• 대한기관윤리심의기구협의회지
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• 제2권2호
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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.

• 척추신경추나의학회지
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• 제8권1호
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• pp.27-38
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• 2013

Objectives : The purpose of this study is to investigate the latest trends of korean Medicine treatments on traffic accident for recent 5 years. Methods : We investigated the studies on korean Medicine treatments for traffic accident via searching 6 Korean web databases. As a result, 65 research papers were found to be analyzed according to their published year, the titles of journals, the types of study, the number of cases, the sites of injury, the types of treatments the instruments for assessment and ethics approvals. Results : 65 articles were published since 2008. The studies on korean Medicine treatments about traffic accident were mainly published in Journal of Oriental Rehabilitation Medicine. 10 case studies, 14 case series, 11 non randomized controlled trials, 21 randomized controlled trials and 9 systemic reviews had been under research. The most frequently occurred symptoms were neck pain and low back pain. In most studies, various korean Medicine treatments were used to treat the symptoms. Visual analogue scale(VAS) and neck disability index(NDI) were used as primary assessments. In most clinical studies, there were no mention about approval of institutional review board(IRB). Conclusion : In this study, we analyzed the trends of korean Medicine treatments on traffic accident from 2008 to 2012. Reviewing the domestic trends of studies on korean Medicine treatments for traffic accident and examining the strong and weak points of those treatments are essential for the future studies. It is needed to adopt the qualitative methods of evaluation in order to develop a level of evidence.

• 국제교류와 융합교육
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• 제4권1호
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• pp.57-83
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• 2024

이 연구는 외국인 유학생들의 한국어 능력 시험(TOPIK) 등급이 학업 적응에 미치는 영향을 알아보고자 하였다. IRB의 승인을 거쳐 모집한 학생은 모두 7명으로 이들의 면담 내용은 실용적 절충주의에 기초한 포괄적 분석절차 (이동성, 김영천, 2014)의 6단계를 활용해 분석했으며 그 결과 학문 목적 한국어 학습자의 학업 적응에 영향을 미치는 요인을 학업, 생활, 심리·정서의 범주로 나눌 수 있었다. 학업적 측면에서 인터뷰 대상자들은 적응하기 힘들었던 전공 용어와 전공 공부를 지적하였고, 한자 및 한자어에 큰 어려움을 경험했다. 다음으로 생활 측면에서는 고급 수준의 토픽 등급 소지자인 연구 참여자들도 대학 생활 적응에 어려움이 있었고 한국 생활에 제대로 적응하기 위해서는 실용적인 표현과 풍부한 어휘 지식이 필요함을 토로했다. 마지막으로 심리·정서적인 범주에서는 이들이 한국인들과의 대화나 발표에 상당한 스트레스를 받고 있음을 파악할 수 있었다. 사회 문화 및 일상 생활 문화에 관한 지식도 부족했기 때문에 한국어를 잘하더라도 화용적인 면에서 실수나 오류를 범하기도 했고 이것이 심리·정서적인 어려움에 처하는 요인이 되기도 했다. 이러한 이야기들을 근거로 한국어 학습자의 학업 적응을 촉진하기 위해서는 한국어 학습의 다양한 기회 부여라는 목표를 기반으로 학습자의 전공 관련 학업 능력 강화, 한국어 숙달도 향상, 학내 관계 형성에 도움을 주어야 한다는 결론을 내렸다. 그리고 연구자는 이를 위한 해결 방안으로 외국인 학습자들을 위한 다양한 비교과 활동을 계획·설계하여 시도해 볼 것을 제안했다.

• 대한한방부인과학회지
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• 제32권1호
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• pp.73-84
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• 2019

Objectives: The purpose of this study is to collect and analyze the KCD codes applied to the treatment of 27 postpartum women who had been treated with Korean traditional medicine in a Korean medicine hospital, so that this study may be used as a basic data for setting the direction of postpartum Korean medical treatment research. Methods: It was approved by the Institutional Review Board (IRB) of ${\bigcirc}{\bigcirc}$ University medical center (IRB approval number : WSOH IRB H1708-02-01). Twenty-seven postpartum women who had been treated at ${\bigcirc}{\bigcirc}$ University medical center were received outpatient treatment for two weeks (from September 27, 2017 to January 5, 2018), and the KCD codes applied to the mothers were collected after obtaining the consent. On the day of registration of the study, the fertility, obstetric history and high-risk pregnancies were identified through an interview. Results: 1. The mean age of the 27 subjects was $33.33{\pm}3.99\;years$ old. Among the subjects, 17 mothers (63.0%) were high-risk pregnancy and 10 mothers (37.0%) were normal. 2. Among the 22 major disease categories, 8 categories were used. M code (musculoskeletal system) was used 243 times (70.85%), followed by R code (unclassified symptom) of 51 times (14.87%) and U code (special purpose code) of 23 times (6.71%). 3. The most commonly used code among the ten frequently used codes was M25.57 (joint pain, ankle and foot), a total of 47 times. Of the remaining nine codes, except for R60.1 (systemic edema) and U68.4 (The deficiency of yang in Bi), all codes were M codes (musculoskeletal system). 4. The M code (musculoskeletal system) was the most used major disease category in high-risk group, a total of 159 times. But in specific categories, the most commonly used code was R60.1 (systemic edema), a total of 28 times. 5. In normal group, the M code (musculoskeletal system) was the most used major disease category, a total of 84 times. Also, in specific categories, the most commonly used code was M25.57 (joint pain, ankle and foot), total 29 times. 6. The U code, corresponding to 'the diagnosis of childbirth and other obstetrical medical use', was used 23 times (6.71%), O code three times (0.87%) and Z code two times (0.58%), which was less than 10% of the total number of codes used. Conclusion: When analyzing KCD codes related to Korean medicine treatment for postpartum diseases, it is important to select the KCD codes that reflect the actual clinical state.

• 한방비만학회지
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• 제20권2호
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• pp.138-148
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• 2020

Objectives: The aim of this study is to evaluate the effects of Bangpungtongseong-san (Fangfengtongsheng-san, BTS) and Daesiho-tang (Dachaihu-tang, DST) on weight loss and improvement in lipid metabolism and glucose metabolism. Furthermore, we intend to develop a prediction model for drug effects through the analysis of the single nucleotide polymorphism (SNP), gut-microbiota, and the expression of immune-related biomarkers. Methods: This study is a single-center, randomized, double-blind, parallel-design clinical trial. One hundred twenty-eight participants will be assigned to the BTS group (n=64) and DST group (n=64). Both groups will be administered 4 g medication three times a day for up to 2 weeks. The primary outcomes is weight loss. The secondary outcomes include bioelectrical impedance analysis, waist circumstance, body mass index, total cholesterol, high-density lipoprotein, triglyceride, insulin resistance. The exploratory outcomes include 3-day dietary recall, food frequency questionnaire, quality of life questionnaire, gut microbiota analysis, immune biomarkers analysis, and SNP analysis. Assessment will be made at baseline and at week 4, 8, and 12. Conclusions: This protocol will be implemented by approval of the Institutional Review Board of Dongguk University. The results of this trial will provide a systematic evidence for the treatment of obesity and enable more precise herbal medicine prescriptions.

• 대한치과의사협회지
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• 제50권4호
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• pp.203-210
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• 2012

Objective: The aim of this study was to investigate the incidence of the C-shaped canal of permanent mandibular second molar (PMSM) in Korean sub-population using Cone-Beam CT (CBCT) data and analyze the types of C-shaped canal. Materials & Methods: The protocol for this study was approved by the Institutional Review Board at the Pusan National University Hospital (E-2011039). Among the CBCT images taken of patients who visited the St. Bennedict Dental Hospital (Busan, Korea) from May 2008 to April 2011 for implant surgery and surgical removal of impacted teeth, high-quality CBCTs from 705 patients (361 male and 342 female) were screened and 607 PMSMs of 383 patients were evaluated retrospectively. All PMSMs were anatomically analyzed in detail by using image viewer software (EasyDent; Vatech). PMSMs were evaluated in the axial plane to investigate the shape of root and canals. The C-shaped canals were classified into five types. The total incidence, gender ratio, bilateral and unilateral appearance. and the correlation between right-side and left-side occurrences of C-shaped PMSMs were computed and compared statistically using the chi-square test. Results: Among the 607 PMSMs of 383 CBCTs of 187 females and 196 males, 198 PMSMs(32.6%) had C-shaped root and 158 PMSMs(26.0%) had C-shaped canals. The shape of C-shaped root canals at the furcalion level did not have significant change at the level of mid root (P<0.0001). Female had more prevalence of C-shaped root canals than male (P<0.0001). The prevalence of bilateral occurrence of C-shaped root canals was higher than unilateral occurrence. Conclusions: The occurrence of C-shaped PMSMs among a Korean population was 32.6% and was higher than other countries and ethnicities. Understanding the prevalence of PMSMs with a C-shaped root and/or canal in a Korean population may be useful for successful endodontic treatments.

• Journal of Acupuncture Research
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• 제23권6호
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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.

• 대한한의학방제학회지
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• 제25권2호
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• pp.135-143
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• 2017

Objectives : This trial aimed to determine if Wasong (Orostachys japonicus) extract can enhance immune system and is safe enough to be approved as a health functional food. Methods : Total 62 people, aged 45 and older, will be recruited to participate in a randomized, double-blind, placebo-controlled clinical trial. This study will compare Wasong extract and placebo. Wasong group will take 1g of Wasong extract, once a day, for 8 weeks. Placebo group will take 1g of crystalline cellulose as placebo, once a day, for 8 weeks. Outcomes will be measured at the baseline, the end of 4th week, and 8th week. Primary outcomes are the ratio of NK cells/total lymphocytes and the ratio of T-helper cells/T-suppressor cells. Secondary outcomes are total white blood cell count, the ratio of neutrophils, lymphocytes, and monocytes in total leukocytes, the ratio of total T cells, T-helper cells, T-suppressor cells, and B cells to lymphocytes, the amount of blood IgM, IgG, IgA, and cytomegalovirus (CMV) IgG, and blood metabolite target &global analysis. Results : This trial was approved by institutional review board of Pusan National University Korean Medicine Hospital (registry number: 2016006), and registered in Clinical Research information Service, one of WHO International Clinical Trials Registry Platform (registry number: PRE20161006-002). Recruitment opened in February 2017 and is supposed to be completed by August 2017. The result is expected to be published by June 2018. Conclusion : This trial will provide clinical information to determine the efficacy and safety of Wasong in enhancing immune system of middle-aged and older people.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• 제34권4호
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• pp.229-235
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• 2023

Objectives: This study aimed to assess the status of the Journal of the Korean Academy of Child and Adolescent Psychiatry (JKACAP) and propose measures for its growth and development. Methods: The study was conducted using a questionnaire survey targeting members of the Korean Academy of Child and Adolescent Psychiatry. The six key elements analyzed were Access to the journal, Convenience following conversion to English, Recognition as an international journal and institutional achievements, Author perspectives on manuscript submission, Transition to an online-only journal, and Content and identity of the journal. Results: The survey revealed that email notification was highly effective for Journal Accessibility, with the website and search engines also frequently being used by members. Conversion to English in 2018 initially impacted readability and submission rates, but these concerns have decreased over time. However, the Recognition of JKACAP as an international academic journal was still not on par with SCIE journals, highlighting the need for further efforts towards SCIE inclusion. Despite these challenges and limited research opportunities, there was an active intention among members to submit manuscripts. Respondents showed a notable preference for the Transition to an online-only journal. Regarding content and identity of the JKACAP, members predominantly favored review articles and perceived the journal as a research and communication platform for Korean child and adolescent psychiatrists. Conclusion: The results indicate the need for JKACAP to enhance its digital accessibility, provide more support for domestic and international authors, and actively seek SCIE indexing. Addressing the varied content preferences of its members, improving the submission process, and transitioning to an online-only format could further its growth and solidify its position as an internationally recognized academic journal in the field of child and adolescent psychiatry.

• 한방비만학회지
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• 제8권1호
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• pp.71-80
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• 2008

Objectives Obesity and climacteric symptom are affected by various cultural, social and psychological factors. This study is performed to recognize the relationship between obesity, climacteric symptom, and other social and psychological factors such as self-esteem, depression, eating attitude, stress response and social readjustment rating. Methods SRRS(social readjustment rating scale), SES(self-esteem scale), SRI(stress response inventory), BDI(Beck depression inventory), KEAT-26 (Korean Eating Attitude Test-26) and Kuperman index were given to 43 peri-menopausal women aged 45-55 and BMI ${\geq}23$. They were given written consent and this study is performed under the permission of institutional review board of Kyung Hee East-west Neo Medical Center. And height, body weight, waist circumference were measured. These variables were treated by correlation and regression analysis for finding effect factors of climacteric symptom. Result BMI and WC were not related to climacteric symptom. There were significant correlation between KEAT-26(r=0.4388, p=0.004), SES (r=-0.4748, p=0.001), SRI(r=0.6941, p<0.001), BDI(r=0.6354, p<0.001) and Kuperman index. In multiple regression, SRI was find to be a prediction factor of Kuperman index.(Kuperman index=19.033+0.7SRI($R^2$=0.490)). Conclusion Climacteric symptom is related to self-esteem, eating attitude, depression and stress response. And the most important prediction factor of climacteric symptom is stress response. So managing of stress response may be essential to treating climacteric syndrome. And it is necessary to study about climacteric symptom with many other effective factors of various peri-menopausal subjects.