• 대한한의학회지
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• 제41권3호
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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.

• 대한한의학회지
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• 제45권1호
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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.

• 대한기관윤리심의기구협의회지
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• 제1권2호
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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.

• 사상체질의학회지
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• 제17권1호
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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.

• 보건의료생명과학 논문지
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• 제9권1호
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• pp.1-9
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• 2021

본 연구에서는 한국보건의료정보원에서 실시하는 EMR 인증기준울 이해할 수 있도록 보건의료정보관리 실습 프로그램에 인증기준을 추가한 모델을 연구하여 제시하였다. 실습 프로그램은 EMR 인증제의 기능성 기준에 해당하는 환자정보관리를 실습하고 이해할 수 있도록 보건의료정보관리 교육시스템에 환자정보관리에 대한 인증기준 기능을 추가하였다. 환자정보관리를 위한 EMR 인증기준 실습프로그램은 다음과 같은 인증기준으로 구성되었다. 등록번호 및 인적사항 관리, 진료예약 일정관리, 인적사항 수정이력관리, 동명이인 구분자 표시, 다중 등록번호 통합관리, 식별정보를 이용한 환자 검색, 진료형태에 따른 환자 검색, 수술시술 동의서 기록·조회, 개인정보활용동의서 기록·조회, 연명의료결정정보 표시, 외부 의료기관문서 등록·조회, 외부 검사결과 등록·조회. 이와 같이 인증기준에 의한 보건의료정보시스템의 기능을 운영하여 실습해봄으로써 인증기준의 기능성 영역에서 환자정보관리의 인증기준과 내역을 이해하고 실습할 수 있다. EMR 인증 기준에 맞춰 환자정보관리 실습을 수행해봄으로써 전자의무기록시스템에서의 표준화된 환자정보관리를 이해할 수 있다. 또한 EMR 인증기준의 기능을 확인할 수 있기 때문에 의료기관에서 보건의료정보관리사의 전자의무기록시스템의 관리 능력을 향상시킬 수 있을 것이다.

• 대한기관윤리심의기구협의회지
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• 제6권1호
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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.

• 지역사회간호학회지
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• 제19권3호
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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.

• 동서간호학연구지
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• 제17권2호
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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.

• 디지털융복합연구
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• 제12권10호
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• pp.597-604
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• 2014

본 연구의 목적은 모델전공 여대생과 일반 여대생의 신체조성 및 기초체력을 비교분석 하는데 있다. 본 연구의 취지를 충분히 설명하고 자발적 참여의 동의서를 작성한 D대학교의 모델전공 여대생 15명과 일반 여대생 15명이었으며, 과거병력과 현재 특별한 질환이 없고, 규칙적인 운동경험이 없는 자들로 구성하였다. 이들은 신체조성검사 및 기초체력검사인 좌 우악력, 배근력, 유연성, 순발력, 근지구력을 실시하여 평균 표준편차를 산출하기 위하여 기술통계를 실시하였고, 집단 간 차이 검증은 independent t-test를 이용하여 분석하였다. 통계적 유의수준은 p<.05로 설정하여 다음과 같은 결론을 얻었다. 모델전공 여대생과 일반 여대생의 체중, 골격근, 체지방량, BMI 및 좌 우악력 및 배근력, 순발력에서 집단 간 유의(p.<05)한 차이를 보였으며, 유연성 및 근지구력은 집단 간 유의한 차이를 보이지 않았다(p>.05).

• 치위생과학회지
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• 제12권2호
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• pp.139-144
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• 2012

본 연구는 2007년부터 시작된 대전 양치교실사업의 효과를 평가하고자 양치교실 실험군 59명과 대조군 60명을 대상으로 하여 2011년 6월- 9월까지 구강검사와 COHIP를 비롯한 설문조사를 실시하였다. 두 군 간의 경제적 상태와 주관적인 건강인식에 차이를 보여 이들 변수를 통제한 후 자료를 분석한 연구 결과는 다음과 같다. 1. 양치교실이 있는 실험군은 대조군과 비교하여 우식경험영구치수, 우식경험영구치면수 모두에서 유의한 차이가 없었다. 2. 양치교실이 있는 실험군은 대조군과 비교하여 치면세균막지수는 유의하게 낮았다(p<0.05). 3. 양치교실이 있는 실험군은 대조군과 비교하여 아동구강건강관련 삶의 질이 유의하게 양호하였다(p<0.01). 4. 양치교실이 있는 실험군은 대조군과 비교하여 불소와 치아홈메우기 사업에 관한 지식이 유의하게 높았다(p<0.01). 5. 양치교실이 있는 실험군은 대조군과 비교하여 구강보건행위면에서 유의한 차이를 보이지는 않았다. 6. 대조군이 양치교실이 있는 실험군과 비교하여 학교집단잇솔질사업에 관한 긍정적인 태도를 보였다(p<0.05) 따라서, 초등학교 양치교실사업은 치면세균막지수 감소효과와 구강건강 관련 삶의 질 증진효과를 가지고 있으나 치아우식경험도를 감소시키기 위해서는 부가적인 치아우식예방법이 요구되며 양치교실 운영시 양치교실이 효율적으로 이용될 수 있도록 운영방안과 학생들의 동기를 유발할 수 있는 프로그램 개발이 필요하다고 사료되었다.