• Title/Summary/Keyword: Human research subjects

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Bioavailability of plant pigment phytochemicals in Angelica keiskei in older adults: A pilot absorption kinetic study

  • Correa, Camila R.;Chen, C.Y. Oliver;Aldini, Giancarlo;Rasmussen, Helen;Ronchi, Carlos F.;Berchieri-Ronchi, Carolina;Cho, Soo-Muk;Blumberg, Jeffrey B.;Yeum, Kyung-Jin
    • Nutrition Research and Practice
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    • v.8 no.5
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    • pp.550-557
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    • 2014
  • BACKGROUND/OBJECTIVES: Angelica keiskei is a green leafy vegetable rich in plant pigment phytochemicals such as flavonoids and carotenoids. This study examined bioavailability of flavonoids and carotenoids in Angelica keiskei and the alteration of the antioxidant performance in vivo. SUBJECTS AND MATERIALS: Absorption kinetics of phytochemicals in Angelica keiskei were determined in healthy older adults (> 60 y, n = 5) and subjects with metabolic syndrome (n = 5). Subjects consumed 5 g dry Angelica keiskei powder encapsulated in gelatin capsules with a low flavonoid and carotenoid liquid meal. Plasma samples were collected at baseline, 0.5, 1, 2, 3, 4, 5, 6, 7, and 8 h. Samples were analyzed for flavonoids and carotenoids using HPLC systems with electrochemical and UV detection, respectively, and for total antioxidant performance by fluorometry. RESULTS: After ingestion of Angelica keiskei increases in plasma quercetin concentrations were observed at 1-3 and 6-8 hr in the healthy group and at all time points in the metabolic syndrome group compared to baseline (P < 0.05). Plasma lutein concentrations were significantly elevated in both the healthy and metabolic syndrome groups at 8 hr (P < 0.05). Significant increases in total antioxidant performance were also observed in both the healthy and the metabolic syndrome groups compared to baseline (P < 0.05). CONCLUSIONS: Findings of this study clearly demonstrate the bioavailability of phytonutrients of Angelica keiskei and their ability to increase antioxidant status in humans.

A Review of Bioethics and the IRB in Social and Behavioral Research (사회행동과학연구에서의 생명윤리와 기관생명윤리위원회(IRB)의 이해)

  • Cho, Songyon
    • Korean Journal of Childcare and Education
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    • v.14 no.2
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    • pp.1-17
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    • 2018
  • Objective: The purpose of this paper is to understand the bioethics and the Institutional Review Board (IRB) in the social and behavioral research area through "The Bioethics and Safety Act" and to examine the IRB's present situation, roles, responsibilities, and tasks. Methods: This paper reviewed articles, materials for education, and "The Bioethics and Safety Act" related with the IRB. Results: Bioethics included all the research in the social and behavioral area, and "The Bioethics and Safety Act" has been enforced in every research projects targeting human subjects since February 2, 2013. Accoding to the law, the IRB must review the research proposals for human subjects and was introduced in social and behavioral research as a self-regulating system. At present, all the related institutions including universities must establish and run the IRB. This paper introduced the definition of bioethics, the IRB's roles and review types, the total number of registered IRB, and "The Bioethics and Safety Act". Conclusion/Implications: Both the central government and the local government have to make an effort for the establishment and settlement of the IRB system. This paper also presented some of the problems of the IRB.

New Haplotypes of the ATP Synthase Subunit 6 Gene of Mitochondrial DNA are Associated with Acute Lymphoblastic Leukemia in Saudi Arabia

  • Yacoub, Haitham Ahmed;Mahmoud, Wael Mahmoud;El-Baz, Hatim Alaa-Eldeen El-Din;Eid, Ola Mohamed;El-Fayoumi, Refaat Ibrahim;Mahmoud, Maged Mostafa;Harakeh, Steve;Abuzinadah, Osama H.A.
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.23
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    • pp.10433-10438
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    • 2015
  • Background: Acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in children and represents approximately 25% of cancer diagnoses among those younger than 15 years of age. Aim and Objectives: This study investigated substitutions in the ATP synthase subunit 6 gene of mitochondrial DNA (mtDNA) as a potential diagnostic biomarker for early detection and diagnosis of acute lymphoblastic leukemia. Based on mtDNA from 23 subjects diagnosed with acute lymphoblastic leukemia, approximately 465 bp of the ATP synthase subunit 6 gene were amplified and sequenced. Results: The sequencing revealed thirty-one mutations at 14 locations in ATP synthase subunit 6 of mtDNA in the ALL subjects. All were identified as single nucleotide polymorphisms (SNPs) with a homoplasmic pattern. The mutations were distributed between males and females. Novel haplotypes were identified in this investigation: haplotype (G) was recorded in 34% in diagnosed subjects; the second haplotype was (C) with frequency of 13% in ALL subjects. Neither of these were observed in control samples. Conclusions: These haplotypes were identified for the first time in acute lymphoblastic leukemia patients. Five mutations able to change amino acid synthesis for the ATP synthase subunit 6 were associated with acute lymphoblastic leukemia. This investigation could be used to provide an overview of incidence frequency of acute lyphoblastic leukemia (ALL) in Saudi patients based on molecular events.

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

  • Song, Young-mi
    • The Korean Society of Law and Medicine
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    • v.20 no.2
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    • pp.173-206
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    • 2019
  • This research examines the characteristic of regulation on Japanese clinical research in recent years. First, Japan has had a severe punishment policy on research misconduct like Korea, but, in recent days, Japan has changed the direction of research ethics policy from restriction to research publicness securement by educational training, in addition, Act of Clinical Research, effected April 2018, has recruited excellent researchers, and then integrated clinical research and medicine clinical trial through raising transparency of funding and integrating ethics screening by mandating announcement on funding information of clinical research. Second, Japan has integrated and organized ethics guideline from dual system that consists of ethics guideline on dynamic research(here after, referred to as 「dynamic guideline」) and ethics guideline on clinical research(here after, referred to as 「clinical guideline」) to ethics guideline on medical research aimed at human(here after, referred to as 「integrated guideline」), thus, it complements repetition and deficit of ethics guideline needed in clinical research and dynamic research, and it has risk evaluation system for protecting human subjects, and also it clarifies the concept of 「invasiveness」, a preliminary consideration of evaluation. 「Evaluation issue of risk and profit」, common contents of international regulation related clinical research, is the method to check whether the research is designed appropriately or not, this is the method for Institutional Review Board to decide whether the risk on human subjects could be justified, and also this is the important standard for future human subjects to participate in clinical trial. Therefore, it is meaningful to define 「invasiveness」 concept, a preliminary consideration of risk evaluation for human subjects. This research examines Japanese clinical trial focusing on change of awareness on prevention of research misconduct, efficiency improvement of research through research screening and integration of human subjects, and clarification and extension of range of 「invasiveness」 concept, a preliminary of risk evaluation to protect human subjects.

An Ethical Consideration on the Standard Operating Procedure Operation Status and the Ethical Review of the Vulnerable Research Subjects of Institutional Review Board, a Medical Institution in Korea (우리나라 의료기관 Institutional Review Board의 취약한 연구 대상자 관련 표준운영지침서 운영 현황과 윤리적 고찰)

  • Eun Hwa Byun;Byung In Choe
    • The Journal of KAIRB
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    • v.5 no.1
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    • pp.21-32
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    • 2023
  • Purspose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among advanced general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans. Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 clinical trial institutions, including 11 AAHRPP-accreditated general hospitals in Korea, as well as the operation of the IRB deliberation. Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why individuals are vulnerable, and for what reasons. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 14 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 15 institutions classified sujects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 8 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 6 classified foreigners as vulnerable. Conclution: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs' classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/benefit, and a review using checklists and spokeperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.

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Predicting Human Performance of Multiple-Target Search Using a Visual Lobe (비쥬얼 롭을 사용한 다수표적 탐색의 수행도 예측)

  • Hong, Seung-Kweon
    • Journal of the Ergonomics Society of Korea
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    • v.28 no.3
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    • pp.55-62
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    • 2009
  • This study is concerned with predicting human search performance using a visual lobe. The most previous studies on human performance in visual search have been limited to a single-target search. This study extended the visual search research to multiple-target search including targets of different types as well as targets of same types. A model for predicting visual search performance was proposed and the model was validated by human search data. Additionally, this study found that human subjects always did not use a constant ratio of the whole visual lobe size for each type of targets in visual search process. The more conspicuous the target is, the more ratio of the whole visual lobe size human subjects use. The model that can predict human performance in multiple-target search may facilitate visual inspection plan in manufacturing.

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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Review on the Luxurious Consumption Trends of the Past and Present (과거와 현대적 관점에서 본 사치소비 - 사치소비의 주.객체, 욕망, 사치소비유형을 중심으로 -)

  • Hong, Eun-Sil
    • Korean Journal of Human Ecology
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    • v.20 no.2
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    • pp.377-389
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    • 2011
  • The object of this study was to analyze the meaning of luxurious consumption, the subjects and the objects of luxurious consumption, the desires that propel luxurious consumption, and the luxurious consumption patterns of the past and the present. The materials and information used for this research were acquired by reviewing literatures from a library. The time frame used to separate the past and the present was the Second World War. The analyzed materials and contents for the research were the subjects and the objects of luxurious consumption, the desires that propel luxurious consumption, and the patterns of luxurious consumption. Comparing the trends of luxurious consumption of the past and present historically, the biggest differentiation between the past and present was the spread of subjects and objects of luxurious consumption. In the past, luxury consumption belonged to the wealthy only, but the accessibility of luxury consumption has increased to the point where anybody can buy what they want at will. Another difference was found in the desires that prompt luxury consumption and the consumption patterns of the past and present. Based on these results, several suggestions about luxury consumption were presented in this paper.

Novel Mutations in the Displacement Loop of Mitochondrial DNA are Associated with Acute Lymphoblastic Leukemia: A Genetic Sequencing Study

  • Yacoub, Haitham Ahmed;Mahmoud, Wael Mahmoud;El-Baz, Hatim Alaa El-Din;Eid, Ola Mohamed;ELfayoumi, Refaat Ibrahim;Elhamidy, Salem Mohamed;Mahmoud, Maged M.
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.21
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    • pp.9283-9289
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    • 2014
  • Background: Acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in children and represents approximately 25% of cancer diagnoses among those younger than 15 years of age. Materials and Methods: This study investigated alterations in the displacement loop (d-loop) region of mitochondrial DNA (mtDNA) as a risk factor and diagnostic biomarker for early detection and diagnosis of acute lymphoblastic leukemia. Using mtDNA from 23 subjects diagnosed with acute lymphoblastic leukemia, the first 450 bp of the d-loop region were amplified and successfully sequenced. Results: This revealed 132 mutations at 25 positions in this region, with a mean of 6 alterations per subject. The d-loop alterations in mtDNA in subjects were all identified as single nucleotide polymorphisms in a homoplasmic distribution pattern. Mutant alleles were observed in all subjects with individual frequency rates of up to 95%. Thirteen mutant alleles in the d-loop region of mtDNA occurred with a high frequency. Novel alleles and locations were also identified in the d-loop of mtDNA as follows: 89 G insertions (40%), 95 G insertions (13%), 182 C/T substitutions (5%), 308 C insertions (19%), and 311 C insertions (80%). The findings of this study need to be replicated to be confirmed. Conclusions: Further investigation of the relationship between mutations in mitochondrial d-loop genes and incidence of acute lymphoblastic leukemia is recommended.

Evaluation of Comfort and Hand Characteristics of Lining Fabrics (안감용 직물의 태와 착용 쾌적성 평가)

  • Shim, Huen-Sup;McCullough, Elizabeth A.
    • Fashion & Textile Research Journal
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    • v.10 no.4
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    • pp.537-543
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    • 2008
  • The purpose of this study was to evaluate the comfort and fabric hand characteristics of selected lining fabrics made of acetate and polyester. The comfort of the linings was determined by human subjects wearing suit blazers constructed with different lining materials in an environmental chamber controlled at $30.6^{\circ}C$ air temperature and 50% relative humidity. The hand characteristics of the lining fabrics were determined by five trained panelists using standard fabric reference samples. The effect of lining fabrics on the subjects' thermal sensations was not statistically significant. But the subjects voted warmer when wearing the polyester surah lined blazer or the polyester taffeta blazer than wearing the acetate blazers. The results of the subjective comfort evaluation indicated that, in general, the subjects rated the acetate linings significantly less sticky, clammy, damp, and non-absorbent than the polyester linings. Acetate surah was rated a little higher than the other acetate fabrics on these comfort descriptors. The results of the subjective hand evaluation indicated that the lining fabrics rated low on the geometric and mechanical hand characteristics and rated moderate on noise. Acetate surah scored the highest on most of the hand characteristics, whereas, polyester taffeta scored the lowest.