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Survey of Operation and Status of the Human Research Protection Program (HRPP) in Korea (2019) (임상시험 및 대상자보호프로그램의 운영과 현황에 대한 설문조사 연구(2019))

  • Maeng, Chi Hoon;Lee, Sun Ju;Cho, Sung Ran;Kim, Jin Seok;Rha, Sun Young;Kim, Yong Jin;Chung, Jong Woo;Kim, Seung Min
    • The Journal of KAIRB
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    • v.2 no.2
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    • pp.37-48
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    • 2020
  • Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

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A Study on Conceptual Suitability or Unfitness of 'Silhak' ('실학實學' 개념의 적합성 또는 부적합성에 관한 연구)

  • Kang, Jeong-Hoo
    • Journal of Ethics
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    • no.88
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    • pp.103-122
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    • 2013
  • This paper aims to study on conceptual suitability or unfitness of Silhak(實學). It is general that by criticizing Chujahak(朱子學) or beyond the limitation of Seonglihak(性理學), Silhak has developed practical tendency to reforming the society in the middle and end of Chosen Dynasty, related to the context of Korean national reflection in modern times. However, it is unfortunate to be understood. As presented in Chosenwangjosillok(『朝鮮王朝實錄』), there has been a few usages in the term 'Silhak'. In short, it was different from its contemporary meaning. At that time, it was usually used to have the meaning of Gyunghak(經學), compared to Sajanghak(詞章學), or rarely, of 'the true study' or 'the practical study'. Therefore, it is to claim that its conception has been manipulated or exaggerated very seriously. Since 1930s, in particular, its conception has been misused in interpreting works of Jung Yak-Yong by some scholars, such as Jung In-Bo, Moon Il-Pyung and An Jae-Hong, who tried to apply the term to overcome the Japanese colonial era symbolised as modernity based on the future life of Korea. Even though their attempt has led to have crucial discussions on the conceptions of Silhak, it has an unnecessary result that there has been a new and totally different understanding of Silhak in South Korea, North Korea, China, Japan, etc., which means that the unsustainable conception of Silhak has been one of major problems in studying of Silhak. To give an practical solution, I would try to make sense of 'time spirit' whose scholars studied Silhak in the middle and end of Chosen Dynasty. A problem, however, is that a scholar group in the name of Bukhakpa(北學派) had certain links and bonds. This is because many scholars studying of Silhak were usually features out of the main stream, which made them it difficult to form any various groups. That is to say, it seems to be natural that they have dreamed of utopian imaginations less than of overlapping points in reality. To sum up, it would be concluded at least that any approach to human lives and thoughts in the given conceptions of Silhak, e.g. ethical thoughts of Silhak, enables us to be indifferentiated to take its true meaning and time spirit of Chosen Dynasty. To be disenchanted of its social roles in Chosen Dynasty, fundamentally, it should be escaped from the wrong net of illusions and sings in understanding Silhak in certain eclectic steps.

A Study on Problems and Improvement of Home-help Services of Long-term Care Insurance (노인장기요양보험 재가서비스의 문제점과 개선방안)

  • Lee, Jun Woo;Jin, Hee
    • 한국노년학
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    • v.29 no.1
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    • pp.149-175
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    • 2009
  • The purpose of this research is to analyze the overall problems at the moment of October 2008, and then to find the improvements of home-help services of the Long-Term Care Insurance(LTCI), which has been revealed many problems since it was released in July 2008. The research uses the literature survey which analyzes 2nd-hand materials studied by other people already, and survey research was executed from active social workers in the area of LTCI. Based on the policy analysis framework of Gilbert and Specht, all the data are analyzed in the scopes of client·benefit(service)·finance·transferring system. This research has found the problems in each scope of home-help services of the LTCI. Firstly, the client system has some problems in mismatching between registered and service clients, estimating client number, and judging service levels. Secondly, the service system reveals deficiency in professionality of social workers, service quality lowering by loose qualification criteria on workers, non-reasonable limitation of service time available, and the same fare system applied to visiting-help service in spite of different levels. Thirdly, in financing system, clients need to pay additional money to get extra services such as meal, hair cutting, bathing etc., due to government financial support stopped, some organizations have to reduce services and replace full-time workers to part-time ones, which makes the service quality worse. Lastly, in the transferring system, the management system for service quality is not well prepared. There are too much competion because of allowing too many home-help service organizations and care worker academies. The suggestions that this research has found to improve the policy are as follows. ① It is desirable to make the registered clients the service ones as many as possible in the long term perspective. ② The LTCI organization requires more workers and higher professionality. ③ Many elderly people who are not eligible now require connection system to be more served. ④ Management system and service manual for care worker are to be developed. ⑤ Laws related to the service contents and process should be modified, the proportion of client charge needs to adjust. ⑥ Home-help service organization licensed by the LTCI needs to be financially supported publicly. ⑦ Monitoring system to home-help service organization needs to be strengthened. ⑧ Evaluation tools to home-help service organization and workers is required. ⑨ Specification to open the home-help service organization needs to be more strict.

A Study of Postural Control Characteristics in Schoolchild with Intellectual Disability (초등학교 지적장애아동의 자세조절 특성)

  • Lee, Hyoung Soo
    • 재활복지
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    • v.14 no.3
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    • pp.225-256
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    • 2010
  • This study aims to provide the basic data of the rehabilitation program for the schoolchild with intellectual disability by designing new framework of the features of postural control for the schoolchild with intellectual disability. For this, the study investigated what sensations the schoolchild are using to maintain posture by selectively or synthetically applying vision, vestibular sensation and somato-sensation, and how the coordinative sensory system of the schoolchild is responding to any sway referenced sensory stimulus. The study intended to prove the limitation of motor system in estimating the postural stability by providing the cognitive motor task, and provided the features of postural control of the schoolchild with intellectual disability by measuring the onset times and orders of muscle contraction of neuron-muscle when there is a postural control taking place due to the exterior disturbance. Furthermore, by comparatively analyzing the difference between the normal schoolchild and the intellectually disabled schoolchild, this study provided an optimal direction for treatment planning when the rehabilitation program is applied in the postural control ability training program for the schoolchild with intellectual disability. Taking gender and age into consideration, 52 schoolchild including 26 normal schoolchild and 26 intellectually disabled schoolchild were selected. To measure the features of postural control, CTSIB test, and postural control strategy test were conducted. The result of experiment is as followed. First, the schoolchild with intellectual disability showed different feature in using sensory system to control posture. The normal schoolchild tended to depend on somato-sensory or vision, and showed a stable postural control toward a sway referenced stimulus on somato-sensory system. The schoolchild with intellectual disability tended to use somato-sensory or vision, and showed a very instable postural control toward a sway referenced vision or a sway referenced stimulus on somato-sensory system. In sensory analysis, the schoolchild with intellectual disability showed lower level of proficiency in somato-sensation percentile, vision percentile and vestibular sensation percentile compare to the normal schoolchild. Second, as for the onset times and orders of muscle contraction for strategies of postural control when there is an exterior physical stimulus, the schoolchild with intellectual disability showed a relatively delayed onset time of muscle control, and it was specially greater when the perturbation is from backward. As for the onset orders of muscle contraction, it started from muscles near coax then moved to the muscles near ankle joint, and the numbers and kinds of muscles involved were greater than the normal schoolchild. The normal schoolchild showed a fast muscle contracting reaction from every direction after the perturbation stimulus, and the contraction started from the muscles near the ankle joint and expanded to the muscles near coax. From the results of the experiments, the special feature of the postural control of the schoolchild with intellectual disability is that they have a higher dependence on vision in sensory system, and there was no appropriate integration of swayed sensation observed in upper level of central nerve system. In the motor system, the onset time of muscle contraction for postural control was delayed, and it proceeded in reversed order of the normal schoolchild. Therefore, when use the clinical physical therapy to improve the postural control ability, various sensations should be provided and should train the schoolchild to efficiently use the provided sensations and use the sensory experience recorded in upper level of central nerve system to improve postural control ability. At the same time, a treatment program that can improve the processing ability of central nerve system through meaningful activities with organizing and planning adapting reaction should be provided. Also, a proprioceptive motor control training program that can induce faster muscle contraction reaction and more efficient onset orders from muscularskeletal system is need to be provided as well.

An Empirical Investigation of Relationship Between Interdependence and Conflict in Co-marketing Alliance (공동마케팅제휴에 있어 상호의존성과 갈등의 관계에 대한 연구)

  • Yi, Ho Taek;Cho, Young Wook;Kim, Ju Young
    • Asia Marketing Journal
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    • v.13 no.3
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    • pp.79-102
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    • 2011
  • Researchers in channel dyads have devoted much attention to relationship between interdependence (i.e. interdependence enymmetry and total interdependence) and conflict that promote channel performance. In social science, in spite of the inconsistent results in marketing practice, there are two contradictory theories explain the relationship between interdependence and conflict - bilateral deterrence theory and conflict spiral theory. The authors apply these theories to co-marketing alliance situation in terms that this relationship is also incorporated both company's dependence, either from one company's perspective or each partner about its respective dependence. Using survey data and archival data from 181 companies enlisted in a telecommunication membership program, the authors find out the relationship between interdependence and conflict as well as investigate the antecedents of interdependence - transaction age, transaction frequency, the numbers of alliance partner, and co-marketing alliance specific assets according to previous researches. Using PLS analysis, the authors demonstrate that, with increasing total interdependence in a telecommunication membership program, two co-marketing partners' conflict level is increased in accord with the author's conflict spiral theory predictions. As expected, higher interdependence asymmetry has negative value to level of conflict even though this result is not statistically significant. Other findings can be summarized as follows. In the perspective of telecommunication company, transaction age, transaction frequency, and co-marketing alliance specific assets have influence on its dependence on a partner as independent variables. To the contrary, in a partner's perspective, transaction frequency, co-marketing alliance specific assets and the numbers of alliance partner have significantly impact on its dependence on a telecommunication company. In direct effect analysis, it is shown that transaction age, frequency and co-marketing alliance specific assets have direct influence on conflict. This results suggest that it is more useful for a telecommunication company to select a co-marketing partner which is frequently used by customers and earned high rates of mileage. In addition, the results show that dependence of a telecommunication company on a co-marketing partner is more significantly effected to co-marketing alliance conflict than partner's one. It provide an effective conflict management strategy to a telecommunication company for controling customer's usage rate or having the co-marketing partner deposit high level of alliance specific investment (i.e. mileage). To a co-marketing partner of telecommunication company, it is required control the percentage of co-marketing sales in total sales revenue or seek various co-marketing partners in order for co-marketing conflict management. The research implications, limitation and future research of these results are discussed.

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Five-year monitoring of microbial ecosystem dynamics in the coastal waters of the Yeongheungdo island, Incheon, Korea (대한민국 인천 영흥도 인근 해역 미소생태계의 5년간의 군집구조 변화 모니터링)

  • Sae-Hee Kim;Jin Ho Kim;Yoon-Ho Kang;Bum Soo Park;Myung-Soo Han;Jae-Hyoung Joo
    • Korean Journal of Environmental Biology
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    • v.41 no.3
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    • pp.179-192
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    • 2023
  • In this study, changes in the microbial ecosystem of the Yeongheungdo island coastal waters were investigated for five years to collect basic data. To evaluate the influence of distance from the coast on the microbial ecosystem, four sites, coastal Site (S1) and 0.75, 1.5, and 3 km away from the coast, were set up and the changes in physicochemical and biological factors were monitored. The results showed seasonal changes in water temperature, dissolved oxygen, salinity, and pH but with no significant differences between sites. For nutrients, the concentration of dissolved inorganic nitrogen increased from 6.4 μM in April-June to 16.4 μM in July-November, while that of phosphorus and silicon phosphate increased from 0.4 μM and 2.5 μM in April-June to 1.1 μM and 12.0 μM in July-November, respectively. Notably, phosphorus phosphate concentrations were lower in 2014-2015 (up to 0.2 μM) compared to 2016-2018 (up to 2.2 μM), indicating phosphorus limitation during this period. However, there were no differences in nutrients with distance from the coast, indicating that there was no effect of distance on nutrients. Phytoplankton (average 511 cells mL-1) showed relatively high biomass (up to 3,370 cells mL-1) in 2014-2015 when phosphorus phosphate was limited. Notably, at that time, the concentration of dissolved organic carbon was not high, with concentrations ranging from 1.1-2.3 mg L-1. However, no significant differences in biological factors were observed between the sites. Although this study revealed that there was no disturbance of the ecosystem, further research and more basic data on the microecosystem are necessary to understand the ecosystem of the Incheon.

Factors and Elements for Cross-border Entrepreneurial Migration: An Exploratory Study of Global Startups in South Korea (델파이 기법과 AHP를 이용한 글로벌 창업이주 요인 탐색 연구: 국내 인바운드 사례를 중심으로)

  • Choi, Hwa-joon;Kim, Tae-yong;Lee, Jungwoo
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.17 no.4
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    • pp.31-43
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    • 2022
  • Startups are recognized as the vitality of the economy, and countries are competing to attract competitive overseas entrepreneurs and startups to their own startup ecosystem. In this global trend, entrepreneurs cross the border without hesitation, expecting abundant available resources and a startup friendly environment. Despite the increasing frequency of start-up migration between countries, studies related to this are very rare. Therefore, this study has chosen the cross-border migration of startups between countries as a research topic, and those who have been involved in the cross-border entrepreneurial migration to South Korea as a research sample. This study consists of two stages. The first research stage hires a Delphi method to collect expert opinions and find major factors related to the global startup migration. Drawing on the prior literature on the regional startup ecosystem at the national level, this stage is to conduct expert interviews in order to discover underlying factors and subfactors important for global migration of startups. The second stage measures the importance of the factors and subfactors using the AHP model. The priorities of factors and factors were identified hiring the overseas entrepreneurs who moved to Korea as the AHP survey samples. The results of this study suggest some interesting implications. First, a group of entrepreneurs with nomadic tendencies was found in the trend of global migration of entrepreneurs. They had already started their own businesses with the same business ideas in multiple countries before settling down in Korea. Second, important unique factors and subfactors in the context of global start-up migration were identified. A good example is the government's support package, including start-up visas. Third, it was possible to know the priority of the factors and subfactors that influence the global migration of startups This study is meaningful in that it preemptively conducted exploratory research focusing on a relatively new phenomenon of global startup migration, which recently catches attention in the global startup ecosystem. At the same time, it has a limitation in that it is difficult to generalize the meanings found in this study because the research was conducted based on the case of South Korea

Factors Influencing the Social and Economic Performance of High-Tech Social Ventures (하이테크 소셜벤처의 사회적·경제적성과에 미치는 영향요인)

  • Kim, Hyeong Min;Kim, Jin Soo
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.17 no.1
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    • pp.121-137
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    • 2022
  • The purpose of this study is to present the necessary success factors and strategies for high-tech social ventures and stakeholders in the related ecosystem by empirically identifying factors that affect their sustainable performance. Based on prior research, the dimensions of three performance factors were presented: core technology competency, core business competency, and social mission orientation. Then, such sub-dimensions such as technology innovation orientation, R&D capability, business model, customer orientation, social network, and social mission pursuit were derived. For empirical analysis, a survey was conducted on domestic high-tech social ventures, and the significance of the hypothesis was tested through PLS-structural equation analysis of the collected 243 valid data. As a result, it was found that the technology innovation orientation was embedded as an abstract organizational and cultural characteristic in the high-tech social venture, which is a research sample, and thus did not significantly affect the dependent variable. In other words, aiming for the latest cutting-edge technology alone cannot affect performance, and it is a result of proving the need for substantial influencing factors that can strengthen it. On the other hand, the business model had a significant effect only on social performance, which is presumed to be the limitation of measurement tools developed for social enterprises, and the results of additional multi-group analysis to determine the cause also supported the basis for this estimation. Excluding the previous two performance factors, R&D competency, customer orientation, social network, and social mission pursuit were all found to have a significant positive (+) effect on social and economic performance. This study laid a foundation for related research by identifying high-tech social ventures emerging in the ecosystem of a social economy and expanded empirical research models related to the performance of existing social enterprises and social ventures. However, in the research method or process, there were limitations such as factor derivation or verification for balance of dual performance, subjective measurement method, and sample representativeness. It is expected that more in-depth follow-up studies will continue by supplementing future limitations and designing improved research models.

A Study on the Effects of Entrepreneurial Marketing Orientation on the Management Performance: Mediated Effect of Organizational Marketing Capabilities (창업자의 앙트레프레니얼 마케팅 지향성이 경영성과에 미치는 영향: 조직내 마케팅역량의 매개효과)

  • Byun, Hong Joo;Byun, Chung Gyu;Ha, Hwan Ho
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.17 no.4
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    • pp.87-100
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    • 2022
  • Early start-up companies have an inherent limitation of lack of resources. Despite these limitations, in order to survive, the entrepreneur's personal ability to efficiently use limited resources is required. In the marketing field, various studies are needed to reduce the business failure rate through establishing growth strategies and innovation. Accordingly, it is necessary to apply the concept of entrepreneurial marketing, which has been researched and developed overseas for 30 years, to fit the domestic reality. According to the flow of this study, an empirical study should be preceded to clarify the influence relationship between entrepreneurial marketing orientation, marketing competency, and management performance, along with a theoretical theorem on entrepreneurial marketing that is suitable for early start-ups and small and medium-sized enterprises(SMEs) and can respond innovatively to changes. The establishment of entrepreneurial marketing orientation and the processes from which this concept leads to business performance through the organization's marketing capabilities and its effects will be empirically verified. For an empirical survey, a survey was conducted on founders of 220 companies, and path analysis using structural equations was used for hypothesis verification. The findings are as follows. First, it was found that the entrepreneurial marketing orientation had a positive effect on both the organization's marketing capabilities and management performance. Second, it was found that the organization's marketing capabilities also had a positive effect on management performance. Third, as a result of empirical analysis of the mediating effect of the organization's marketing capabilities on the relationship between entrepreneurial marketing orientation and management performance, it was found that marketing capabilities showed a greater mediating effect on non-financial performance than financial performance. On the other hand, it was confirmed that marketing performance had a stronger mediating effect on financial performance than non-financial performance. By confirming and presenting the concept and constituent factors of entrepreneurial marketing orientation of domestic start-ups, which were academic gaps for the purpose of this paper, the academic research is differentiated in that they were verified as six components of entrepreneurial marketing. The practical implications of the research results will be that the entrepreneurial marketing-oriented mindset of small and medium-sized companies will optimize market analysis capabilities, network with various stakeholders, and increase the organization's ability to demonstrate marketing capabilities.

Satisfaction Survey on Video Lectures using the Metaversity App (메타버시티 앱을 이용한 동영상 강의 만족도 조사)

  • Jeongkyu Park;Byeongkyou Jeon;KyeongHwan Jeong
    • Journal of the Korean Society of Radiology
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    • v.18 no.2
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    • pp.101-108
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    • 2024
  • Recently, Metaverse technology has emerged as an important topic in various fields. Metaverse refers to a three-dimensional virtual space in which social and economic activities similar to the real world are possible. Among the 235 third-year students who applied the Metaversity app in the radiology department of this university from September to December 2023, 200 participated in a survey to determine the difference in student response and satisfaction when applying the Metaversity app. analyzed. First, the most satisfactory VOD viewing method was viewing through the Metaversity app, followed by viewing through the LMS. Second, 'I think online videos are appropriate for holiday reinforcement.' showed the highest score at 4.35±0.60, 'I want face-to-face classes and online classes to be held simultaneously.' was 4.25±0.87, and 'I think meta. 'I watched it well through the Metaversity app' was the lowest at 4.10±0.30, and 'VOD viewing through the Metaversity app was used appropriately in class' was the lowest at 3.99±0.75. Also, there was no significant difference in the response to the teaching method (p>0.05). Third, in terms of satisfaction with VOD viewing using the Metaversity app, 'Applying the Metaversity app was interesting and fun' ranked the highest at 4.24±0.88. The score was high, with 'Better improvement is needed to actively utilize the metaversity app' at 4.00±0.45, and 'I hope the metaversity app is implemented in other remote classes' at 3.77±0.88. appear. 'VOD classes through the Metaversity app are better than the existing LMS method.' was found to be 3.44±0.66. Additionally, there was no significant difference in satisfaction with classes according to age and gender (p>0.05). The correlation between response and satisfaction with the metaversity app is 0.601, which can be considered very significant (p>0.001). As a limitation of this study, although we surveyed students' satisfaction with using the Metaversity app, we were unable to investigate the satisfaction of instructors who interact with students. In the future, we did not consider the instructor's satisfaction in classes using the Metaversity app. Research must be conducted, and universities must have institutional support and continued interest until metaversity apps are selected and used to prepare for distance learning.