• Title/Summary/Keyword: IRB

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A study on the proposed amendment bill of Bioethics and Safety Law (2010): focusing on the meaning of significant contents related to the clinical research ("생명윤리 및 안전에 관한 법률" 전부개정안의 내용과 의의: 임상연구와의 관계를 중심으로)

  • Kim, Eun-Ae
    • The Korean Society of Law and Medicine
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    • v.12 no.1
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    • pp.99-131
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    • 2011
  • To strengthen the protection of human research subjects and human materials, the Korean Ministry of Health and welfare proposed the amendment bill of Bioethics and Safety Law(2010) to the Congress. It includes so many meaningful clauses. According to the bill, the scope that this act shall apply will be expended to the research involving human subjects and human materials. In the bill, there are the principles of this act; the protection of the life, health, and dignity of the human subjects, the obtaining of the adequate informed consent, the protection of the human subject's information confidentiality and the human subject's privacy, the assessment and minimizing of the risks involved and the guarantee of the safety for the human subjects, the preparation of the special protection program for the vulnerable human subjects, and so on. According to the bill, Institutional Bioethics Review Board(the same as Institutional Review Board) will be responsible for the auditing and monitoring on the research that was approved by IBRB, conducting the education program for the researchers, IBRB members and administrative staffs, preparing of the special protection program for the vulnerable human subjects, and forming the guidelines for the researchers as well as the review of the research protocols. And the State and local governments shall take necessary measures to support the expending of the social infrastructure. In addition to, IBRB will have to be assessed and to be gained the accreditation by the Korean Ministry of Health and welfare. So, if Bioethics and Safety Law is amended, it will contribute enormously to enhance the level of the human research subjects protection. Also, if this Law is amended, IBRB will play a major role for the conduct of the ethically, scientifically, and legally proper research. But now, as a matter of fact, the capability of IBRB members and IBRB office members is not enough to charge of this role because some people and some organizations does not know the importance of IBRB exactly. In spite of, IBRB shall be able to this role to protect the human subjects and to develop the level of the research On the international level. Therefore, the State, local governments and the Organization shall back up the administrative and financial terms of the IRB and IRB Office.

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Automatic Left Ventricle Segmentation by Edge Classification and Region Growing on Cardiac MRI (심장 자기공명영상의 에지 분류 및 영역 확장 기법을 통한 자동 좌심실 분할 알고리즘)

  • Lee, Hae-Yeoun
    • The KIPS Transactions:PartB
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    • v.15B no.6
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    • pp.507-516
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    • 2008
  • Cardiac disease is the leading cause of death in the world. Quantification of cardiac function is performed by manually calculating blood volume and ejection fraction in routine clinical practice, but it requires high computational costs. In this study, an automatic left ventricle (LV) segmentation algorithm using short-axis cine cardiac MRI is presented. We compensate coil sensitivity of magnitude images depending on coil location, classify edge information after extracting edges, and segment LV by applying region-growing segmentation. We design a weighting function for intensity signal and calculate a blood volume of LV considering partial voxel effects. Using cardiac cine SSFP of 38 subjects with Cornell University IRB approval, we compared our algorithm to manual contour tracing and MASS software. Without partial volume effects, we achieved segmentation accuracy of $3.3mL{\pm}5.8$ (standard deviation) and $3.2mL{\pm}4.3$ in diastolic and systolic phases, respectively. With partial volume effects, the accuracy was $19.1mL{\pm}8.8$ and $10.3mL{\pm}6.1$ in diastolic and systolic phases, respectively. Also in ejection fraction, the accuracy was $-1.3%{\pm}2.6$ and $-2.1%{\pm}2.4$ without and with partial volume effects, respectively. Results support that the proposed algorithm is exact and useful for clinical practice.

Relationships Between Blood Pressure and Serum Lipids, Obesity Indices in Adults using Health Examination Data (건강검진자료에 의한 일반 성인들의 혈압과 혈청지질 및 비만지표와의 관련성)

  • Yoon, Seok-Han
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.14 no.9
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    • pp.4394-4401
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    • 2013
  • The purpose of this study was to investigate the association of blood pressures and serum lipids, obesity indices in adults who examined health checkup. Study subjects were 2,734 adults of 20 years and over (1,344 males, 1,390 females), who underwent health package check-up at an university hospital during one year of 2012. We observed the age, sex, SBP, DBP, TC, TG, HDL-C, LDL-C, AI, BMI, body fat rate and waist circumference of study subjects after confirmed IRB of the hospital. As a results, TC, TG, AI was significantly higher in the group of hypertension than that of normotensive in both sex, but in only female, HDL-C and LDL-C was higher in the each group of normotensive and hypertension. BMI, body fat rate and waist circumference was significantly higher in the group of hypertension than that of normotensive in both sex. SBP and DBP was positive correlated with TC, TG, AI, BMI, body fat rate and waist circumference, but HDL-C and LDL-C was each correlated with positive and negative in female only. Age-adjusted odds ratio for hypertension by blood serum lipids and obesity indices was significantly increased in the group of abnormal than normal of TC, TG, BMI, but HDL-C and waist circumference was each increased in the abnormal group of female, and in the abnormal group of male. Above results suggested that the blood pressure related with serum lipid levels and obesity indices.

Verification of effectiveness of evaluation of long-term care institution (장기요양기관(시설급여) 평가의 효과성 검증)

  • Kim, Yun-Jeong;Kim, Young-Jea;Lee, Sang-Jin
    • Asia-pacific Journal of Multimedia Services Convergent with Art, Humanities, and Sociology
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    • v.9 no.5
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    • pp.781-791
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    • 2019
  • The purpose of this study was to evaluate the evaluation of long - term care institutions (evaluation rating, evaluation rating, suitability of evaluation index), quality of service of caregivers, Quality satisfaction, life satisfaction, and facility choice. After receiving the IRB, in January and February of 2018, the survey was completed for 79 long-term care institution managers, 381 nursing care workers, and 381 elderly people. The survey carried out an allocation sample reflecting the 2015 long - term care (facility benefit) evaluation results. The results of this study are as follows. First, it is found that the institutional evaluation (evaluation level, change of evaluation level, recognition of suitability of the index) has a greater impact on the quality of life of the elderly, appear. However, the intention of reselecting the facility after discharge was more influenced by the quality of services of caregivers. Therefore, except for the intention to reschedule the facility, it can be said that the evaluation of the National Health Insurance Corporation was partially validated.

The Relationship between Nurses Perception of the Elderly and Communication (간호사의 노인에 대한 인식과 의사소통과의 관계)

  • Yu, Myeonghwan;Kang, Jisook
    • 한국노년학
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    • v.41 no.4
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    • pp.455-468
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    • 2021
  • This study was performed to utilize for foundation data of research related nursing communication and developing nursing intervention by examining the relationship between nurses' perception of the elderly and communication. This study is a descriptive research using a set of questionnaires that examines the relationship between nurses who provide care to the elderly by confirming their perception of the elderly, communication difficulties with the elderly, communication behavior, and satisfaction with communication. After IRB approval, data were collected either face-to-face survey or by online survey. A total of 292 nurses participated in this study. The collected data were analyzed as descriptive statistics, t-test and ANOVA, Duncan test and Pearson's Correlation Coefficients, Multiple Regression Analysis by using SPSS/WIN 26 program. As a result, a significant correlation was identified between perception of the elderly and communication disorders, communication behavior, and communication satisfaction. We found that nurses who had more positive perceptions about the elderly had less communication disorders, better communication behaviors, and higher communication satisfaction with the elderly. From this result, we suggest that nurses caring for the elderly should receive education on communication methods with elderly to improve their perception. Furthermore, we suggest future studies to improve nurse's perception of the elderly and communication.

A Study on the Information Poverty of North Korean Refugees in South Korea: Based on Chatman's Information Poverty (북한이탈주민의 정보빈곤에 관한 연구: Chatman의 정보빈곤이론을 기반으로)

  • Min, Soo Jin;Yi, Yong Jeong
    • Journal of the Korean Society for information Management
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    • v.39 no.3
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    • pp.241-261
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    • 2022
  • The present study aims to investigate the effects of information poverty on North Korean refugees' social adaptation to South Korea based on Chatman's Theory of Information Poverty (1996). Based on the Theory of Information Poverty, information poverty consists of four variables: Secrecy, Deception, Risk-taking, and information acceptance in response to situational relevance. And based on the previous studies, adaptation to South Korean life is divided into social adaptation and psychological adaptation. From August 4 to August 30, 2021, after approval by the IRB through the North Korean refugee support organization , surveys were conducted with North Korean refugees who had lived in South Korea for at least one year and were aged 19 or older. The 100 collected valid data were analyzed using frequency analysis, reliability analysis, correlation analysis, and multiple linear regression analysis. Findings of the study indicated that information poverty had significant effects on North Korean refugees' social and psychological adaptation. In particular, the "deception" variable had negative effects on social and psychological adaptation. The study has theoretical implications that it explains North Korean refugees' adaptation to South Korea based on Theory of Information Poverty by defining them as information poor. Above all, it attempts a quantitative approach through operationalization of key concepts unlike previous studies that were conducted with qualitative approaches.

Comparison and Analysis of Domestic and International Medical Library Association Support Programs to Strengthen the Capabilities of Medical Librarians: Focusing on MLA and KMLA (의학사서 역량 강화를 위한 국내외 의학도서관협회 지원 프로그램 비교 및 분석 - MLA 및 KMLA를 중심으로 -)

  • Hey-Young Rhee
    • Journal of the Korean BIBLIA Society for library and Information Science
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    • v.34 no.4
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    • pp.149-182
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    • 2023
  • This study was conducted for the purpose of suggesting ways to improve KMLA's support programs to strengthen the capabilities of domestic medical librarians. To this end, after investigating the roles of professional associations, common roles were extracted and categorized into five areas, and then the support programs of MLA and KMLA were compared and analyzed. As a result, six suggestions can be made as ways to improve KMLA's support program. First, policy development is needed to officially and continuously support medical librarians. Second, in the area of (continued) education and training programs, educational support in professional areas required in the medical field is needed, as well as education for the role of the IRB committee. Third, in terms of research and publication support, various support for research funds and training programs is required. Fourth, in terms of network and cooperation support, mentoring, leadership, and fellowship programs are needed, and improvements to domestic and international partnerships and support for various awards should also be planned. Fifth, in terms of professional certification and various certificate systems, it is necessary to provide support for obtaining degrees in related fields and to issue certificates through support for various courses. Sixth, KMLA's active internal and external promotion and activities should be carried out to attract donations.

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

  • Cheong Yeun Sook
    • Journal of the International Relations & Interdisciplinary Education
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    • v.4 no.1
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    • pp.57-83
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    • 2024
  • This study aimed to investigate the impact of scores on the Test of Proficiency in Korean (TOPIK) among foreign exchange students on academic adaptation. Recruited students, approved by the Institutional Review Board (IRB), totaled seven, and their interview contents were analyzed using a comprehensive analysis procedure based on pragmatic eclecticism (Lee, Kim, 2014), utilizing six stages. As a result, factors influencing academic adaptation of Korean language learners for academic purposes were categorized into three dimensions: academic, daily life, and psychological-emotional aspects. On the academic front, interviewees pointed out difficulties in adapting to specialized terminology and studying in their majors, as well as experiencing significant challenges with Chinese characters and Sino-Korean words. Next, from a daily life perspective, even participants holding advanced TOPIK scores faced difficulties in adapting to university life, emphasizing the necessity of practical expressions and extensive vocabulary for proper adjustment to Korean life. Lastly, within the psychological-emotional dimension, despite being advanced TOPIK holders, they were found to experience considerable stress in conversations or presentations with Koreans. Their lack of knowledge in social-cultural and everyday life culture also led to linguistic errors and contributed to psychological-emotional difficulties, despite proficiency in Korean. Based on these narratives, the conclusion was reached that in order to promote the academic adaptation of Korean language learners, it is essential to provide opportunities for Korean language learning. With this goal in mind, efforts should be directed towards enhancing learners' academic proficiency in their majors, improving Korean language fluency, and fostering interpersonal relationships within the academic community. Furthermore, the researchers suggested as a solution to implement various extracurricular activities tailored for foreign learners.

Restoration-oriented anatomical analysis of alveolar bone at mandibular first molars and implications for immediate implant placement surgery: a CBCT study

  • Quan Shi;Yang Huang;Na Huo;Yi Jiang;Tong Zhang;Juncheng Wang
    • The Journal of Advanced Prosthodontics
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    • v.16 no.4
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    • pp.212-220
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    • 2024
  • PURPOSE. This cone-beam computed tomography (CBCT) study aimed to analyze the anatomical characteristics of alveolar bone at mandibular first molar (MFM) and their implications for immediate implant placement surgery. MATERIALS AND METHODS. 100 patients with 140 MFMs were reviewed retrospectively. We first performed a 3D reconstruction of the patient's CBCT data to determine a reference plane with ideal implant placement and orientation. The following parameters of MFM region were analyzed: mesial-distal socket size (MDSS), buccal-lingual socket size (BL-SS), root furcation fornix to inferior alveolar nerve (IAN) distance (RF-I), interradicular bone thickness (IRB), mesial/distal root apex to the IAN distance (MRA-I/DRA-I), thickness of the buccal/lingual bone of the mesial root (MR-B/MR-L), thickness of the buccal/lingual bone of the distal root (DR-B/DR-L). RESULTS. The MD-SS of MFM was 8.74 ± 0.76 mm, and the BLSS was 8.26 ± 0.72 mm. The MR-B, DR-B was 1.01 ± 0.40 mm and 1.14 ± 0.50 mm, and the difference was statistically significant (P = .001). The values of the MR-L, DR-L were 2.71 ± 0.78 mm and 3.09 ± 0.73 mm, and the difference was also statistically significant (P < .001). The mean distance of RF-I was 15.68 ± 2.13 mm, and the MRA-I was 7.06 ± 2.22 mm, which was greater than that of DRA-I (6.48 ± 2.30 mm, P < .001). The IRB at 2 mm, 4 mm apical from the furcation fornix, and at apex level was 2.81 ± 0.50 mm, 3.30 ± 0.62 mm, and 4.44 ± 1.02 mm, respectively. CONCLUSION. There is relatively sufficient bone mass in interradicular bone in height, but an adequate width is lacking for the bone between the mesial and distal root after the extraction of the MFM for immediate implantation. The thickness of the MFM buccal bone is relative thin, especially for the mesial root.

Comparison of Internal Audits by A University Hospital Institutional Review Board Members and Quality Assurance Officers: Factors Influencing Internal Audit Results (A 대학병원 Institutional Review Board 위원 기반 내부 점검 사례 및 Quality Assurance 담당자 내부 점검과의 비교: 내부 점검 결과에 영향을 미치는 요인)

  • Na-Ya Ha;Byung-In Choe
    • The Journal of KAIRB
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    • v.6 no.2
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    • pp.48-55
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    • 2024
  • Purpose: The purpose of this study is to introduce the Institutional Review Board (IRB) member-based internal audit method performed at A University Hospital, a secondary medical institution, and to identify the differences in audit results according to the characteristics of each auditor and the factors affecting the internal audit results. Furthermore, we will find out what needs to be improved in the internal audits to achieve Quality assurance (QA) objectives for human subject research conducted in medical institutions. Methods: The auditors were divided into group A (IRB member belonging to institution A) and group B (clinical trial QA administrator belonging to other institutions) and independently inspected the 2 studies using the same internal audit checklist (consisting of 11 domains, 130 items), and the differences in the internal inspection checklists written by each auditor were compared and analyzed. Results: In the case of audit for the study 1, the number of missing checklists is 1 for group A and 0 for group B, and the number of the matters to be pointed out is 1 for group A and 12 for group B. In the case of audit for the study 2, the number of missing checklists is 2 for both A and B, and the number of points is 5 for A and 4 for B. The differences in the internal audit results written by each auditor that the authors verified are summarized as follows. First, there were more comments from group B auditor than from group A auditor. Second, the results may vary because each auditor has different criteria for evaluating the appropriateness of an item. Third, there are cases where the questions on the checklist are vague or the definition is not clear, so they have the same opinion but check it with different answers. Fourth, if the auditors make a mistake when filling out the checklist, it causes to led to different the results. Conclusion: We propose the following items that should be improved in order to conduct consistent and efficient internal audits. First, it is necessary to test the tool in order to carry out reliable and consistent internal audits. Second, it is necessary to complete specialized training related to internal audit before conducting internal audit. Third, before notifying the audit results, it is necessary to have a procedure or a final review system to check whether the audit contents are appropriate. Fourth, Institutional support is needed to recruit specialized personnel for internal audits.

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