• Title/Summary/Keyword: Institutional Review Board (IRB)

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Review of Domestic Clinical Research Trends of Korean Medicine on Alopecia areata (원형탈모증의 국내 한의학 임상 연구동향)

  • Hea Sun, Chun
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.36 no.6
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    • pp.221-228
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    • 2022
  • The purpose of this study is to report the research trends of Korean medicine treatment for alopecia areata. We investigated the studies on Korean medicine treatments for alopecia areata via searching 4 web databases of Korea. 13 papers were selected, and we classified them according to publication year, published journals, the types of study, research subject, the methods of treatment, confirmation of recurrence, methods of evaluation, and institutional review board(IRB). We analyzed a total of 13 clinical studies of Korean medicine on alopecia areata based on various criteria and reviewed the research trends. Based on this, we suggested points to be improved and supplemented when conducting clinical research on alopecia areata in the future. Clinical studies on alopecia areata started to be published in 2001, and acupuncture, pharmacopuncture, herbal medicines, etc. were used as treatment methods for alopecia areata. Most of the clinical studies on alopecia areata were case studies, so it is thought that various types of clinical studies are needed. In addition, it is necessary to confirm the recurrence of alopecia areata and to improve the awareness of research ethics.

Literature Review of the Safety Studies among Nursing Students (간호대학생 대상 안전 관련 국내 연구 동향)

  • Lee, Seonhye
    • The Journal of the Convergence on Culture Technology
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    • v.8 no.1
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    • pp.131-138
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    • 2022
  • This study was to investigate the characteristics of nursing students' safety by reviewing literature reported in Korea. Methods: A total of 29 articles were selected by the combination with 'safety', 'safety*', 'patient safety', 'patient safety*' 'nursing students', and 'nursing * students' from the database(via DBpia, KCI, KISS, NANET, NDSL, NL, RISS). Results: Publication year of researchs are '2015-2019' 69.0%, publication journal 'non-nursing' 79.3%, mean of participants 242.4 persons, 'under 200 persons' 51.7%, number of participating area 'one region' 48.2%, number of participating schools 'over three schools' 42.3%, participating grade 'senior in colleges' 56.2%. Participant were calculated by G*Power and unapproved by Institutional Review of Board(IRB) were 58.6%. Most of statistics measures were 'regression' 75.9%, and authors' number were '2 co-authors' 58.6%. In keyword analysis, it has changed from knowledge-oriented to patient-centered. Conclusion: Future research will require research and policy support for the development of an integrated educational approach and intervention plan to strengthen the safety competency of nursing students.

Domestic Research Trends on Nurse Happiness (간호사 행복에 대한 국내 연구 동향)

  • Lee, Seonhye
    • The Journal of the Convergence on Culture Technology
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    • v.4 no.1
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    • pp.201-206
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    • 2018
  • The purpose of this study was to investigate the characteristics of nurse' happiness by reviewing literature on happiness of nurses reported in Korea. A total of seven articles were selected as a result of searching for academic papers announced in combination with "nurses," and "happiness" from the database(via NANET, RISS, KSI-KISS, DBpia). Since 2013, a paper on the happiness of nurses has been published The results of this study are as follows: research sources are "nursing journal" and "other nursing journal", research tools are Lyuvomirsky & Lepper (1999) and OECD Better Life Index (2012), Institutional Review of Board(IRB) "approval" and "unapproved" 50% respectively. Future research seems to require the development of happiness tools for considering organizational culture and intervention program for increasing happiness of nurses.

Survey of Operation and Status of the Human Research Protection Program (HRPP) in Korea (2019) (임상시험 및 대상자보호프로그램의 운영과 현황에 대한 설문조사 연구(2019))

  • Maeng, Chi Hoon;Lee, Sun Ju;Cho, Sung Ran;Kim, Jin Seok;Rha, Sun Young;Kim, Yong Jin;Chung, Jong Woo;Kim, Seung Min
    • The Journal of KAIRB
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    • v.2 no.2
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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.

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Retrospective Clinical Analysis of Treatment for Primary Warm Autoimmune Hemolytic Anemia (원발성 온난자가면역용혈빈혈의 치료에 대한 후향적 분석)

  • Moon, Hong Seop;Park, Chiyoung
    • Korean Journal of Clinical Pharmacy
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    • v.25 no.3
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    • pp.166-170
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    • 2015
  • Background: Primary warm autoimmune hemolytic anemia (AIHA) is a relatively rare hematologic disorder resulting from autoantibody production against red blood cells. There has been very few studies about primary warm AIHA in South Korea because of its low incidence. We retrospectively analyzed the treatment outcome of primary warm AIHA. Method: We reviewed retrospectively the medical records of 9 primary warm AIHA patients from December 2002 to January 2015. We analyzed the causes and clinical characteristics of primary warm AIHA patients. We retrospectively analyzed the clinical data in electronic medical records for 9 Korean patients with AIHA patients who were diagnosed during the period from December 2002 to January 2015 at the Regional University Hospital in Korea. The study protocol was approved by the Institutional Review Board (IRB #2015-08-007, Chosun University Hospital IRB). Results: The mean age was 52 years (range 27~78), the mean hemoglobin level was 5.0 g/dL (range 2.5~6.4 g/dL). All patients received steroids at therapeutic dosages (corticosteroid 1 mg/Kg) as first line treatment. Eight of them showed complete response (5/8, 62.5%) and partial response (3/8, 37.5%), one patient required second-line treatment with rituximab. Two patients who responded first line treatment were relapsed at 86 weeks and 24 weeks after response, respectively. Only one patient of them was retreated with corticosteroid because of anemic symptoms. Conclusion: This study indicates that oral corticosteroid is an effective therapy for primary warm AIHA.

Analysis of Ethical Requirements for the Publication Guidelines of Oriental Medicine Journals in Korea (국내 한의학 관련 학술지 투고규정의 윤리기준 분석)

  • Kim, Yun-Young;Kwon, Ji-Hye;Lee, Si-Woo;Jang, Eun-Su;Yoo, Jong-Hyang
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.26 no.3
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    • pp.392-398
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    • 2012
  • This research aims to analyze the ethical requirements and to find the problems for the publication guidelines of oriental medicine journals. A total of 13 domestic journals, related to oriental medicine and registered in 'National Research Foundation of Korea' list, were selected for the analysis of ethical requirements. We inquired the revised year of the publication guideline and the status of ethics committee of selected journals. The ethical requirements of publication guidelines were evaluated by categorizing them into Institutional Review Board(IRB), Helsinki Declaration, Informed Consent, confidentiality and anonymity of subjects, and conflict of interest. In the case of revised year of the publication guidelines, the year of the most recently revised journal was 2011. However, the revised year of publication guidelines were not announced for three journals and a few journals haven't revised the publication guidelines since 2002. In the case of ethics committee status, four journals out of 13 journals maintained the ethics committee. In the result of ethical requirement analysis, nine journals included the information for confidentiality and anonymity of subjects, and four journals included the information for Helsinki Declaration and Informed Consent. However, only one journal included the information for IRB and conflict of interest. Recently, the importance of clinical researches has been increased to prove the effect of oriental medicine scientifically and objectively. The clinical researches should be considered in scientific side and ethical side as well, because they have potential risks to human subjects. In this sense, announcing the ethical requirements in the publication guidelines can be one way to secure the morality of researches. Thus, it is required to prepare correct publication guidelines and ethical requirements in oriental medicine journals.

A Study on Constitutional Medicine Researchers' View and Attitude Concerning Human Research Ethics (체질의학임상연구자들의 임상연구 윤리에 대한 인식 및 태도 조사)

  • Kwon, Ji-Hye;Yoo, Jong-Hyang;Kim, Yun-Young;Kim, Ho-Suk;Lee, Si-Woo
    • Journal of Sasang Constitutional Medicine
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    • v.23 no.4
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    • pp.514-525
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    • 2011
  • 1. Objectives This study aims to find out identify the recognition and attitude about the research ethic among Constitutional medicine researchers. 2. Methods This survey was conducted to the 37 researchers who were currently participating in Korea Constitution Multicenter Study guided by Korea institute of Oriental medicine(KIOM). The survey consist of 4 parts that level of acknowledgment about the systems and laws on clinical research ethic, clinical research experiences and education, the level of acknowledgment about Institutional Review Board(IRB) and the recognition about overall research ethic. 3. Results Thirty one questionnaires were collected. Most researchers had low level of acknowledgment about the guidelines of basic research ethic. It was proved that more than 65% of the respondents have never received education for clinical research ethic. Moreover, 70% of them felt the need for education of clinical research ethic. In addition, most of the respondents recognized the fact that IRB is responsible for ethically implementing clinical research. 39% of the researchers thought that they themselves have a firm ethical viewpoint, while the rest of the group showed somewhat difficulty on their own ethical implementation of clinical research. 4. Conclusions Most of researcher had partial awareness of regulations and laws on clinical research ethic. And Educational needs of research ethic was high. Therefore education and Public Relations need to be done to extend research ethic. Moreover, standardized course of education on research ethic should be developed and activated.

Analysis of Research Studies Published in Journal of Korean Critical Care Nursing : 2008-2013 (중환자간호학회지 2008~2013년 게재 논문 분석)

  • Son, Youn-Jung;Kang, Jiyeon;Song, Hyo-Jeong;Park, Young-Rye;Lee, Yun-Mi;Park, Jin-Hee;Kim, Minju
    • Journal of Korean Critical Care Nursing
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    • v.6 no.2
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    • pp.78-88
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    • 2013
  • Purpose: The purpose of this study was to identify the trends in studies published in Journal of Korean Critical Care Nursing (JKCCN) from 2008 to 2013. Methods: A total of 65 studies published between 2008 to 2013 were reviewed using criteria developed by researchers. Results: Approximately 36% of studies were conducted with patients. Intensive care unit (ICU) was the most popular site as the study setting. Among 59 research papers, 42.4% were approved by institutional review board (IRB). Quantitative studies were 78.6%, while qualitative studies were 4.6%. The research designs for the quantitative studies were survey (52.3%), quasi-experimental (16.9%), and so on. There was no randomized controlled trial. The most frequently used methods to provide nursing intervention was education. In addition, "nurse" and "ICU" were most commonly used keyword. Conclusion: Considering the low rate of IRB approval, more stringent application of research ethics is necessary to improve the quality of JKCCN. In addition, more randomized controlled trials should be encouraged to support evidence-based practice in critical care.

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Effect of Health Beliefs and Critical Thinking Disposition on the Performance of Taking Standard Precautions of Nursing Students (간호대학생의 감염관리 건강신념과 비판적 사고성향이 감염관리 표준주의 수행도에 미치는 영향)

  • Kim, Yunyoung
    • Journal of Convergence for Information Technology
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    • v.11 no.11
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    • pp.85-94
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    • 2021
  • In this study, the effects of infection control health beliefs and critical thinking tendencies of nursing students on infection control standards were investigated. This study collected and analyzed the data of 222 nursing students from the College of Nursing located in City A from June 2021 to July 2021. Data were collected according to IRB-approved contents, and the collected data were analyzed using the SPSS 26.0 Statistics Program. The infection control health beliefs and critical thinking tendencies of nursing students affect the performance of standard infection control precautions(F=16.634, p<.001), and the explanatory power of the model was 22.0%. It is necessary to develop a nursing education program to improve health beliefs and critical thinking disposition and systematic and efficient infection control education to improve the performance of standard precautions for infection control of nursing students.

Randomized, Double-blind, and Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Allium Fistulosum L. Root Extract on Improvement of Child Height Growth: Study Protocol (총백추출물의 어린이 키 성장에 대한 유효성 및 안전성을 평가하기 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜)

  • Shim, Soo Bo;Ko, Byoung Seob;Ryuk, Jin Ah;Lee, Jung Hwan;Lee, Ho Bong;Ha, Ki Chan;Kim, Yeung Mi;Lee, Hye Lim
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.2
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    • pp.11-20
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    • 2021
  • Objectives The purpose of the study is to evaluate the safety of the Allium Fistulosum extract in children and its effectiveness in height growth. Methods This study is randomized, double-blind, placebo-controlled trial. The participants are children between the 3rd and 25th percentiles in height, and between the ages of 5 and 12 years. They are randomly assigned to treatment group or control group. The treatment group will take 5 g (1 g as Allium Fistulosum extract) for 24 weeks, 1 time a day. The control group will take the 5 g (0 g as Allium Fistulosum extract) of placebo for 24 weeks, 1 time a day. The primary outcome is change in height, and the secondary outcomes are growth rate, height standard deviations, Insulin-like growth factor-1 (IGF-1), Insulin-like growth factor binding protein-3 (IGFBP-3), IGF1-1/IGFBP-3 ratio, growth hormone, bone age, osteocalcin, and Z-score for growth. Results This protocol has been approved by the institutional review board (IRB) of Daejeon Korean Medicine Hospital of Daejeon University (IRB No. DJDSKH-20-BM-15), and registered in the Clinical Research Information Service (CRIS) (Registry No. KCT0005981). Conclusions This study will provide clinical information about the effectiveness and safety of Allium Fistulosum extract in children for their growth.