• 제목/요약/키워드: Institutional Review Board (IRB)

검색결과 89건 처리시간 0.022초

우리나라 권역 장애인구강진료센터 이용자 만족요인 비교 (Comparison of factors among the regional oral health center for the disabled in Korea)

  • 정윤숙;최영애;강재민;이영은;송근배
    • 한국치위생학회지
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    • 제21권2호
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    • pp.183-191
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    • 2021
  • Objectives: The purpose of this study was to identify the factors of satisfaction with regional oral health centers for people with disabilities in Korea. Methods: A survey was conducted with 784 patients who visited regional oral health care centers in Korea. A self-developed questionnaire (29 items) was adapted with a consent form and IRB (Institutional Review Board). All collected data were analyzed for statistics using SPSS version 25.0. Results: The study participants were 452 (57.7%) male patients, 207 (26.4%) aged 20-29 years old, and mostly had physical, developmental, and mental disabilities. The patients were introduced by their acquaintances, and the major reason for visit was specific dental care for the disabled. Most patients used their cars and took half to one hour to commute. The common factor affecting the comprehensive satisfaction was the facility satisfaction. Conclusions: A more comprehensive and standardized questionnaire should be developed for the annual evaluation of all centers. This study presents the basic data that can aid to activate the operation of the four oral health care centers for the disabled, which are scheduled to be implemented in the future, as well as 10 currently operated centers.

치주질환에 대한 한의치료의 환자성과, 연구 가능성, 예비 효과, 안전성 및 경제성 평가를 위한 예비 연구 프로토콜 (A Preliminary Study Protocol to Evaluate Patient Outcomes, Feasibility, Preliminary Effectiveness, Safety and Economic Evaluation of Korean Medicine Treatment for Periodontal Disease)

  • 이지윤;한경선
    • 한방안이비인후피부과학회지
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    • 제37권2호
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    • pp.14-26
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    • 2024
  • Objectives : The purpose of this study is to assess the feasibility of conducting a study on traditional Korean medicine treatments for periodontal diseases, specifically gingivitis and mild periodontitis. Methods : This study will employ a randomized, controlled, parallel-group design. Subjects with gingivitis and mild periodontitis will be recruited in one university hospital. In total, 45 subjects will be randomized into three arms (Acupuncture therapy group, herbal mouthwash group and usual care group), and will be followed up for 4 weeks. We will assess clinical variables such as, pocket depth, bleeding on probing, gingival index, plaque index, visual analog scale, uroqol-5 dimensions-5 levels to analyze changes in microbial flora before and after the intervention. Results : The protocol for this study was approved by the Institutional Review Board (IRB) of Dongguk University Ilsan Oriental Medicine Hospital, and registered with the Korean Clinical Trial Registry on March 29, 2024. Conclusions : This study is the first clinical research on periodontal diseases conducted in a Korean traditional medicine institution. The research aims to broaden the scope of traditional Korean medicine and is expected to serve as crucial data for future large-scale studies.

학문 목적 한국어 학습자의 한국어 능력과 학업 적응에 관한 연구 (The narrative inquiry on Korean Language Learners' Korean proficiency and Academic adjustment in College Life)

  • 정연숙
    • 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.

WHO 침구임상 지침서 개정을 위한 국제회의 보고 (Reports on 'Meeting on the Revision of Guidelines for Clinical Research on Acupuncture')

  • 박히준;서정철;김세현;김상우;안경애;임사비나;김용석;최도영;강성길
    • Journal of Acupuncture Research
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    • 제22권5호
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    • pp.195-199
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    • 2005
  • The Working Group on the revision of Clinical Research Methodology for Acupuncture met in Seoul, Republic of Korea from 24 to 26 August 2005. The main objectives of the meeting were to review the regional publication guidelines for Clinical Research on Acupuncture, to make necessary revisions in the guidelines, to make recommendations on further collaboration and activities in the field of research on acupuncture, and to discuss scientific evidence-based approaches in the clinical research on acupuncture. Fourteen members from the eight Member States, one secretariat staff from the WHO Regional Office for the Western Pacific and ten observers from the Republic of Korea attended the meeting. The members presented their papers to review the current status of clinical research on acupuncture. The drafts of proposed revision to the previous guidelines for clinical research methodology on acupuncture were discussed extensively. The issues covered during the discussion included: the definition of the new terms; reorganization of clinical research design; revision and update of contents (e.g., control group); introduction of Institutional Review Board (IRB) on the section of ethical approval; additional outcomes including health-related quality of life (HRQOL), qualitative measures, etc. In the course of these discussions, the working group developed the revised guidelines for clinical research on acupuncture and made recommendations for promoting the dissemination of the revised guidelines.

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근관절건강학회지 게재 논문 분석: 2008년부터 2020년까지 (Analysis of Published Research in the Journal of Muscle and Joint Health from 2008 to 2020)

  • 박미성;이경숙;신계영;우수희;임경춘;최희정;진수지;박연환
    • 근관절건강학회지
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    • 제29권1호
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    • pp.69-80
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    • 2022
  • Purpose: To identify research trends in the Journal of Muscle and Joint Health. Methods: In total, 315 studies published between 2008 and 2020 in the Journal of Muscle and Joint Health were reviewed using analysis criteria developed by the authors Results: Most participants were adults or older adults, they mostly had arthritis. The types of research design were descriptive research (46.4%), quasi-experimental design (21.9%), randomized controlled trial (1.9%), and qualitative research (4.1%). The occupation of most authors was professor in universities (61.0%). Data were collected mostly in hospitals (41.6%) or communities (24.4%) using a questionnaire (52.4%). Written consent was obtained at 75.6% and 47.9% of studies were approved by the Institutional Review Board (IRB). The instruments measuring physical concepts such as pain, flexibility, sense of balance and fatigue were mostly used. The most common interventions in experimental studies were physical interventions, with the main being exercise. Key words were categorized into four nursing meta-paradigms: human, health, environment and nursing. The most frequently reported key words were included in the health domain. The most frequently used key words were physical intervention, older patient, osteoarthritis, pain and depression. Conclusion: The results suggest that more research studies targeting various age groups related to muscle and joint health are required. Additionally there is a need to increase the number of qualitative studies, randomized experimental studies, and systematic review studies. It is necessary to pay attention to compliance with research ethics publication regulations.

Coronavirus Disease 2019 폐렴의 임상적, 영상의학적 소견: 대구의 단일 기관에서 51명의 성인 환자를 대상으로 한 분석 (Clinical and Radiological Findings of Coronavirus Disease 2019 Pneumonia: 51 Adult Patients from a Single Center in Daegu, South Korea)

  • 이승은;김영선
    • 대한영상의학회지
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    • 제81권3호
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    • pp.591-603
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    • 2020
  • 목적 본 연구는 Coronavirus disease 2019 (이하 COVID-19) 폐렴 환자의 임상 양상과 흉부 전산화단층촬영(이하 CT) 소견을 분석하고자 하였다. 대상과 방법 IRB의 승인을 받은 연구로, 51명의 COVID-19 확진 환자들을 후향적으로 분석하였다. 환자들을 임상 양상에 따라 경증과 중증으로 나누어 두 그룹 간에 임상 양상과 흉부 CT 소견을 비교하였다. 결과 총 51명의 환자(남자 22명, 여자 29명, 평균 56.5 ± 16세, 범위 22~88세) 중 37명(72.5%)은 경증, 14명(27.5%)은 중증이었다. 중증 환자들의 평균 연령(68.7 ± 12.5세)은 경증 환자들(51.8 ± 14.9세)보다 많았다(p < 0.001). 중증 환자가 기저질환을 가지고 있는 경우가 많았으며(71% vs. 41%, p = 0.049), 혈액검사에서 림프구 백분율 감소를 보이는 경우가 많았다(86% vs. 32%, p = 0.001). 흉부 CT 소견은 대부분의 환자들에서 간유리음영과 폐경화가 혼합된 양상이거나(76%) 간유리음영으로(22%) 나타났고, 양측 폐 하부, 후방, 변연부에 나타나는 경우가 많았다. 중증 환자에서 병변이 더 많은 수의 폐엽을 침범했고, CT 위중도 점수도 높았다. 결론 COVID-19 폐렴 확진 환자의 특징적인 흉부 CT 소견을 숙지하는 것이 빠른 진단과 적절한 치료에 도움이 될 것이다.

최근 일본의 의학계 연구규율의 특색 (The Characteristic of Research Regulation in Recent Japanese Medical World)

  • 송영민
    • 의료법학
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    • 제20권2호
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    • pp.173-206
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    • 2019
  • 본 연구는 최근 일본의 임상연구 관련 규율의 특색을 검토한 것이다. 첫째, 우리나라와 같이 일본에서도 그 동안 연구부정에 대해서는 엄벌주의를 취하여 왔지만, 최근 일본에서는 연구윤리정책을 제재가 아닌 교육연수에 의한 연구공정성 확보로 방향을 전환하였다는 점과 2018년 4월부터 시행된 임상연구법은 임상연구에 관한 자금제공 정보의 공표를 의무화하여 임상연구에 따른 자금제공의 투명성을 높인 점 및 의학계 연구의 윤리심사의 집약화 및 피험자를 집중시켜 증례나 우수한 연구자를 모집하여 임상연구·치험을 집약화한 점, 둘째, 그 동안 역학연구에 관한 윤리지침(이하, 「역학지침」이라 함)과 임상연구에 관한 윤리지침(이하, 「임상지침」이라 함)으로 이원화되어 있었던 윤리지침을 인간을 대상으로 하는 의학계 연구에 관한 윤리지침(이하, 「통합지침」이라 함)으로 통합 정비하여 임상연구와 역학연구에 필요한 윤리지침의 중복과 흠결을 보완했다는 점 이외에도 피험자보호를 위한 리스크 평가제도를 둔 점 이외에도 평가의 선결문제인 「침습」 개념을 명확히 했다는 점에서 긍정적인 평가를 받고 있다. 임상연구관련 국제규범상의 공통적인 내용인 「위험과 이익의 평가 문제」는 연구자의 연구가 적절히 고안되었는지를 검사하는 수단이다. 이는 연구윤리위원회가 피험자에게 가해질 위험이 정당화될 수 있는지 여부를 결정하는 방법이며, 장래의 피험자가 임상시험의 참여여부를 결정하는 중요한 기준이 되기도 한다. 그러므로 피험자의 리스크 평가의 선결문제인 「침습」 개념을 명확히 정의한 것은 의미 있는 것이다. 본 연구에서는 특히 최근 일본의 임상시험에서의 연구부정방지 대책에 대한 인식의 전환, 연구심사 및 피험자의 집약화를 통환 연구의 효율성 제고, 피험자 보호를 위한 리스크 평가의 전제가 되는 「침습」 개념의 명확화와 범위의 확장 등에 관한 논점을 중심으로 검토한 것이다.

The relationship between radiological features and clinical manifestation and dental expenses of keratocystic odontogenic tumor

  • Min, Jung-Hyun;Huh, Kyung-Hoe;Heo, Min-Suk;Choi, Soon-Chul;Yi, Won-Jin;Lee, Sam-Sun;Bae, Kwang-Hak;Choi, Jin-Woo
    • Imaging Science in Dentistry
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    • 제43권2호
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    • pp.91-98
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    • 2013
  • Purpose: This study was performed to identify correlations between keratocystic odontogenic tumor (KCOT) data from CT sections, and data on the KCOT clinical manifestation and resulting dental expenses. Materials and Methods: Following local Institutional Review Board (IRB) approval, a seven-years of retrospective study was performed regarding patients with KCOTs treated at the Seoul National University Dental Hospital. A total of 180 KCOT were included in this study. The following information was collected: age, gender, location and size of the lesion, radiological features, surgical treatment provided and dental expenses. Results: There was no significant association between the size of the KCOT and age, gender, and presenting preoperative symptoms. In both jaws, it was unusual to find KCOTs under 10 mm. The correlation between the number of teeth removed and the size of the KCOT in the tooth bearing area was statistically significant in the mandible, whereas in the maxilla, no significant relationship was found. Dental expenses compared with the size of the KCOT were found to be significant in both jaws. Conclusion: The size of KCOT was associated with a significant increase in dental expenses for both jaws and the number of teeth removed from the mandible. These findings emphasize the importance of routine examinations and early detection of lesions, which in turn helps preserving anatomical structures and reducing dental expenses.

우리나라 다빈도 섭취 과일의 당 함량 및 혈당지수에 관한 연구 (Sugar composition and glycemic indices of frequently consumed fruits in Korea)

  • 유지현;임정은;석완희;이한송이;안혜진;김영설;박천석;조여원
    • Journal of Nutrition and Health
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    • 제45권2호
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    • pp.192-200
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    • 2012
  • Fruits are generally recommended for a balanced meal, as they are good sources of vitamins, minerals, and fiber, which may improve blood glucose control. However, fruits have simple sugars with a wide glycemic index (GI) range. The purpose of this study was to analyze the sugar content and composition and to determine the glycemic indices of the most frequently consumed fruits in Korea, including apple, tangerine, pear, water melon, persimmon, grape, oriental melon, and peach. The sugar content and composition of the fruits were analyzed by high performance anion-exchange chromatography (Dinonex model DX-600). The GI of the fruits was measured in 13 healthy subjects (seven females and six males) after permission was received from the University Hospital institutional review board (KHU-IRB 1114-06). The subjects consumed 50 g of glucose as a reference and carbohydrate portions of eight fruits. Blood samples were collected at 0, 30, 60, 90, and 120 min after consuming the fruits. The GI values for the fruits were calculated by expressing the increase in the area under the blood glucose response curve for each subject. As a result, the total sugar contents of 100 g fruits were: grape (13.9 g), apple (12.3 g), persimmon (11.9 g), oriental melon (11.2 g), watermelon (9.3 g), tangerine (8.9 g), peach (8.6 g), and pear (8.3 g). The GI values of the fruits were as follows: GI value of peach ($56.5{\pm}14.17$), watermelon ($53.5{\pm}18.07$), oriental melon ($51.2{\pm}18.14$), tangerine ($50.4{\pm}15.16$), grape ($48.1{\pm}14.05$), persimmon ($42.9{\pm}18.92$), pear ($35.7{\pm}14.38$), and apple ($33.5{\pm}11.92$). These findings will help individuals choose fruit for controlling blood sugar.

Report of the 3rd Japan-Korea Workshop on Acupuncture and EBM;Protocol development for the acupuncture trial on the osteoarthritis of the knee

  • Jang, Jun-Hyouk;Kenji, Kawakita;Hahn, Seo-Kyung;Park, Hi-Joon;Lee, Seung-Deok;Kim, Yong-Suk;Norihito, Takahashi;Toshiyuki, Shichidou;Kazunori, Itoh;Eiji, Sumiya;Eiji, Furuya;Hitoshi, Yamashita;Hiroshi, Tsukayama
    • 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.

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