• 대한기관윤리심의기구협의회지
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• 제2권1호
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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.

• 한국임상약학회지
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• 제24권2호
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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.

• 한국보육지원학회지
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• 제14권2호
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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.

• 대한기관윤리심의기구협의회지
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• 제4권1호
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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.

• 한국기록관리학회지
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• 제23권1호
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• pp.127-132
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• 2023

공공기관이자 의료기관인 인천광역시의료원의 특성을 반영하는 부서인 인천광역시의료원 임상연구윤리심의위원회(이하 IRB)는 2013년 설치되었으며, 의료원에서 시행된 연구의 윤리성을 심의·검증함으로써 연구자와 연구대상자를 보호하고 지역책임의료기관 역할 수행에 기여하고 있다. IRB는 지금까지 총 80여 건의 인간대상연구 및 인체유래물연구 계획을 검토하였으며, 현재 의료원장 직속의 독립된 처리과로 존재하고 있다. 본 고에서는 IRB 관련 기록물의 등록 및 보존, 기록관리기준표 및 관련 규정, 문서고의 정비에 관하여 설명하고, 기록물 공개와 활용, 분류에 있어 한계 및 개선 사항을 제시하고자 한다.

• 대한기관윤리심의기구협의회지
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• 제1권1호
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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.

• 보건행정학회지
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• 제32권1호
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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.

• 대한기관윤리심의기구협의회지
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• 제2권2호
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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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• 한국방재학회 2008년도 정기총회 및 학술발표대회
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• pp.807-810
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• 2008

영가철(ZVI)를 사용하는 투수성 반응벽체(PRB, Permeable reactive barrier)는 TCE(Trichloroethylene)와 같은 난분해성 유기물질이 포함된 지하수를 처리하는데 사용될 수 있다. 여기서 ZVI(Zero-valent iron)가 Ferric iron으로 산화되면서 TCE를 ethene으로 환원시킨다. Ferric iron으로 변화된 iron은 환원과정을 통해 Ferrous iron으로 다시 재생을 시켜야 PRB의 처리수명을 연장시킬 수 있다. Ferric iron을 Ferrous iron으로 환원시키기 위해서 철환원 박테리아(IRB, Iron-reducing bacteria)를 이용한다. 이번 연구에서는 IRB가 Ferric iron을 환원시키기 위해서 Ferric iron을 용해를 한다는 concept으로 실험을 해보았다. 실험은 증류수(DI water, De-ionized water), DI-water에 배지를 포함한 용액, 그리고 DI-water에 배지 및 IRB가 포함된 용액, 이 3가지 조건으로 수행했다. 실험결과 $Fe^{3+}$의 용해가 IRB가 포함된 용액, 배지가 포함된 용액, 증류수 순으로 잘 되는 것으로 나타났다.

• 대한기관윤리심의기구협의회지
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• 제5권1호
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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.