• 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.

• The Journal of Korean Medicine
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• v.28 no.1 s.69
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• pp.42-50
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• 2007

Objectives . This study was to assess the Korean Traditional Medicine forecast subjects that had been expected to be accomplished by 2005. The result will help the Korean medical society plan far policies and studies on Korean Traditional Medicine. Methods : Assessed targets were 64 subjects (expected to be studied until 2005) of the total 93 subjects from the 'Mid- to Long-Term Forecast and Plan Study for Korean Traditional Medicine'. The subjects were classified into two types : political subjects and research and development (R&D) subjects. These were determined by the quantity and contents of related political reports, political research projects, thesis, patent, placing products on sale, etc. Results :1) 5 items of a total 12 political subjects were accomplished or partially accomplished (41.7%), and 9 items of a total 46 R&D subjects were accomplished or partially accomplished (9.5%). 2) While the accomplishment percentage (accomplished or partial accomplished) in literature arrangement and D/B construction field was 100%, it was under 10% in product or system development field. Thus, it seems that practical subjects were less accomplished than academic subjects. 3) On 8 subjects of 'Forecast Research on Future of Oriental Medicine' which had been performed in Japan, the Korean expected dates when the subjects would be realized were earlier than the Japanese ones, but no subjects were realized. Conclusion · Political and academic subjects weir accomplished more than R&D and practical subjects.

• International Journal of Vascular Biomedical Engineering
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• v.3 no.1
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• pp.14-22
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• 2005

In the present study, our aim is to investigate whether responses to the head-up tilt (HUT) on nonlinear properties of heart rate variability (HRV) in young and elderly subjects are different or not. Thirteen young-healthy subjects ($24.5{\pm}3.7$ years) and 18 old-aged healthy subjects ($74.5{\pm}7.4$ years) participated in this study. An electrocardiogram (ECG) in the supine posture, at $0^{\circ}$, and in the standing posture, at $70^{\circ}$ of head-up tilt, was recorded. Detrended fluctuation analysis (DFA) and approximate entropy (ApEn), measures of short-/long-term correlation properties and overall complexity of heart rate (HR) respectively, along with spectral components of HR variability (HRV) were analyzed for both the supine and HUT postures. We observed that the short-term fractal exponent ${\alpha}_1$ increased during HUT posture (F(1, 29) = 39.79, P = 0.000), especially, the young subjects showed a significantly higher values compared to the elderly subjects. ApEn significantly decreased (F(1, 29) = 8.61, P = 0.006) during HUT posture. HUT posture decreased the complexity in HR dynamics and increased short-term fractal exponent values in young subjects but not in elderly subjects. These results imply that there are differences of response to HUT on nonlinear properties between young and elderly subjects.

• The Journal of the Society of Korean Medicine Diagnostics
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• v.18 no.1
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• pp.11-24
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• 2014

Objectives The aim of this study is to contribute to the establishment of the Traditional Korean Medicine (TKM) policies in future, which is through the assessment to predict the realization by diagnostic subjects. Methods First, we evaluated 8 subjects that were deduced by professionals in 1996 regarding whether or not to be realized in 2013. Second, the governmental and private research projects, reports, articles, domestic patents and products were reviewed and investigated. Third, the Subjects in domestic fields of TKM were investigated on the followings: importance, time of realization, domestic Research and Development level, principal agents and methods for the realization, and hindrance factor on the realization. Results Of the 8 forecasting subjects, one subject was realized, two subjects were partly realized and five subjects were unrealized. Thus, their realization rate was 12.5%. The realized subject is the 'Standard naming of the TKM diagnosis'. Conclusion Continuous researches are necessary to realize the TKM subjects and moreover, professionals should predict new feasible TKM subjects, based on this study.

• Journal of Korean Biological Nursing Science
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• v.23 no.2
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• pp.127-137
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• 2021

Purpose: This study was conducted to investigate the current status of the biological nursing curriculum and faculties' perceptions on biological nursing subjects in South Korea. Methods: Biological nursing subjects' titles and credits were searched through the nursing schools' website. Perceived adequacy of subjects' title and credit in each biological nursing subject and the degree of perceived importance and satisfaction of learning contents by subjects were collected from 30 professors of biological nursing subjects. Results: Many schools still use the titles of medical subjects for those of biological nursing subjects. The perceived importance and satisfaction of genetics-related learning contents, "nursing case study" or "project team presentation," were lower than other learning contents. Conclusion: Standardization of biological nursing subjects' titles and learning contents is needed.

• 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.

• Journal of Ginseng Research
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• v.18 no.2
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• pp.113-117
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• 1994

To assess a polential relationship of Korean ginseng to allergic reactions, the effect of Korean ginseng on the total IgE in serum as an allergologic parameter was investigated in humans. Serum total IgE levels were measured in 8 subjects who have been taking ginseng for more than 5 years, 4 subjects of weak constitution, 10 newly hired workers in the ginseng processing industry and 7 normal subjects unexposed to Korean ginseng as control group. Blood samples were taken before and after the exposure to Korean ginseng. Total IgE levels after the exposure to Korean ginseng were not significantly different from those before the exposure within each group. And also, the IgE levels of control subjects were not significantly different compared with those of other groups. These results suggest that the exposure to Korean ginseng dose not affect significantly the IgE immune response of the subjects.

• Journal of Acupuncture Research
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• v.30 no.3
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• pp.109-115
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• 2013

Objectives : This study was aimed to find the motivation and satisfaction of subjects who participated in acupuncture and moxibustion clinical trials and to suggest ways to improve clinical trial management. Methods : We conducted a survey and collected the data of 233 subjects of acupuncture and moxibustion clinical trials from 6 university hospitals. Results : For all 233 subjects, the mean of the total satisfaction score was 4.07 (perfect score 5.0), and the score was particularly high in aspects of the investigator and clinical research coordinator, but low in the site and sponsor aspects. There were no differences in the satisfaction degree with general characteristics. The satisfaction degree of the acupuncture and moxibustion clinical trials was strong positive correlated with participation benefits(r=0.595) and easy contact with the research team (r=0.500). Conclusions : Most subjects showed positive perception and interest in the clinical trials. Future studies should investigate how personal factors influence the satisfaction of subjects, should identify a specific classification criterion, and create a standardized protocol for the clinical trials.

• 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.

• Korean Journal of Community Nutrition
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• v.11 no.3
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• pp.317-326
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• 2006

To explore the relationship between weight status and food intake pattern, the Nutrition Survey results of the 2001 National Health and Nutrition Survey were analyzed. Dietary intake data of Korean adults aged 20 to 64. years who participated in the 2001 National Health and Nutrition Survey, was used along with their demographic data. Subjects were classified into 4 groups based on the BMI value of subjects: underweight, normal, overweight and obese. For male adults, obese subjects had significantly higher mean intake of energy, protein, carbohydrates, and fat than normal subjects. In addition, obese male adults consumed more animal foods, especially more meats, than normal subjects. However, females obese subjects did not show higher intake of energy or fat. Although obese male adults showed higher energy intake, calcium and iron intake per 1000 kcal was lower than normal adults. Average calcium intake in females was low; about 70% of RDA regardless of obesity level. In addition, riboflavin and Vitamin A intake was lower in overweight and obese female than in normal females. Percentage of subjects with low fruit and vegetable intake (< 400 g per day) was also high in female subjects. These results showed that food and nutrient intake patterns of obese population were different between male and female adults. These dietary intake patterns need to be considered in developing and implementing nutrition policy and intervention programs to prevent and control obesity. Moreover, the National Survey and monitoring system should be developed for continuous and effective investigation on the relationship between obesity and dietary intake.