• Proceedings of the Korean Society of Applied Pharmacology
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• 1997.11a
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• pp.57-74
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• 1997

To make a proposal for the revision of KGCP, ICH Harmonized Tripartite Guideline for Good Clinical Practice, which is on the stage of worldwide implementation, was compared with current GCPs of tripartite countries of ICH, namely USA, Europe and Japan as well as Korea. On the basis of the classification in ICH GCP, comprehensive comparisons among the corresponding articles of 4 regions or countries were made in the order of IRB / IEC, Investigator, Sponsor and Clinical Trial Protocol. Based on the comparisons of the contents in ICH-GCP with those in current GCPs, major suggestions for the revision of current KGCP can be made as follows. Firstly, the function of IRB / IEC needs to be strengthened for the initiation and continuation of clinical trial. Current 2-step approval system of IRB / IEC and Health Authorities requires to be converted into the system similar to that of developed countries. Secondly, sponsor's obligation needs to be tightened to control and assure the quality of clinical trial. Inspection of regulatory authorities should be made to perform during and / or after clinical trial, when it is necessary. In other words, sponsor should be made to establish written Standard Operating Procedures (SOPs) for all aspects of clinical trial including monitoring to ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirement (s). Besides, the provision of ‘Quality Control and Quality Assurance’ should be added to the protocol to establish the credibility of the result of the clinical trial.

• Journal of Korean society of Dental Hygiene
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• v.14 no.2
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• pp.241-250
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• 2014

Objectives : The purpose of the study was to examine the ethical requirements for the protection of human subjects in the publication guidelines of dental health journals. Methods : The guidelines of 27 dental health journals were reviewed to determine ethical standards alone, with Helsinki Declaration, by an institutional review board (IRB), informed consent, protection of subject privacy and confidentiality, and no conflicts of interest. Results : 1. Dentistry journals listed on National Research Foundation of Korea had a conflict of interest disclosure provisions of the contribution(76.9%) and the IRB approval(61.5%). 2. Half of the dental health journals were not listed on National Research Foundation of Korea Society but they agreed the advance posting provisions. 3. Dental hygiene journals provide 100% of ethics alone and receive 75% of IRB in the papers. 4. Dental health and dental hygiene journals have conflicts of interest disclosure regulations(59.2%) and IRB approval(51.8%). 5. There existed statistically significant differences between the dental health journals whether they were listed on the human subjects and ethical standards for protection in National Research Foundation of Korea or not. Conclusions : While the publication guidelines of dental health journals have followed to a greater extent in recent years, there is still a need for further instructions to ensure that the authors satisfy all ethical requirements in conducting research on human subjects. IRB approval for dental journals must be standardized and reinforced reflecting the characteristics of each journals. The researchers should obey the code of ethics suitable for education and the editors must review the paper continuously.

• 한국지구과학회:학술대회논문집
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• 2004.02a
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• pp.52-57
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• 2004

Korean Peninsula located between Japan and China where earthquakes frequently occur, have little geophysical observation despite its tectonic importance. This study suggests the inland conductive structures inferred from GDS data measured in Korean Peninsula and try to interpret induction arrows quantitatively with the aid of 2- and 3-D geomagnetic induction modeling. Ogcheon Belt (OCB) and Imjin River Belt (IRB) are regarded as main conductive structures in Korea Peninsula, the induction arrows for the period of 60 minutes show very weak anomaly due to sea effect, which is supported by the results of 3-modeling also. However, for the period of 10 minutes, induction arrows at YIN and ICHN show anomalous patterns considered as the effect of IRB in spite of sea effect. The results of 2-D modeling which simplify geological situations provide overall information on IRB

• 대한임상약리학회:학술대회논문집
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• 2000.04a
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• pp.44-60
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• 2000

• Journal of Physiology & Pathology in Korean Medicine
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• v.25 no.5
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• pp.927-933
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• 2011

This study aimed to evaluate the quality of herbal medicine-related RCT (Randomized controlled clinical trial) papers. 79 papers were searched from the domestic Hakjin paper list, and 16 papers of them were evaluated in terms of the Jadad Quality Assessment Scale and the adequacy of allocation concealment, and ethical validity. The evaluation results from Jadad Quality Assessment Scale showed that 15 papers showed high quality with the Jadad score of 3 points or higher, and none of the papers had a problem with randomization and double-blinding. The evaluation results from adequacy of allocation concealment showed that 3 of the papers were executed proper allocation concealment, and all of them had 5 points of Jadad score. IRB (Institutional Review Board) approval and written consent was investigated for the evaluation of ethical validity, and 12 papers had the IRB approval, and 14 papers had written consent. The papers published before 2005 were absent of IRB approval and written consent, and none of the papers had IRB approval number. From the above results, it is concluded that rigorous clinical research led high quality of research papers, and the ethical aspect of clinical researches are getting more important to protect the rights of research participants.

• Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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• 2013.04a
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• pp.401-406
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• 2013

This paper presents experimental evaluation of IRE (isolation roller bearing) seismic isolation device. From the combination of base isolation on the IRE system displacement response spectrum and acceleration response spectrum, the compressive strength and the coefficient of friction experiments. Also the IRE system is evaluated by environment test according to KS standards. Both the resonance and seismic experiments using a combination of the IRE and Natural Rubber Bearing (NRB) are performed in order to analyze the seismic isolation of the IRE system dynamic characteristics. For the given load and exciting frequency, the resonant frequency becomes lower, but the resonant magnification remains to be same. However, it is shown that when we consider the IRE only, the vibration on the table with the horizontal movement and the independent horizontal displacement due to the rolling motion of the plate and roller are significantly reduced. This result verifies that the proposed optimal design method of the IRE system is very effective.

• The Journal of KAIRB
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• v.6 no.1
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• pp.1-4
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• 2024

The strengthening of Institutional Review Board (IRB) and Human Research Protection Program (HRPP) for clinical research on advanced regenerative medicine reflecting the 3 Principles of the Belmont Report (Respect, Beneficence, Justice) is very important. The research institution IRB should naturally be in charge of managing the clinical research process. And it is crucial to reinforce HRPP for the protection of research subjects in institutions conducting advanced regeneration clinical research. So, it is needed to establish a Protection System for Advanced Regenerative Medical Research Subjects composed of clinical research management communication system for advanced regenerative medicine between KAIRB (Korean Association of IRB) of research institutes and National Management Agency for Advanced Regenerative Medical Research. In advanced regenerative medicine clinical research to verify safety and efficacy of the investigational drugs to the subjects with rare and incurable diseases rather than to treat the patients, it is hoped that a management system that guarantees the scientific characteristics of research and the rights of research subjects would be well organized and operated.

• Journal of Korean Society of Environmental Engineers
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• v.30 no.11
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• pp.1146-1153
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• 2008

Numerical simulation was carried out to study the trichloroethylene (TCE) degradation by permeable reactive barrier (PRB), and revealed the effect of concentration of TCE, iron medium mass, and concentration of iron-reducing bacteria (IRB). Newly developed model was based on axial dispersion reactor model with chemical and biological reaction terms and was implemented using MATLAB ver R2006A for the numerical solutions of dispersion, convection, and reactions over column length and elapsed time. The reaction terms include reactions of TCE degradation by zero-valent iron (ZVI, Fe$^0$) and ferrous iron (Fe$^{2+}$). TCE concentration in the column inlet was maintained as 10 mg/L. Equation for Fe$^0$ degradation includes only TCE reaction term, while one for Fe$^{2+}$ has chemical and biological reaction terms with TCE and IRB, respectively. Two coupled equations eventually modeled the change of TCE concentration in a column. At Fe$^0$ column, TCE degradation rate was found to be more than 99% from 60 hours to 235 hours, and declined to less than 1% in 1,365 hours. At the Fe$^{2+}$ and IRB mixed column, TCE degradation rate was equilibrated at 85.3% after 210 hours and kept it constant. These results imply that the ferrous iron produced by IRB has lowered the TCE degradation efficiency than ZVI but it can have higher longevity.http://kci.go.kr/kciportal/ci/contents/ciConnReprerSearchPopup.kci#

• 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.

• 대한임상약리학회:학술대회논문집
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• 2003.12a
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• pp.9-9
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• 2003