• The Journal of Korean Medicine
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• v.41 no.3
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• pp.66-80
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• 2020

Objectives: We investigated the current status of the consent form for bee-venom pharmacopuncture therapy, which is using in Korean medicine hospitals. We suggest the development of a standard informed consent form. Method: Through the questionnaire survey, status of using informed consent form was identified at 24 Korean medicine hospitals. We analyze different types of informed consent form, which was developed by each hospitals. We investigated the types of informed consent forms for various medical procedures through electronic searches. A standard informed consent form for bee-venom pharmacopuncture therapy was developed based on the medical law and the standard informed consent form for medical procedures developed by Korea Fair Trade Mediation Agency. Result: In our survey, 65% of the hospitals do not use consent well, only 35% of the hospitals use informed consent form, and the most hospitals use self-developed informed consent form. As a result of analyzing the contents of informed consent form used in each hospitals, the explanation of diagnosis, treatment precautions, suggestions for other treatments, consequences of not performing the scheduled procedure, possibility of treatment change was insufficient. 48% of hospitals manage consent in recording on a chart, 39% in scanned documents, and 13% in digital electronic consent form. Conclusion: A standard informed consent form for Bee-venom pharmacopuncture therapy include diagnosis, effectivness, necessity, indications, method, skin reaction test, hypersensitivity questionnaire, treatment precautions, possible hypersensitivity reactions and countermeasures, suggestions for other treatments, consequences of not performing the scheduled procedure, possibility of treatment change and the name of doctor.

• The Journal of Korean Medicine
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• v.45 no.1
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• pp.182-201
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• 2024

Objectives: This study was conducted to develop a standard acupotomy consent form that takes into account the unique characteristics of Korean Medicine. The study was motivated by the increasing importance of patient autonomy and the growing number of legal disputes related to medical malpractice in the clinical field of Korean Medicine. Methods: The analysis phase of the study involved a survey of the current status of acupotomy consent forms in Korean Medicine hospitals nationwide. The items of each form were analyzed based on the contents of the Medical law and the standard contract for medical procedures of the Fair Trade Commission (FTC). In the development and evaluation phase, the items and contents of the acupotomy consent form were evaluated using a 5-point Likert scale and content validity was assessed through two rounds of Delphi surveys. In the improvement phase, the contents of the consent form were revised based on the results of a survey of inpatient and outpatient patients in the Department of Acupuncture and Moxibustion at Pusan National University Korean Medicine Hospital, and real-time online meeting. The final version of the standard acupotomy consent form was completed after undergoing proofreading and corrections by a linguistics expert. Results: Only 30% of Korean Medicine hospitals have implemented acupotomy consent forms. The items of the consent forms did not fully include the items presented in the Medical act and the standard contract for medical procedures of the FTC. To address this issue, two rounds of Delphi surveys and a real-time discussion were conducted with a panel of 12 experts on 27 preliminary items of consent forms. The items and contents that met the criteria for content validity ratio, convergence, and consensus were derived. Based on the derived items and content, a standard acupotomy consent form was developed. Conclusions: The standard consent form for acupotomy is anticipated to ensure patient autonomy and enhance transparency and liability in acupotomy. Furthermore, it is expected to serve as evidence in case of medical disputes related to acupotomy and contribute as a reference document for the development of standard consents forms for various procedures of Korean Medicine. However, the limitations of the study include that the survey of consent forms was limited to only training hospitals of Korean Medicine, and the standard consent form is only applicable to adults in Korea. Future studies are needed to address these limitations.

• The Journal of KAIRB
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• v.1 no.2
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• pp.30-42
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• 2019

In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.

• Journal of Sasang Constitutional Medicine
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• v.17 no.1
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• pp.45-55
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• 2005

1. Objectives In this study, we analysed the up-to-the-present data in the SCIB and the chart of Iksan Wonkwang Oriental Medical Clinic, to develop the system and factors of data for the SCIB(Sasang constitution Information Bank). 2. Methods SCIB data is composed of analyses about the QSCC II(Questionnaire for the Sasang Constitution Classification II), Cold-hot questionaire, Ban-chi constitution questionnaire, Body composition, Body measurement, 24-hour food intake & Activity examination, MBTI & MMTIC, Informed consent & Blood sampling, and data presented by committee of Sasang constitution diagnosis expert. And the chart data of Iksan Wonkwang Oriental Medical Clinic is composed of analyses about Inspection, Ausculfation and olfaction, Inquiry, Pulse feeling and palpitation, and treatment field. 3. Results and Conclusions Almost data in the SCIB are lack of regular forms because they are based on mainly the QSCC II and additionally other examinations. Conclusionly important matters of the SCIB data are as follows: (1) the standard form including 4 whole diagnostic factors (2) the standard form including symptoms, pattern identifications, treatment processes and treatment results (3) objectivity and practicality to collect data.

• Journal of the Health Care and Life Science
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• v.9 no.1
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• pp.1-9
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• 2021

In this study, a model in which certification standards were added to the health information management practice program was studied and presented in order to understand the EMR certification standards implemented by the Korea Health and Medical Information Service. In the practice program, the certification standard function for patient information management was added to the health information management education system to practice and understand patient information management that corresponds to the functional standard of the EMR certification system. The EMR certification standard practice program for patient information management is composed of the following certification standards. registration number and personal information management, treatment reservation schedule management, personal information revision history management, identification of people with the same name, integrated management of multiple registration numbers, patient search by identification information, patient search by health care type, surgical procedure consent record and inquiry, record/inquiry of consent form for personal information use, display of life-sustaining medical decision information, registration/inquiry of external medical institution documents, registration and inquiry of external examination results. In this way, by operating and practicing the functions of the health information system according to the certification standards, it is possible to understand and practice the certification standards and details of patient information management in the functional area of the certification standards. In addition, since the function of the EMR certification standard can be checked, it will be possible to improve the management ability of the electronic medical record system of the health information manager in the medical institution.

• The Journal of KAIRB
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• v.6 no.1
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• pp.5-16
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• 2024

Purpose: The purpose of this study is to investigate the current status of pediatric assent in nationwide hospitals and to assess the children's comprehension for pediatric assent by interviewing pediatricians/pediatric neurologists to determine whether children of the age (elementary and middle school students) can understand the purpose, risks, benefits, and concepts of voluntary participation in clinical research described in the assent form, and to help improve the administrative efficiency of multicenter clinical trials. Methods: The status of pediatric assent was surveyed online using Google Forms at 141 university hospitals with administrative staff who are members of the Institutional Review Board (IRB) administrative staff subcommittee with in Korean Association of Institutional Review Boards (KAIRB). Additionally, face-to-face interviews were conducted with 7 pediatricians/pediatric neurologists. Survey and interview responses were summarized using descriptive statistics. Results: Out of the 141 institutions surveyed, 35 institutions (24.8%) responded. Among them, 30 institutions (85.7%) reported having age criteria for acquiring pediatric assent forms in the case of children. The age range for pediatric assent acquisition have been from 7 years old to 12 years old (15 institutions, 50%), and from 7 years old to 15 years old (7 institutions, 23.3%). Nine institutions (25.7%) have had criteria for obtaining both parents' consent in cases involving the participation of children. Nineteen institutions (54.3%) have had checklists or guidelines available for use by IRB members in study protocols involving vulnerable research subjects. Three pediatricians/pediatric neurologists have believed that upper-grade elementary school students (5th-6th grade) could comprehensively understand informed consent forms. Two have believed that middle school students would be able to understand them if they included personal information. Two pediatricians/pediatric neurologists have believed that even lower-grade elementary school students (1st-4th grade) could understand the explanations if they were made simpler. Conclusion: It is suggested that not only elementary school students (7-12 years old) but also middle school students (13-15 years old) should receive pediatric assent forms, as it would facilitate a comprehensive understanding of the forms. To enhance the comprehension of assent form content, it is necessary to use age-appropriate words, language, and expressions in the forms hospital. It is also recommended to create comics or videos to make the content of the assent forms more accessible for children.

• Research in Community and Public Health Nursing
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• v.19 no.3
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• pp.378-387
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• 2008

Purpose: The purposes of this study were to investigate factors related to the depression of the elderly dwelling in a big city, and to explore the influence of physical health, cognitive symptom and nutritional status on the elders' depression. Methods: After the approval of the Institutional Review Board (IRB) and obtaining the participants' consent form, a face to face and private interview was conducted with each participant from Mar, 2007 to Aug, 2007 by trained graduate level students. A total of 201 elders aged over 65 years participated in the study. The questionnaire consisted of K GDS, PHQ 15 and Nutritional Screening Initiative (NSI). Collected data were analyzed with the SPSS 13.0 program, which was used for frequency, percentage, mean, standard deviation, Pearson correlation coefficients, and multiple regression. Results: The major findings of this study were as follows. 1) 28.4% of the subjects belonged to the depression group, 78.1% had one or more diseases, 85.6% had experienced somatic symptoms, and 49.7% belonged to the nutritional risk group. 2) Older age, lower educational level, more pocket money a larger number of diseases, more severe cognitive symptoms and poorer nutritional status were significantly related to a higher depression score. 3) Significant factors influencing depression were nutritional status, cognitive symptoms and the number of diseases, which explained 38.1% of the variance of elderly depression, and nutritional status was the most influencing factor. Conclusion: The finding of this study gives useful information for developing assessment tools and interventions for elders' depression.

• Journal of East-West Nursing Research
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• v.17 no.2
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• pp.81-86
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• 2011

Purpose: The purpose of this study was to examine job involvement according to working pattern and daytime sleepiness in hospital nurses. Methods: At 2 hospitals in affiliation of university, after obtaining participant's consent form, data were collected from October to November, 2007. Twohundred fifty nurses participated in the study. Questionnaire consisted of Epworth Sleepiness Scale (ESS), Job Involvement. Collected data was analyzed with SPSS 14.0 program, which was used for frequency, percentage, mean, standard deviation, t-test and Pearson correlation coefficients. Results: Major findings of this study were as follows 1) The nurses for 3 shift work was 172 (68.8%), the nurses for 2 shift work was 3 (1.2%) and the nurses for day fixation was 75 (30.0%). 2) Mean of ESS was 5.94 (3.28), daytime sleepiness was 13.2% and Job involvement had a mean of $21.27.{\pm}4.61.3$) There were significant differences between shift work and day fixed work on ESS (t=4.33, p<.001), job involvement (t=6.54, p<.001). Higher ESS were significantly related to lower job involvement (r=-.185, p=.003). Conclusion: The finding of this study gives useful informations about sleep and work involvement of hospital nurses. It is need to develop systemic management for shift work nurses by hospital, nurse organization, and government.

• Journal of Digital Convergence
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• v.12 no.10
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• pp.597-604
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• 2014

This research aimed at comparative analysis of body composition and basic physical strength of model majored female college students and general female college students. The research object was composed of 15 model majored female college students of D University, who learned the purpose of this research enough and wrote the consent form of voluntary participation and 15 general female college students, who have no medical history and currently no special disease, and no experience in regular exercise. They underwent body composition inspection, left right grasping power which is the basic physical strength, back muscle strength, flexibility, rapidity, muscle endurance, and the researcher performed descriptive statistics to calculate the average standard deviation, and analyzed to verify difference between groups by using independent t-test. With statistical significance level p<.05, the results are as follows. model majored female college students and general female college students showed meaningful difference between groups in weight, skeletal muscles, body fat volume, BMI and left right grasping power, back muscle strength, rapidity(p<.05). between groups in flexibility and muscle endurance(p>.05).

• Journal of dental hygiene science
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• v.12 no.2
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• pp.139-144
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• 2012

Daejeon school-based toothbrushing program using toothbrushing room started at 2007. Ministry of Health and Welfare started national toothbrushing room program without pilot project at 2011. The aim of this study was to provide the basic data to assess of the effect of this program. 59 experimental subjects and 60 control subject were selected after written consent. Oral Examination was done by 1 dentist using WHO standard and Survey of Child Oral Health-Related Quality of Life(COHIP), oral health knowledge and oral health behavior were done using self-registration form. We analyzed the result after adjusting economic status and subjective for the difference between experimental and control groups using SPSS 19.0. The experimental group had lower plaque index, better COHIP and more oral health knowledge significantly(p<0.05). But, The significance was not found in dental caries index and oral health behavior. We suggested the oral health education program and other dental caries prevention program including sealants were needed to prevent dental caries, although school-based toothbrushing program could improve COHIP.