• The Journal of KAIRB
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• v.2 no.1
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• pp.6-22
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• 2020

Purpose: Clinical studies require institutional review board (IRB) approval based on the ethical principle and regulations. While the number of clinical studies has been increased and diversified, duplicated IRB review for multi-center studies has become a major issue. Therefore, single IRB system has been suggested in revised Common Rule. This study aimed to identify and assess the current status of single IRB in Korea and the anticipated needs of single IRB from researchers and IRB member or administrators. Methods: We developed 14 questions including perceived advantages and disadvantages of single IRB, and anticipated problems. The online survey collected opinions on single IRB from researchers, IRB members and IRB administrators. We also interviewed five IRB administrators who have an experience of single IRB. Results: A total of 80 responses were analyzed in this study. Although efficiencies were suggested for the advantages of single IRB in terms of reducing burden of duplicated review, respondents also perceived that the different review criteria between single IRB and each IRB would be a major hurdle for adopting single IRB system. Therefore, the standardization of standard of procedures (SOP) and the standardization of IRB submission materials should be preceded. According to the small group experiences of single IRB in Korea, we also observed the similar anticipated problems of single IRB. Conclusion: Single IRB system has many advantages for conducting multi-center trial. However, many specialists still have a lot of concerns about introducing a single IRB system in Korea. Therefore, a gradual, step-by-step process for conducting a single IRB system in Korea will be needed. Many studies for improving currently suggested single IRB system and the improvement of awareness about the essential of single IRB system would be needed.

• Korean Journal of Clinical Pharmacy
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• v.24 no.2
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• pp.135-143
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• 2014

Purpose: Aim of this study was to gather and evaluate perceptions of investigators, IRB members, and IRB administrators on the appropriateness of IRB review process and bioethical oversight system of national R&D (NR&D) projects. Method: Investigators, IRB members, and IRB administrators at 17 different institutions were surveyed using convenience sampling and survey questionnaires were partially group-specialized to consider any differences between the groups. Results: Participants included 29 investigators, 37 IRB members, and 17 administrators with response rate of 100% (83 of 83). According to the responses obtained, insufficient preparation time for constructing protocol and gaining IRB approval was one of the main problems in the IRB review process (investigator 79.3%, IRB administrator 88.2%). Also, discrepancy between NR&D and IRB's protocol formats was another major issue (IRB members 96.4%, IRB administrator 100%) and most investigators (89.7%) had to modify the original NR&D protocol to obtain IRB approval. Moreover, it was reported that 13.8% of investigators and 31.3% of IRB administrators did not submit midyear reports to IRB and for bioethical issues of NR&D projects, 17.2% of investigators did not include information on project status and safety issues in the annual reports. Conclusion: In conclusion, for successful and ethical completion of R&D projects, revision of both IRB review process and NR&D project protocol formats as well as implementation of appropriate bioethical oversights are necessary.

• Korean Journal of Childcare and Education
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• v.14 no.2
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• pp.1-17
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• 2018

Objective: The purpose of this paper is to understand the bioethics and the Institutional Review Board (IRB) in the social and behavioral research area through "The Bioethics and Safety Act" and to examine the IRB's present situation, roles, responsibilities, and tasks. Methods: This paper reviewed articles, materials for education, and "The Bioethics and Safety Act" related with the IRB. Results: Bioethics included all the research in the social and behavioral area, and "The Bioethics and Safety Act" has been enforced in every research projects targeting human subjects since February 2, 2013. Accoding to the law, the IRB must review the research proposals for human subjects and was introduced in social and behavioral research as a self-regulating system. At present, all the related institutions including universities must establish and run the IRB. This paper introduced the definition of bioethics, the IRB's roles and review types, the total number of registered IRB, and "The Bioethics and Safety Act". Conclusion/Implications: Both the central government and the local government have to make an effort for the establishment and settlement of the IRB system. This paper also presented some of the problems of the IRB.

• The Journal of KAIRB
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• v.4 no.1
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• pp.5-15
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• 2022

To suggest future directions for the improvement in the Institutional Review Board (IRB) review process and efficient operation of IRB, we have analyzed the IRB review results from 460 new research proposals submitted to the Review by the Convened IRB of the Keimyung University Dongsan Hospital IRB from January 2019 to July 2021. IRB is an independently established institutional committee to protect the human subjects by reviewing the research protocol in ethical as well as scientific aspects, so it is necessary to continuously contemplate the ethical versus scientific dilemma of 'what is ethical or scientific and what can actually protect human subjects.' Particularly, in this process, it is necessary to consider diverse ways to strengthen self-supervision through continuous Internal Audit rather than simple reporting outcomes. In addition, if it does not directly affect the protection of the human subjects, the discussion with the committee members is needed so that the comments such as administrative and typographical errors can be reduced as much as possible. Furthermore, as statistical analysis methods can have a significant impact on the safety of human subjects, if a legal basis and/or support related to statistics is provided for the composition of IRB members, a more specialized IRB review will be achieved.

• Journal of Korean Society of Archives and Records Management
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• v.23 no.1
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• pp.127-132
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• 2023

The Incheon Medical Center Institutional Review Board (IRB), a department that reflects the characteristics of Incheon Medical Center, a medical and public institution, was established in 2013. IRB contributes to performing its role as a local accountable care hospital and protecting researchers and subjects by proving the ethics of research conducted at the medical center. So far, IRB has reviewed a total of 80 research proposals for human subject research and human-derived material research, and it currently exists as an independent department directly under the president of the medical center. This paper aims to explain the registration and preservation of IRB-related records, the maintenance of the Records Management Standard Table and related regulations, and archives, as well as to present limitations and improvements in the disclosure, utilization, and classification of records.

• The Journal of KAIRB
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• v.1 no.1
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• pp.5-21
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• 2019

Purpose: Institutional review board (IRB) classifies risks of clinical trials into less than minimal risk, minor increase over minimal risk, and more than minimal risk. Based on classification and evaluation for risk, IRB decides whether permitting consent exemption or asking additional protection for clinical research subject or not. The purpose of this study is to analyze how IRB members evaluate minimal risk by sending questionnaire survey with 12 predetermined scenarios. Methods: IRB members and researchers (pediatrician, gastroenterologist, neurologist, and neurosurgeon) in 11 different hospitals were asked to answer survey questions via email or online. We analyzed the differences of answers among several subgroups in each predetermined scenarios. Result: Responders were 212 personnel(110 researchers and 102 IRB members) from 11 centers. There were significant differences between IRB members and researchers in response such as blood sampling, skin prick test, one time catheterization in a girl, spinal tapping in child, non-enhance MRI in child, non-enhance MRI with chrolal hydrate in a child, spinal tapping without anesthesia in adult, bioequivalence test, gastric endoscopy, and non-enhance CT. significant differences between medical IRB members and non-medical members were also revealed in one time catheterization in a girl, spinal tapping in a child, non-enhance MRI in a child, bioequivalence test. Depending on researchers' department, they responded differently in several questionnaires as well. Conclusions: We have found that IRB members and researchers evaluate the risks differently. Researchers compared to IRB members, medical IRB members compared to non-medical members answered less than minimal risk in many cases. In assessing and evaluating the risks associated with the study, medical IRB members answered predetermined scenarios as less dangerous compared to non-medical IRB members. Difference among researchers where also revealed significantly. Researchers answered predetermined scenarios as less dangerous compare to other department researchers, especially in predetermined scenarios containing procedures they are familiar with.

• Health Policy and Management
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• v.32 no.1
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• pp.1-2
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• 2022

With the rising attention dedicated to research ethics, the responsibility of researchers to comply with research ethics is also highlighted. Among a number of research ethics obligations that researchers should abide by, an institutional review board (IRB) review is the most essential step to be taken before launching research. As the health service research field grapples with human subjects, it closely aligns with IRB deliberation. However, it seems that researchers still do not fully understand their obligations of IRB reviews. Due to the nature of health services research, there are many cases that are exempt from IRB reviews, which often elicits confusion in the research field. On that note, we aim to explore the issues regarding IRB reviews that health service researchers need to know.

• The Journal of KAIRB
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• v.2 no.2
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• pp.33-36
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• 2020

In December 2019, coronavirus disease 2019 (COVID-19) was discovered in Wuhan, China. The disease was so severe that as early as 30 January 2020 COVID-19 was declared by WHO as a Public Health Emergency of International Concern. There have been a lot of concerns about conducting COVID-19 clinical researches scientifically and ethically in pandemic. This article is directed at addressing these issues from the perspective of IRB. First of all, the urgency of COVID-19 research requires prompt IRB process through efficient ethics review and oversight system. IRB should determine whether the risks that will be presented to human subjects are justified after assessing possible harm and anticipated benefits. The safety of subjects should not be compromised. Furthermore, informed consent should be voluntarily obtained by sufficient information in consideration of special circumstances during a pandemic.

• 한국방재학회:학술대회논문집
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• 2008.02a
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• pp.807-810
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• 2008

Permeable reactive barriers containing Zero-valent iron (ZVI) are used to purify ground-water contaminants. One of the representative contaminant is trichloroethylene (TCE). ZVI can act as a reducing agent of TCE. When ZVI is oxidized to Ferric iron, TCE reduced to Ethene, which is non-harmful matter. As a ZVI becomes ferric iron, the reducing effect decreases and iron becomes unavailable. So, constant reduction of TCE requires the regular supply of reducing agent. So, we use Iron-reducing bacteria(IRB) to extend the TCE degrading ability. We perform three experiment DI water, DI water with medium, and DI water with medium and IRB. By the experiment we try to found the dissolve ability.

• The Journal of KAIRB
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• v.5 no.1
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• pp.1-13
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• 2023

In the United States (US), due to the Common Rule, completely revised in 2017, single Institutional Review Board (IRB) review has become mandatory for government-sponsored multi-institutional research since 2020 regardless of the number of participating institutions. The goal of these changes is to reduce redundant reviews by the IRB at each institution and better protect research participants. In this paper, single IRB and Human Research Protection Program (HRPP) in the US and Korea were compared and considered, and their implications were discussed. A comparison of the HRPP evaluation and certification systems of the US and Korea includes that of SMART IRB in the US and Korea Central IRB, aiming at single IRB review for efficient review with support from the country and building a more efficient national human subject research network in the future. Its comparison and analysis will be helpful in deriving future tasks and development directions of single IRB and HRPP in Korea.