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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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Monitoring and risk assessment of 1,4-Dioxane in Nakdong river (낙동강 수계 중 1,4-dioxane의 모니터링 및 위해성 평가)

  • Lee, Ji-Young;Kim, Joung-Hwa;Kim, Hyun-Koo;Choi, Jong-Ho;Kim, Seungki;Pyo, Heesoo
    • Analytical Science and Technology
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    • v.21 no.5
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    • pp.383-391
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    • 2008
  • International Agency for Research on Cancer (IARC) has classified it as a possible carcinogen and World Health Organization (WHO) has suggested 50 ng/mL as a guideline value for 1,4-dioxane. Considering the toxicity of 1,4-dioxane and ingestion rate of drinking water, the monitoring of 1,4-dioxane in drinking water in Nakdong river is very important. We analyzed 1,4-dioxane four times per year for the 12 samples of treated water and 4 samples of raw water in Nakdong river in Korea from 2000 to 2007 and surveyed the trend of concentrations of 1,4-dioxane. As a results of analysis, 1,4-dioxane was detected from 0.24 to 240.2 ng/mL in treated water and from 0.39 to 81.9 ng/mL in raw water from 2000 to 2007. The average concentrations are 22.68 ng/mL and 19.15 ng/mL in treated water and raw water, respectively. The detected concentrations was decreased but frequency of detection was not changed since establishment of regulation in 2004. Results of comparison of 95 percentile excessive cancer risk of 1,4-dioxane in treated and raw water were each $6.63{\times}10^{-6}$, $3.17{\times}10^{-6}$ before 2004 and $2.10{\times}10^{-6}$, $1.22{\times}10^{-6}$ after 2004. Also, comparing the detected concentration and frequency for each season, these were more detected the concentration and frequency for 1,4-dioxane in treated and raw water from winter to spring.

Studies on a Characteristic of 『About Stage Drama Arts』 (연극론 『연극예술에 대하여』의 특성 연구)

  • Kim, Jeong-Soo
    • (The) Research of the performance art and culture
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    • no.22
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    • pp.123-155
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    • 2011
  • This study aims to closely read Kim Jong-il's "About Stage Drama Arts" and disclose the new reality as evaluated by him. The study took the method by which to compare Kim Jong-il's theory on drama and North Korea's drama theory in the 1950s, and the findings of this study revealed that it was irrational to grant the adjective "new" to Kim Jong-il's drama theory. This is because tradition inheritance and newness cross each other. First, his tradition inheritance aspect was found in his playwriting method. In playwriting method, Kim Jong-il's argument about characters and language is an extension of the 1950s drama theory, and his theory on JongZa(seeds) is the transformation of the concept proposed in the 1950s. Also, the expression means of dramas and drama arts is dialogue, and his guideline to focus on the art of conversation rather than on acting is interpreted to be a reduced concept of drama arts, compared with the 1950s drama theory. On the other hand, his newness aspect can be clearly discovered in the materialization of stage. The fixed stage background, without dark change, shifts to another situation as it is, and this stage setting is clearly distinguished from the previous stage setting. The attempt is worth highly evaluating to allow the stage to reflect actors' emotional flows and let them act. Also, the attempt is distinctively distinguished from previous drama theories to allow the chorus' positive involvement in dramas so as to directly deliver characters' emotions to the audience and to trigger the audience' response as intended by creators. From the perspectives of drama evaluation, Kim Jong-il's theory and practice regarding stage and music is understood to maximize the audio-visual effects. Therefore, Kim Jeong-il's drama theory, as he argues, is not a completely new theory, but a transformational inheritance of existing drama theories, and a creation theory with focus on expansion of spectacles.

Quality Characteristics of Apple Jangachi Manufactured by Farmhouse and Commercial Jangachi (농가생산 사과장아찌와 시판 장아찌의 품질 특성)

  • Oh, C.H.;Yang, J.H.;Kang, C.S.
    • Journal of Practical Agriculture & Fisheries Research
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    • v.18 no.1
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    • pp.79-91
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    • 2016
  • Quality factors which characterize 11 kinds of farm-manufactured apple Jangachi and commercial Jangachi, have been studied in order to provide a guideline to improve the quality and marketing strategy of farm-manufactured pickled apples. Moisture content ranged from 74% to 84% and 81% to 91% in Doenjang Jangachi and vinegar Jangachi, respectively; 38% to 64% in Kochujang Jangachi; 57% to 64% in radish Kochujang Jangachi. Moisture content was 89% in Doenjang Jangachi. Even though moisture content of apple Kochujang Jangachi indicated 48% which is lower than that of radish Jangachi, it was higher than that of a persimmon pickled in Kochujang (38%) and that of Japanese apricot Jangachi (49%). pH and titratable acidity, two indicators used to determine the appropriate ripening period of Jangachi, were pH 3.4~5.6, 0.03~0.14%, respectively. The pH ranged from 5.2 to 5.6 in radish Jangachi; 3.4 to 4.1 in Cucumber Jangachi. pH of persimmon Jangachi, Japanese apricot Jangachi and apple Jangachi showed 4.1, 3.5 and 4.1, respectively. Compared with the pH of traditional Jangachi (3.03~5.36), pH of all of the above Jangachi fall into an appropriate range. The brix of apple Jangachi (30%) was 12% to 18% higher than that of Kochujang radish Jangachi, but it was relatively lower than that of persimmon Jangachi (39%) and that of Japanese apricot Jangachi (49%). Salinity of Jangachi varied depending on which marinating material was used. Salinity in the descending order according to each marinating material demonstrated Kanjang (6% to 13%), Doenjang (7%), Kochujang (3% to 4%). Salinity of apple Jangachi was 3.28% which was relatively lower than that of commercial Jangachi which used either Kanjang or Doenjang as its marinating material. Chromaticity test shows that the brightness value of apple Jangachi (54.70) was similar to that of cucumber Jangachi (50.86, 56.02); the redness value and yellowness of apple Jangachi (16.21 and 26.78) were higher than the redness value (7.27 to 11.23) and the yellowness value (10.62 to 14.69) of radish Kochujang Jangachi. Sensory Characteristics value of apple Jangachi, along with radish and cucumber Jangachi in its color, odor and taste (7.00, 7.50, 7.00, respectively) placed high on the list implying higher preference. However, overall preference value of apple Jangachi was 6.83 which was lower than that of Japanese apricot Jangachi or that of radish Jangachi. The result can be explained by the tendency of people preferring crispy Jangachi and points out that the texture of apple Jangachi needs to be improved to gain popularity. Furthermore, for increased sales of apple Jangachi as a niche product, more rigorous market testing is required.

Comparative Study on the Carbon Stock Changes Measurement Methodologies of Perennial Woody Crops-focusing on Overseas Cases (다년생 목본작물의 탄소축적 변화량 산정방법론 비교 연구-해외사례를 중심으로)

  • Hae-In Lee;Yong-Ju Lee;Kyeong-Hak Lee;Chang-Bae Lee
    • Korean Journal of Agricultural and Forest Meteorology
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    • v.25 no.4
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    • pp.258-266
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    • 2023
  • This study analyzed methodologies for estimating carbon stocks of perennial woody crops and the research cases in overseas countries. As a result, we found that Australia, Bulgaria, Canada, and Japan are using the stock-difference method, while Austria, Denmark, and Germany are estimating the change in the carbon stock based on the gain-loss method. In some overseas countries, the researches were conducted on estimating the carbon stock change using image data as tier 3 phase beyond the research developing country-specific factors as tier 2 phase. In South Korea, convergence studies as the third stage were conducted in forestry field, but advanced research in the agricultural field is at the beginning stage. Based on these results, we suggest directions for the following four future researches: 1) securing national-specific factors related to emissions and removals in the agricultural field through the development of allometric equation and carbon conversion factors for perennial woody crops to improve the completeness of emission and removals statistics, 2) implementing policy studies on the cultivation area calculation refinement with fruit tree-biomass-based maturity, 3) developing a more advanced estimation technique for perennial woody crops in the agricultural sector using allometric equation and remote sensing techniques based on the agricultural and forestry satellite scheduled to be launched in 2025, and to establish a matrix and monitoring system for perennial woody crop cultivation areas in the agricultural sector, Lastly, 4) estimating soil carbon stocks change, which is currently estimated by treating all agricultural areas as one, by sub-land classification to implement a dynamic carbon cycle model. This study suggests a detailed guideline and advanced methods of carbon stock change calculation for perennial woody crops, which supports 2050 Carbon Neutral Strategy of Ministry of Agriculture, Food, and Rural Affairs and activate related research in agricultural sector.

Viability Test and Bulk Harvest of Marine Phytoplankton Communities to Verify the Efficacy of a Ship's Ballast Water Management System Based on USCG Phase II (USCG Phase II 선박평형수 성능 평가를 위한 해양 식물플랑크톤군집 대량 확보 및 생물사멸시험)

  • Hyun, Bonggil;Baek, Seung Ho;Lee, Woo Jin;Shin, Kyoungsoon
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.22 no.5
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    • pp.483-489
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    • 2016
  • The type approval test for USCG Phase II must be satisfied such that living natural biota occupy more than 75 % of whole biota in a test tank. Thus, we harvested a community of natural organisms using a net at Masan Bay (eutrophic) and Jangmok Bay (mesotrophic) during winter season to meet this guideline. Furthermore, cell viability was measured to determine the mortality rate. Based on the organism concentration volume (1 ton) at Masan and Jangmok Bay, abundance of ${\geq}10$ and $<50{\mu}m$ sized organisms was observed to be $4.7{\times}10^4cells\;mL^{-1}$and $0.8{\times}10^4cells\;mL^{-1}$, and their survival rates were 90.4 % and 88.0 %, respectively. In particular, chain-forming small diatoms such as Skeletonema costatum-like species were abundant at Jangmok Bay, while small flagellate ($<10{\mu}m$) and non chain-forming large dinoflagellates, such as Akashiwo sanguinea and Heterocapsa triquetra, were abundant at Masan Bay. Due to the size-difference of the dominant species, concentration efficiency was higher at Jangmok Bay than at Masan Bay. The mortality rate in samples treated by Ballast Water Treatment System (BWMS) (Day 0) was a little lower for samples from Jangmok Bay than from Masan Bay, with values of 90.4% and 93%, respectively. After 5 days, the mortality rates in control and treatment group were found to be 6.7% and >99%, respectively. Consequently, the phytoplankton concentration method alone did not easily satisfy the type approval standards of USCG Phase II ($>1.0{\times}10^3cells\;mL^{-1}$ in 500-ton tank) during winter season, and alternative options such as mass culture and/or harvesting system using natural phytoplankton communities may be helpful in meeting USCG Phase II biological criteria.

Incidence of Dental Discoloration After Tetracycline Exposure in Korean Children: A Nationwide Population-Based Study

  • Ji Young Lee;Eun Hwa Kim;Myeongjee Lee;Jehee Shin;Sung Min Lim;Jee Yeon Baek;MinYoung Kim;Jong Gyun Ahn;Chung-Min Kang;Inkyung Jung;Ji-Man Kang
    • Pediatric Infection and Vaccine
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    • v.31 no.1
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    • pp.25-36
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    • 2024
  • Purpose: Tetracycline is not recommended for children under 12 by guideline due to the risk of tooth discoloration. We aimed to assess the incidence of dental discoloration in Korean children prescribed tetracyclines and investigate whether its risk was greater in tetracycline-exposed children than in the general population. Methods: This population-based cohort study using the Health Insurance Review and Assessment service database included children aged 0-12 years exposed to tetracyclines for at least 1 day between January 2008 and December 2020. The primary outcome was the incidence rate of dental discoloration ≥6 months after prescription, and the standardized incidence ratio (SIR) was evaluated as secondary outcome. Results: 56,990 children were included-1,735 and 55,255 aged <8 and 8-12 years, respectively. 61% children were prescribed tetracycline for <14 days with mostly second-generation tetracyclines, doxycycline (61%) and minocycline (35%). The 5- and 10-year cumulative incidence rates of dental discoloration were 4.1% (95% confidence interval [CI], 3.0-5.7%) and 5.7% (95% CI, 4.1% to 7.8%), respectively, in the 0-7 years age group and 0.8% (95% CI, 0.7% to 0.9%) and 1.3 (95% CI, 1.1% to 1.4%), respectively, in the 8-12 years age group. Tetracycline exposure did not increase such risk compared to that in the general population (SIR, 1.08; 95% CI, 0.69 to 1.60). Conclusions: The incidence of dental discoloration was lower than previously suggested. Relieving the age restriction for prescribing tetracyclines may be considered.

A Study on the Design of Sustainable App Services for Medication Management and Disposal of Waste Drugs (약 복용 관리와 폐의약품 처리를 위한 지속 가능한 앱 서비스 디자인 연구)

  • Lee, Ri-Na;Hwang, Jeong-Un;Shin, Ji-Yoon;Hwang, Jin-Do
    • Journal of Service Research and Studies
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    • v.14 no.2
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    • pp.48-68
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    • 2024
  • Due to the global pandemic aftermath of the coronavirus, the importance of health care is being emphasized more socially. Due to the influence of these changes, domestic pharmaceutical companies have introduced regular drug delivery services, that is, drug and health functional food subscription services. Currently, this market is continuously growing. However, these regular services are causing new environmental problems in which the number of waste drugs increases due to the presence of unused drugs. Therefore, this study proposes a service that not only promotes health management through regular medication adherence to reduce the amount of pharmaceutical waste but also aims to improve awareness and practices regarding proper medication disposal. As a preliminary survey for service design, a preliminary survey was conducted on 51 adults to confirm their perception of drug use habits and waste drug collection. Based on the Honey Comb model, a guideline for service design was created, and a prototype was produced by specifying the service using the preliminary survey results and service design methodology. In order to verify the effectiveness of the prototype, a first user task survey was conducted to identify the problems of the prototype, and after improving this, a second usability test was conducted on 49 adults to confirm the versatility of the service. Usability verification was conducted using SPSS Mac version 29.0. For the evaluation results of the questionnaire, Spearmann Correlation Analysis was conducted to confirm the relationship between frequency analysis and evaluation items. This study presents specific solutions to the problem of waste drugs due to the spread of drug subscription services.

Establishment of the Room Acoustic Criteria for the Korean Traditional Music Halls Using Subjective Listening Tests (청감실험에 의한 국악당의 음향설계조건 설정)

  • Haan, Chan-Hoon;Shin, Jic-Su
    • The Journal of the Acoustical Society of Korea
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    • v.26 no.7
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    • pp.343-352
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    • 2007
  • The present study aims to investigate the design standard for acoustic criteria of Korean traditional music which could be used for the design of Korean traditional music halls. In order to do this, subjective listening tests were undertaken to musicians using auralized sounds which were convolved with the impulse response of traditional instruments recorded in an anechoic chamber. 94 pairs of sound were made which have different value of acoustic parameters including RT, BR, Brilliance, G, C80, ITDG, IACC. A paired comparison method(PCM) was used to analyze the results from the subjective listening tests. The results show that the preference of acoustic criteria for the Korean traditional music is far different from those of western music. As a result, specific range of acoustic criteria were suggested for the appropriate acoustic conditions of Korean traditional music. Also, a guideline of the acoustic design of halls for performing the Korean traditional music was suggested which could be used as a basic reference in the future works.

주사용 요오드화 조영제 및 MRI용 가돌리늄 조영제 유해 반응에 대한 한국 임상진료지침: 개정된 임상적 합의 및 권고안(2022년 제3판)

  • Se Won Oh;So Young Park;Hwan Seok Yong;Young Hun Choi;Min Jae Cha;Tae Bum Kim;Ji Hyang Lee;Sae Hoon Kim;Jae Hyun Lee;Gyu Young Hur;Jae Yeon Hwang;Sejoong Kim;Hyo Sang Kim;Ji Young Ryu;Miyoung Choi;Chi-Hoon Choi
    • Journal of the Korean Society of Radiology
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    • v.83 no.2
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    • pp.254-264
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    • 2022
  • The Korean Society of Radiology and Medical Guidelines Committee amended the existing 2016 guidelines to publish the "Korean Clinical Practice Guidelines for Adverse Reactions to Iodide Contrast for Injection and Gadolinium Contrast for MRI: The Revised Clinical Consensus and Recommendations (2022 Third Edition)." Expert members recommended and approved by the Korean Society of Radiology, the Korean Academy of Asthma, Allergy and Clinical Immunology, and the Korean Nephrology Society participated together. According to the expert consensus or systematic literature review, the description of the autoinjector and connection line for the infection control while using contrast medium, the acute adverse reaction, and renal toxicity to iodized contrast medium were modified and added. We would like to introduce the revised contents.