• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1997년도 추계학술대회
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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.

• 한국치위생학회지
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• 제14권2호
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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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• 한국지구과학회 2004년도 춘계학술발표회 논문집
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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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• 대한임상약리학회 2000년도 춘계워크샵
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• pp.44-60
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• 2000

• 동의생리병리학회지
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• 제25권5호
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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.

• 한국소음진동공학회:학술대회논문집
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• 한국소음진동공학회 2013년도 춘계학술대회 논문집
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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.

• 대한기관윤리심의기구협의회지
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• 제6권1호
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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.

• 대한환경공학회지
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• 제30권11호
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• pp.1146-1153
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• 2008

본 연구에서는 지하수 내 투수성 반응벽체(permeable reactive barrier, PRB)의 TCE 처리에 관한 모델링을 수행하여 trichloroethylene (TCE)의 농도, 컬럼의 단위 부피당 철 매질의 질량, 철환원균(iron-reducing bacteria, IRB)의 농도에 대하여 각각의 유기적인 관계를 고찰하였다. 1차원 이송 확산 반응 방정식을 MATLAB을 이용하여 이송, 확산, 그리고 분해 반응 등을 컬럼의 길이, 실험 수행 시간에 따라 모델하였으며, 유한차분법(finite differential method, FDM)으로 수치해를 구하였다. 영가철 및 2가 산화철은 TCE에 의한 반응항과 철환원균에 의한 반응 항으로 나누어서 식을 정리했다. TCE 주입농도는 10 mg/L로 설정하여 영가철 및 2가 산화철에 의한 각각의 관계를 모델링했다. 또한, 철환원균 농도와 산화철 환원 모델을 통해 철환원균의 농도에 따른 산화철 환원 효율을 해석했고, 이것이 전체 TCE 분해에 어떤 영향을 주는지 모델로 나타냈다. 영가철 컬럼에서는 TCE 제거 효율이 60시간에서 235시간 동안 99% 이상을 나타냈고, 1,365시간 이후에 1% 이하로 떨어졌다. 2가 산화철 컬럼의 경우 TCE와 반응을 시작한 210시간 이후에 평형을 이루었고, 85.3%의 일정한 제거 효율을 나타냈다. 모델의 결과에 따르면, 철환원균에 의한 2가 산화철의 경우 영가철보다 TCE 제거 효율이 떨어지지만 더 높은 제거수명을 가질 수 있는 것으로 나타났다.

• 대한기관윤리심의기구협의회지
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• 제2권2호
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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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• 대한임상약리학회 2003년도 제12차 추계학술대회
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• pp.9-9
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• 2003