Survey of Operation and Status of the Human Research Protection Program (HRPP) in Korea (2019) (임상시험 및 대상자보호프로그램의 운영과 현황에 대한 설문조사 연구(2019))
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- 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.
According to Soil Taxonomy which has been developed over the past 20 years in the soil conservation service of the U. S. D. A, Soils in Korea are classified. This system is well suited for the classification of the most of soils. But paddy field soils have some difficulties in classification because Soil Taxonomy states no proposals have yet been developed for classifying artificially irrigated soils. This paper discusses some problems in the application of Taxonomy and suggestes the classification of paddy field soils in Korea. Following is the summary of the paper. 1. Anthro aquic, Aquic Udipsamments : The top soils of these soils are saturated with irrigated water at some time of year and have mottles of low chroma(2 or less) more than 50cm of the soil surface. (Ex. Sadu, Geumcheon series) 2. Anthroaquic Udipsamments : These sails are like Anthroaquic, Aquic Udipsamments except for the mottles of low chroma within 50cm of the soil surface. (Ex. Baegsu series) 3. Halic Psammaquents : These soils contain enough salts as distributed in the profile that they interfere with the growth of most crop plants and located on the coastal dunes. The water table fluctuates with the tides. (Ex. Nagcheon series) 4. Anthroaquic, Aquic Udifluvents : They have some mottles that have chroma of 2 or less in more than 50cm of the surface. The upper horizon is saturated with irrigated water at sometime. (Ex. Maryeong series) 5. Anthro aquic Udifluvents : These soils are saturated with irrigated water at some time of year and have mottles of low chroma(2 or less) within 50cm of the surface soils. (Ex. Haenggog series) 6. Fluventic Haplaquepts : These soils have a content of organic carbon that decreases irregularly with depth and do not have an argillic horizon in any part of the pedon. Since ground water occur on the surface or near the surface, they are dominantly gray soils in a thick mineral regolith. (Ex Baeggu, Hagseong series) 7. Fluventic Thapto-Histic Haplaquepts : These soils have a buried organic matter layer and the upper boundary is within 1m of the surface. Other properties are same as Fluventic Haplaquepts. (Ex. Gongdeog, Seotan series) 8. Fluventic Aeric Haplaquepts : These soils have a horizon that has chroma too high for Fluventic Haplaquepts. The higher chroma is thought to indicate either a shorter period of saturation of the whole soils with water or some what deeper ground water than in the Fluventic Haplaquepts. The correlation of color with soil drainage classes is imperfect. (Ex. Mangyeong, Jeonbug series) 9. Fluventic Thapto-Histic Aeric Haplaquepts : These soils are similar to Fluventic Thapto Histic Haplaquepts except for the deeper ground water. (Ex. Bongnam series) 10. Fluventic Aeric Sulfic Haplaquepts : These soils are similar to Fluventic Aeric Haplaquepts except for the yellow mottles and low pH (<4.0) in some part between 50 and 150cm of the surface. (Ex. Deunggu series) 11. Fluventic Sulfaquepts : These soils are extremely acid and toxic to most plant. Their horizons are mostly dark gray and have yellow mottles of iron sulfate with in 50cm of the soil surface. They occur mainly in coastal marshes near the mouth of rivers. (Ex. Bongrim, Haecheog series) 12. Fluventic Aeric Sulfaquepts : They have a horizon that has chroma too high for Fluventic Sulfaquepts. Other properties are same as Fluventic Sulfaquepts. (Ex. Gimhae series) 13. Anthroaquic Fluvaquentic Eutrochrepts : These soils have mottles of low chroma in more than 50cm of the surface due to irrigated water. The base saturation is 60 percent or more in some subhroizon that is between depth of 25 and 75cm below the surface. (Ex. Jangyu, Chilgog series) 14. Anthroaquic Dystric Fluventic Eutrochrepts : These soils are similar to Anthroaquic Fluvaquentic Eutrochrepts except for the low chroma within 50cm of the surface. (Ex. Weolgog, Gyeongsan series) 15. Anthroaquic Fluventic Dystrochrepts : These soils have mottles that have chroma of 2 or less within 50cm of the soil surface due to artificial irrigation. They have lower base saturation (<60 percert) in all subhorizons between depths of 25 and 75cm below the soil surface. (Ex. Gocheon, Bigog series) 16. Anthro aquic Eutrandepts : These soils are similar to Anthroaquic Dystric Fluventic Eutrochrepts except for lower bulk density in the horizon. (Ex. Daejeong series) 17. Anthroaquic Hapludalfs : These soils' have a surface that is saturated with irrigated water at some time and have chroma of 2 or less in the matrix and higher chroma of mottles within 50cm of the surface. (Ex. Hwadong, Yongsu series) 18. Anthro aquic, Aquic Hapludalfs : These soils are similar to Anthro aquic Hapludalfs except for the matrix that has chroma 2 or less and higher chroma of mottles in more than 50cm of the surface. (Ex. Geugrag, Deogpyeong se ries)
We investigated what factors motivate gamers to participate in a guild and why they continue to be engaged as members of the guild. We find that, based on the result of focus group interviews with MMORPG gamers, social support and self-esteem factors play important roles. Considering both prior research and the focus group interviews we have conducted, we define social support and character control as independent variables. Character identity, guild identity, and self-esteem are proposed as mediating variables while guild flow and game loyalty as dependent variables. Accordingly, we develop the research model and hypotheses, and verify them empirically. Based on our experiences of playing the WoW game, we proposed a research model and conducted focus-group interviews (FGIs). FGIs involve formulating a hypothesis and then collecting some relevant data. FGIs were conducted face-to-face with students of C University in Korea. We formulated structured interview schedules, and the questions were based on our research variables and personal experiences. The questions for the interviews encompassed the following areas: (a) the demographic characteristics of the focus group; (b) the number of years for which respondents had played online games; (c) the motive for starting a game; (d) the number of game-characters assumed by each gamer; (e) the type of game played; and (f) other issues such as the reasons for involvement in the play, the willingness to reuse the game in case new versions were released, etc. On average, it took two hours to interview each of three groups. A primary set of FGIs was conducted with three groups on the premise that there would be some differences caused by character race (Horde vs. Alliance) or by playable server (Normal vs. Combat). With respect to the manner of playing, we found that guild members shared information, felt a sense of belonging, and played computer games for quite a long time through the guild; however, they did not undergo these experiences when playing alone. Gamers who belonged to a specific guild helped other players without expecting compensation for that, freely shared information about the game, gave away items for free, and more generous with other members who made mistakes. The guild members were aware of the existence other members and experienced a sense of belonging through interactions with, and evaluations from, other players. It was clear that social support was shown within the guild and that it played an important role as a major research variable. Based on the results of the first FGIs, a second set of in-depth FGIs was carried out with a focus on the psychology of the individual within the guild and the social community of the guild. The second set of FGIs also focused on the guild's offline meetings. Gamers, over all, recognize the necessity of joining a community, not only off-line but also online world of the guild. They admit that the guild is important for them to easily and conveniently enjoy playing online computer games. The active behavior and positive attitudes of existing guild members can motivate new members of the guild to adapt themselves to the guild environment. They then adopt the same behaviors and attitudes of established guild members. In this manner, the new members of the guild strengthen the bonds with other gamers while feeling a sense of belonging, and developing social identity, thereby. It was discovered that the interaction among guild members and the social support encouraged new gamers to quickly develop a sense of social identity and increase their self-esteem. The guild seemed to play the role of socializing gamers. Sometimes, even in the real world, the guild members helped one another; therefore, the features of the guild also spilled over to the offline environment. We intend to use self-esteem, which was found through the second set of FGIs, as an important research variable. To collect data, an online survey was designed with a questionnaire to be completed by WoW gamers, who belong to a guild. The survey was registered on the best three domestic game-sites: 'WoW playforum,' 'WoW gamemeca,' and 'Wow invent.' The selected items to be measured in the questionnaire were decided based on prior research and data from FGIs. To verify the content of the questionnaire, we carried out a pilot test with the same participants to point out ambiguous questions as a way to ensure maximum accuracy of the survey result. A total of 244 responses were analyzed from the 250 completed questionnaires. The SEM analysis was used to test goodness-of-fit of the model. As a result, we found important results as follows: First, according to the statistics, social support had statistically significant impacts on character control, character identity, guild identity and self-esteem. Second, character control had significant effects on character identity, guild identity and self-esteem. Third, character identity shows its clear impact on self-esteem and game loyalty. Fourth, guild identity affected self-esteem, guild flow and game loyalty. Fifth, self-esteem had a positive influence on the guild flow. These days, the number of virtual community is rising along with its significance largely because of the nature of the online games. Accordingly, this study is designed to clarify the psychological relationship between gamers within the guild that has been generally established by gamers to play online games together. This study focuses on the relationships in which social support influences guild flow or game loyalty through character control, character identity, guild identity, and self-esteem, which are present within a guild in the MMORPG game environment. The study results are as follows. First, the effects of social support on character control, character identity, guild identity and self-esteem are proven to be statistically significant. It was found that character control improves character identity, guild identity and self-esteem. Among the seven variables, social support, which is derived from FGIs, plays an important role in this study. With the active support of other guild members, gamers can improve their ability to develop good characters and to control them. Second, character identity has a positive effect on self-esteem and game loyalty, while guild identity has a significant effect on self-esteem, guild flow and game loyalty. Self-esteem affects guild flow. It was found that the higher the character and guild identities become, the greater the self-esteem is established. Contrary to the findings of prior research, our study results indicate that the relationship between character identity and guild flow is not significant. Rather, it was found that character identity directly affects game players' loyalty. Even though the character identity had no direct effect on increasing guild flow, it has indirectly affected guild flow through self-esteem. The significant relationship between self-esteem and guild flow indicates that gamers achieve flow, i.e., a feeling of pleasure and excitement through social support. Several important implications of this study should be noted. First, both qualitative and quantitative methods were used to conduct this study. Through FGIs, it was observed that both social support and self-esteem are important variables. Second, because guilds had been rarely studied, this research is expected to play an important role in the online community. Third, according to the result, six hypotheses (H1, H5, H6, H7, H8, and H11) setup based on FGIs, were statistically significant; thus, we can suggest the corresponding relationships among the variables as a guideline for follow-up research. Our research is significant as it has following implications: first, the social support of the guild members is important when establishing character control, character identity, guildidentity and self-esteem. It is also a major variable that affects guild flow and game loyalty. Second, character control when improved by social support shows notable influence on the development of character identity, guild identity and self-esteem. Third, character identity and guild identity are major factors to help establish gamers' own self-esteem. Fourth, character identity affects guild flow through self-esteem and game loyalty. The gamers usually express themselves through characters; the higher character identity is, the more loyalty a gamer has. Fifth, guild identity, established within the guild, has clear effects on self-esteem, guild flow and game loyalty. Sixth, qualitative and quantitative methods are employed to conduct this study. Based on the results of focus group interviews and SEM analysis, we find that the social support by guild members and psychological factors are significant in strengthening the flow of guild and loyalty to the game. As such, game developers should provide some extra functions for guild community, through which gamers can play online games in collaboration with one another. Also, we suggest that positive self-esteem which is built up through social support can help gamers achieve higher level of flow and satisfaction, which will consequently contribute to minimizing the possibility for the players to develop negative attitude toward the guild they belong to.
Go bears significant meanings in terms of cultural and entertaining functions in Asia Eastern such as China and Japan. Beyond the mere entertaining level, it produces philosophical and mythic discourse as well. As a part of effort to seek an identity of Korean traditional garden culture, this study traced back to find meanings of rock-go-board and taste for the arts which ancestors pursued in playing Go game, through analysis and interpretation of correlation among origin of place name, nearby scenery, carved letters and vicinal handed-down place name. At the same time, their position, shape and location types were interpreted through comprehensive research and analysis of stone-go-boards including rock-go-board. Particularly, it focused on the rock names related to Sundoism(仙道) Ideal world, fixed due to a connection between traces of Sundoism and places in a folk etymology. Series of this work is to highlight features of the immortal sceneries, one of traditional landscaping ideals, by understanding place identity and scenic features of where the rock-go-boards are carved. These works are expected to become foundation for promotion and preservation of the traditional landscaping remains. The contents of this study could be summarized as follows; First, round stone and square board for round sky and angled land, black and white color for harmony of yin and yang and 361paths for rotating sky are symbols projecting order of universe. Sayings of Gyuljungjirak(橘中之樂), Sangsansaho(商山四皓), Nangagosa(爛柯故事) formed based on the idea of eternity stand for union of sky and sun. It indicates Go game which matches life and nature spatiotemporally and elegant taste for arts pursuing beauty and leisure. Second, the stone-go-boards found through this research, are 18 in total. 3 of those(16.1%), Gangjin Weolnamsaji, Yangsan Sohanjeong and Banryongdae ones were classified into movable Seokguk and 15(83.9%) including Banghakdong were turned out to be non-movable rock-go-boards carved on natural rocks. Third, upon the result of materializing location types of rock-go-boards, 15 are mountain stream type(83.9%) and 3 are rock peak type(16.1%). Among those, the one at Sobaeksam Sinseonbong is located at the highest place(1,389m). Considering the fact that all of 15 rock-go-boards were found at mountainous areas lower than 500m, it is recognizable that where the Go-boards are the parts of the living space, not far from secular world. Fourth, there are 7 Sunjang(巡將) Go with 17 Hwajeoms(花點), which is a traditional Go board type, but their existences, numbers and shapes of Hwajeom appear variously. Based on the fact, it is recognizable that culture of making go-board had been handed down for an extended period of time. Among the studied rock-goboards, the biggest one was Muju Sasunam[