• Title/Summary/Keyword: Ethics committee

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An analysis of Empirical Studies of Musical Literary Work Plagiarism Standard : The Popular Music (음악저작물 표절 기준에 관한 고찰 : 대중음악을 중심으로)

  • Jo, Jin-Wan;Shin, Mi-Hae;Park, Areum;Kim, Young-Chul
    • The Journal of the Korea Contents Association
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    • v.14 no.3
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    • pp.176-185
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    • 2014
  • This study deals with the precedents regarding music works among 'The suits to claim an infringement of copyright' and 'Suits to claim indemnification for damage' that have been filed in Korea up so far in order to establish clear criteria to judge plagiarism based on the ground of legal judgment and judge the similarity of two works that have been in controversy previously. The study has been performed through literature review and also precedents. According to the study result, 'criteria to judge music works on plagiarism' are largely classified into (1) creativity, (2) access, and (3) substantial similarity. It is almost the same to judge creativity and substantial similarity. With the components of music works, say, melody, harmony, and rhythm, comparative analysis is conducted. About creativity, the original composer's song is analyzed with another object to be compared whereas about substantial similarity, two songs in controversy get to be analyzed. Regarding the current criteria to judge creativity, it is needed to set the number of objects to be compared which have been regarded similar. And access has limitations in setting up objective criteria for it. Lastly, we should develop digitized criteria for substantial similarity based on the preliminary review system of the Committee on Performance Ethics in the past.

A Study on Single Dose Toxicity of Intravenous Injection of Mecasin Herbal Acupuncture

  • Lee, Seong Jin;Jeong, Ho Hyun;Lee, Jong Chul;Cha, Eun Hye;Park, Man Yong;Song, Bong Gun;Son, Il Hong;Kim, Sung Chul
    • Journal of Acupuncture Research
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    • v.33 no.1
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    • pp.1-7
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    • 2016
  • Objectives : This study was conducted to analyze the single dose toxicity of Mecasin (Gami-Jakyak Gamcho buja Decoction) herbal acupuncture administered in the vein of Sprague-Dawley rats. Methods : All experiments were performed at the Medvill, an institution licensed to conduct nonclinical studies, under the Good Laboratory Practice (GLP) regulations. Sprague-Dawley rats were chosen in this pilot study. In the experiment, Sprague-Dawley rats were divided into four groups of five male and five female animals per group. Doses of Mecasin herbal acupuncture, at 0, 500, 1,000, and 2,000 mg/kg, were given to the experimental groups, and a dose of normal saline solution, at 2 ml/kg, was administered to the control group. Mecasin herb acupuncture and normal saline were injected into the vein at once, and we observed mortality, clinical signs, weights, and gross findings for 14 days after injection. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results : There is no death or abnormality in any of the four groups. All groups put on weights favorably. There are no significant gross findings in necropsy examinations. Conclusions : The above results showed that intravenous injection of 500-2,000 mg/kg of Mecasin herb acupuncture did not cause any changes in weight or, in the results of necropsy examinations, in mortalities. Therefore, the toxicity of Mecasin herb acupuncture was not confirmed, and the presumptive lethal dose of Mecasin herb acupuncture was higher than 2,000 mg/kg. The outcomes suggest that treatment with Mecasin herbal acupuncture is relatively safe. Further evaluations on this subject are needed to yield more concrete evidence.

Lung Cancer Knowledge among Secondary School Male Teachers in Kudat, Sabah, Malaysia

  • Al-Naggar, Redhwan Ahmed;Kadir, Samiah Yasmin Abdul
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.1
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    • pp.103-109
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    • 2013
  • Background: The objective of this study is to determine knowledge about lung cancer among secondary school male teachers in Kudat, Sabah, Malaysia. Materials and Methods: A cross-sectional study was conducted among three secondary schools located in Kudat district, Sabah, Malaysia during the period from June until September 2012. The protocol of this study was approved by ethics committee of Management and Science University, Malaysia. The aims were explained and a consent form was signed by each participant. Respondents were chosen randomly from each school with the help of the headmasters. Self-administrated questionnaires, covering socio-demographic characteristics and general knowledge of lung cancer, were distributed. Once all 150 respondents completed the questionnaire, they passed it to their head master for collecting and recording. All the data were analyzed using Statistical Package for the Social Sciences (SPSS) version 13. ANOVA and t-test were applied for univariate analysis; and multiple linear regression for multivariate analysis. Results: A total of 150 male secondary school teachers participated in this study. Their mean age was $35.6{\pm}6.5$ (SD); maximum 50 and minimum 23 years old. More than half of the participants were Malay and married (52%, 79%; respectively). Regarding the knowledge about lung cancer, 57.3% of the participants mentioned that only males are affected by lung cancer. Some 70.7% mentioned that lung cancer can be transmitted from one person to another. More than half (56.7%) reported that lung cancer is not the leading cause of death in Malaysian males. As for risk factors, the majority reported that family history of lung cancer is not involved. However, 91.3% were aware that cigarettes are the main risk factor of lung cancer and more than half (52%) believed that second-hand smoking is one of the risk factor of lung cancer. More than half (51.3%) were not aware that asbestos, ionizing radiation and other cancer causing substances are risk factors for lung cancer. Quitting smoking, avoiding second-hand smoking and avoiding unnecessary x-ray image of the chest (53.3%, 96.0%, 87.3%; respectively) are the main preventive measures mentioned by the participants. For the factors that influence the participants knowledge, univariate and multivariate analysis showed that only race was significant. Conclusions: Overall, the knowledge of school male teachers about lung cancer was low. However, few items were scored high: cigarettes are the main risk factor; avoiding second-hand smoking; and avoiding x-rays. Interventions to increase lung cancer awareness are needed to improve early detection behavior. Increase the price of pack of cigarettes to RM 20 and banning smoking in public places such as restaurants are highly recommended as primary preventive measures.

A Study on the Protection of Trial Subjects in Clinical Trials of Investigational New Drug (의약품 임상시험에서 피험자 보호)

  • We, Kye Chan
    • The Korean Society of Law and Medicine
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    • v.13 no.2
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    • pp.79-113
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    • 2012
  • This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

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Knowledge and Perceptions of Cancer and Cancer Prevention among Malaysian Traditional Healers: a Qualitative Study

  • Al-Naggar, Redhwan A.;Bobryshev, Yuri V.;Abdulghani, Mahfoudh Al-Musali Mohammed;Rammohan, Subramanian;Al-Jashamy, Karim
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.8
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    • pp.3841-3850
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    • 2012
  • Objective: The objective of this study was to explore the knowledge and perceptions of Malaysian tradition healers towards cancer and cancer prevention. Methodology: A total of 25 participants agreed to participate in this qualitative study during the period from $20^{th}$ July 2011 until $24^{th}$ of September 2011. The proposal of this study was approved by the Ethics Committee of Management and Science University (MSU). Once the participant agreed to be interviewed, date, time and place of the interviews were determined. Consent form was obtained from participants before the interview began. Participants were briefed about the study and its purpose, and after asking their permissions, their replies were recorded. The data was organized into themes and analyzed manually. Results: Twenty-five Malaysian traditional healers participated in this qualitative study. The age of participants ranged between 26 to 78 years old. The majority were in the age group of 31-60 years old, male, Chinese, degree holders with a monthly income ranging from 1,000-5,000 Ringgit Malaysia (RM) and were married (56%, 80%, 48%, 52%, 68%, 84% respectively). The majority defined cancer as having high cholesterol or abscess accumulation. A few of them defined cancer as a type of cell growth. The majority mentioned that food and unhealthy lifestyles are the primary causes of cancer. Surprisingly some of them mentioned that cancer is caused by interference by ghosts. Regarding the diagnosis of cancer, the majority mentioned that they refer their patients to modern physicians' medical report when it comes to diagnosing or treating patients with cancer. The most common cancers that many patients came to seek treatment were breast cancers, followed by colon cancers, liver and lung cancers. Conclusions: Despite good knowledgeabout the causes of cancer among traditional healers, misconceptions still exist. Insufficient knowledge about the definition of cancer was noted among the traditional healers. This urges immediate action by the Ministry of Health of Malaysia to set up a strict regulation and regular monitoring of the traditional healers nationally. Traditional and Complementary Medicine may be integrated into the healthcare system and need to have sustained cooperation for the benefit of patients since about 80% of patients use traditional medicines.

Health Promoting Lifestyle Behaviour in Medical Students: a Multicentre Study from Turkey

  • Nacar, Melis;Baykan, Zeynep;Cetinkaya, Fevziye;Arslantas, Didem;Ozer, Ali;Coskun, Ozlem;Bati, Hilal;Karaoglu, Nazan;Elmali, Ferhan;Yilmaze, Gulay
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.20
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    • pp.8969-8974
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    • 2014
  • Background: The aim of this study was to determine the predictors of health promoting lifestyle behaviour among medical students attending seven of the medical schools in Turkey. Materials and Methods: This crosssectional descriptive study was performed during the second semester of the first and last (sixth) years of study from March to May 2011. A questionnaire with two sections was specifically designed. The first section contained questions on demographic characteristics; the second consisted of the Health Promoting Lifestyle Profile II (HPLP) Scale. From a total of 2,309 medical students, 2,118 (response rate 91.7%) completed the questionnaire. Data were analyzed using descriptive statistics, t, Anova, Tukey test and binary logistic regression analysis. The research was approved by the Ethics Committee of Erciyes University. Results: The mean age was $20.7{\pm}2.9$ years and it was found that 55.1% were men, 62.3% were in the first year. The overall prevalence of smoking was 19.1%, and for drinking alcohol was 19.4%. HPLP point averages of the first year students were $129.2{\pm}17.7$, and for last year $125.5{\pm}19.0$. The overall mean score for the HPLP II was $2.5{\pm}0.4$. They scored highest on the spiritual growth subscale ($2.9{\pm}0.5$), interpersonal relations ($2.8{\pm}0.5$), health responsibility subscale ($2.3{\pm}0.5$), nutrition subscale ($2.3{\pm}0.5$), stress management subscale ($2.3{\pm}0.4$), and the lowest subscale physical activity ($2.0{\pm}0.5$). It is established that student's grade, educational level of parents, economic status of family, marital status, smoking and general health perception of the students resulted in a significant difference in HPLP Scale total score average and the mean score of majority of subscales. There was no statistically significant difference between the total HPLP when evaluated for gender, chronic disease, alcohol drinking status and BMI. Conclusions: Based on these results, particularly in the curriculum of medical students in order to increase positive health behaviours including physical activity, health promotion issues, and giving more space to aim at behaviour change in these matters is recommended.

A Study on Main Issues of the Constitutional Petition against "the Newspaper Law" (신문법 위헌소송의 주요 쟁점에 관한 연구)

  • Lee, Yong-Sung
    • Korean journal of communication and information
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    • v.33
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    • pp.227-251
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    • 2006
  • The Law Ensuring the Freedom and the Functions of Liability of the Newspapers ("The Newspaper Law") which was passed in the National Assembly on January 1, 2005 is considered as a tremendous setback compared to "the Newspaper Bill" of civil press organizations. Of the two instruments to ensure the editorial freedom, the regulation on the newspaper company ownership share distribution was eliminated and the editorial committee (editorial codes of ethics) became an arbitrary system. That is, the Newspaper Law was criticized as a law of "half-success." However, the Newspaper Law has its own benefit by institutionalizing the establishment of the Korea Commission for the Press, the Press Fund, and the Korea Newspaper Circulation Service for Promoting Newspaper Businesses and by strengthening the criteria to estimate market dominant businesspeople in newspaper market than general markets to ensure the diversity of public opinions. As the Newspaper Law was promulgated, Donga-Ilbo and Chosun-Ilbo submitted the Constitutional Petition against "the Newspaper Law" and the Constitutional Court is expected to give the decision soon. Based on the "Supplements on the Grounds of the Constitutional Petition against the Newspaper Law" ("the Petition"), this paper will examine the main issues of the debates over the Constitutionality of the Newspaper Law.

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Toxicity of Eun-bi San Pharmacopuncture Injection inthe Muscle of Rats

  • Lee, Jongcheol;Jeong, Hohyun;Cha, Eunhye;Park, Manyong;Choi, Sungyoul;Yook, Taehan;Song, InJa;Kim, Sungchul
    • Journal of Pharmacopuncture
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    • v.18 no.1
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    • pp.63-71
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    • 2015
  • Objectives: This study was carried out to analyze the single-dose toxicity of Eun-Bi San pharmacopuncture injected into the muscle of Sprague-Dawley (SD) rats. Methods: All experiments were performed at Biotoxtech, an institution certified to conduct non-clinical studies under the Good Laboratory Practice (GLP) regulations. Six week old SD rats reared by ORIENTBIO were chosen for this pilot study. The reason SD rats were chosen is that they have been widely used in safety tests in the field of medicine, so the results can be easily compared with many other databases. The Eun-Bi San pharmacopuncture was made in a clean room at the Korean Pharmacopuncture Institute (KPI, K-GMP). The constituents of the Eun-Bi San pharmacopuncture are Angelicae gigantis radix, Strychni semen and Glycyrrhizae radix. These were extracted at low temperature and low pressure in an aseptic room at the KPI. Doses of Eun-Bi San pharmacopuncture, 0.25, 0.5 and 1.0 mL, were administered to the experimental groups, and a dose of normal saline solution, 1.0 mL, was administered to the control group. This study was performed under the approval of the Institutional Animal Ethics Committee of Biotoxtech Co., Ltd. Results: No deaths or abnormalities occurred in any of the four groups. No significant changes in weight, hematological parameters or clinical chemistry between the control group and the experimental groups were observed. To determine if abnormalities existed in any organs and tissues, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs or tissues. Conclusion: The results of this study suggest that treatment with Eun-Bi San pharmacopuncture is relatively safe and that its clinical use may be beneficial. Further evaluations and studies on this subject will be needed to provide more concrete evidence in support of these conclusions.

Pectus Excavatum and Pectus Carinatum: Associated Conditions, Family History, and Postoperative Patient Satisfaction

  • Kuru, Pinar;Cakiroglu, Aylin;Er, Aynur;Ozbakir, Hincal;Cinel, Ali Emin;Cangut, Busra;Iris, Merve;Canbaz, Berkay;Picak, Ebru;Yuksel, Mustafa
    • Journal of Chest Surgery
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    • v.49 no.1
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    • pp.29-34
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    • 2016
  • Background: Pectus excavatum (PE) and pectus carinatum (PC) are the most common chest wall deformities. In this study, we aimed to characterize how patients obtained information about these deformities, as well as patients' family history, associated medical problems, and postoperative satisfaction after the Nuss and Abramson procedures. Methods: This cross-sectional retrospective study included patients who were operated by a single surgeon between 2006 and 2013. Follow-up calls were made after approval of our institution's ethics committee. We reached 207 of the 336 PE patients (61.6%) and 73 of the 96 PC patients (76%). Results: The majority of the patients were male (85% of the PE patients and 91.8% of the PC patients). The age of diagnosis of PE was $14.52{\pm}0.51years$ and the age at the time of operation was $17.89{\pm}0.42years$; for PC patients, the corresponding ages were $15.23{\pm}0.55years$ and $16.77{\pm}0.55years$, respectively. A total of 70% of the PE patients and 63.8% of the PC patients obtained information about pectus deformities through the Internet. In 27.1% of the PE patients with an associated anomaly, 57.1% (n=13) had scoliosis, while 41.1% of the PC patients with an associated anomaly had kyphosis (n=5). Postoperative satisfaction, as evaluated on a scale from 0 to 10, was $8.17{\pm}0.15$ for PE patients and $8.37{\pm}0.26$ for PC patients. The postoperative pain duration was $51.93{\pm}5.18days$ for PE patients and $38.5{\pm}6.88days$ for PC patients. Conclusion: In this study, we found that most patients with pectus deformities were male. The Internet was an important resource for patients to learn about their deformities. Family history and associated anomalies were identified as important aspects for consideration in the clinical setting. The patients reported high levels of postoperative satisfaction, and pain management was found to be one of the most important elements of postoperative care.

Association between High Diffusion-Weighted Imaging-Derived Functional Tumor Burden of Peritoneal Carcinomatosis and Overall Survival in Patients with Advanced Ovarian Carcinoma

  • He An;Jose AU Perucho;Keith WH Chiu;Edward S Hui;Mandy MY Chu;Siew Fei Ngu;Hextan YS Ngan;Elaine YP Lee
    • Korean Journal of Radiology
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    • v.23 no.5
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    • pp.539-547
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    • 2022
  • Objective: To investigate the association between functional tumor burden of peritoneal carcinomatosis (PC) derived from diffusion-weighted imaging (DWI) and overall survival in patients with advanced ovarian carcinoma (OC). Materials and Methods: This prospective study was approved by the local research ethics committee, and informed consent was obtained. Fifty patients (mean age ± standard deviation, 57 ± 12 years) with stage III-IV OC scheduled for primary or interval debulking surgery (IDS) were recruited between June 2016 and December 2021. DWI (b values: 0, 400, and 800 s/mm2) was acquired with a 16-channel phased-array torso coil. The functional PC burden on DWI was derived based on K-means clustering to discard fat, air, and normal tissue. A score similar to the surgical peritoneal cancer index was assigned to each abdominopelvic region, with additional scores assigned to the involvement of critical sites, denoted as the functional peritoneal cancer index (fPCI). The apparent diffusion coefficient (ADC) of the largest lesion was calculated. Patients were dichotomized by immediate surgical outcome into high- and low-risk groups (with and without residual disease, respectively) with subsequent survival analysis using the Kaplan-Meier curve and log-rank test. Multivariable Cox proportional hazards regression was used to evaluate the association between DWI-derived results and overall survival. Results: Fifteen (30.0%) patients underwent primary debulking surgery, and 35 (70.0%) patients received neoadjuvant chemotherapy followed by IDS. Complete tumor debulking was achieved in 32 patients. Patients with residual disease after debulking surgery had reduced overall survival (p = 0.043). The fPCI/ADC was negatively associated with overall survival when accounted for clinicopathological information with a hazard ratio of 1.254 for high fPCI/ADC (95% confidence interval, 1.007-1.560; p = 0.043). Conclusion: A high DWI-derived functional tumor burden was associated with decreased overall survival in patients with advanced OC.