• The Korean Society of Law and Medicine
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• v.12 no.1
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• pp.99-131
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• 2011

To strengthen the protection of human research subjects and human materials, the Korean Ministry of Health and welfare proposed the amendment bill of Bioethics and Safety Law(2010) to the Congress. It includes so many meaningful clauses. According to the bill, the scope that this act shall apply will be expended to the research involving human subjects and human materials. In the bill, there are the principles of this act; the protection of the life, health, and dignity of the human subjects, the obtaining of the adequate informed consent, the protection of the human subject's information confidentiality and the human subject's privacy, the assessment and minimizing of the risks involved and the guarantee of the safety for the human subjects, the preparation of the special protection program for the vulnerable human subjects, and so on. According to the bill, Institutional Bioethics Review Board(the same as Institutional Review Board) will be responsible for the auditing and monitoring on the research that was approved by IBRB, conducting the education program for the researchers, IBRB members and administrative staffs, preparing of the special protection program for the vulnerable human subjects, and forming the guidelines for the researchers as well as the review of the research protocols. And the State and local governments shall take necessary measures to support the expending of the social infrastructure. In addition to, IBRB will have to be assessed and to be gained the accreditation by the Korean Ministry of Health and welfare. So, if Bioethics and Safety Law is amended, it will contribute enormously to enhance the level of the human research subjects protection. Also, if this Law is amended, IBRB will play a major role for the conduct of the ethically, scientifically, and legally proper research. But now, as a matter of fact, the capability of IBRB members and IBRB office members is not enough to charge of this role because some people and some organizations does not know the importance of IBRB exactly. In spite of, IBRB shall be able to this role to protect the human subjects and to develop the level of the research On the international level. Therefore, the State, local governments and the Organization shall back up the administrative and financial terms of the IRB and IRB Office.

• The Journal of KAIRB
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• v.6 no.1
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• pp.1-4
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• 2024

The strengthening of Institutional Review Board (IRB) and Human Research Protection Program (HRPP) for clinical research on advanced regenerative medicine reflecting the 3 Principles of the Belmont Report (Respect, Beneficence, Justice) is very important. The research institution IRB should naturally be in charge of managing the clinical research process. And it is crucial to reinforce HRPP for the protection of research subjects in institutions conducting advanced regeneration clinical research. So, it is needed to establish a Protection System for Advanced Regenerative Medical Research Subjects composed of clinical research management communication system for advanced regenerative medicine between KAIRB (Korean Association of IRB) of research institutes and National Management Agency for Advanced Regenerative Medical Research. In advanced regenerative medicine clinical research to verify safety and efficacy of the investigational drugs to the subjects with rare and incurable diseases rather than to treat the patients, it is hoped that a management system that guarantees the scientific characteristics of research and the rights of research subjects would be well organized and operated.

• The Journal of KAIRB
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• v.4 no.1
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• pp.5-15
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• 2022

To suggest future directions for the improvement in the Institutional Review Board (IRB) review process and efficient operation of IRB, we have analyzed the IRB review results from 460 new research proposals submitted to the Review by the Convened IRB of the Keimyung University Dongsan Hospital IRB from January 2019 to July 2021. IRB is an independently established institutional committee to protect the human subjects by reviewing the research protocol in ethical as well as scientific aspects, so it is necessary to continuously contemplate the ethical versus scientific dilemma of 'what is ethical or scientific and what can actually protect human subjects.' Particularly, in this process, it is necessary to consider diverse ways to strengthen self-supervision through continuous Internal Audit rather than simple reporting outcomes. In addition, if it does not directly affect the protection of the human subjects, the discussion with the committee members is needed so that the comments such as administrative and typographical errors can be reduced as much as possible. Furthermore, as statistical analysis methods can have a significant impact on the safety of human subjects, if a legal basis and/or support related to statistics is provided for the composition of IRB members, a more specialized IRB review will be achieved.

• Korean Journal of Human Ecology
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• v.16 no.6
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• pp.1231-1241
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• 2007

This study was conducted to investigate the nutrient supplement use and its related influencing factors by high school students in Chonbuk area. Self administered questionnaires were collected from 489 (urban: 268, rural: 221). Statistical data analysis was completed using a SPSS v. 10.0 program. The results are summarized as follows. According to the general characteristic of subjects, the job and education level of parents and family monthly income respectively affected the nutrient supplement use of subjects (p<0.001). According to the living area, taking a nutrient supplement of parents and nutritional information respectively affected the nutrient supplement use of subjects (p<0.001). About 42.2% of subjects, who taking a nutrient supplement, responded to take a traditional medicine type, and 24.4% of them a multivitamin. Their mothers were important recommended person. The main reason for taking was 'to recommended from parent' (38.5%) and 'recovery from tiredness' (29.6%). The main reason for not-taking was that they were health, therefore nutrient supplements were not necessary. In the future about 43.7% of urban and 33.9% of rural area responded to take a nutrient supplements (p<0.05). These findings show that the behaviors of nutritional supplement usage by subjects are not reasonable, and their supplement usage tends to be affected by general characteristics. Therefore, nutritional understanding and education that are intended to from reasonable behaviors toward nutritional supplement usage of adolescents should be provided with considering the relationship between general characteristic of subjects and supplement usage.

• Nuclear Engineering and Technology
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• v.51 no.3
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• pp.683-691
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• 2019

In this paper, we propose a novel method to quantify the neural synchronization between subjects in the collaborative process through electroencephalogram (EEG) hyperscanning. We hypothesized that the neural synchronization in EEGs will increase when the communication of the operators is smooth and the teamwork is better. We quantified the EEG signal for multiple subjects using a representative EEG quantification method, and studied the changes in brain activity occurring during collaboration. The proposed method quantifies neural synchronization between subjects through bispectral analysis. We found that phase synchronization between EEGs of multi subjects increased significantly during the periods of collaborative work. Traditional methods for a human error analysis used a retrospective analysis, and most of them were analyzed for an unspecified majority. However, the proposed method is able to perform the real-time monitoring of human error and can directly analyze and evaluate specific groups.

• The Journal of KAIRB
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• v.4 no.2
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• pp.30-35
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• 2022

The Human Research Protection Program (HRPP) includes all subject protection activities and entities involved in the process of planning, reviewing, and conducting clinical research and it ultimately aims that research can be conducted ethically and scientifically while protecting the rights and welfare of research subjects. At the beginning of its introduction in Korea, it was settled down by adopting the United States HRPP, especially the form of AAHRPP element and regulations. However, regulations and operating forms of HRPP have been changed according to the Korean domestic research environment. Actually, all the Korean institutions are adopted the Korean HRPP guidelines that have been officially announced by the Ministry of Food and Drug Safety in Korea. Recently, Korean domestic laws such as the "Advanced Regenerative Biology Act" or "In Vitro Diagnostic Medical Device Act" have been dramatically innovated and our research environment becomes to be more complicated. Therefore, the development of a suitable Korean HRPP model considering the Korean research environment is strongly demanded. For the early settle down of the Korean HRPP model, the positive incentive method should be applied, when the HRPP is operated and/ or properly operated. These improvements in the Korean HRPP environment will eventually lead to the appropriate protection of subjects who are participating in human clinical research and the quality improvement of clinical research.

• Journal of the Korean Magnetic Resonance Society
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• v.16 no.1
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• pp.46-66
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• 2012

Metabolomic studies using human urine have shown that human metabolism is altered by a variety of environmental, cultural, and physiological factors. Comprehensive information about normal human metabolite profiles is necessary for accurate clinical diagnosis of disease and for disease prevention and treatment. In this study, metabolite correlation analyses, using $^1H$ nuclear magnetic resonance (NMR) spectroscopy coupled with multivariate statistics, were performed on human urine to compare metabolic differences based on gender and/or obesity in healthy human subjects. First, we applied partial least squares discriminant analysis to the NMR spectral data set to verify the data's ability to discriminate by gender and obesity. Then, the differences in metabolite-metabolite correlation between male and female, and between normal and high body mass index (obese) subjects were investigated through pairwise correlations. Creatine and several metabolites, including isoleucine, trans-aconitate, and trimethylamine N-oxide (TMAO), exhibited different quantitative relationships depending on gender. Dimethylamine had a different correlation with glycine and TMAO, based on gender. The correlation of TMAO with amino acids was considerably lower in obese, compared to normal, subjects. We expect that the results will shed light on the metabolic pathways of healthy humans and will assist in the accurate diagnosis of human disease.

• Journal of Korean society of Dental Hygiene
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• v.14 no.2
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• pp.241-250
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• 2014

Objectives : The purpose of the study was to examine the ethical requirements for the protection of human subjects in the publication guidelines of dental health journals. Methods : The guidelines of 27 dental health journals were reviewed to determine ethical standards alone, with Helsinki Declaration, by an institutional review board (IRB), informed consent, protection of subject privacy and confidentiality, and no conflicts of interest. Results : 1. Dentistry journals listed on National Research Foundation of Korea had a conflict of interest disclosure provisions of the contribution(76.9%) and the IRB approval(61.5%). 2. Half of the dental health journals were not listed on National Research Foundation of Korea Society but they agreed the advance posting provisions. 3. Dental hygiene journals provide 100% of ethics alone and receive 75% of IRB in the papers. 4. Dental health and dental hygiene journals have conflicts of interest disclosure regulations(59.2%) and IRB approval(51.8%). 5. There existed statistically significant differences between the dental health journals whether they were listed on the human subjects and ethical standards for protection in National Research Foundation of Korea or not. Conclusions : While the publication guidelines of dental health journals have followed to a greater extent in recent years, there is still a need for further instructions to ensure that the authors satisfy all ethical requirements in conducting research on human subjects. IRB approval for dental journals must be standardized and reinforced reflecting the characteristics of each journals. The researchers should obey the code of ethics suitable for education and the editors must review the paper continuously.

• Korean Journal of Community Nutrition
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• v.19 no.1
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• pp.41-50
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• 2014

As Korea is moving toward multicultural society, the number of Muslim, whose religion has a great influence on diet-related behaviors, is increasing in Korea. Since the number of immigrants from Indonesia ranks within top ten in Korea and Indonesia is one of the most representative Islamic countries in Asia, understanding the diet-related behaviors and food preferences of Indonesians is needed. This study was conducted to investigate diet-related behaviors, factors affecting the diet-related perceptions, and food preferences of the Indonesians. The subjects included 500 Indonesians dwelling in Jakarta, Indonesia. About ninety % of the subjects in this study were Muslims. They did not eat pork and dog meat for religious reason and they practiced fasting during Ramadan period. Indonesians avoided pineapple, durian, and hot foods during pregnancy and usually ate vegetables and fruits after birth, which seemed to be due to sociocultural influence. Among the subjects, 21.5% were obese and major health problems reported were hypertension and hyperlipidemia. Their preference for fried food items might have contributed to health problems. Subjects had meals mostly at home (2.3 times/day) and dined out occasionally (1.2 times/week) at Indonesian restaurants (56.6%) or family restaurants (21.0%). In conclusion, Indonesians had home-based and native food-oriented dietary life with strong religious and sociocultural influence on food choices. Further research on specific nutrient intake analysis is needed to better understand and to improve dietary life of Indonesians in Korea.

• Korean Journal of Human Ecology
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• v.24 no.4
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• pp.541-554
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• 2015

In this research in order to grasp the recent research trends of clothing comfort in Korea, 584 theses have been analyzed about the forms, contents and subjects of their researches which have been published in four Korean Journals from 2000 to 2012. The results are as follows: Many of the research contents were on the clothing comfort and environmental adaptation clothes in all journals. Handle, skin temperature, clothing pressure and working clothes showed the highest frequency ln the key words. The review studies were the fewest, and experimental or survey researches were largely conducted. The research forms showed the significant differences according to the research contents. The subjects were largely focused on those aged from 18 to 29, and among the research subjects on clothing comfort, female were more than male. However, in the researches on clothing quantity and clothes wearing conditions, many of them were the studies whose subjects were both men and women. The male and old subjects increased more and more. The number of the theses in the field of clothing environmentology showed the gradually increasing tendency. The most rates were the theses on clothing comfort, but as the number of those on environment adaptation clothes increased more and more, the research contents in the two fields showed much the same. Though the attention to aging and smart clothes is increasing, the research on this is very few. Therefore, it is thought that the study on this field will have to be conducted actively.