• 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 GEO-environmental Society
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• v.18 no.3
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• pp.5-14
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• 2017

Experimental study on strength characteristics of frozen soils is necessary for the safety evaluation of design and construction in cold region. The objective of this study is to evaluate the direct shear strength of frozen soils obtained from traditional system (Type-1), system with roller on the upper shear box (Type-2), and system with fixed upper shear box separated from bottom shear box (Type-3). Specimens mixed with sand, silt, and water are frozen to $-5^{\circ}C$, and then direct shear tests are conducted under the normal stress of 5, 10, 25, and 50 kPa. Experimental results show that the upper shear box of Type-1 touches the bottom shear box due to the rotation of the upper shear box. The shear strength obtained from Type-2 is overestimated because the preventing rotation force is added to shear force. Type-3 may acquire the only strength of the specimen, and shear strain at peak shear strength is similar to that at the beginning of vertical displacement occurrence. In addition, internal friction angle and cohesion at both peak and residual stresses in Type-3 are smaller than those of Type-2. This study shows that high strength specimens including frozen soils can be effectively evaluated using improved shear box system such as Type-3.

• Journal of the Korean Geotechnical Society
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• v.15 no.6
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• pp.307-317
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• 1999

The purpose of this study is to utilize conventional procedures for evaluation of liquefaction potential and to compare the results obtained by modified detailed method based on Korean earthquake magnitude (M=6.5). Liquefaction potential is assessed by comparing liquefaction strength of soil and cyclic shear stress generated in the soil layers during earthquakes. The cyclic shear stress is computed from the earthquake response analysis, and liquefaction strength of soil is evaluated by using results from cyclic triaxial tests. The cyclic triaxial tests are performed on many different conditions of sample ; relative densities(50%, 60%, and 70%), initial effective confining pressures (70kPa, 100kPa, and 150kPa), and fine contents(10%, 20%, and 30%). From the result of comparing the conventional procedure with the modified detailed method, it is found that the modified detailed method tends to evaluate larger safety factor against liquefaction in the weak sand site$(FS \leq1.5)$. Therefore in this case, it is suggested that liquefaction potential should be evaluated by using the modified detailed method based on cyclic triaxial tests. It is also found that in modified detailed method based on earthquake magnitude 6.5, critical depth where liquefaction can be generated is around 15m from the ground surface.

• Journal of Korean Society of Steel Construction
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• v.24 no.1
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• pp.101-108
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• 2012

The orthotropic steel deck bridge made by using relatively thin steel plate, and structural members such as transverse and longitudinal ribs, cross beam, etc. in the bridge are fabricated with complex shape by welding. Therefore, the possibility occurring deformation and defects by welding is very high, and stress states in the welded connection parts are very complex. Also, the fatigue cracks in orthotropic steel deck bridge are happening fromthe welded connection parts of secondary member than main member. However, stress evaluation for main members is mainly carried out in the design process of the bridge, detailed stress evaluation and characteristic analysis is not almost reviewed in the structural details which fatigue crack occurred. For the orthotropic steel deck bridge with open ribs which has been serviced for 29 years, in this study, the cause of fatigue crack is investigated and the fatigue safety of the bridge is examined based on fieldmeasurement by the loading test and real traffic condition. Also, structural analyses using gridmodel and detailed analysis model were carried out for the welded connection parts of longitudinal rib and diaphramthat fatigue crack occurred. Additionally, the behavior characteristics due to running vehicles were investigated by using influence area analysis for these structural details, and the occurrence causes of fatigue crack in the target bridge were clarified.

• Journal of Korean Tunnelling and Underground Space Association
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• v.9 no.4
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• pp.403-413
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• 2007

As rock bolts become one of the main support systems in tunnels and underground structures, the integrity of the rock bolts affects the safety of these types of structures. The purpose of this study is the evaluation of rock bolt integrity using Fourier and wavelet transforms of the guided ultrasonic waves. After five rock bolt specimens with various defect ratios are embedded into a large scale concrete block, guided waves are generated by a PZT (lead zirconate titanate) element and measured by an acoustic emission (AE) sensor. The captured signals are analyzed in the frequency domain using the Fourier transform, and in the time-frequency domain using the wavelet transform based on a Gabor wavelet. The spectrum obtained from the Fourier transform shows that a portion of high frequency contents increases with increase in the defect ratio. Peak values in the time-frequency domain represent the interval of travel time of each echo. The energy velocities of the guided waves increase with the defect ratio. This study shows that the spectrum ratio and the energy velocity may be indicators fur the evaluation of rock bolt integrity.

• Journal of the Korea Concrete Institute
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• v.24 no.5
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• pp.613-621
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• 2012

Steel corrosion is one of the most critical deteriorations in concrete structures due to the problems associated with both durability and structural safety issues. For protection of steel against corrosion problems, researches to improve concrete durability and steel corrosion protection such as rebar coating by hot-dip galvanizing steel have been carried out. This study was performed to quantitatively evaluate anti-corrosion and structural performance of concrete structures reinforced with hot-dip galvanizing steel rebar. Preliminary tests for several metal coatings such as zinc, aluminum, and their alloy (Zn 45% + AL 55%) were performed. After evaluation of corrosive characteristics, Zn was selected for the coating material and the corrosion behaviors in Zn-coated steel were evaluated in various conditions. Furthermore, tensile and adhesive strengths were evaluated for the normal and the hot-dip galvanized steel. The crack patterns and structural behaviors of RC specimens with the normal and coated steel were investigated. Also, corrosion characteristics including corrosion in various coating metal and potential change in metal with notch were evaluated. Structural performances of tensile and adhesive strengths as well as RC beam behavior under flexural/shear loading were evaluated. The test and evaluation results showed that the applicability of hot-dip galvanized steel rebar can be used as corrosion resistant reinforcements for RC structures.

• Transactions of the Korean Society of Mechanical Engineers A
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• v.36 no.5
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• pp.513-521
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• 2012

The aim of this study was to determine the brittle fracture behavior of reactor pressure vessel steel by considering the temperature dependence of a damage model. A multi-island genetic algorithm was linked to a Weibull stress model, which is the model typically used for brittle fracture evaluation, to improve the calibration procedure. The improved calibration procedure and fracture toughness test data for SA508 carbon steel at the temperatures $-60^{\circ}C$, $-80^{\circ}C$, and $-100^{\circ}C$ were used to decide the damage parameters required for the brittle fracture evaluation. The model was found to show temperature dependence, similar to the case of NUREG/CR-6930. Finally, on the basis of the quantification of the difference between 2- and 3-parameter Weibull stress models, an engineering equation that can help obtain more realistic fracture behavior by using the simpler 2-parameter Weibull stress model was proposed.

• Journal of Life Science
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• v.27 no.2
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• pp.194-201
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• 2017

Rapeseed (Brassica napus L.) is an oil crop classified as Brassicaceae, and it is widely grown worldwide. To develop a drought-resistant rapeseed, the ${\beta}$-glucosidase 1 (AtBG1) gene was introduced into rapeseed because drought- and salt-resistance phenotypes were observed when the AtBG1 gene was overexpressed in arabidopsis. Newly developed genetically modified crop must be proved to be safe. Safety assessments are based on the historical usage and scientific reports of a crop. In this study, we examined the potential acute oral toxicity of AtBG1 protein expressed in genetically modified (GM) rapeseed and calculated the minimum lethal dose at 6 weeks in both male and female ICR mice. AtBG1 protein was fed at a dose of 2,000 mg/kg body weight in five male and five female mice according to the marginal capacity concentration of OECD, 2,000 mg/15 ml/kg. Mortalities, clinical findings, and body weight changes were monitored for 14 days after dosing, and postmortem necropsy was performed on day 14. This study showed that no deaths occurred in the test group, and AtBG1 protein did not result in variations in common symptoms, body weight, and postmortem findings between the two groups. This showed that the minimum lethal dose of AtBG1 protein expressed in transgenic rapeseed exceed 2,000 mg/kg body weight in both sexes.

• Journal of Pharmaceutical Investigation
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• v.30 no.3
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• pp.191-199
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• 2000

Genomics is providing targets faster than we can validate them and combinatorial chemistry is providing new chemical entities faster than we can screen them. Historically, the drug discovery cascade has been established as a sequential process initiated with a potency screening against a selected biological target. In this sequential process, pharmacokinetics was often regarded as a low-throughput activity. Typically, limited pharmacokinetics studies would be conducted prior to acceptance of a compound for safety evaluation and, as a result, compounds often failed to reach a clinical testing due to unfavorable pharmacokinetic characteristics. A new paradigm in drug discovery has emerged in which the entire sample collection is rapidly screened using robotized high-throughput assays at the outset of the program. Higher-throughput pharmacokinetics (HTPK) is being achieved through introduction of new techniques, including automation for sample preparation and new experimental approaches. A number of in vitro and in vivo methods are being developed for the HTPK. In vitro studies, in which many cell lines are used to screen absorption and metabolism, are generally faster than in vivo screening, and, in this sense, in vitro screening is often considered as a real HTPK. Despite the elegance of the in vitro models, however, in vivo screenings are always essential for the final confirmation. Among these in vivo methods, cassette dosing technique, is believed the methods that is applicable in the screening of pharmacokinetics of many compounds at a time. The widespread use of liquid chromatography (LC) interfaced to mass spectrometry (MS) or tandem mass spectrometry (MS/MS) allowed the feasibility of the cassette dosing technique. Another approach to increase the throughput of in vivo screening of pharmacokinetics is to reduce the number of sample analysis. Two common approaches are used for this purpose. First, samples from identical study designs but that contain different drug candidate can be pooled to produce single set of samples, thus, reducing sample to be analyzed. Second, for a single test compound, serial plasma samples can be pooled to produce a single composite sample for analysis. In this review, we validated the issue whether the second method can be applied to practical screening of in vivo pharmacokinetics using data from seven of our previous bioequivalence studies. For a given drug, equally spaced serial plasma samples were pooled to achieve a 'Pooled Concentration' for the drug. An area under the plasma drug concentration-time curve (AUC) was then calculated theoretically using the pooled concentration and the predicted AUC value was statistically compared with the traditionally calculated AUC value. The comparison revealed that the sample pooling method generated reasonably accurate AUC values when compared with those obtained by the traditional approach. It is especially noteworthy that the accuracy was obtained by the analysis of only one sample instead of analyses of a number of samples that necessitates a significant man-power and time. Thus, we propose the sample pooling method as an alternative to in vivo pharmacokinetic approach in the selection potential lead(s) from combinatorial libraries.

• Journal of Energy Engineering
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• v.16 no.4
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• pp.155-163
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• 2007

To insure nuclear reactor safety, the reactivity of control rods should be calculated by measuring the criticality of reactor core and it is regularly performed during the annual physics test period. Also, the core criticality should be monitored during the start-up operation to avoid reactivity induced accidents. Many research works on control rod reactivity measurement and subcriticality measurement have been accomplished throughout the world for decades and recently a new method named "Modified Neutron Source Multiplication Method (MNSM)" was proposed in Japan which is known to be improved overcoming limitations of traditional Neutron Source Multiplication Method (NSM). In this study, MNSM was tested in calculation of subcriticalities and in evaluation of application validity using the educational reactor in Kyung Hee University, AGN-201. For this study, a revised nuclear data library and a neutron transport code system TRANSX - PARTISN were established. Correction factors for various control rod positions were produced using the k-effective values and the corresponding flux distributions and adjoint flux distributions. Experimental values of the core criticality were obtained using the neutron count rates of the BF3 proportional counters. The results showed that the expected reactivity worth of control rods by MNSM agreed well with the theoretical values and the correction factors contributed much for this purpose.