• 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.

• Genomics & Informatics
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• v.20 no.4
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• pp.44.1-44.13
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• 2022

Brugada syndrome (BS) is an autosomal dominant inheritance cardiac arrhythmia disorder associated with sudden death in young adults. Thailand has the highest prevalence of BS worldwide, and over 60% of patients with BS still have unclear disease etiology. Here, we performed a new viral metagenome analysis pipeline called VIRIN and validated it with whole genome sequencing (WGS) data of HeLa cell lines and hepatocellular carcinoma. Then the VIRIN pipeline was applied to identify viral integration positions from unmapped WGS data of Thai males, including 100 BS patients (case) and 100 controls. Even though the sample preparation had no viral enrichment step, we can identify several virus genes from our analysis pipeline. The predominance of human endogenous retrovirus K (HERV-K) viruses was found in both cases and controls by blastn and blastx analysis. This study is the first report on the full-length HERV-K assembled genomes in the Thai population. Furthermore, the HERV-K integration breakpoint positions were validated and compared between the case and control datasets. Interestingly, Brugada cases contained HERV-K integration breakpoints at promoters five times more often than controls. Overall, the highlight of this study is the BS-specific HERV-K breakpoint positions that were found at the gene coding region "NBPF11" (n = 9), "NBPF12" (n = 8) and long non-coding RNA (lncRNA) "PCAT14" (n = 4) region. The genes and the lncRNA have been reported to be associated with congenital heart and arterial diseases. These findings provide another aspect of the BS etiology associated with viral genome integrations within the human genome.

• Korea Journal of Hospital Management
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• v.7 no.1
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• pp.41-63
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• 2002

The purpose of this study is to analyze the interrelation of influential factors in organizational conflict and organizational commitment. The data for this study were collected through a self-administered survey with a structured Questionnaire to 1,167 subjects from several nursing staff members, administration staff members and medical technicians of six hospitals. In this analysis frequency test, t-test, ANOVA, hierarchical multiple regression and structural equation model were used. The main findings of this study are as follows. 1. Factors which influence organizational conflict were analyzed. The type of occupation and the year of service were socio-demographic variables which influenced organizational conflict positively. Adjusted R square was 0.03. Perceptions on organizational structure and organizational culture were analyzed with two- level variables that were added. The findings were as follows. Adjusted R square increased to 0.25. The year of service, internal process culture and rational goal culture were positive variables. The design of organizational structure, human relations culture and open system culture were negative variables. 2. Variables which influence organizational commitment were analyzed. Age and the year of service were positive variables, while academic background based on high school education was a negative variable. Adjusted R square was 0.16. Perceptions on organizational structure and organizational culture were analyzed with two-level variables that were added. The findings were as follows. The characteristics of organizational structure, human relations culture and organizational culture were positive variables. Adjusted R square increased to 0.55. The variables of organizational conflict were added in 3 steps. Findings were as follows. The variables of hierarchical conflict showed negative influence and were included in two-level influential variables. Adjusted R square increased to 0.56. 3. Structural equation model was analyzed in order to examine the relation between organizational structure and the variables of organizational culture, organizational conflict and organizational commitment. Thirteen path coefficients out of seventeen path coefficients were significant. Age had negative influence on organizational conflict and positive influence on organizational commitment. The year of service had positive influence on organizational conflict and organizational commitment. The design of organizational structure, human relations culture and open system culture had negative influence on organizational. conflict. They had positive influence on organizational commitment. Internal process culture and rational goal culture had positive influence on organizational conflict. Organizational conflict had negative influence on organizational commitment. The squared multiple correlation of this model was 25.1% in organizational conflict and 52.7% in organizational commitment. The conclusion of this study is as follows. Factors in organizational structure and organizational culture, rather than socio-demographic factors, had a stronger influence on the organizational conflict and organizational commitment of hospitals. In order to decrease organizational conflict, to increase organizational commitment and to maximize the effectiveness of hospital management, it is necessary to understand the overall relation between organizational structure, organizational culture, organizational conflict and organizational commitment, with the effort of improving personalized factors and individual factors of organization management.

• The Korean Society of Law and Medicine
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• v.16 no.2
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• pp.55-84
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• 2015

The tuberculosis is the infectious disease. Generally, the active tuberculosis patient can infect the 10 persons for one year within the daily activities like casual conversation and singing together. The infectivity of tuberculosis can continue for a life time, and infected persons can remain at risk for developing active tuberculosis. To control this contagious disease, along with the active tuberculosis patients, non-infectious but non-compliant patients who can be infectious if their immune systems become impaired have to be managed. To control the non-complaint patients, medical treatment order should be combined with the public order. Because tuberculosis is the risk of community health, the human rights like liberty and freedom of movement can be restricted for public welfare under the article 37(2) of constitution. Even when such restriction is imposed, no essential aspect of the freedom or right shall be violated. The degree of restriction on the rights of citizens is different what methods are chosen to non-complaint patients. For example, under the directly observed therapy program, the patients and medical staffs make an appointment and meet to confirm the drug intakes according to the schedule, which is the medical treatment combined with the mildest public order. If the patients break the appointments or have the history of disobedient, the involuntary detention can obtain the legitimate cause. The Tuberculosis Prevention Act has the two step programs on this involuntary detention, The admission order (Article 15) is issued when the patients are infectious. The quarantine order (Artle 15-2) is issued when the patients are infectious and non-complaint. The legal criteria for involuntary detention are discussed and published through the international conventions and covenants. For example, World Health Organization had made guidance on human rights and involuntary detention for tuberculosis control. The restrictions should be carried out in accordance with the our law and in the legitimate objective of public interest. And the restriction should be based on scientific evidence and not imposed in an unreasonable or discriminatory manner. We define and adopt these international criteria under our constitution and legal system. Least restrictive alternative principle, proportionality principle and the individual evaluation methods are explained through the reviews of United States court decisions. Habeas Corpus Act is reviewed and adopted as the procedural due process to protect the patient rights as a citizen. Along with that, what conditions and facilities which are needed to performed quarantine order are discussed.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.8 no.2
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• pp.163-174
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• 1997

This study was to know the influence of familial environment and moral development on conduct disorder. Subjects were composed of 47 male and female patients with conduct disorder(patients group), 113 general male and female students(normal group), and 173 juvenile prisoners(JP group). The Korean Form of the Family Environment Scale(FES) was used to assess the family environment of the subjects and the Korean Defining Issues Test(DIT) was used to assess the moral development. Conduct disorder was diagnosed with the DSM-III-R criteria for conduct disorder. The influence of familial environment and moral development on conduct disorder was analyzed with ANOVA and the differences among groups were verified with Scheffe test. There was no difference in the socioeconomic status and the physical abuse by the parents among the three groups. But the rates of divorce or separation of the parents were significantly highest in the JP group and higher in the patients group than in the normal group. Especially the subjects of the JP group experienced the divorce or separation of their parents during the preschool or the elementary school periods. In regard to the family environment, there was no difference among the three groups in the Subscales of Expressiveness, Independence, Intellectual-cultural orientation, Moral-religious emphasis, Organization, and Control. ‘Cohesion Subscale’ was significantly higher in the normal group than in the JP group. ‘Conflict Subscale’ was significantly higher in the JP and patients groups than in the normal group. ‘Achievement orientation Subscale’ was significantly lower in the JP group than in the patients and normal groups. ‘Activerecreational orientation’ was significantly lower in the normal group than in the JP and patients groups. In gegard to the moral developmental stage, the lower moral developmental step was higher in the JP and patients groups than in the normal group. The higher steps were significantly higher in the normal group than in the JP group. There was no significant correlation between the degree of ‘Moral-religious emphasis Subscale’ and the moral development. The clinical implication and limitation of present study were listed and discussed.

• Journal of Preventive Medicine and Public Health
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• v.28 no.4 s.51
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• pp.809-844
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• 1995

The purposes of this study are to define the scope of occupational health management and to classify occupational management by review of related journals from 1945 to 1994 in Korea. The steps of this study were as follows: (1) Search of secondary reference; (2) Collection and review of primary reference; (3) Survey; and (4) Analysis and discussion. The results were as follows ; 1. Most of the respondents majored in occupational health(71.6%), and were working in university (68.3%), males and over the age 40. Seventy percent of the respondents agreed with the idea that classification of occupational health management is necessary, and 10% disagreed. 2. After integration of the idea of respondents, we reclassified the scope of occupational health management. It was defined 3 parts, that is , occupational health system, occupational health service and others (such as assessment, epidemiology, cost-effectiveness analysis and so on). 3. The number of journals on occupational health management was 510. It was sightly increased from 1986 and abruptly increased after 1991. The kinds of journals related to occupational health management were The Korean Journal of Occupational Medicine(18.2%), Several Kinds of Medical Colloge Journal(17.0%), The Korean Journal Occupational Health(15.1%), The Korean Journal of Preventive Medicine(15.1%) and others(34.6%). As for the contents, the number of journals on occupational health management systems was 33(6.5%) and occupational health services 477(93.5%). Of the journals on occupational health management systems, the number of journals on the occupational health resource system was 15(45.5%), occupational finance system 8(24.2%), occupational health management system 6(18.2%), occupational organization 3(9.1%) and occupational health delivery system 1 (3.0%). Of the journals on occupational health services, the number of journals on disease management was 269(57.2%), health management 116(24.7%), working environmental management 85(18.1%). As for the subjects, the number of journals on general workers was 185(71.1%), followed by women worker, white coiler workers and so on. 4. Respondents made occupational health service(such as health management, working environmental management and health education) the first priority of occupational health management. Tied for the second are quality analysis(such as education, training and job contents of occupational health manager) and occupational health systems(such as the recommendation of systems of occupational and general disease and occupational health organization). 5. Thirty seven respondents suggested 48 ideas about the future research of occupational health management. The results were as follows: (1) Study of occupational health service 40.5%; (2) Study of organization system 27.1%; (3) Study of occupational health system (e.g. information network) 8.3%; (4) Study of working condition 6.2%; and (5) Study of occupational health service analysis 4.2%.

• Journal of agricultural medicine and community health
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• v.25 no.2
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• pp.353-377
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• 2000

This study was performed to investigate the performance state and improvement countermeasure of Primary Health care Posts(PHPs). The operation reports of PHPs(1996 330 PHPs, 1999 313 PHPs) located in Kyongsangbuk-Do and data collected by self-administered questionnaire survey of 280 community health practitioners(CHPs) were analyzed. The major results were as follows: Population per PHP in 1999 decreased in number compared with 1996. But population of the aged increased in number. The performance status of PHP in 1999 increased compared with 1996. A hundred forty one community health practitioners(50.4%) replied that the fiscal standing of PHP was good. Only 1.4% replied that the fiscal standing of PHP was difficult. For the degree of satisfaction in affairs, overall of community health practitioners felt proud. The degree of cooperation between PHP and public health institutions was high and the degree of cooperation of between PHP and private medical institutions was high. The degree of cooperation between PHP and Health Center was significantly different by age of CHP, the service period of CHP, and CHP's service period at present PHP. Over seventy percent of CHPs replied that they had cooperative relationship with operation council, village health workers, community organization. CHPs who drew up the paper on PHP's health activity plan were 96.4 % and only 11.4% of CHPs participated drawing up the report on the second community health plan. CHPs who grasped the blood pressure and smoking status of residents over 70% were 88.2%, 63.9% respectively and the grasp rate of blood pressure fur residents were significantly different according to age and educational level of CHP. CHPs received job education in addition continuous job education arid participated on research program in last 3 years were 27.5%, respectively. CHPs performed the return health program for residents in last 3years were 65.4%. Over 95% of CHPs replied that PHPs might be necessary and 53.9% of CHPs replied that the role of PHPs should be increased. CHPS indicated that major reasons of FHPs lockout were lack of understanding for PHP and administrative convenience, CHPs were officials in special government service governors intention of self-governing body. CHPs suggested number of population in health need such as the aged and patients with chronic disease, opinion of residents, population size, traffic situation and network in order as evaluation criteria for PHP and suggested results of health performance, degree of relationship with residents, results of medical examination anti treatment, ability for administration and affairs in order as evaluation criteria for CHP. CHPs replied that the important countermeasures for PHPs under standard were affairs improvement of PHPs and shifting of location to health weakness area in city. Over 50% of CHPs indicated that the most important thing for improvement of PHPs was affairs adjustment of CLIP. And CHPs suggested that health programs carried out in priority at PHP were management of diabetes mellitus and hypertention. home visiting health care, health care for the aged. The Affairs of BLIP should be adjusted to satisfy community health need and health programs such as management of diabetes mellitus and hypertention, home visiting health care, health care for the aged should be activated in order that PHPs become organization reflecting value system of primary health care.

• Journal of Korean Academy of Nursing Administration
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• v.3 no.2
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• pp.41-59
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• 1997

This study surveyed nurses' value of reward and recognition level of organizational reward, and measured the fit of both. It also looked into the relationship between the reward fit and attitude of nurses toward their job and organization (job involvement${\cdot}$organizational commitment). It was planned to suggest the alternative of a future reward system. The sample consisted of 625 nurses of 8 private University Hospitals. Data for this study was collected from Mar. 25 to Apr. 17 by structured questionnaire. This study examined the differences of nurses' value of reward by their demographic characteristics, and looked into the relationship between the reward fit and job involvement${\cdot}$organizational commitment. Four instruments and a demographic questionnair were used to collect the data. Developed for myself and repaired by panel of judges, the value of reward scale and organizational reward scale consisted of 34 items on five points Likert-type scale. Developed by Kanungo and repaired by panel of judges, the job involvement scale measured overall job involvement on 7 items. The organizational commitment scale was developed by Mowday et al and repaired by panel of judges on 10 items. The data was analyzed by frequency, percentage, ranking, one-way ANOVA, Pearson's correlation coefficient, Chronbach alpha coefficient, t-test, SNK test, factor analysis with SPSS/PC+ progra,.Major findings are as follows 1. The mean of nurses' value of reward is 4.2435 and job content rewards are seen as the most important(M=4.5532). The following orders are seen as follows; financial rewards(M=4.4181), human realtion rewards(M=4.4130), establishment ${\cdot}$ facilities rewards(M=4.1632), professional rewards(M=4.1117), social status or prestige rewards(M=3.9228), career rewards(M=3.8816). Of 34 indivisual reward factors, the retainment allowance is seen to be thought of as the most important thing. 2. The mean of nurses' actual reward is 2.6035. The actual reward responded to the most extremely offered is job content rewards. The following orders are seen as follows ; human relation rewards(M=2.9420), financial rewards(M=2.7682), professional rewards(M=2.4601), social status or prestige rewards(M=2.3696), career rewards(M=2.3466), establishment ${\cdot}$ facilities rewards(M=1.9364). Of 34 indivisual reward factors, medical insurance benefits are felt to be most extremely offered. 3. The mean of fit of reward is -1.6874 and that means actual reward doesn't egual the value of the reward. What is offered mostly to nurses' value of reward is human relation rewards. The following orders are seen as follows; job content rewards(M=-1.5938), career rewards(M=-1.6381), social status of prestige rewards(M=-1.6382), financial rewards(M=-1.6836), professional rewards(M=-1.6854), establishment${\cdot}$facilities rewards(M=-2.3130). Of 34 indivisual factors, the item of fered most closely to nurses' value of reward is seen as the participation in educational programs at the nursing department of the hospital. 4. The mean of nurses' job involvement is 3.1987 and SD is 0.5667. 5. The mean of murses' organizational commitment is 2.9348 and SD is 0.6124, that is seen as a little lower than job involvement. 6. Significant value of reward differences were found among nurses by their demographic characteristics such as married status, tenure, academic career. 7. The fit of reward was significant related to job involvement and organizational commitment. When generalizing the result of this study, the value of reward, which nurses consider important and appropriate offers a reward that corresponds to the nurses' value of reward. This increases nurses' job and organization devotion further, as well as hospital effectiveness. It appears that nurses have recognized that the present reward offered in hospitals doesn't come up to their expectations so I think it is urgent to plan and perform the new reward system which is in accord with the nurses' reward fit.

• Journal of dental hygiene science
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• v.17 no.2
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• pp.142-149
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• 2017

This study targeted 123 dental hygienists working at the university and dental hospital as well as the dental clinic in Busan. The study ran for 5 months beginning July 23, 2016. The purpose of the study was to understand the relationship between core competencies and job performance for dental hygienists. The major core competencies of dental hygienists were interpersonal relation competency (3.61) was the highest, followed by management and educational competency (3.59), organizational relation competency (3.57), and basic dental hygiene management competency (3.56). Regarding the subjects' job performance, 'the task requested by a boss could be finished by the deadline' (3.93) was the highest, followed by 'there has been no case where others were harmed owing to carelessness' (3.76). 'The performance exceeding the targets set by the boss' (3.11) was relatively low. The group working for dental hospitals showed higher job performance than the group working for dental clinics (p=0.009) while there were high correlations between core competencies and job performance (p=0.733). Also, analysis for understanding relevant variables of core competencies that affected job performance revealed that the interpersonal relation competency (p=0.25), self-control competency (p=0.32), and basic dental hygiene competency (p=0.15) were significant. In summary, reinforcement of the dental hygienists' core competencies has a positive effect on job performance. Improved job performance in turn should improve patient care as well as the performance of the healthcare organization overall which will be eventually helpful to the provision of high-quality medical service to patients, and helpful for the hospital organization Helpful in making their performance better. Therefore, it would be necessary to establish administrative/educational support to facilitate dental hygiene education to develop major competencies and vocational basic abilities, as well as reinforce diverse competency educational programs for the current dental hygienists.

• Korean Journal of Psychosomatic Medicine
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• v.24 no.2
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• pp.146-156
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• 2016

Objectives : The aim of this study was to evaluate the associations between vasomotor symptoms and factors such as sociodemographics, health behaviors, medical condition, depression, stress, anxiety, attitude toward menopause, and quality of life. Methods : We conducted a cross-sectional study in peri- and post-menopausal women enrolled by the Korean Association of Health Promotion. Subjects submitted self-report questionnaires about vasomotor symptoms and other clinical symptoms. Associations between vasomotor symptoms and clinical variables were analyzed using stepwise multiple regression analyses. Results : 1951 women completed self-report questionnaires and 1022 women were enrolled in the study. The prevalence of vasomotor symptoms in peri- and post-menopausal women was 63.9%. Variables showing significant differences between subjects with vasomotor symptoms and subjects without them were score of Beck Depression Inventory, Brief Encounter Psychosocial Instrument-Korean Version, proportions of clinically significant depression(Beck Depression Inventory ${\geq}16$), Menopausal rating scale, attitude towards menopause, the 4 subscales of World Health Organization Quality of Life-BREF(Physical health, psychological, social relationships, environment), and a History of Premenstrual syndrome/Premenstrual dysphoric disorder. Stepwise multiple regression analyses indicated that Beck Depression Inventory, Brief Encounter Psychosocial Instrument-Korean Version, Menopausal Rating Scale, and the Psychological subscale of World Health Organization Quality of Life -BREF show associations with vasomotor symptoms. Conclusions : Menopausal vasomotor symptoms are associated with various psychological factors, especially with depression. Midlife women suffering vasomotor symptoms should therefore be screened for depression. Future prospective studies where clinical subjects are diagnosed using structured interviews, focusing on the causal relationship between depression and vasomotor symptoms are necessary.