow of evacuation in Gwanggyo Central Station. This case study demonstrates the effectiveness of the proposed framework for assessing evacuation vulnerability in enhancing subway station user safety and can be effectively applied in disaster response and management plans for major underground facilities.

• Journal of Food Hygiene and Safety
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• v.39 no.4
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• pp.335-342
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• 2024

This study aimed to examine the delivery conditions and microbial contamination of fresh-cut and ready-to-eat foods purchased from online markets between February and November 2023. Upon arrival, the average surface temperature of the products was 11.3℃. In the fresh-cut foods, the average number of total aerobic bacteria and coliforms was 4.5 log colony-forming units (CFU)/g and 1.2 log CFU/g, respectively, whereas in the ready-to-eat foods, these values were 10.6 log CFU/g and 1.2 log CFU/g, respectively. Pathogens, such as Staphylococcus aureus, Salmonella spp., Clostridium perfringens, Listeria monocytogenes, and pathogenic Escherichia coli were absent from all samples. Bacillus cereus was found in 2.7% of the fresh-cut foods and 0.9% of the ready-to-eat foods, with contamination levels averaging 0.05 log CFU/g and 0.01 log CFU/g, respectively. In the four samples in which B. cereus was detected, genetic testing of the six toxin genes produced by B. cereus revealed the presence of at least one enterotoxin gene, excluding the emetic toxin. L. monocytogenes was absent from ready-to-eat foods but was detected in 0.9% of fresh-cut foods. Analysis of the isolated L. monocytogenes confirmed the presence of six pathogenicity-related genes, including iap, indicating the potential risk of foodborne diseases.

• The Korean Journal of Nuclear Medicine Technology
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• v.14 no.2
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• pp.9-16
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• 2010

Purpose: With increasing medical use of radiation and radioactive isotopes, there is a need to better manage the risk of radiation exposure. This study aims to grasp and analyze the individual radiation exposure situations of radiation-related workers in a medical facility by specific job, in order to instill awareness of radiation danger and to assist in safety and radiation exposure management for such workers. Materials and Methods: 1 January 2007 to 31 December 2009 to work in medical institutions are classified as radiation workers Nuclear personal radiation dosimeter regularly, continuously administered survey of 40 workers in three years of occupation to target, Imaging Unit beautifully, age, dose sector, job function-related tasks to identify the average annual dose for a deep dose, respectively, were analyzed. The frequency analysis and ANOVA analysis was performed. Results: Imaging Unit beautifully three years the annual dose PET and PET/CT in the work room 11.06~12.62 mSv dose showed the highest, gamma camera injection room 11.72 mSv with a higher average annual dose of occupation by the clinical technicians 8.92 mSv the highest, radiological 7.50 mSv, a nurse 2.61 mSv, the researchers 0.69 mSv, received 0.48 mSv, 0.35 mSv doctors orderly, and detail work employed the average annual dose of the PET and PET/CT work is 12.09 mSv showed the highest radiation dose, gamma camera injection work the 11.72 mSv, gamma camera imaging work 4.92 mSv, treatment and safety management and 2.98 mSv, a nurse working 2.96 mSv, management of 1.72 mSv, work image analysis 0.92 mSv, reading task 0.54 mSv, with receiving 0.51 mSv, 0.29 mSv research work, respectively. Dose sector average annual dose of the study subjects, 15 people (37.5%) than the 1 mSv dose distribution and 5 people (12.5%) and 1.01~5.0 mSv with the dose distribution was less than, 5.01~10.0 mSv in the 14 people (35.0%), 10.01~20.0 mSv in the 6 people (15.0%) of the distribution were analyzed. The average annual dose according to age in occupations that radiological workers 25~34 years old have the highest average of 8.69 mSv dose showed the average annual dose of tenure of 5~9 years in jobs radiation workers in the 9.5 mSv The average was the highest dose. Conclusion: These results suggest that medical radiation workers working in Nuclear Medicine radiation safety management of the majority of the current were carried out in the effectiveness, depending on job characteristics has been found that many differences. However, this requires efforts to minimize radiation exposure, and systematic training for them and for reasonable radiation exposure management system is needed.

• Journal of Preventive Medicine and Public Health
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• v.31 no.1 s.60
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• pp.139-156
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• 1998

Diving related disease including decompression sickness is an important occupational health problem and diving fishermen remain a fairly hazardous occupation in Korea. To prevent diving related disease, we investigate diving patterns, incidence of diving related diseases, and contributing factors of 433 diving fishermen of three coast interviewing and mailing questionnaire in 1996. Mean age of divers was 39.7 years, ranged from 24 to 58 years, 92.8% of these were male, and 58.4% of divers were high school graduates. Mean duration of work as a diver was 12.9 years, ranged from 2 to 40 years. It was found that 70.4% of divers were using hookah system, 22.2% of helmet, and only 2.5% SCUBA. About half of them have learned diving skills from other divers. The peak season of diving was from April to June and mean working days were 20.3 days per month during the peak season. On the average, the divers dived 5-6 times, ranged from 1 to 10 times a day with 51.1 minutes of diving time, ranged from 20 to 120 minutes, at 30 m or 40 m in depth, and 35.5 minute of interval on surface. Most divers ascended slowly making decompression stop, yet the decompression profile used was not based on any scientific knowledge except for their own experiences. It appeared that each diving system had slightly different diving patterns. There were 282(65.0%) divers that suffered from DCS in 1995 and 31.2% of divers were given recompression therapy at a medical facility since they worked as diving fishermen. Skin and musculoskeletal complaints were common symptoms of DCS and 39% of divers experienced a voiding difficulty. In univariate analysis, females have an increased frequency of DCS(93% vs 66% for males). Old age, long duration of work, helmet diving, diving time, diving depth, repetitive diving, and blow up were all contributing factors to DCS. It was found that most diving patterns exceed no decompression limit and did not use the standard decompression table. This suggests that most of divers are at high risk of developing diving related disease with prolonged dives and lengthy repetitive diving in deep depth. Considering the diving patterns and economic aspect of professional diving, the incidence of DCS among diving fishermen in Korea will not decrease in the near future. These findings suggest that periodical health surveillance for divers, and education of health and safety are important for reducing the risk of diving related disease in the population of diving fishermen.

• Journal of Chest Surgery
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• v.39 no.5 s.262
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• pp.354-358
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• 2006

Background: Pulsatile pumps for extracorporeal circulation have been known to be better for tissue perfusion than non-pulsatile pumps but be detrimental to blood corpuscles. This study is intended to examine the risks and benefits of $T-PLS^{TM}$ through the comparison of clinical effects of $T-PLS^{TM}$ (pulsatile pump) and $Bio-pump^{TM}$ (non-pulsatile pump) used for coronary bypass surgery. Material and Method: The comparison was made on 40 patients who had coronary bypass using $T-PLS^{TM}\;and\;Bio-pump^{TM}$ (20 patients for each) from April 2003 to June 2005. All of the surgeries were operated on pump beating coronary artery bypass graft using cardiopulmonary extra-corporeal circulation. Risk factors before surgery and the condition during surgery and the results were compared. Result: There was no significant difference in age, gender ratio, and risk factors before surgery such as history of diabetes, hypertension, smoking, obstructive pulmonary disease, coronary infarction, and renal failure between the two groups. Surgery duration, hours of heart-lung machine operation, used shunt and grafted coronary branch were little different between the two groups. The two groups had a similar level of systolic arterial pressure, diastolic arterial pressure and mean arterial pressure, but pulse pressure was measured higher in the group with $T-PLS^{TM}\;(46{\pm}15\;mmHg\;in\;T-PLS^{TM}\;vs\;35{\pm}13\;mmHg\;in\;Bio-pump^{TM},\;p<0.05)$. The $T-PLS^{TM}$-operated patients tended to produce more urine volume during surgery, but the difference was not statistically significant $(9.7{\pm}3.9\;cc/min\;in\;T-PLS^{TM}\;vs\;8.9{\pm}3.6\;cc/min\;in\;Bio-pump^{TM},\;p=0.20)$. There was no significant difference in mean duration of respirator usage and 24-hour blood loss after surgery between the two groups. Plasma free Hb was measured lower in the group with $T-PLS^{TM}\;(24.5{\pm}21.7\;mg/dL\;in\;T-PLS^{TM}\;versus\;46.8{\pm}23.0mg/dL\;in\;Bio-pump^{TM},\;p<0.05)$. There was no significant difference in coronary infarction, arrhythmia, renal failure and morbidity rate of cerebrovascular disease. There was a case of death after surgery (death rate of 5%) in the group tested with $T-PLS^{TM}$, but the death rate was not statistically significant. Conclusion: Coronary bypass was operated with $T-PLS^{TM}$ (Pulsatile flow pump) using a heart-lung machine. There was no unexpected event caused by mechanical error during surgery, and the clinical process of the surgery was the same as the surgery for which $Bio-pump^{TM}$ was used. In addition, $T-PLS^{TM}$ used surgery was found to be less detrimental to blood corpuscles than the pulsatile flow has been known to be. Authors of this study could confirm the safety of $T-PLS^{TM}$.