• Title/Summary/Keyword: Human Subjects

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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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Models for evaluating and predicting the user satisfaction of product designs (제품다자인의 감성만족도 평가 및 예측모델 개발)

  • Han, Seong-Ho
    • Journal of the Ergonomics Society of Korea
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    • v.20 no.1
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    • pp.87-113
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    • 2001
  • This study introduces the concept of image/impression of a product design, human interface elements, and the relationships between them. It is assumed that the human interface can be decomposed into detailed design elements, called human interface elements. This study attempts to build functional relationships between the image/impression of a product and human interface elements. Two different human factors experiments were conducted to demonstrate the effectiveness of the approach suggested in this study. A total of 35 audio/visual consumer electronics products (e.g., CD players, VCRs) were shown on a display screen and the subjects were instructed to evaluate them in terms of eight image/impression dimensions. One experiment was conducted using Korean subjects while the other using American subjects. The functional relationships were modeled by using the multiple linear regression technique. Similarity and difference between the Korean and the American subjects were analyzed. The approach suggested in this study is expected to help designers and developers identify important design variables to enhance the subjective satisfaction of a product design.

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A Study on the Patterns of Nutrient Supplement Usage and its related influencing factors of High School Students in Chonbuk Area (전북지역 일부 고등학생의 영양보충제 섭취실태 및 섭취요인 연구)

  • Cha, Youn-Soo;Kim, Jong-Sun;Rho, Jeong-Ok
    • Korean Journal of Human Ecology
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    • v.16 no.6
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    • pp.1231-1241
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    • 2007
  • This study was conducted to investigate the nutrient supplement use and its related influencing factors by high school students in Chonbuk area. Self administered questionnaires were collected from 489 (urban: 268, rural: 221). Statistical data analysis was completed using a SPSS v. 10.0 program. The results are summarized as follows. According to the general characteristic of subjects, the job and education level of parents and family monthly income respectively affected the nutrient supplement use of subjects (p<0.001). According to the living area, taking a nutrient supplement of parents and nutritional information respectively affected the nutrient supplement use of subjects (p<0.001). About 42.2% of subjects, who taking a nutrient supplement, responded to take a traditional medicine type, and 24.4% of them a multivitamin. Their mothers were important recommended person. The main reason for taking was 'to recommended from parent' (38.5%) and 'recovery from tiredness' (29.6%). The main reason for not-taking was that they were health, therefore nutrient supplements were not necessary. In the future about 43.7% of urban and 33.9% of rural area responded to take a nutrient supplements (p<0.05). These findings show that the behaviors of nutritional supplement usage by subjects are not reasonable, and their supplement usage tends to be affected by general characteristics. Therefore, nutritional understanding and education that are intended to from reasonable behaviors toward nutritional supplement usage of adolescents should be provided with considering the relationship between general characteristic of subjects and supplement usage.

Effects of Multimodal Stimuli on Human Sensibility (시청각 복합자극에 대한 인감감성의 변화)

  • 이구형;김병주;정일석
    • Science of Emotion and Sensibility
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    • v.4 no.1
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    • pp.43-51
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    • 2001
  • When consumer evaluates a product, every aspec of the product affects the evaluation. Human uses at least five sensory organs for the evaluation. Multi-sensory or multi-modal design tries to add auditory and olfactory factors to the traditional visual-centered design. For the multi-modal design, it is essential to understand relationships between combined sensory stimuli and human sensibility. Information between simple sensory stimulus and human sensibility is pre-requisite to combine multi-modal stimuli. This study investigated human sensibility against 8 colors and 30 sounds, presented independently. The combined stimuli of color and sound were made based on the sensibility generated by each stimulus. Human sensibility generated by the combined stimuli of color and sound were made based on the sensibility generated by each stimulus. Human sensibility generated by the combined stimuli was investigated with 20 female subjects. For combined stimuli that generated the same kind of sensibility respectively, generated sensibility was same but strength was diminished. For combined stimuli that generated the different sensibilities respectively, subjects showed neutral sensibility or no special sensibilities. Sensibilities to the same stimuli also showed difference depending on personal background of the subjects.

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Weight-Control Attempt by Korean College Students Participating in a Nutrition Education Class via the Internet; Skipping Dinner or Exercise

  • Lee, Jeong-Hee;Kim, Jin-Sook;Lee, Mi-Young;Cheong, Sun-Hee;Chang, Kyung-Ja
    • Journal of Community Nutrition
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    • v.5 no.3
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    • pp.151-159
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    • 2003
  • The purpose of this study was to investigate the difference in dietary attitudes, dietary behaviors and health-related lifestyles among Korean college students (392 males, 808 females) participating in a web class of nutrition education. This cross-sectional survey was conducted by a self-administered questionnaire and data was analyzed by SPSS program. Most female subjects with weight-control attempt had eating habit problems such as overeating and food jags. The female subjects with weight-control attempt showed significantly higher rate of skipping dinner compared to those without weight-control attempt. As for frequency of exercise, the subjects with weight-control attempt exercised more frequently compared to those without weight-control attempt. In subjects, weight-control attempt was significantly associated with exercise. Nutrient adequacy ratio and mean adequacy ratio of the subjects with weight-control attempt were significantly lower compared to those without weight-control attempt. These results suggest that skipping dinner or exercise might be used as weight-control methods in Korean college female students participating in a nutrition education class via the internet.

A novel qEEG measure of teamwork for human error analysis: An EEG hyperscanning study

  • Cha, Kab-Mun;Lee, Hyun-Chul
    • Nuclear Engineering and Technology
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    • v.51 no.3
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    • pp.683-691
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    • 2019
  • In this paper, we propose a novel method to quantify the neural synchronization between subjects in the collaborative process through electroencephalogram (EEG) hyperscanning. We hypothesized that the neural synchronization in EEGs will increase when the communication of the operators is smooth and the teamwork is better. We quantified the EEG signal for multiple subjects using a representative EEG quantification method, and studied the changes in brain activity occurring during collaboration. The proposed method quantifies neural synchronization between subjects through bispectral analysis. We found that phase synchronization between EEGs of multi subjects increased significantly during the periods of collaborative work. Traditional methods for a human error analysis used a retrospective analysis, and most of them were analyzed for an unspecified majority. However, the proposed method is able to perform the real-time monitoring of human error and can directly analyze and evaluate specific groups.

Suggested Improvement Strategies for the Efficient Review and Rational Operation of Institutional Review Board (IRB) Based on the Analysis of IRB Review Results (Institutional Review Board 심의 결과 분석을 통한 효율적 심사 및 합리적 운영에 대한 개선안 모색)

  • Lee, Yoon Jin;Jang, Hye Yun;Jang, Jung-Hee
    • The Journal of KAIRB
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    • v.4 no.1
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    • pp.5-15
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    • 2022
  • To suggest future directions for the improvement in the Institutional Review Board (IRB) review process and efficient operation of IRB, we have analyzed the IRB review results from 460 new research proposals submitted to the Review by the Convened IRB of the Keimyung University Dongsan Hospital IRB from January 2019 to July 2021. IRB is an independently established institutional committee to protect the human subjects by reviewing the research protocol in ethical as well as scientific aspects, so it is necessary to continuously contemplate the ethical versus scientific dilemma of 'what is ethical or scientific and what can actually protect human subjects.' Particularly, in this process, it is necessary to consider diverse ways to strengthen self-supervision through continuous Internal Audit rather than simple reporting outcomes. In addition, if it does not directly affect the protection of the human subjects, the discussion with the committee members is needed so that the comments such as administrative and typographical errors can be reduced as much as possible. Furthermore, as statistical analysis methods can have a significant impact on the safety of human subjects, if a legal basis and/or support related to statistics is provided for the composition of IRB members, a more specialized IRB review will be achieved.

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Nutrition Knowledge, Dietary Attitudes, and Dietary Behaviors by Gender of High School Students in Incheon (인천지역 일부 고등학생의 성별에 따른 영양지식, 식태도 및 식행동에 관한 연구)

  • Erdenebileg, Zolzaya;Park, So Hyun;Park, Su Ji;Chang, Kyung Ja
    • Journal of the Korean Society of Food Culture
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    • v.31 no.6
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    • pp.652-660
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    • 2016
  • This study was performed to investigate the nutrition knowledge, dietary attitudes, and dietary behaviors among high school students by gender. The subjects were 275 students (127 male, 148 female) in Incheon metropolitan area. Self-administered questionnaires consisted of general characteristics and anthropometric data, nutrition knowledge, dietary attitudes, and dietary behaviors. The average score of nutrition knowledge was significantly higher in female subjects (9.4) compared to male subjects (8.2) (p<0.01). Male subjects had a higher score for dietary attitudes than female subjects (p<0.001). Frequency of meals was significantly higher in male subjects compared to female subjects (p<0.05). Duration of meal time in male subjects was significantly higher ('5-10 minutes') compared to female subjects (p<0.001). Unbalanced diet was significantly higher in female subjects (66.3%) compared to male subjects (48.9%) (p<0.01). Male subjects showed significantly higher consumption frequency of 'dairy' (p<0.001) and 'beans' (p<0.001) compared to female subjects. For snack consumption, male subjects showed higher consumption frequency of 'nuts' (p<0.001), 'soda' (p<0.05), 'fast foods' (p<0.001), and 'ramyeon' (p<0.01), but lower consumption frequency of 'biscuits and bakery' (p<0.01) compared to female subjects. Therefore, it is necessary to develop a systemic nutrition education program for high school students by gender.

Correlation analysis of human urinary metabolites related to gender and obesity using NMR-based metabolic profiling

  • Kim, Ja-Han;Park, Jung-Dae;Park, Sung-Soo;Hwang, Geum-Sook
    • Journal of the Korean Magnetic Resonance Society
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    • v.16 no.1
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    • pp.46-66
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    • 2012
  • Metabolomic studies using human urine have shown that human metabolism is altered by a variety of environmental, cultural, and physiological factors. Comprehensive information about normal human metabolite profiles is necessary for accurate clinical diagnosis of disease and for disease prevention and treatment. In this study, metabolite correlation analyses, using $^1H$ nuclear magnetic resonance (NMR) spectroscopy coupled with multivariate statistics, were performed on human urine to compare metabolic differences based on gender and/or obesity in healthy human subjects. First, we applied partial least squares discriminant analysis to the NMR spectral data set to verify the data's ability to discriminate by gender and obesity. Then, the differences in metabolite-metabolite correlation between male and female, and between normal and high body mass index (obese) subjects were investigated through pairwise correlations. Creatine and several metabolites, including isoleucine, trans-aconitate, and trimethylamine N-oxide (TMAO), exhibited different quantitative relationships depending on gender. Dimethylamine had a different correlation with glycine and TMAO, based on gender. The correlation of TMAO with amino acids was considerably lower in obese, compared to normal, subjects. We expect that the results will shed light on the metabolic pathways of healthy humans and will assist in the accurate diagnosis of human disease.

Effects of Diet Therapy Related to Constitution on Over Weight and Obese Human (체질에 따른 식사요법이 체중과다 및 비만에 미치는 영향)

  • 허봉수;백숙은
    • Journal of the East Asian Society of Dietary Life
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    • v.8 no.3
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    • pp.261-270
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    • 1998
  • This study was conducted in order to investigate the effect of diet therapy on over weight and obese humans in Korea Subseng Research Institute from January 1, 1994 to August 31, 1997. The constitutions of subjects were classified mild negative, strong negative, mild positive and strong positive respectively by ecology and O-ring test. These results were obtained from the subjects who practiced at least 75% diet therapy recommended for over weight and obese human for 14~400days. The constitutions of over weight and obese human by Relative Body Weight (RBW$\geq$110%) were 89 mild negative humans, 62 strong negative humans, 56 mild positive humans and 30 strong positive humans. The constitutions of over weight and obese human by Body Mass Index(BMI$\geq$25) were 77 mild negative humans, 50 strong negative humans 46 mild positive humans and 23 strong positive humans. The negative subjects were higher than the positive subjects on over weight and obese humans. The diet therapy related to constitiution on over weight and obese humans showed RBW reduction of 6.73$\pm$0.53 on mild negative human, 7.78$\pm$1.69 on strong negative human, 6.94$\pm$0.76 on mild positive human, and 7.80$\pm$1.15 on strong positive human at p<0.001 by student paired t-test. The diet therapy related to constitution on over weight and obese humans showed BMI reduction of 1.47$\pm$0.12 on mild negative humans, 1.24$\pm$0.11 on strong negative humans, 1.59$\pm$0.17 on mild positive humans, and 1.66$\pm$0.30 on strong positive humans at p<0.001 by student paired t-test.

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