• The Journal of KAIRB
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• v.5 no.2
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• pp.43-50
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• 2023

Purpose: Due to the stringency of regulations related to clinical research, researchers face various requirements in the Institutional Review Board (IRB) review process. Specifically, they encounter time constraints and administrative burdens. In order to cultivate a more favorable review culture and establish a robust research environment, it is necessary to analyze researchers' perceptions of the IRB review. Therefore, this study aims to assess researchers' overall experiences with the IRB and identify researchers' educational needs and demands for research-related policies. Methods: A semistructured questionnaire with 34 items was developed and refined in consultation with advisors from IRB and Human Research Protection Program (HRPP). The questionnaire was distributed via an online survey to researchers with experience in IRB review. The survey covered general characteristics, satisfaction with the IRB review process (rated on a 10-point scale), experiences with IRB review, HRPP policy demands. Results: The study's descriptive statistics revealed a moderate satisfaction level (average rating, 6.75 out of 10) with the IRB review. Researchers from clinical medicine and other disciplines showed similar satisfaction scores of 6.65 and 6.87, respectively. However, respondents with over 5 years of research experience expressed higher satisfaction (mean score, 7.03) compared to those with less experience (mean score, 6.57). Institutional support was emphasized for improving the IRB review process. Certain training topics generated higher demands for addressing frequently raised IRB issues among minor discipline researchers compared to clinical medicine (p=0.017). Conclusion: We conducted an analysis of researchers' perceptions regarding the IRB as well as their demands concerning educational and HRPP policies. It is imperative to address the pinpointed areas for enhancement and integrate a range of perspectives in order to effectively cultivate a robust research ethics culture and ensure comprehensive participant protection.

• The Journal of KAIRB
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• v.5 no.2
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• pp.33-42
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• 2023

In the conduct of multicenter clinical trials, multiple reviews by multiple Institutional Review Board (IRB) result in unnecessary duplication of efforts, delays and increased expenses of the trials, placing unavoidable burdens on not only investigators and sponsors but also IRBs. During the coronavirus disease 2019 pandemic periods, as the need of multicenter clinical trials for its therapeutics and vaccines increased, a centralized IRB became more important than before in order to efficiently conduct the multicenter trials without unnecessary multiple reviews. Accordingly, government-supported central IBR as a new centralized IRB has launched to foster multicenter clinical trials while to avoid unnecessary reviews and delays and to reduce burdens of all stakeholders. However, there are still barriers to be overcome and problems to be solved in the central IRB. In this review, we introduce background and history of the central IRB and try to propose some strategies or solutions against the barriers and problems.

• Computational Structural Engineering
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• v.21 no.4
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• pp.61-66
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• 2008

• Transactions of the Korean Society for Noise and Vibration Engineering
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• v.23 no.2
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• pp.185-191
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• 2013

This paper presents a new method for roller design of IRB(isolation roller bearing) seismic isolation device using experimental evaluation. Three layered plate is adopted for the IRB in which the upper plate is placed on x direction and the lower plate is placed on y direction. The rollers placed in each plate make a plate movement. The roller is then optimally designed using variable geometric conditions. Stress distribution depends on the diameter and length of the roller and hence this is used for the determination of optimal geometry of the roller. In the experimental evaluation, it is observed that stress concentration at the end sides of roller is decreased and geometric coefficients depend on crowning dimension. In addition, in order to determine optimal design parameters of the roller the plastic deformation and friction are experimentally identified.

• Transactions of the Korean Society for Noise and Vibration Engineering
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• v.23 no.4
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• pp.332-337
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• 2013

This paper presents a subsequent research work on the roller design of IRB(isolation roller bearing) seismic isolation device presented in Part 1 by focusing on heat treatment. The hardness and friction factor are very important factors of material and after-treatment process selection. Normally, roller bearing consists of roller and retainer. The roller gets high pressure constantly, while the retainer gets tensile and compressive stress. Therefore, sensitive material selection and heat treatment of each part is quite important. In this experimental evaluation, carbon steel, chrome special steel and others are employed and their characteristics after heat treatment are identified. Each material is prepared by refining high frequency heat treatment. The friction factor and static load capacity of manufactured material are experimentally identified and destructive test of material is processed. Optimal material and heat treatment conditions for IRB roller bearing are determined based on experiment results.

• Asia-Pacific Journal of Business
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• v.12 no.4
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• pp.41-52
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• 2021

Purpose - This study is to identify the relationship between the gap of in-role behaviour (IRB) on employee's interpersonal behaviour with the different perspective considering this behaviour as a social action that employees show in their work life, away from the perspective of conventional research that treats IRB as task performance. Design/methodology/approach - This study focus on the level of IRB gap that individuals have with their colleagues and its effect on the interpersonal behaviours such as helping and incivility instigation. The higher the level of difference, the more likely it would negatively affect their interpersonal behaviour through stress. The analysis was conducted on 250 employees of Korean companies through partial least squares structural equation modelling. Findings - The analysis shows that IRB gaps have a negative effect on employee's fully helping, and partly instigated incivility, in mediating stress. Implications based on the results of the study were presented in the conclusion. Research implications or Originality - The approaches and findings thus study showed are unique because most of existing studies have not tried to focus on the gap of in-role behaviour between employees and their colleagues. This study can give novels inspirations to other researchers in the related field.

• Journal of Yeungnam Medical Science
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• v.35 no.1
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• pp.36-39
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• 2018

In the personalized medicine era, utilizing paraffin blocks in pathology archives for investigating human diseases has come into the limelight. This archived material with clinical data will reduce the research time and could prevent new patient recruitment to obtain tissue for research. However, the clause indicating the necessity of consent from human material providers in the Korean Bioethics and Safety Act has made the Institutional Review Board (IRB) deny permission to use paraffin blocks for research without consent, and alternatively to get the same before starting an experiment. Written consent may be waived off in studies using paraffin blocks with anonymous status or conditions not linked to personal information by applying the paragraph 3, article 16 of the current Bioethics and Safety Act. Also, the IRB should recommend researchers to preserve the blocks as medical records of patients in long-term archives.

• The Journal of KAIRB
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• v.4 no.2
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

• The Journal of KAIRB
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• v.2 no.1
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• pp.23-31
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• 2020

Purpose: To obtain opinions from Korean Institutional Review Board (IRB) members' self-evaluation on ability to conduct fairness review of clinical trial protocol with presence of conflict of interest and from investigators and IRB members on financial conflict of interest through surveying. Methods: IRB members and researchers in 9 different hospitals were asked to answer survey questions via email. Results: Responders were 115 personnel (IRB Chair/vice 18, medical member 30, non-medical member 28, and researcher 39) from 9 centers. Compared to IRB medical members, IRB chair/vice respondents scored higher with statistically significance on 10 point scale (8.44±1.381 vs. 7.30±1.685, p=0.005) when asked to self-evaluate fairness reviewing a protocol proposed by an investigator from the same department and a protocol from the company that supports the scientific committee of responders. When reviewing a protocol proposed by a hospital director, non-medical members scored statistically significantly higher than medical-members (7.47±1.76 vs. 8.07±2.70, p=0.034). When asked about the limitation of labor fee for principal investigator on phase 3 Human clinical trials of the Investigational new drug, while the responses range was wide, 60% answered that labor cost of principal investigator should be less than 30% of total budget for clinical trials with a budget of 100 million won. 51.3% answered that there is no need to disclose the labor cost of the principal investigator in the consent form. Since every investigator can be influenced unconsciously by conflict of interest, the answer that 'responder agrees that there is need for management' was the most chosen answer (IRB member 61.8%, investigator 64.1%, multiple answers allowed). Conclusion: Considering scores on questions of fairness by IRB members were between 7.23-8.56 on scale of 0 to 10 point when IRB members were asked about reviewing a clinical trial protocol, it cannot be said with absolute certainty that there is no issue regarding fairness in the review process. Therefore, there should be more ways to safeguard fairness for these issues. There is a need that the disclosure amount of honorarium from sponsor should be lower than 100 million Korean won. Considering the results of the survey in which respondents expressed their thoughts, it is likely that more education on the concept of conflict of interest is needed.

• Korean Journal of Clinical Pharmacy
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• v.26 no.1
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• pp.77-83
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• 2016

Background: Oversight on the bioethical compliance of national R&D projects or research personnel is currently conducted exclusively by IRB (Institutional Review Board) within the relevant research institute. Considering current state of affairs in Korea, there is an imperative to establish a national oversight system for bioethical compliance, conduct comprehensive oversight on bioethical compliance of national R&D projects, and enhance subject protection system. Methods: We examined opinions from researchers and IRB personnels regarding ethical oversight system on R&D projects. Additionally, we looked at IRB assessment by KAIRB (Korea Association of Institutional Review Board) in order to identify status and problems with current IRB system in Korea. Assessment was also done for four other countries (US, UK, Germany, Singapore) through in-person visits as well as surveys in writing for a total of 6 months (2012.12.1~2013.5.31). The research comprised of two aspects: system management and R&D project audit. Based on this, we examined current status and problems of the existing system in Korea and made recommendations for improvement. Results: Regulatory objectives and backgrounds of biomedical researches are different from each country due to different characteristics of bioethical oversight system. This shows that each country sets up its own regulations and procedures to fit each situation. Bioethical compliance oversight system greatly varied between the countries. From this study, it can be seen that improvement of existing procedures and oversight system or establishment of new ones are essential in Korea. Conclusion: In terms of system management, a dedicated government organization need to be established for bioethical compliance, subject protection, IRB inspection, training, evaluation, and certification of systems, and also support for IRB e-system. Regarding R&D project oversight, it is essential to confirm IRB review results before start of a research, to conduct a review on ethical aspects of research plans, and to carry out continued oversight on bioethical compliance through interim reports.