• The Journal of KAIRB
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• v.2 no.1
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• pp.1-5
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• 2020

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule, 45 CFR 46, Subpart A). The Common Rule was initially promulgated in 1991 and amended in 2005. The Final Rule to update the current regulations was published in the Federal Register on 19 January 2017. The final compliance date of the revised Common Rule including the cooperative research requirement is effective on 20 January 2020 after twice to delay. The revised Common Rule aims to make more effective conduct of minimal risk research reflecting modern research activities and recognize evolving technologies, including mobile technologies, internet, and the growth in computing power. The revisions to the Common Rule were based on a variety of sources of public, stakeholder, and expert comments. The author summarized the key changes and the implications to Korean human research regulations.

• The Journal of KAIRB
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• v.3 no.2
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• pp.19-27
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• 2021

Purpose: This study aimed to analyze the knowledge levels, attitudes, and factors affecting the choices on the education of the participants who completed their education of persons conducting clinical trial workers, and to assess the problems of the current education system for clinical trial workers, leading to improvements. Methods: Clinical trial workers (including principal investigators/subinvestigators, members of the Institutional Review Board [IRB], clinical research coordinators) who were affiliated to one of the 4 university hospitals running their own clinical trial center and IRB in Daegu and completed their education of persons conducting clinical trial workers were the subjects of this study. One hundred seven online questionnaires were answered from 2021-04-02 to 2021-04-17. Descriptive statistics and Pearson correlation analysis were used to analyze the acquired data. Independent t-test and 1-way analysis of variance were used to analyze the differences in the knowledge levels and attitudes following the characteristics of the education participants. Results: The baseline characteristics of the 107 participants were as follows: the majority of the participants were female (72.0%), were in their 30s (36.4%), had a nursing major (29.0%), were clinical research coordinators (63.6%), had never experienced a principal investigator (79.4%), had participated 3 or more educations (58.9%), had completed their maintenance course (55.1%), had 5 or more years of clinical trial experiences (34.6%). The fields on which participants had low levels of objective knowledge were "types and preparations on audits of clinical trials," "regulations on clinical trials (Pharmaceutical Affairs Act, Korea Good Clinical Practice)." The difficulties that the participants faced were on "annual educations" and "lack of information regarding the educations." Factors that showed significant differences in objective knowledge were sex (p=0.02), number of educations (p=0.004), the curriculum of 2020 (p=0.001). Age (p=0.004), having experienced a principal investigator (p=0.006), number of educations (p<0.001), the curriculum of 2020 (p<0.001), clinical trial career (p=0.001) were factors that significantly affected subjective knowledge. Attitudes toward the education were positively correlated with objective knowledge (r=0.20, p=0.04) and subjective knowledge (r=0.32, p=0.001). Major sources through which information on educations was acquired were "institutional notices," and major factors affecting the choices on the education were "when the education took place" and "where the education took place." "Within the affiliated institution," "Online classes (recorded)" and "IRB and review processes" were each the most preferred place, mode, and content of the education. Conclusion: Knowledge levels varied largely among participants who completed their education of persons conducting clinical trial workers, depending on their characteristics such as the number of educations. Participants also complained about their lack of information on educations. The quality of education may be improved if clinical trial organizations are designated as education facilities. Education programs must be developed considering the knowledge level and demand of the participants. Furthermore, as offline classes may be impossible due to pandemics such as the coronavirus disease 2019, the development of diverse and sophisticated online classes is looked forward to.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.19 no.10
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• pp.300-312
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• 2018

This study was conducted to identify the impact on department adaptation of field practice adaptation, college adaptation, and awareness of death of nursing students, as well as to establish basic data for adaptation of the major, adaptation to field practice, and measures to raise awareness of death. The subjects of this study were 252 Junior and Senior nursing students living in C, J city. Data were collected after approval from the IRB of C University on April 30, 2018 and analyzed by the mean values, percentages, t-test, ANOVA, Pearson's correlation coefficient and multiple regression using IBM SPSS 21.0. The subjects' field practice adaptation was 3.58, college adaptation was 3.33, awareness of death was 3.15 and department adaptation was 3.38. There were significant correlations between department adaptation and field practice adaptation (r=0.56, p<0.001), negative of death (r=-0.15, p=0.016), respect for life (r=0.33, p<0.001) of nursing students, field practice adaptation and college adaptation (r=0.48, p<0.001) and respect for life (r=0.16, p=0.009) of nursing students and between college adaptation and respect for life (r=0.32, p<0.001) of nursing students. The factors that have effect on the department adaptation of the subjects; As a factor influencing the department adaptation, department adaptation, field practice adaptation, and respect for life were explained by 67.5% (F=171.67, p<0.001). Therefore, a positive attitude toward death and a curriculum related to change in perception must be provided to undergraduates to change the attitude toward death. It is also suggested that research regarding nursing department adaptation effects be conducted after implementing the program to improve respect for life.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.18 no.1
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• pp.406-416
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• 2017

The purpose of this study was to examine violence response, burnout, and job satisfaction according to violent episodes of emergency room workers. Methods : This Study was a descriptive survey design using convenience sampling. This study was exempt from needing an IRB approval. There were 167 emergency room workers, who agreed to participate in this study, and took a self-report questionnaire between July and August 2015. SPSS 21.0 version was used for descriptive analysis, frequency, percentage, mean, standard deviation, independent t-test, Pearson correlation coefficients, and multiple regression. The major findings of this study were as follows: 1) 84.4% of participant experienced violent episodes. The frequency of verbal violence was highest. Violent attackers were patients and guardians with drunken state. The time of violence episodes was usually during the night. Violent experience of doctors and nurses was very high. 2) There were significant differences in the emotional response according to violent episodes (t=2.528, p=0.12) 3) The correlation between \response and burnout was statistically significant, and indicates a high positive correlation (r=.616, p=<.001). The correlation between violence response and job satisfaction was statistically significant, indicating a negative correlation (r=-.512, p=<.001). There was a negative correlation between burnout and job satisfaction with statistical significance (r=-.568, p=<.001). 4) Significant factors influencing job satisfaction were emotional response to violence and burnout. Conclusion: The findings of this study provide basic information for the strategies of preventing violence, decreasing burnout, and improving job satisfaction by developing a violence management program.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.19 no.4
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• pp.374-382
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• 2018

This study aimed to identify the mediating effect of nurse's communication on the relationship between nursing needs and nursing satisfaction in hospital patients. After IRB approval, this study was performed by administering questionnaires to 180 university hospital patients between April and June, 2017. Collected data were analyzed with SPSS 22.0. The average score of nurse's communication, nursing needs, and nursing satisfaction were $3.88{\pm}0.52$, $3.96{\pm}0.55$, and $3.74{\pm}0.59$ out of 5, respectively. There were significant differences in educational and therapeutic needs versus satisfaction. As for nurse's communication and nursing satisfaction, there were significant differences by patient's room. There were positive correlations among nurse's communication and nursing needs (r=.286, p<.001) as well as nurse's communication and nursing satisfaction (r=.524, p<.001), In addition, there were positive correlations between nursing needs and satisfaction (r=.488, p<.001). Nursing communication had a partial mediating effect between nursing needs and satisfaction, which showed significance in Sobel's test (Z=2.450, p=.014). Therefore, it is suggested that a continuous program for strengthening communication of hospital nurses is needed.

• Proceedings of the KWS Conference
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• 2009.11a
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• pp.29-29
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• 2009

On this research, laser welding technology for manufacturing automobile body is studied. Laser welding technology is one of the important technologies used in the manufacturing of lighter, safer automotive bodies at a high level of productivity; the leading automotive manufacturers have replaced spot welding with laser welding in the process of car body assembly. Korean auto manufacturers are developing and applying the laser welding technology using a high output power Nd:YAG laser and a 6-axes industrial robot. On the other hand, the robot-based remote laser welding system was equipped with a long focal laser scanner system in robotic end effect. Laser system, robot system, and scanner system are used for realizing the high speed laser welding system. The remote laser welding system and industrial robotic system are used to consist of robot-based remote laser welding system. The robot-based remote laser welding system is flexible and able to improve laser welding speed compared with traditional welding as spot welding and laser welding. The robot-based remote laser systems used in this study were Trumpf's 4kW Nd:YAG laser (HL4006D) and IPG's 1.6kW Fiber laser (YLR-1600), while the robot systems were of ABB's IRB6400R (payload:120kg) and Hyundai Heavy Industry's HX130-02 (payload:130kg). In addition, a study of quality evaluation and monitoring technology for the remote laser welding was conducted. The welding joints of steel plate and steel plate coated with zinc were butt and lapped joints. The quality testing of the laser welding was conducted by observing the shape of the beads on the plate and the cross-section of the welded parts, analyzing the results of mechanical tension test, and monitoring the plasma intensity and temperature by using UV and IR detectors. Over the past years, Trumf's 4kW Nd:YAG laser and ABB's IRB6400R robot system was used. Nowadays, the new laser source, robot and laser scanner system are used to increase the processing speed and to improve the efficiency of processes. This paper proposes the robot-based remote laser welding system as a means of resolving the limited welding speed and accuracy of conventional laser welding systems.

• 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 KIPS Transactions:PartB
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• v.15B no.6
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• pp.507-516
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• 2008

Cardiac disease is the leading cause of death in the world. Quantification of cardiac function is performed by manually calculating blood volume and ejection fraction in routine clinical practice, but it requires high computational costs. In this study, an automatic left ventricle (LV) segmentation algorithm using short-axis cine cardiac MRI is presented. We compensate coil sensitivity of magnitude images depending on coil location, classify edge information after extracting edges, and segment LV by applying region-growing segmentation. We design a weighting function for intensity signal and calculate a blood volume of LV considering partial voxel effects. Using cardiac cine SSFP of 38 subjects with Cornell University IRB approval, we compared our algorithm to manual contour tracing and MASS software. Without partial volume effects, we achieved segmentation accuracy of $3.3mL{\pm}5.8$ (standard deviation) and $3.2mL{\pm}4.3$ in diastolic and systolic phases, respectively. With partial volume effects, the accuracy was $19.1mL{\pm}8.8$ and $10.3mL{\pm}6.1$ in diastolic and systolic phases, respectively. Also in ejection fraction, the accuracy was $-1.3%{\pm}2.6$ and $-2.1%{\pm}2.4$ without and with partial volume effects, respectively. Results support that the proposed algorithm is exact and useful for clinical practice.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.14 no.9
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• pp.4394-4401
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• 2013

The purpose of this study was to investigate the association of blood pressures and serum lipids, obesity indices in adults who examined health checkup. Study subjects were 2,734 adults of 20 years and over (1,344 males, 1,390 females), who underwent health package check-up at an university hospital during one year of 2012. We observed the age, sex, SBP, DBP, TC, TG, HDL-C, LDL-C, AI, BMI, body fat rate and waist circumference of study subjects after confirmed IRB of the hospital. As a results, TC, TG, AI was significantly higher in the group of hypertension than that of normotensive in both sex, but in only female, HDL-C and LDL-C was higher in the each group of normotensive and hypertension. BMI, body fat rate and waist circumference was significantly higher in the group of hypertension than that of normotensive in both sex. SBP and DBP was positive correlated with TC, TG, AI, BMI, body fat rate and waist circumference, but HDL-C and LDL-C was each correlated with positive and negative in female only. Age-adjusted odds ratio for hypertension by blood serum lipids and obesity indices was significantly increased in the group of abnormal than normal of TC, TG, BMI, but HDL-C and waist circumference was each increased in the abnormal group of female, and in the abnormal group of male. Above results suggested that the blood pressure related with serum lipid levels and obesity indices.

• Asia-pacific Journal of Multimedia Services Convergent with Art, Humanities, and Sociology
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• v.9 no.5
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• pp.781-791
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• 2019

The purpose of this study was to evaluate the evaluation of long - term care institutions (evaluation rating, evaluation rating, suitability of evaluation index), quality of service of caregivers, Quality satisfaction, life satisfaction, and facility choice. After receiving the IRB, in January and February of 2018, the survey was completed for 79 long-term care institution managers, 381 nursing care workers, and 381 elderly people. The survey carried out an allocation sample reflecting the 2015 long - term care (facility benefit) evaluation results. The results of this study are as follows. First, it is found that the institutional evaluation (evaluation level, change of evaluation level, recognition of suitability of the index) has a greater impact on the quality of life of the elderly, appear. However, the intention of reselecting the facility after discharge was more influenced by the quality of services of caregivers. Therefore, except for the intention to reschedule the facility, it can be said that the evaluation of the National Health Insurance Corporation was partially validated.