• 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.

• Journal of the Korean Society of Food Science and Nutrition
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• v.38 no.2
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• pp.252-260
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• 2009

Whereas the numbers of childcare centers and kindergartens are increasing rapidly, systematic management to control the food safety of foodservice operation is not yet well established. Samples from 12 centers in Seoul and Gyeonggi Province were collected to assess the microbiological quality of 32 raw materials, 24 cooked foods, 76 food-contact surfaces (knives, cutting boards, dish towels and gloves), 17 employees' hands and 12 air-borne bacteria. The microbiological analyses were performed for aerobic plate counts (APC), Enterobacteriaceae, E. coli and 7 pathogens (B. cereus, C. jejuni, C. perfringens, L. monocytogenes, Salmonella spp., S. aureus, and V. parahaemolyticus). Among raw materials, E. coli ($1.39{\sim}2.08\;\log\;CFU/g$) were detected in 4 out of 6 meats and 7.46 log CFU/g of APC in tofu. High enterobacteriaceae levels of 4.23, 5.14 and 4.19 log CFU/g were found in cucumber salad, steamed spinach with seasonings and steamed bean sprout with seasonings, respectively. No pathogens were found in all samples except for C. perfringens detected from raw spinach and raw lotus root. Only APC and enterobacteriaceae were found in food-contact surfaces. Two of the 23 knives and three of the 24 kitchen boards showed over 500 CFU/$100\;cm^2$ of APC; also, APC levels (5.03 to 5.44 log CFU/g) were detected in 4 of the 12 dish towels. Only one glove showed Enterobacteriaceae (2.44 log CFU/glove) contamination. Enterobacteriaceae were found in 2 employees' hands ($2.37{\sim}4.44\;\log\;CFU$/hand) among the 16 employees. The contamination levels of air-borne bacteria were shown unacceptable in two (2.25 and 2.30 log CFU/petri-film/15 min) out of the 12 kitchen areas. These results suggest that the microbiological hazards in some foods and environments are not well controlled and thus a guideline should be provided to ensure the food safety in childcare center and kindergarten foodservice operations.

• Journal of Chest Surgery
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• v.38 no.1 s.246
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• pp.44-49
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• 2005

Although thymomas are relatively common mediastinal tumors, to date not only has a universal system of pathologic classification not been established but neither has a clearly defined predictable relationship between treatment and prognosis been made. Recently, a new guideline for classification was reported by WHO, and efforts, based on this work, have been made to better define the relationship between treatment and pro­gnostic outcome. In the present study a comparative analysis between the WHO classification and Masaoka stage system with the clinical disease pattern was conducted. Material and Method: A total of 98 patients undergoing complete resection for mediastinal thymoma between Juanuary 1993 and June 2003 were included in the present study. The male female ratio was 48 : 50 and the mean age at operation was $49.6{\pm}13.9\;years.$ A retrospective analytic comparison studying the relationship between the WHO classification and the Masaoka stage system with the clinical disease pattern of thymoma was conducted. Pathologic slide specimens were carefully examined, details of postoperative treatment were documented, and a relationship with the prognostic outcome and recurrence was studied. Result: There were 7 patients in type A according to the WHO system of classification, 14 in AB, 28 in B 1, 23 in B2, 18 in B3, and 9 in type C. The study of the relationship between the Masaoka stage and WHO classification system showed 4 patients to be in WHO system type A, 7 in type AB, 22 in B 1, 17 in B2, and 3 in type B3 among 53 $(54{\%})$ patients shown to be in Masaoka stage I. Among 28 $(28.5{\%})$ patients in Masaoka stage II system, there were 2 patients in type A, 7 in AB, 4 in B 1, 2 in B2, 8 in B3, and 5 in type C. Among 15 $(15.3{\%})$ in Masaoka stage III, there were 1 patient in type B1, 3 in B2, 7 in B3, and 4 in type C. Finally, among 2 $(2{\%})$ patients found to be in Masaoka stage IV there was 1 patient in type B1, and 1 in type B2. The mean follow up duration was $28{\pm}6.8$ months. There were 3 deaths in the entire series of which 2 were in type B2 (Masaoka stages III and IV), and 1 was in type C (Masaoka stage II). Of the patients that experienced relapse, 6 patients remain alive of which 2 were in type B2 (Masaoka III), 2 in type B3 (Masaoka I and III) and 2 in type C (Masaoka stage II). The 5 year survival rate by the Kaplan-Meier method was $90{\%}$ for those in type B2 WHO classification system, $87.5{\%}$ for type C. The 5 year freedom from recurrence rate was $80.7{\%}$ for those in WHO type B2, $81.6{\%}$ for those in type B3, and $50{\%}$ for those in type C. By the Log-Rank method, a statistically significant correlation between survival and recurrence was found with the WHO system of classification (p<0.05). An analysis of the relationship between the WHO classification and Masaoka stage system using the Spearman correction method, showed a slope=0.401 (p=0.023), showing a close correlation. Conclusion: As type C of the WHO classification system is associated with a high postoperative mortality and recurrence rate, aggressive treatment postoperatively and meticulous follow up are warranted. The WHO classification and Masaoka stage system were found to have a close relationship with each other and either the WHO classification method or the Masaoka stage system may be used as a predict prognostic outcome of Thymoma.