• Title/Summary/Keyword: Protection subjects

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Analysis of Indicated Points and Main Factors Affecting the Quality of Clinical Research for the Development of Internal Audit Tools (자체점검 도구 개발을 위한 지적사항 및 임상연구의 품질에 작용하는 요인 분석)

  • Hye Yun Jang;Jung-Hee Jang;Yoon Jin Lee
    • The Journal of KAIRB
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    • v.5 no.1
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    • pp.14-20
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    • 2023
  • Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

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직물의 자외선 방어율에 따른 인체의 Vit. $D_3$ 합성과 온열생리적인 반응

  • 송명견;안령미;신정화
    • Journal of the Korean Society of Clothing and Textiles
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    • v.23 no.7
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    • pp.980-986
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    • 1999
  • This study was done to ivestigate the fabrics thatminimized harmfulness of UVB(ultraviolet B) and that might product Vit. {{{{ {D }`_{3 } ^{ } }} by UVB. Twelve female subjects wearing in three different types i.e fabric A(UVB 100% protection) fabric B(UVB 50% protection) and bikinii were exposed to outdoor environment (Air Temp : 25℃, 42% R,H Air velocity : 0.13m/s UV does :6KJ/m2) Blood samples were taken 24 hours before the after the experiment in order to examine concentration of vit.{{{{ {D }`_{3 } ^{ } }} in the blood. During the experiment axillary temperature skin temperature of 7 areas(forehead Chest Upper arm, Hand Thigh Lower leg, Foot) were measured. The more irradiated areas by UVB were the more the concentration of serum 25(OH){{{{ {D }`_{3 } ^{ } }} were significantly. Mean skin temperature was significantly low levekl in wearing the fabric of UVB 50% protection (p<0.001) Axillary temperature was significantly high level in wearing the fabric of UVB 50% protection (p<0.001). Therefore the fabric of UVB 50% protection intercepts the radiation and has advantage to give off body heat over other fabrics

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A Survey on the Current Status of Human Research Protection Program Settlement and Subject Protection Activities in Korea (국내 임상시험 및 대상자 보호프로그램 도입 현황과 안전관 리체계에 대한 설문조사 연구)

  • Park, Sinyoung;Cho, Su Jin;Seo, Kyung Jeong;Kim, Jin Seok
    • The Journal of KAIRB
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    • v.3 no.2
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    • pp.28-36
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    • 2021
  • Purpose: The purpose of this study is to assess the status of the Human research Protection Program (HRPP) within a hospital or a research institute in Korea. Methods: Survey was conducted during June 12th-21th 2019. Survey was distributed to the members of Korean Association of IRB (KAIRB) through each IRB office. Descriptive statistics were performed using SPSS ver. 26. Results: A total of 86 people responded, and 75 (87.0%) answered that they have perceived the HRPP. Seventy out of 86 respondents (81.4%) were conducting internal audit, several institutions were operated simultaneously the other form of audits such as IRB audit, system audit. Regarding the management of Suspected Unexpected Serious Adverse Reaction (SUSAR), 62.8% answered that they have regulation that can decide to suspend the study when there is a risk to subject safety. Among the respondents, 66.3% performed 'Help desk.' Conclusion: In this study, we assessed the current status of HRPP operation at each research institution based on Ministry of Food and Drug Safety (MFDS) HRPP guidelines. The HRPP accredited institution operated the subject protection activities according to this program, and even if the HRPP was not officially operated, the related activities were conducted focusing on the cases that could have a significant impact on the safety of research subjects. In order to ensure the quality of domestic clinical trials and to stably establish the HRPP, efforts at the individual institution level will be required.

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HIV/AIDS Related Knowledge and Attitude of Korean Childbearing Women (가임여성의 에이즈관련 지식과 태도)

  • Chang, Soon-Bok
    • The Korean Nurse
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    • v.33 no.5
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    • pp.46-62
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    • 1995
  • The purpose of this study was to identify the level of HIV/AIDS related knowledge and attitudes of Korean childbering women. The subject were 1152 Korean women who were living in the Seoul area and whose age was between 17-50 years. Data was collected by self reporting with a questionnaire of 57 items developed by the researcher. The reliability of the instrument for the HIV/AIDS related knowledge and attitudes were Cronbach's alpha. .6954 and .7987 respectively. The results were as follows: The mean age of the subjects was 26 years and 46.8% of them were married. The mean score for HIV/AIDS related knowledge was 14.7 out of a possible maximum score of 22. The correct answer rate for HIV/AIDS related knowledge was between 87.0-94.1% for the risk factors. and 36.4-54.8% for the transmission mode. Even though 87% of the subjects knew that homosexuals are risk group for HIV/AIDS. only half(55.8%) of the subjects answered that anal sex is the transmission mode. And only 57% of the subjects knew that HIV/AIDS transmission is possible through heterosexual contact. Their agreement level for attitudes was in order of communal coping (95%). pregnant women protection (94%). Problem appraisal (82%). patients isolation(68%). and disclosure of infection(67%). It was shown that the group who had a pregnancy (t=2.07, p=.039), used contraceptives (t=2.57, p=.OO1). and the group of college level graduates(t=3.61, p=.000) had a higher level of HIV/AIDS related knowledge. The agreement level of pregnant women protection. patient isolation. and problem appraisal were higher in the group of having had a pregnancy, having used contraceptives. and the group over 30 years of age. It was concluded that Korean childbearing women were quite knowledgeable about the risk factors but confused about the transmission mode. especially heterosexual contact. and they showed responsive attitudes to the HIV/AIDS issues considering the 339 infected cases in Korea. They preferred isolation of patients and communal coping as behavioral attitudes. Therefore it can be suggested that a HIV/AIDS prevention program should be focused on transmission mode.

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A Case Study for Improvement of Users' Right to Informational self-determination: Focusing on the GDPR of EU and the CCPA of California, USA (국내 기업의 개인정보 자기결정권 강화를 위한 논의: EU의 GDPR과 미국 캘리포니아주의 CCPA를 중심으로)

  • Yoon, Young-Ho;Yoon, Hyun Shik
    • The Journal of Information Systems
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    • v.28 no.4
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    • pp.65-103
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    • 2019
  • Purpose The purpose of this study is to find out in extent to which the companies in Korea and oversea, which has been subjected by different laws of their country, have guaranteed the personal information rights and have provided proper 'right to access' to the information subjects. Design/methodology/approach This study compared Korean laws with 'General Data Protection Regulation (GDPR)' of EU and 'California Consumer Privacy Act (CCPA)' to check each of the level of 'right to access' guarantee. In terms of the difference in guaranteeing the right, this study compared Korean IT leading companies with US global leading IT companies to find out how much 'right to access' are properly implemented in their policies and functions they provide. Findings The result of the study shows that 'right to access' has not been well guaranteed by Korean law, as it does not provide the right to choose method and medium by information subjects and does not clarify the types of diverse information. This was clearly opposite with the other laws providing the right to choose what method and medium that subjects want with clarifying every types of personal information possible to be more. In addition, 'right to access' has not been well guaranteed by Korean companies in comparison with by the oversea companies which proactively guarantee the right by setting the function enabling subjects to browse their information through their websites or applications.

Study on the Effect of Life Safety Awareness and Safety Behaviors of Fire Professional Engineers on Life Safety (소방기술사의 안전의식, 안전행동과 인명안전과의 관계 연구)

  • Kim, Myung-Cheol;Ko, Han-Mog;Park, Jae-Kwan;Seo, Hae-Yeol;Yu, Byoung-Sun;Yoo, Chang-Bum;Youn, Hae-Kwon;Joo, Seung-Ho
    • Fire Science and Engineering
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    • v.32 no.5
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    • pp.112-121
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    • 2018
  • In the present study, a group of subjects consisting of "Fire Professional Engineers" was selected to examine the effects of life safety awareness and safety behaviors of the subjects on life safety through an analyses of the descriptive statistics, factors, reliability, and correlation; simple regression and three-stage regression analyses on mediation were also carried out based on the hypotheses developed. The results showed that the degree of safety behavior increased by 72.1% in accordance with the increased safety awareness of fire professional engineers; the life safety was also increased by 61.5% and 64.5% by the increases in safety awareness and safety behavior of fire professional engineers, respectively. In addition, the safety behaviors demonstrated a partial mediatory effect in the relationship between safety awareness and life safety. All hypotheses (H1, H2, H3, H4), established for the present study, were accepted based on statistical verifications that justified an amendment of the Acts pertinent to firefighting service focusing on life safety; the data are expected to be exploited to reflect significance of life safety.

A Study on Vehicle Frontal Structure for Crash Compatibility (상호 안전성 대응 차체 전방 구조에 관한 연구)

  • Shin, Jangho;Kim, Yun Chang;Kim, Hye Yeon
    • Journal of Auto-vehicle Safety Association
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    • v.3 no.2
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    • pp.11-16
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    • 2011
  • In recent years, rapid-increasing market share of compact cars and SUVs has brought for both consumer and automaker to pay more attention on crash compatibility between the compact passenger vehicles and the light trucks (i.e., Pickups and SUVs). Vehicle compatibility regarding both self and partner protection in frontal crash of different class vehicles is one of hot issues in vehicle safety. Furthermore, it is expected that the amendment of UNECE-Regulation 94 to implement compatibility issues in couple of coming years. In this study, conceptual design of compatibility compliant frontal vehicle structure which subjects to improve? the distribution of frontal crash loading and structural engagement between vehicles is introduced. The effects of proposed vehicle structure on both possible candidates (i.e. FWRB, FWDB and PDB) for a compatibility evaluation test procedure and car-to-car crash are also investigated.

The Effects of a Parental Developmental Bibliotherapy Program for Their Young Children's Sexual Abuse Self-Protection (발달적 독서치료를 활용한 부모 대상의 유아 성학대 자기보호 교육자 훈련프로그램의 개발 및 효과검증)

  • Chun, Hui-Young
    • Journal of the Korean Home Economics Association
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    • v.47 no.9
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    • pp.37-53
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    • 2009
  • The purpose of this study was to assess the effects of a children sexual abuse (CSA) parental training program with applied developmental bibliotherapy on parents. Subjects were 54 mothers, 24 of whom participated in the program which included 8 sessions for 4 weeks. Four dependent variables were subjected to analysis of covariance (ANCOVA); mothers’ knowledge, myths and stereotypes related to CSA, and their children’s levels of prevention concepts comprehension and self-protection skills of CSA. The results showed that the program increased mothers’ knowledge of CSA and decreaesd their beliefs on myths and stereotypes, and also increased their comprehension level of CSA prevention concepts and their level of children self-protection skills. These positive effects of the program show that the program can be incorporated into early childhood education practices. We are also pursuing the development of other research programs on this subject.

Development of the Sunshade hat with a large brim (Part II) - Human trial test at outdoors - (양산형 일광차단모의 개발(제2보) -실외 인체착용시 복사열 및 자외선의 차단효과-)

  • 최정화;김경수
    • Journal of the Korean Society of Clothing and Textiles
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    • v.28 no.3_4
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    • pp.414-421
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    • 2004
  • To reduce farmer's stress from solar radiation and ultraviolet radiation(UV), the sunshade hat with a large brim and special structure for ventilation was developed and tested with manikin heads outdoors at previous study(Kim and Choi, 2002). To evaluate the protection efficiency of the sunshade hat, human trial test was performed at outdoors. The results were as follows; Skin temperatures(7 sites), heart rate, temperature inside the hats, temperature and relative humidity inside clothing on the back in wearing developed sunshade hat were significantly lower than those in wearing the controlled hat. In subjective sensation, subjects answered to feel significantly hotter, more humid and more uncomfortable in wearing the controlled hat. But relative humidity inside the hats was significantly higher in wearing developed hat. In rectal temperature, there were no significant differences between two hats.

Development of Movable Sunshade Tent (이동식 천막형 일광차단장비의 개발)

  • 김경수;최정화
    • Journal of the Korean Home Economics Association
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    • v.42 no.1
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    • pp.99-113
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    • 2004
  • To protect farmers from solar radiation and UV, the movable sunshade tent was designed and its protection efficiency was measured in the artificial chamber and outdoors. Sunshade tent and the existing farmer's hat were examined. The results were as followes; Heart rate, total body weight loss and temperature of clothing microclimate on the chest and the back were lower in using sunshade tent than those in wearing existing hat in two experiments. In subjective sensation, subjects answered to feel significantly hotter and more uncomfortable in wearing existing hat in two experiments. Rectal temperature was significantly lower using the sunshade hat in experiment at outdoors(p<0.001).