• 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.

• 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.

• The Journal of KAIRB
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• v.2 no.1
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• pp.1-5
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• 2020

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule, 45 CFR 46, Subpart A). The Common Rule was initially promulgated in 1991 and amended in 2005. The Final Rule to update the current regulations was published in the Federal Register on 19 January 2017. The final compliance date of the revised Common Rule including the cooperative research requirement is effective on 20 January 2020 after twice to delay. The revised Common Rule aims to make more effective conduct of minimal risk research reflecting modern research activities and recognize evolving technologies, including mobile technologies, internet, and the growth in computing power. The revisions to the Common Rule were based on a variety of sources of public, stakeholder, and expert comments. The author summarized the key changes and the implications to Korean human research regulations.

• Journal of Haehwa Medicine
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• v.25 no.1
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• pp.1-13
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• 2016

Objectives : Lateral epicondylitis on elbow is one of the most common causes of elbow pain. Lateral epicondylitis can be managed with acupuncture, but the evidence for its effectiveness is uncertain. The purpose of this review is to investigate the trends of acupuncture treatments on lateral epicondylitis. Methods : We investigated the studies about acupuncture treatments for lateral epicondylitis via searching 5 Korean web databases(KTKP, RISS, OASIS, KCI, Kisti) The key search terms were 'Lateral epicondylitis', 'Tennis elbow', 'External epicondylitis'. 12 research papers(10 case reports, 1 RCT, 1NRCT) were found to be analyzed according to their published year, the titles of journals, published institution, the types of study, the number of cases, the types of treatments, the instruments for assessment and ethical approvals. The effectiveness of acupuncture treatment was classified. Results : 12 papers were published since 2003. The studies on acupuncture treatments about lateral epicondylitis were mainly published in The journal of pharmacopuncture. 10 case reports, 1 non-randomized controlled trials, 1 randomized controlled trials had been under research. In most of the research, the number of the cases were not enough. In 9 cases of the studies, various korean medicine treatments including acupuncture were used to treat the symptoms. In 3 cases of the studies single method was used to treat the symptoms. Visual analogue scale(VAS) and range of motion(ROM), grip strength were used as primary assessments. Among 12 clinical studies, 1 of them were accepted by institutional review board(IRB). Conclusions : In this study, we analyzed the trends of acupuncture treatments on lateral epicondylitis. Reviewing the domestic trends of studies on acupuncture treatments for lateral epicondylitis and examining the strong and weak points of those treatments are essential for the future studies.

• Journal of Oriental Neuropsychiatry
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• v.29 no.4
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• pp.255-266
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• 2018

Objectives: The objective of this study was to evaluate the reliability and validity of Pattern Identifications Tool for Cognitive Disorders (PIT-C) and verify the correlation with other related scales. Methods: The study in this protocol is a single group, prospective, observational one. The subjects of the study were men and women between the ages of 45 and 85, diagnosed with neurocognitive disorders by Diagnostic and Statistical Manual of Mental Disorder (fifth Edition) criteria (n=60, Clinical Dementia Rating (CDR)=0.5, Korean Version of Montreal Cognitive Assessment $(MoCA-K){\leq}22$). The reliability of PIT-C was evaluated as test-retest and inter-rater reliability. And correlation between PIT-C and other related scales was also assessed. Results: This study was approved by the Institutional Review Board (IRB) of Dunsan Korean Medicine Hospital of Daejeon University and registered in the Clinical Research Information Service (CRIS), and was made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: The results of this study can be used to classify neurocognitive disorders as Korean medicine and PIT-C will be helpful tool for primary health care.

• Journal of the Korean Society of Radiology
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• v.81 no.3
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• pp.591-603
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• 2020

Purpose The purpose of this study was to describe the clinical features and chest computed tomography (CT) findings of coronavirus disease 2019 (COVID-19) pneumonia. Materials and Methods An Institutional Review Board-approved retrospective review was performed for 51 laboratory-confirmed COVID-19 pneumonia patients. Patients were divided into two groups depending on their clinical status: mild and severe. Clinical characteristics and chest CT findings were compared between the two groups. Results Among the 51 patients (22 men, 29 women; mean age, 56.5 ± 16 years; range, 22-88 years), 37 (72.5%) were in the mild group and 14 (27.5%) were in the severe group. The patients in the severe group (68.7 ± 12.5 years) were older than the patients in the mild group (51.8 ± 14.9 years, p < 0.001). Premorbid conditions and decreased lymphocyte counts were more often observed in the severe group than in the mild group (71% vs. 41%, p = 0.049 and 86% vs. 32%, p = 0.001, respectively). On chest CT, most patients exhibited a mixed ground-glass opacification (GGO) with consolidation (76%) or a GGO (22%) pattern. The majority of lesions were predominantly bilateral in the lower lung with a posterior, peripheral distribution. The patients in the severe group had higher severity scores than those in the mild group. Conclusion Patients with laboratory-confirmed COVID-19 pneumonia have typical chest CT findings that provide important information regarding expected disease severity.

• Journal of Pharmacopuncture
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• v.19 no.3
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• pp.197-206
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• 2016

Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery's pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single-arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz ($SE_{10-30Hz}$) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. Discussion: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. Ethics and dissemination: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University's Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number: This trial was registered with the Clinical Research Information Service (CRIS) at the Korea National Institute of Health (NIH), Republic of Korea (KCT0001663), which is a registry in the World Health Organization's (WHO's) Registry Network.

• Journal of Acupuncture Research
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• v.23 no.6
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• pp.239-254
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• 2006

The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.