• 제목/요약/키워드: Informed consent education program

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임상연구 동의서 교육 시행의 효용성 검증 (Validation of the Effectiveness of Education for Obtaining Consent in Clinical Study)

  • 김지은;이미성;김설화;양지혜;고승아;이초롱;양수연;신혜주;김보아;정종우
    • 대한기관윤리심의기구협의회지
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    • 제5권2호
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    • pp.51-58
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    • 2023
  • Purpose: To validate the effectiveness of obtaining consent education on errors in the consent process and to develop the education program for researchers. Methods: From February 2019 to February 2022, a 30-minute, 1:1 face-to-face consent education developed using the ADDIE model was conducted on 78 nurses as principal investigators. An informed consent audit tool, which includes 6 items developed by Asan Medical Center Human Research Protection Center, was used to analyze errors in obtaining informed consent process. Data analysis was performed using the SPSS ver. 25.0, and the Mann-Whitney U-test and χ2-test were utilized to verify the difference in errors between the experimental and control groups. Results: The participants consisted of 42 in the experimental group and 36 in the control group, with no statistically significant difference between the 2 groups. Both 2 groups showed the highest frequency of documentation errors, followed by format errors, errors related to a suitability of investigator, participant, or participant's legally acceptable representative, witness and confidentiality issues. After education, there was a significant decrease in both format errors (p=0.002) and documentation errors (p<0.001) in the experimental group. The proportion of participants without any errors in all items was higher in the experimental group (35.7%) compared to the control group (5.6%), and this difference was statistically significant (p=0.001). Conclusion: The obtaining consent education program was found to be effective in reducing informed consent errors. This study emphasizes the importance of education, suggesting the need for its expansion and accessibility, as well as the necessity for all researchers conducting clinical studies to receive the obtaining consent education.

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사전동의(Informed Consent)에 관한 입원환자의 경험 (A Study on the In-Patients' Experiences of Informed Consent)

  • 유명숙
    • 간호행정학회지
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    • 제12권2호
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    • pp.255-264
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    • 2006
  • Purpose: This study was carried out to understand the in-patients' experiences related on informed consent for examination, treatment or surgery. Method: The study was conducted with 578 patients who were admitted to the departments of internal medicine and surgery for examination, treatment or surgery requiring informed consent from November 1 to 30, 2004 at three general hospitals in Daegu, Busan and Gyeongsangbuk-do. The data was analyzed by using SPSS 11.5 for Windows. Results: Although the one who explains during the process of informed consent should be doctors, 6.6% was informed by nurses or others. In addition, the majority has been told for complications and risk while relatively fewer patients were informed for necessity, method and costs of the procedure, and no one ever heard of other alternatives or the right to terminate the procedure at any time. While 40% of patients were not the final decision-makers of examination, treatment or surgery, 11.9% of patients answered their opinions were not considered during the final decision-making process. Conclusion: The study suggest that the ethically appropriate informed consent has not been achieved in the clinical practice, and therefore it is necessary to develop the specific behavioral guidelines and nursing ethics education program for nurses in order to settle down the desirable informed consent at the dimension of nursing management.

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선천적 심질환아의 수술동의서 작성과 관련된 부모의 요구 (Needs of Parents Who have the Child with Congenital Heart Disease Related to the Informed Consent)

  • 최미영
    • 부모자녀건강학회지
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    • 제6권1호
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    • pp.18-30
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    • 2003
  • Congenital heart disease is the most frequently shown congenital disease among children, most of them can be corrected with operation. However, Patients and their parents need nursing intervention when they face this risky incident of operation. Therefore, parents' experiences are absolutely needed to plan nursing intervention to give practical help to the patients and their parents. The purpose of this study is to provide basic resources to develop a feasible intervention program for the parents by understanding the experiences related to the informed consent of cardiac surgery of their child. From January to June 2003, 10 parents of children patients with congenital heart disease were interviewed who filled out Operation Agreement before the primary operation after they are diagnosed as congenital heart disease in pediatric chest surgery of A hospital in Seoul. They were asked to give opinion regarding pre-operation needs and the interviewed information was analyzed. The results of this study are as follows : Firstly, they were asked what they felt before they were told about the operation of their children from the doctor before filling out the informed consent of operation. They felt 1) vague, 2) confusion of choose, 3) risky, 4) resented, 5) uneasy, 6) guilty, and 7) the burden of operation. Secondly, they were asked what they felt after they filled out the informed consent of operation and the doctor gave them detailed information on the operation of their children. They felt 1) confused, 2) responsible, 3) rejected, 4) angry, 5) plain, 6) to have hope, 7) trying to trust medical people, 8) that consolation is needed, and 9) conditional reduction of the burden of operation. Thirdly, followings are the categories of congenital parents' demand before operation based on the analysis of experiences related to the preparation of the informed consent of operation. 1) Information Demand (1) Anticipatory information (2) Concrete and precise information (3) Individual information 2) Support (1) Empathy (2) Parental supporting (3) Support of parents in the same situation 3) Education and consulting (1) Children-oriented Education (2) Consultation Considering the results of this study, parents of the child with congenital heart disease seem to have various emotional experiences related to filling out the informed consent and they need concrete and practical helps before cardiac surgery. This study proposes that systematic nursing intervention is needed according to the needs of the parents who have the child with congenital heart disease before operation in the field of child health nursing.

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임상시험 연구간호사의 업무 실태와 직무만족에 관한 연구 (Job Status and Job Satisfaction among Clinical Research Coordinator)

  • 김태은;김계하
    • 간호행정학회지
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    • 제15권3호
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    • pp.336-345
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    • 2009
  • Purpose: The purpose of this study was to examine job status and job satisfaction among clinical research coordinators. Method: Subjects were 91 clinical research coordinators participating in clinical trials at hospitals in Korea. Data were collected from July to August, 2008 using a structured questionnaire that include informed consent, and question as pertaining to, general characteristics, job related characteristics, and job satisfaction. The collected data were analyzed using SPSS 12.0 version. Result: Almost half of the subjects were called as nurse researcher. Major tasks included participant screening (100%), participant scheduling (100%), and obtaining informed consent from participants (98.9%). The most difficult aspect of work was salary (28.6%). The mean score on the job satisfaction was 80.21 (range: 54.00-109.00). Item related to promotion ranked lowest in job satisfaction. There were significant differences in job satisfaction according to the type of hospital (t=-3.640, p<.001), title (t=7.894, p=.001), and route for information of CRC (t=4.970, p=.001). Conclusions: Subjects feel poorly compensated, unrecognized, and perceive a limited career path. These factors are likely to diminish job satisfaction over time. Attention to these aspects through education program and criteria for clinical research coordinators could be helpful.

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학령전기 아동 부모의 아동 건강지식 정도, 건강습관 지도이행도 수준 및 건강교육 요구도 조사 (Health Knowledge, Health-Guidance Execution and Health-Education Needs of Parents of Preschoolers)

  • 서현미;전미양;최나영
    • 한국보건간호학회지
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    • 제23권2호
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    • pp.207-218
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    • 2009
  • Purpose: In an attempt to develop a parental health improvement education program for day care children, survey questions were devised to measured the extent of parental health knowledge, health-guidance execution and needs. Method: Participants were 727 parents whose children attended daycare centers in J province informed consent was provided prior to participation. Result: Respondents were overwhelmingly (91.6%) mothers. Questions with high percentage of incorrect answers were "What should I do if my child swallows harmful drugs, bleach or detergents?" (98.1%) and "What should I do if insects or other bugs enter my child's ear?" (96.6%). In most cases, parental health-guidance execution exceeded 90% except in response to the survey question "Does your child have a dental check-up every 6 months" (51%). Taken together, parental education is necessary concerning growth and development (12.8%), nutrition (12.1%), healthy life styles (10.3%) and general health issues (10.0%). Conclusions: Parental health knowledge about preschooler's health varies with degree of income, education and type of employment. Consideration of these variables is important in a parental health education program.

Implant system에 있어서 치과위생사의 assist work (Assist works as to implant system which dental hygienists perform in a clinical field)

  • 남용옥;김선숙;김민자;주온주
    • 한국치위생학회지
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    • 제9권2호
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    • pp.147-163
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    • 2009
  • This study was attempted in order to look into 'Assist work' as to Implant system which dental hygienists perform in a clinical field. Subjects of this research were 362 dental hygienists who work at general hospital, University hospital, dental hospital, and dental clinics located in Seoul, Kyeong-gi, In-chon, and Jeon-buk area. As to research tool, we produced questionnaire which was comprised of the total 25 items regarding 3 of general features (age, career of dental hygienist, and personality), 6 of implant system assist work, 3 of Informed consent before surgery, 6 of preoperative preparation and maintenance related business, and 7 items related to postoperative maintenance. By using SPSS program, collected data was analyzed. Results of analysis in this study were as follow; 1. As to implant related education, dental hygienists' experience of education was high as 77.7%, and the people who is needed more education was 86.3%. Consequently, dental hygienists' concern about the implant related education was very high. 2. It was observed that most of informed consent making approvement by announcement to the surgical operation was made by dental hygienist before implant as 95%. 3. Over 80% of dental hygienists performed acquisition of cleanliness technology, motivation, back up articles preparation, treatment area arrangement, and etc. which we can check by preoperative maintenance items. In particular, response about the motivation was very high as more than 90%. 4. When performing an operation, in the case of disinfecting finger was low for 53.9% and the method was mainly washing with drug solution, and gown sterilization was performed only in 52.2%. Therefore education regarding disinfection was urgently needed. 5. Significance of education could be known that answers of hygienists experienced education appeared highly in items of maintenance method and there was statistically significant difference(p<0.05). 6. In case that assist work were 21cases or greater, agitation measurement was the most many performed in 68.9% and difference was showed up significantly(p<0.001). 7. Evaluation about periodontal tissue was high in dental hygienists who had experienced education and also there was statistically significant difference. In conclusion, assist work of dental hygienists was very comprehensive when implant surgery was performed, and all of items excluding hand disinfection or gown disinfection were highly showed up in most of hygienists. However, since there is the limit that we didn't investigate the quality of performing contents. It is considered that further study regarding the content has to be progressed for supporting this result in the future.

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골관절염 환자를 위한 지역사회기반 수중운동 프로그램 참여 경험 (Qualitative Content Analysis for Participation in a Community-based Aquatic Exercise Program for Patients with Osteoarthritis)

  • 김종임;손행미;김선애;송영신;김선경
    • 근관절건강학회지
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    • 제24권1호
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    • pp.1-13
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    • 2017
  • Purpose: This study was conducted to explore the experiences of women with osteoarthritis in the community-based aquatic exercise program. Methods: A total of 13 women who lived urban-rural complex areas participated in 8 weeks of aquatic exercise. Data were collected from two focused group interviews of those who signed informed consent. Results: Four categories emerged from the contents analysis: 1) assisting a remedial program (participant-centered education, alleviation of physical symptoms, and relieving stress), 2) Pleasure of being together (group exercise, feeling of pleasure and joy, and strong and confident supporter), 3) burden of participation (economic burden, low accessibility and unaccustomed swimming pool), 4) organizing and activating a self-help group(acquired confidence over exercise, hoping for continue exercise, and Needs of self-help meeting). Conclusion: Aquatic exercise was good for women living urban-rural area as it gave not only reliving arthritic symptoms but also improving social relationships. It is optimal to assist in making of a self-supporting group and continuing activities through it.

지진 및 해일 대비 안전교육에 대한 보육교사들의 인식 및 실태조사 연구 (Early childhood teachers' perspectives and actual conditions of earthquakes and tsunami safety education)

  • 양선이
    • 한국응급구조학회지
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    • 제15권3호
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    • pp.81-96
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    • 2011
  • Purpose : The purpose of this study was to analyse early childhood teachers' perspectives and actual conditions of earthquakes and tsunami safety education. Methods : A total of 119 teachers were recruited from kindergarten and child-care center located in J city, all of whom gave consent to take part in these research. The data have been collected for 45 days from May to July in 2011. The data was analyzed by SPSS (version 17.0) and chi-square test. Results : The results of this study are summarized as follow. 1. 97.5% of the subjects considered earthquakes and tsunami safety education necessary, however, only 34.6% of them were given the education related to earthquakes and tsunami. 2. 63.9% of the early childhood teachers provided children in the kindergarten or childhood center with earthquakes and tsunami safety education, however, 30.3% of them were found to be without any experiences of earthquakes and tsunami safety education. 3. 68.5% of the teachers were informed earthquakes and tsunami safety knowledge. 4. 35.0% of respondents answered that the single session of earthquake and tsunami education was not efficient, thus expecting to receive continuing education. Conclusions : The study suggested that more teachers necessarily provide earthquake and tsunami safety education to reduce children's mortality rate in earthquakes and tsunami. The education program should be developed and systematized to improve teacher's knowledge. Moreover, the program should be continuously provided to teachers and children in the kindergarten or childhood center.

영양플러스 사업의 비용편익분석 - 대전 동구보건소를 중심으로 - (The Cost-Benefit Analysis of the NutriPlus Program in Daejeon Dong-gu Health Center)

  • 김현주;김성한
    • 한국식품영양학회지
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    • 제28권4호
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    • pp.717-727
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    • 2015
  • Although the NutriPlus program has shown considerable evidence of enhancing users' nutritional status, the budget does not cover all eligible mothers and children. This study aimed to conduct a cost-benefit analysis of the NutriPlus program to assess its economic efficiency. 53 families with 79 users in the NutriPlus program at Daejeon Dong-gu Health Center participated in this study with informed consent. The costs and benefits were estimated from both the administrator's and users' perspectives. We converted the time cost into Korean currency based on the minimum wage in 2014. The value of nutrition education and service (B2), estimated by contingency valuation method (CVM), was counted as an economic benefit. 6 families (11.3%) were recipients of national medical care and 22 families (41.5%) paid 10% of the food package cost by themselves. The total cost was \7,450,167 and the total benefit was \12,402,239. The budget for the health center (C1+C2+C3+C4) was \5,984,381 a month. Time and transportation cost for receiving nutrition education (C6) differed significantly according to the economic status of families. Household food consumption increase (C4-B4) was 40,379 in the poverty group, which was four times more than in the other groups. The net benefit (B-C) was \4,852,172 and the B/C ratio was 1.66. Therefore, the NutriPlus program is beneficial in the economic aspect as well as in the nutritional aspect. If the enhancement of nutritional status was also considered, the total benefit would be even higher. These results confirm the legitimacy of a secure budget for the NutriPlus program. And we suggest expanding its budget to cover more eligible individuals to improve people's health and welfare.

The Development and Evaluation of an Incontinence Intervention Program for the Elderly Women at Elderly Welfare Center

  • Kim Jeungim
    • 대한간호학회지
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    • 제34권8호
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    • pp.1427-1433
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    • 2004
  • Purpose. The elderly with UI experienced urine leakage for a long time. The prevalence of UI has increased and it makes costly. Particularly, the elderly were reluctant to visit a hospital or a clinic for the reasons of modesty and poverty. To solve this problem, incontinence intervention programs should be provided at the elderly welfare center. The purpose of this research was to develop Incontinence Intervention Program for the Elderly Women (IIPE) and evaluate in its effect. Methods. The study design was quasi-experimental with pre and post-test. The study was performed for ten weeks at one elderly welfare center, Seoul, Korea. The subjects were gathered through an official announcement and informed consent was obtained. IIPE, in this study, was consisted of diagnosis, education, exercise and evaluation. The study variables were PFM exercise adherence, pelvic muscle strength, Continence self-efficacy, geriatric depression and incontinence stress. The effects of the IIPE on PFM exercise adherence, pelvic muscle strength, Continence self-efficacy, geriatric depression and incontinence stress were also evaluated. Results. The mean age of the subjects was 75.2 years. The average attendance was 6.2 times. The IIPE improved PFM exercise adherence, intra-vaginal contraction power and CSE significantly. But it was not significant in incontinence stress and geriatric depression. Other important results were that the two-finger test and urine stream interruption were more useful for elderly women with rigid vaginas in teaching and evaluating. Conclusion. The Findings suggest that IIPE is effective to the community-residing elderly. Further investigation is needed on a long-term basis with control group.