• The Korean Society of Law and Medicine
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• v.23 no.2
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• pp.119-139
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• 2022

Brain stimulation technology that administers electrical and magnetic stimulation to a brain has shown a significant level of possibility for treating a wide range of various neurological and psychiatric disorders. Depending on its nature, the technology is defined either as invasive or non-invasive, and deep brain stimulation (DBS) is one of the most well-known invasive brain stimulation technologies. Currently categorized as grade 4 medical device in accordance with Guideline On Medical Devices And Their Grades, a Notification of Ministry of Food and Drug Safety (MFDS), the DBS has been used as a stable treatment for several diseases. At the same time, the DBS technology has recently achieved substantial advancement, encouraging active discussions for its use from various perspectives. On the contrary, debates over legal regulation related to the use of DBS has relatively been smaller in numbers. In this context, this article aims to 1) introduce the DBS technology and its safety in setting out the tone; 2) touch upon major legal issues that would potentially rise from its use for four different purposes of treatment, clinical study, areas of non-standard treatment where no other methods are available, and enhancement; and finally 3) highlight disputes concerning common emerging issues observed in the aforementioned four purposes from the viewpoint of legal responsibility and liability of using the DBS, which are benefit-risk assessment, physicians' duty of information, patients' capacity to consent, control for device, and insurance coverage.

• The Journal of KAIRB
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• v.4 no.2
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

• The Journal of KAIRB
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• v.5 no.1
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• pp.21-32
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• 2023

Purspose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among advanced general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans. Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 clinical trial institutions, including 11 AAHRPP-accreditated general hospitals in Korea, as well as the operation of the IRB deliberation. Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why individuals are vulnerable, and for what reasons. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 14 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 15 institutions classified sujects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 8 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 6 classified foreigners as vulnerable. Conclution: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs' classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/benefit, and a review using checklists and spokeperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.

• Nuclear Engineering and Technology
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• v.54 no.11
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• pp.4348-4358
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• 2022

The thermal-hydraulics phenomena in a containment during an accident will necessarily include radiative heat transfer (i) within the gas mixture due to the high radiative absorption and emission of steam and (ii) between the gas mixture and the surrounding structures. The analysis of some previous PANDA experiments (PSI, Switzerland) demonstrated the importance of the proper modelling of radiation for the benefit of numerical simulations. These results together with dedicated scoping calculations conducted for the present experiments indicated that the radiative heat transfer is considerable, even for a very low amount of steam (≈2%). The H2P2 series conducted in the large-scale PANDA facility at the Paul-Scherrer-Institut (PSI) in the framework of the OECD/NEA HYMERES-2 project is intended to enhance the understanding of thermal radiation phenomena and to provide a benchmark for corresponding numerical simulations. Thus, the test matrix was tailored around the two opposite extremes: either gas compositions with small steam content such that radiative heat transfer phenomena can be neglected. Or gas mixtures containing larger amounts of steam, so that radiative heat transfer is expected to play a dominant role. The H2P2 series consists of 5 experiments designed to isolate the radiation phenomena from convective and diffusive effects as much as possible. One vessel with a diameter of 4 m and a height of 8 m was preconditioned with different mixtures of air / steam at room and elevated temperatures. This was followed by the build-up of a stable helium stratification at constant pressure in the upper part of the vessel. After that, helium was injected from the top into the vessel which leads to an increase of the vessel pressure and a corresponding elevation-dependent and transient rise of the gas temperature. It is shown that even the addition of small amounts of steam in the initial gas atmosphere considerably impacts the radiative heat transport throughout all phases of the experiments and markedly influences i) the monitored gas peak temperature, ii) the temperature history during the compression and iii) the following relaxation phase after the compression was stopped. These PANDA experiments are the first of its kind conducted in a large scale thermal-hydraulic facility.

• Journal of Korea Water Resources Association
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• v.56 no.8
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• pp.485-496
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• 2023

Recently, South Korea has been making efforts to mitigate the risk of water scarcity during droughts by utilizing various drought response measures in dam operations. While various studies have been conducted on this topic, there is currently a lack of research on the economic effects of drought response measures. In this study, we evaluated the economic effects of drought response measures on nationwide multipurpose dams by using a long-term simulated inflow model based on ARIMA and Copula and a dam operation model that reflects drought response measures. The results showed that the expected benefits per unit flow rate were highest for coordinated operation and alternative water supply measures, at KRW 1,176 and KRW 1,139, respectively, while the benefits of emergency water supply utilization and water supply adjustment were estimated at KRW 956 and KRW 875, respectively. Additionally, when we examined the changes in the economic benefits of drought response measures based on the assumption of increased drought severity in the future, the changes in the drought risk resulting from reduced inflow increased the economic benefits of all drought response measures. The economic benefits of water supply adjustment increased by 2.6% compared to the baseline, while the economic benefits of coordinated operation and alternative water supply measures increased by 11.7% compared to the baseline. This suggests that dam-network-based measures, such as coordinated operation and alternative water supply measures, are crucial as drought risk increases. This study is expected to serve as a fundamental reference for selecting and utilizing drought response measures in the future.

• Korean Journal of Culture and Social Issue
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• v.8 no.1
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• pp.165-187
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• 2002

This study examines Korean representation of the biotechnology and psychological factors which can influence lay people's perception and attitude about biotechnology. Korean college students(N=433) and lay adults(N=90) whom had college education participated in the study. Participants of the study 1 were asked to list words which comes to mind when associate with the biotechnology in broad sense, and several specific applications in health, medicines, agriculture and research. Participants of the study 2 were asked to list possible benefits and costs of biotechnology and their specific applications. In study 3, Participants responded the questionnaires about perceptions and attitudes of biotechnology. Korean people associated the biotechnology with its costs or risks and benefits. Korean college students mainly got the informations of the biotechnology from TV, newspapers, or internet. They trusted the scientist group and NGO group on their judgements about the assessment of risk and benefit of the biotechnology. College students showed the positive attitude with the applications in medicines and negative attitude with the applications in agriculture and public using of individual's genetic information. The radicalism, sensitivity in behavioral activation system, and trust/cynicism were to be found as a significant influencing factor for interest/knowledge and behavioral intention in related with biotechnology. Finally, more extensive knowledge of biotechnology did not lead to greater acceptance of it.

• Environmental and Resource Economics Review
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• v.13 no.1
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• pp.49-82
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• 2004

The study aimed to evaluate cancer damage cost due to risk from benzene inhalation. We performed health risk assessment based on US EPA guideline to estimate annual population risk in Ulsan metropolitan city. Also, we estimated a willingness-to-pay amount for reducing a cancer mortality rate to evaluate a value of statistical life. We combined the annual population risk and the value of statistical life to calculate the cancer damage cost. In the health risk assessment, we applied the benzene unit risk ($2.2{\times}10^{-6}{\sim}7.8{\times}10^{-6}$) in the US EPA'S Integrated Risk Information System to assess the annual population risk. Average concentration of benzene in ambient air is $7.88{\mu}g/m^3$(min: 1.16~max: $23.32{\mu}g/m^3$). We targeted an exposure population of 516,641 persons who aged over 30 years old. Using a Monte-Carlo simulation for uncertainty analysis, we evaluated that the population risk of benzene during ten years in Ulsan city is 2.90 persons (5 percentile: 0.32~95 percentile: 9.11persons). And the monthly average WTP for 5/1,000 cancer mortality reduction during ten years is 14,852 Won(95% C.I: 13,135~16,794 Won) and the implied VSL is 36 million Won(95% C.I: 30~40 million Won). Cancer damage cost due to risk from benzene inhalation during 10 years in Ulsan city is about 104 million Won(5 percentile: 13~95 percentile: 328 million Won). Health benefit cost to reduce a cancer mortality risk of benzene is about 50 million Won is Ulsan metropolitann city. But, it is very important that this cost is not for all health damage cost of cancer mortality in some area. We just recommended a model for evaluating a cancer risk reduction, so we must re-evaluate an integrated application of total VOCs damage cost including benzene.

• Journal of Korean Society of Environmental Engineers
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• v.38 no.11
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• pp.611-617
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• 2016

Remanufacturing that is the rebuilding of a product to specifications of the original manufactured product by collecting used-product, completely disassembling, cleaning and repairing or replacing with a new part and reassembling has been received attention in aspects of resource, recycling because it is a great environmental improvement. Remanufacturing is the rebuilding of a product to specifications of the original manufactured product by collecting used-product, completely disassembling, cleaning and repairing or replacing with a new part and reassembling. With a great environmental improvement and resource recycling and conservation, many studies were conducted. Up to date, remanufacturing activities are mainly applied to automobile parts and printer toner cartridge in South Korea. However, remanufacturing of rental product is not well conducted although rental products are collected in good condition and could be remanufactured in the same condition as a new product. Therefore, in this study, we conducted life cycle assessment (LCA) to an air cleaner product that is one of rental products. This study attempts to identify the processes in new products and remanufacturing life cycles that contribute the most environmental impacts. The results show that air cleaner remanufacturing could reduce about 20% of environmental impacts compared to new product. The greatest benefit related to environmental impact is with regard to ozone layer depletion potential (ODP), which is reduced by 94%. In the life cycle of air cleaner, raw material extraction stage had the most environmental impacts, especially with regard to abiotic depletion potential (ADP) and global warming potential (GWP). In the environmental impacts in each part, the ABS power had the highest environmental impacts.

• Journal of Nutrition and Health
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• v.49 no.3
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• pp.179-188
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• 2016

Purpose: This cross-sectional study aimed to document the dietary behaviors, dietary changes, and health status of female marriage immigrants residing in Gwangju, Korea. Methods: The survey included 92 female immigrants attending Korean language class at a multi-cultural family support center. General characteristics, health status, anthropometric data, dietary behaviors, and dietary changes were collected. Results: Mean age of subjects was 31.3 years, and home countries of subjects were Vietnam (50.0%), China (26.0%), Philippines (12.0%), and others (12.0%). Frequently reported chronic diseases were digestive diseases (13.2%), anemia (12.1%), and neuropsychiatry disorder (8.9%). Seventeen percent of the subjects was obese ($BMI{\geq}25kg/m^2$). Dietary score by Mini Dietary Assessment was 3.45 out of 5 points. Dietary scores for dairy foods, meat/fish/egg/bean intake, meal regularity, and food variety were low, and those for fried foods and high fat meat intake were also low. Thirty-three percent of subjects answered that they have changed their diet and increased their consumption of fruits and vegetables after immigration. Length of residence in Korea was positively associated with BMI and waist circumference. Length of residence tends to be positively associated with dietary changes and obesity as well as inversely associated with disease prevalence. Conclusion: The study shows that length of residence is inversely related to disease prevalence. However, this association is thought to be due to the relatively short period of residence in Korea and thus the transitional phase to adapting to dietary practices. As the length of residence increases, disease patterns related to obesity are subject to change. Healthy dietary behaviors and adaptation to dietary practices in Korea in female marriage immigrants will not only benefit individuals but also their families and social structure. Therefore, varied, long-term, and target-specific studies on female marriage immigrants are highly needed.

• The Journal of Fisheries Business Administration
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• v.22 no.2
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• pp.75-99
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• 1991

A quantitative analysis was carried out to monitor the commercial yield level of walleye pollock Theragra chalcogramma in the east coast of Korea, based on available data on catch and fishing effort, catch per unit of effort including fish prices from 1911 to 1988, using a traditional yield model. The results from the quantitative assessment were based to estimate maximum economic yield (MEY) and optimal fishing effort (E-opt) at MEY. On the other hand, interaction aspects between danish seine fishery and trawl fishery mainly targeting walleye pollock in the east coast of Korea were studied to predict optimal situation in fishing effort level from economic point of view which gives the most benefits to the two fisheries. Total production of walleye pollock in 1911 when its catch record was begun for the first time was about 12, 000 metric tons(M/T), and then the catch trend maintained nearly at the level of 50, 000 M/T per annum, showing a decreasing trend until 1930. The highest production from historical data base on walleye pollock fishery statistics was from the years in 1939 and 1940, about 270, 000 M/T and 26, 000 M/T, respectively. No production of the fish species was recorded during the years from 1943 to 1947, and from 1949 to 1951. From 1952 onwards annual production was only available from the southern part of 38$^{\circ}$N in the east coast. During two decades from 1952 to 1970, the production had sustained about less than 30, 000 M/T every year. Annual production showed an increasing trend from 1971, reaching a maximum level of approximately 162, 000 M/T in 1981. Afterwards, it has deceased sharply year after year and amounted to 180, 000 M/T in 1988. The catch composition of walleye pollock for different fishery segments during 1970~1988 showed that more than 70% of the total catch was from danish seine fishery until 1977 but from 1978 onwards, the catch proportion did not differ from one another, accounting for the nearly same proportion. Catch per unit of effort (CPUE) for both danish seine fishery and trawl fishery maintained a decline tendency after 1977 when the values of CPUE were at level of 800 kg/haul for the former fishery and 1, 300 kg/haul for the latter fishery, respectively. CPUEs of gillnet fishery during 1980~1983 increased to about 3.5 times as high value as in the years, 1970~1979 and during 1987~1988 it decreased again to the level of the years, 1970~1978. The bottom longline fishery's CPUE wa at a very low level (20 kg/basket) through the whole study years, with exception of the value (60 kg/basket) in 1980. Fishing grounds of walleye pollock in the east coast of Korea showed a very limited distribution range. Danish seine fishery concentrated fishing around the coastal areas of Sokcho and Jumunjin during January~February and October~December. Distributions of fishing grounds of trawl fishery were the areas along the coastal regions in the central part of the east coast. Gillnet and bottom longline fisheries fished walleye pollock mainly in the areas of around Sokcho and Jumunjin during January~February and December. Relationship between CPUEs' values from danish seine fishery and trawl fishery was used to standardize fishing effort to apply to surplus production model for estimating maximum sustainable yield (MSY) and optimum fish effort (F-opt) at MSY. The results suggested a MSY of 114, 000 M/T with an estimated F-opt of 173, 000 hauls per year. Based on the estimates of MSY and F-opt, MEY was estimated to be about 94, 000 M/T with a range of 81, 000 to 103, 000 M/T and E-opt 100, 000 hauls per year with a range of 80, 000 to 120, 000 hauls. The estimated values of MEY and E-opt corresponded to 82% of MSY and 58% of F-opt, respectively. An optimal situation in the fishing effort level, which can envisage either simultaneously maximum yield or maximum benefit for both danish seine fishery and trawl fishery, was determined from relationship between revenue and cost of running the fleet : the optimal fishing effort of danish seine fishery was about 52, 000 hauls per year, corresponding to 50 danish seiners and 27, 000 hauls per year which is equal nearly to 36 trawlers, respectively. It was anticipated that the net income from sustainable yield estimated from the respective optimal fishing effort of the two fisheries will be about 3, 800 million won for danish seine fishery and 1, 000 million won for trawl fishery.