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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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Embryonic and Larval Development of Slender Catfish, Silurus microdorsalis Mori, 1936, Endemic to Korea (한국 고유종 미유기(Silurus microdorsalis Mori, 1936)의 난 발생 및 자치어 형태발달)

  • Kang-Rae Kim;Yeong-Ho Kwak;Mu-Sung Sung;Heon Yang;Seong-Jang Cho;Bong Han Yun;In-Chul Bang
    • Korean Journal of Ichthyology
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    • v.35 no.2
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    • pp.91-100
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    • 2023
  • The early life history of Silurus microdorsalis living in Jahocheon Stream was studied by observing egg and morphological development. Live fish were captured in June 2018, then reared in a circulating filtration system under a 14L : 10D photoperiod with a water temperature of 18℃. To artificially induce spawning, females were injected with 0.5 mL of Ovaprim (Syndel, Nanaimo, BC, Canada) per kg of body weight, and males were injected with 10,000 IU/kg body weight of human chorionic gonadotropin. Approximately 15 h later, eggs were artificially inseminated by the dry method. Mature eggs were light pale yellow, which separated them from immature eggs. Fertilized eggs were 2.16±0.06 mm (n=8) in diameter and fully hatched at 181 h after fertilization. The fertilization rate was 63.1±2.2%, and 10.0±3.7% of the embryos were malformed at 18℃. The rates of development were 181 h at 18℃, 109 h at 21℃, and 76 h at 24℃. The larval size immediately after hatching was 4.64±0.22 mm (n=8), and the larvae displayed negative phototaxis at 1 day after hatching. The total larval length on 7 days after hatching was 12.47±0.53 mm, with 25~30 basal anal fin rays and 14~16 basal caudal fin rays observed. The total larval length was 14.13±0.51 mm on 9 days after hatching, and approximately 90% of the black endoplasmic reticulum was deposited on the head and body. The dorsal fin had formed, and a single basal body was observed. On 15 days after hatching, the total larval length was 16.69±0.31 mm; the number of basal caudal fin rays (18 poles) was an integer because 2 dorsal fin basal rays and 60~63 anal fin basal rays were observed. The total larval length was 28.96±1.10 mm on 50 days after hatching; the numbers of caudal fins (n=18), dorsal fins (n=3), pectoral fins (n=11), and anal fin basal rays (n=67~73) were integers.

Adaptable Tropical Japonica High quality New Rice Cultivar 'Japonica 6' (열대지역 적응 고품질 자포니카 벼 신품종 'Japonica 6')

  • Jeong, O-Young;Torollo, Gideon;Bombay, Maurene;Baek, Man-Kee;Ahn, Eok-keun;Hyun, Woong-Jo;Park, Hyun-Su;Jeong, Jong-Min;Cho, Jun-Hyeon;Lee, Jeong-Heui;Yeo, Un-Sang;Lee, Jeom-Sig;Jeong, Eung-Gi;Kim, Choon-Song;Suh, Jung-Pil;Kim, Bo-Kyeong;Lee, Jeom-Ho
    • Journal of the Korean Society of International Agriculture
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    • v.31 no.3
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    • pp.249-254
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    • 2019
  • 'Japonica 6' is a japonica rice variety developed from a cross between 'MS11', the beginning variety adaptable to tropical region, and 'IR86743-28-1-4', an elite line of high yield and good plant type by a Korea(RDA)-IRRI cooperative breeding program at IRRI in 2017. The growth duration of 'Japonica 6' is 121 days from sowing to harvest. It is 10 days later than that of the check variety 'MS11'. The culm length of 'Japonica 6' is 70 cm, and 1,000-brown rice grain weight is 26.7 g. It has a shorter culm and a larger grain. size than that of MS11. 'Japonica 6' is moderately resistant to blast disease but susceptible to bacterial blight, tungro virus and plant hoppers. The milled rice recovery rate of 'Japonica 6' is improved than that of 'MS11'. The head rice rate of 'Japonica 6' is significantly higher than that of 'MS11'. Yield of 'Japonica 6' is averagely 3.59 MT/ha of milled rice in 5 areas of the Philippines. The 'Japonica 6' was registered in Philippines and would be adaptable to the diverse regions of tropical Asia (Registration No in Philippines. BPI-NSIC-2017-Rc 484SR).

A Wide Region of Tropical Asia Adaptable Japonica Rice 'Asemi' (아시아 광지역 적응성 자포니카 벼 '아세미')

  • Jeong, Eung-Gi;kang, Kyeong-Ho;Hong, Ha-Cheol;Cho, Young-Chan;Jung, O-Young;Jeon, Yong-Hee;Chang, Jae-Ki;Lee, Jeom-Ho;Won, Yong-Jae;Yang, Un-Ho;Jung, Kuk-Hyun;Yeo, Un-Sang;Kim, Bo-Kyeong
    • Journal of the Korean Society of International Agriculture
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    • v.31 no.1
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    • pp.76-81
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    • 2019
  • 'Asemi' is a rice variety derived from a cross between 'Jinmibyeo' which has translucent milled rice and medium maturity and 'Cheolwon46', an elite line with high yield and early maturity by the rice breeding team at NICS, RDA in 2013. The heading date of 'Asemi' is August 1, six days earlier than the check variety 'Hwaseong'. It has 82 cm culm length and 109 spikelets per panicle. 'Asemi' is resistant to blast disease, stripe virus and tungro virus, but susceptible to other viruses and planthoppers. The milled rice of this variety exhibits translucent, clear non-glutinous endosperm and short grain shape. It has protein content (6.7%) higher than 'Hwaseong', and amylose content (19.5%) similar to 'Hwaseong'. The milled rice recovery rate of 'Asemi' is similar to that of 'Hwaseong'. However, the head rice rate of 'Asemi' is higher than that of 'Hwaseong'. Milled rice yield of 'Asemi' is 5.23 MT/ha in ordinary cultivation. ' Asemi' could be adaptable to the wide region of tropical Asia (Registration No. 5639).

Comparison of Rice Growth and Yield in Different Direct Seeding Methods Following by Italian Ryegrass Harvest (사료작물 후작 벼 직파 방법별 생육 및 수량 비교)

  • Park, K.H.;Park, S.T.
    • Journal of Practical Agriculture & Fisheries Research
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    • v.21 no.1
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    • pp.49-59
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    • 2019
  • The field trial was performed to evaluate the rice growth and yield in different direct seeding methods after Italian Ryegrass Harvest The required time for seed emergence was for 7 ~ 8days in the tested direct seeding methods and there was high in seedling establishment in order of wet hill-seeding with iron-coated seeds > water seeding with iron-coated seeds > wet hill-seeding with soil coverage with pregerminated seeds. The rice plant height was shorter in the tested direct seeding methods than that of machine transplanting until 45day after seeding but there was not significant difference in terms of statistical analysis at 63day after seeding. The growth of tiller number in the rice plant was high in water seeding with iron-coated seeds and wet hill-seeding with soil coverage and low in wet hill-seeding with iron-coated seeds compared to machine transplanting. The yield component in the tested direct seeding methods was not significant difference in terms of statistical analysis. The milled rice yield in the tested direct seeding methods was higher 2 ~ 8% being with 4.94 ~ 5.24t/ha than that of machine transplanting but there was not significant difference in terms of statistical analysis. The percentage of head rice was low in the tested direct seeding methods compared to machine transplanting. The weedy rice was not occurred in the tested rice cultivation methods. In conclusion the direct seeding method would be recommended to be a suitable to in following by Italian ryegrass harvesting in southern area of Korea in terms of reduction in production cost and high income basis for rice growing farmers.

Estimation of Rice Heading Date of Paddy Rice from Slanted and Top-view Images Using Deep Learning Classification Model (딥 러닝 분류 모델을 이용한 직하방과 경사각 영상 기반의 벼 출수기 판별)

  • Hyeok-jin Bak;Wan-Gyu Sang;Sungyul Chang;Dongwon Kwon;Woo-jin Im;Ji-hyeon Lee;Nam-jin Chung;Jung-Il Cho
    • Korean Journal of Agricultural and Forest Meteorology
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    • v.25 no.4
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    • pp.337-345
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    • 2023
  • Estimating the rice heading date is one of the most crucial agricultural tasks related to productivity. However, due to abnormal climates around the world, it is becoming increasingly challenging to estimate the rice heading date. Therefore, a more objective classification method for estimating the rice heading date is needed than the existing methods. This study, we aimed to classify the rice heading stage from various images using a CNN classification model. We collected top-view images taken from a drone and a phenotyping tower, as well as slanted-view images captured with a RGB camera. The collected images underwent preprocessing to prepare them as input data for the CNN model. The CNN architectures employed were ResNet50, InceptionV3, and VGG19, which are commonly used in image classification models. The accuracy of the models all showed an accuracy of 0.98 or higher regardless of each architecture and type of image. We also used Grad-CAM to visually check which features of the image the model looked at and classified. Then verified our model accurately measure the rice heading date in paddy fields. The rice heading date was estimated to be approximately one day apart on average in the four paddy fields. This method suggests that the water head can be estimated automatically and quantitatively when estimating the rice heading date from various paddy field monitoring images.

Development of a prototype simulator for dental education (치의학 교육을 위한 프로토타입 시뮬레이터의 개발)

  • Mi-El Kim;Jaehoon Sim;Aein Mon;Myung-Joo Kim;Young-Seok Park;Ho-Beom Kwon;Jaeheung Park
    • The Journal of Korean Academy of Prosthodontics
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    • v.61 no.4
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    • pp.257-267
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    • 2023
  • Purpose. The purpose of the study was to fabricate a prototype robotic simulator for dental education, to test whether it could simulate mandibular movements, and to assess the possibility of the stimulator responding to stimuli during dental practice. Materials and methods. A virtual simulator model was developed based on segmentation of the hard tissues using cone-beam computed tomography (CBCT) data. The simulator frame was 3D printed using polylactic acid (PLA) material, and dentiforms and silicone face skin were also inserted. Servo actuators were used to control the movements of the simulator, and the simulator's response to dental stimuli was created by pressure and water level sensors. A water level test was performed to determine the specific threshold of the water level sensor. The mandibular movements and mandibular range of motion of the simulator were tested through computer simulation and the actual model. Results. The prototype robotic simulator consisted of an operational unit, an upper body with an electric device, a head with a temporomandibular joint (TMJ) and dentiforms. The TMJ of the simulator was capable of driving two degrees of freedom, implementing rotational and translational movements. In the water level test, the specific threshold of the water level sensor was 10.35 ml. The mandibular range of motion of the simulator was 50 mm in both computer simulation and the actual model. Conclusion. Although further advancements are still required to improve its efficiency and stability, the upper-body prototype simulator has the potential to be useful in dental practice education.

A Case Study on the Success Factors of Overseas Agricultural Startup: Focusing on the Case of Banana Farm in Cote d'Ivoire (해외 농업스타트업(Agricultural Startup) 성공요인에 관한 사례연구: 'C사'의 제2창업기(바나나 팜 개발사례)를 중심으로)

  • Jin hwan Park;Sang soon Kim
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.18 no.3
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    • pp.61-79
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    • 2023
  • This study is a case study of overseas banana farms as a global agricultural startup that has hardly been attempted so far in terms of paradigm shift in the industry, beyond regional limitations. It was researched for the purpose of revealing the success factors of 'global agricultural startup' in terms of business process, entrepreneurship, and management dimensions learned through direct participation and observation at the local level. In order to study global agricultural startups, this study also conducted a comparative analysis of global startups (global startups) and global agricultural startups(global agricultural startups). In fact, the analysis consists of 'definition', 'components', and 'success factors', and we want to confirm the difference between the two concepts that can be distinguished. The case analysis tried to maximize the advantages of 'participatory action research' by directly observing and experiencing banana farms. In the case of banana farm cases, by dividing them into preparation process for farm development and farm development and management process, various variables considered in farm management were explained through the whole process of farm management. Through the process of overcoming and responding to specific failure cases, we tried to secure the reliability and validity of the research, and the case studies related to entrepreneurship, management, and organization analyzed by applying them by subdividing them into theoretical areas belonging to components and management that were theorized in existing preceding studies. This study is almost the first study on the process of creating a local entry business by directly moving the head office overseas rather than entering overseas agriculture as a subsidiary, joint venture or overseas corporation. In particular, it is a unique case that corresponds to agriculture in terms of region(Africa), scale(startup), and industry that have not been introduced so far as a global agricultural startup. In terms of entrepreneurship, it also concretely exemplified how entrepreneurship components such as innovativeness, risk-taking propensity, proactiveness, vision sharing, social contribution, leadership, etc., which have not been attempted so far in agricultural cases, are manifested and effective. The management and cultural aspects also went beyond the argument that only cultural aspects are important in overseas business, and also confirmed individual failure cases and their responses in recruitment, job, wage, retirement, development, organizational structure management, etc. As a result, there is significance and implications of this study in that it provides theoretical confirmation as well as practical and responsive basis for 'entrepreneurship', 'farming management', and 'management' aspects in overseas agricultural startup business operation.

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Research to Establish a Common Standard for Assent by Assessing the Current State of the Assent Process and Conducting Interviews with Pediatrician/Pediatric Neurologist (소아승낙 현황조사와 소아청소년과/소아신경과 전문의를 대상으로 면담조사를 통한 소아승낙서 공통기준 수립 연구)

  • Yoon Jin Lee;Sun Ju Lee;Su Jin Kang;Dae Ho Lee;Kyun-Seop Bae;Jong Woo Chung;Byung Soo Kim;Jin Seok Kim;Myung Ah Lee
    • The Journal of KAIRB
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    • v.6 no.1
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    • pp.5-16
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    • 2024
  • Purpose: The purpose of this study is to investigate the current status of pediatric assent in nationwide hospitals and to assess the children's comprehension for pediatric assent by interviewing pediatricians/pediatric neurologists to determine whether children of the age (elementary and middle school students) can understand the purpose, risks, benefits, and concepts of voluntary participation in clinical research described in the assent form, and to help improve the administrative efficiency of multicenter clinical trials. Methods: The status of pediatric assent was surveyed online using Google Forms at 141 university hospitals with administrative staff who are members of the Institutional Review Board (IRB) administrative staff subcommittee with in Korean Association of Institutional Review Boards (KAIRB). Additionally, face-to-face interviews were conducted with 7 pediatricians/pediatric neurologists. Survey and interview responses were summarized using descriptive statistics. Results: Out of the 141 institutions surveyed, 35 institutions (24.8%) responded. Among them, 30 institutions (85.7%) reported having age criteria for acquiring pediatric assent forms in the case of children. The age range for pediatric assent acquisition have been from 7 years old to 12 years old (15 institutions, 50%), and from 7 years old to 15 years old (7 institutions, 23.3%). Nine institutions (25.7%) have had criteria for obtaining both parents' consent in cases involving the participation of children. Nineteen institutions (54.3%) have had checklists or guidelines available for use by IRB members in study protocols involving vulnerable research subjects. Three pediatricians/pediatric neurologists have believed that upper-grade elementary school students (5th-6th grade) could comprehensively understand informed consent forms. Two have believed that middle school students would be able to understand them if they included personal information. Two pediatricians/pediatric neurologists have believed that even lower-grade elementary school students (1st-4th grade) could understand the explanations if they were made simpler. Conclusion: It is suggested that not only elementary school students (7-12 years old) but also middle school students (13-15 years old) should receive pediatric assent forms, as it would facilitate a comprehensive understanding of the forms. To enhance the comprehension of assent form content, it is necessary to use age-appropriate words, language, and expressions in the forms hospital. It is also recommended to create comics or videos to make the content of the assent forms more accessible for children.

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Studying the Differences in the Effects of Theoretical and Practical, Face-to-face and Virtual Teaching Methods on Entrepreneurship and Willingness to Start a Business: University Students During the Coronavirus Pandemic (이론 및 실습, 대면 및 비대면 교육 방식이 기업가정신과 창업의지에 미치는 효과 차이 연구: 코로나 펜데믹 상황의 대학생들을 대상으로)

  • Park, Mijung;Lee, Cheolgyu;Hwangbo, Yun
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.19 no.2
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    • pp.81-96
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    • 2024
  • This study analyzed the differences in the effects on entrepreneurship and entrepreneurial willingness of college students under the coronavirus pandemic by dividing theoretical education into practical education, face-to-face education, and non-face-to-face education, and analyzed the differences in the effects on entrepreneurship and entrepreneurship willingness according to the education method. This study conducted entrepreneurship education for 552 students at a comprehensive university in Chungcheong-do, Korea, and analyzed the sample by dividing it into theoretical and practical education, face-to-face education, and non-face-to-face education. In addition, a two-way repeated measures ANOVA was conducted to determine whether there were differences in the entrepreneurship education course operation form according to the pre- and post-education time points. The results showed that, first, the difference between the effectiveness of entrepreneurship education before and after theoretical and practical education was significant, and the entrepreneurship of practical education was higher than that of theoretical education after education. In the test of pre- and post-training differences in entrepreneurial intention, the difference in effectiveness was significant only in practical training. Second, the results of the repeated measures ANOVA analysis of the course operation type of theoretical and practical courses according to the difference between the pre- and post-education time points showed that there were differences in the entrepreneurship effectiveness of theoretical and practical courses according to the time point of education. Third, the difference in the effectiveness of entrepreneurship education according to face-to-face and non-face-to-face education was significant, and only the effect of non-face-to-face education on entrepreneurial intention was significant before and after education. Fourth, the results of repeated measures ANOVA analysis of face-to-face and non-face-to-face course operation type showed that the effect of face-to-face and non-face-to-face entrepreneurship education differed depending on the time of education. The pre-post difference in entrepreneurial intention was significant only for the non-face-to-face program. The implication of this study is that in order to increase the effectiveness of entrepreneurship and entrepreneurial will among university students, it is necessary to expand the amount of practical classes in which students actively participate in activities related to entrepreneurship. In addition, in order to increase the effectiveness of entrepreneurial will, a non-face-to-face education method that utilizes the metaverse space and increases the role of each student can contribute to increasing the effectiveness of entrepreneurial will.

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