• The Journal of KAIRB
• /
• v.5 no.2
• /
• pp.51-58
• /
• 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.

• Journal of Korean Academy of Nursing Administration
• /
• v.15 no.3
• /
• pp.336-345
• /
• 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.

• The Journal of Korean Medicine
• /
• v.43 no.1
• /
• pp.6-17
• /
• 2022

Objectives: This study describes the implementation of a training course that aimed to increase the competency of undergraduate students of Korean medicine at a single college to obtain informed consent and perform bee venom acupuncture using an objective structured clinical examination (OSCE). Methods: We developed and implemented a short training course for 111 fourth-year students of Korean medicine during their clinical rotation at the Department of Acupuncture and Moxibustion Medicine. Lectures were conducted on the effects of and hypersensitivity reactions to bee venom acupuncture, obtaining informed consent, performing skin test and bee venom acupuncture. Due to the COVID-19 pandemic, some students were offered online lectures, and some could not experience the performance of OSCE in person. A survey with 16 closed and three open questions was used to investigate self-efficacy, opinions about the online lectures, and the OSCE. Results: Out of 111 questionnaires, 104 were completed (94%). Students were generally satisfied with the online lectures and OSCE. For the subjective questionnaire about what was helpful in the training of bee venom acupuncture techniques and OSCE, the authenticity of the teaching method was recorded the highest. Conclusions: This study showed that online lectures were effective in teaching clinical skills of Korean Medicine. It is necessary to produce standard educational materials for clinical skills of Korean Medicine, and studies to analyze the reliability and validity of OSCE are needed.

• The Korean Journal of Pain
• /
• v.37 no.3
• /
• pp.256-263
• /
• 2024

Background: Cervical epidural block (CEB) is an effective intervention for managing cervical radicular pain. This study aimed to investigate the current status of performing CEB in South Korea. Methods: Pain physicians affiliated with the Korean Pain Society were asked to complete anonymous questionnaires regarding CEB between September and October 2022. The questionnaire consisted of 24 questions assessing the current status and methods of CEB in detail. Results: Of the 198 surveys collected, 171 physicians (86.4%) reported performing CEB. Among those, the majority (94.7%) used fluoroscopy during the procedure. The paramedian interlaminar (IL) approach was the most preferred method (50.3%). Respondents performing fluoroscopic-guided IL CEB were categorized into two groups based on clinical experience: those with ≤10 years of experience (≤10-year group, n = 91) and those with >10 years of experience (>10-year group, n = 71). The proportion of physicians obtaining informed consent in the ≤10-year group and >10-year group was 50.5% and 56.3%, respectively. When entering the epidural space during IL CEB, the contralateral oblique view was the second most frequently used in both groups (≤10-year group, 42.9%; >10-year group, 29.6%). In targeting the upper cervical lesions (C3-4), the proportion of respondents who used an IL space higher than C6-7 was 17.6% in the ≤10-year group and 29.5% in the >10-year experience group. Conclusions: This study demonstrated variability in the CEB technique used by pain physicians in South Korea. The findings highlight the need for education on informed consent and techniques to enhance safety.

• International Journal of Advanced Culture Technology
• /
• v.10 no.1
• /
• pp.187-195
• /
• 2022

Since most of the first witnesses of cardiac arrest in clinical settings are nurses, the ability to perform CPR is important. The purpose of this study is to provide basic data for developing education that strengthens CPR performance in the future by examining inactive nurses' CPR knowledge, attitude, performance confidence, device discomfort, continued use intention, and educational achievement. The final subjects of this study were 88 inactive nurses residing in B city. The study period was from June 23, 2020 to December 24, 2020. The collected data were analyzed by descriptive statistics and Pearson correlation using SPSS WIN 24.0 program. After obtaining the subject's consent for the study, an inactive nurse who understood the purpose of the study and voluntarily consented to the study participated. To investigate the perception of experience, the subjects watched 360-degree virtual reality contents about CPR in the hospital using HMD. The data of this study were analyzed using SPSS WIN 22.0.program. As a result of this 360-degree study on CPR in the hospital, the average score for the inactive nurses on CPR knowledge was 12.70±3.43, the average score for performance confidence was 6.04±2.45, and the average score for attitude was 4.63±0.80. As a result of experience recognition of 360-degree virtual reality contents for CPR in hospitals, the average score for device discomfort was 4.01±0.94, the average score for continued use intention was 2.07±0.85, and the average score for educational achievement was 2.11±0.79. As a result of correlation analysis, educational achievement and continued use intention were significantly positively correlated (r=.77, p<.001). Based on the results of this study, in order to strengthen the CPR performance capability of inactive nurses in emergency situations, it is necessary to increase CPR knowledge and confidence in performing CPR, and to cultivate a positive attitude toward performing CPR. In addition, it is necessary to implement CPR simulation education based on patient cases by applying content that considers educational achievement and continuous use intention.

• Journal of Korean Neurosurgical Society
• /
• v.62 no.4
• /
• pp.398-404
• /
• 2019

Objective : Recently, three-dimensional (3D) printed models of the intracranial vascular have served as useful tools in simulation and training for cerebral aneurysm clipping surgery. Precise and realistic 3D printed aneurysm models may improve patients' understanding of the 3D cerebral aneurysm structure. Therefore, we created patient-specific 3D printed aneurysm models as an educational and clinical tool for patients undergoing aneurysm clipping surgery. Herein, we describe how these 3D models can be created and the effects of applying them for patient education purpose. Methods : Twenty patients with unruptured intracranial aneurysm were randomly divided into two groups. We explained and received informed consent from patients in whom 3D printed models-(group I) or computed tomography angiography-(group II) was used to explain aneurysm clipping surgery. The 3D printed intracranial aneurysm models were created based on time-of-flight magnetic resonance angiography using a 3D printer with acrylonitrile-butadiene-styrene resin as the model material. After describing the model to the patients, they completed a questionnaire about their understanding and satisfaction with aneurysm clipping surgery. Results : The 3D printed models were successfully made, and they precisely replicated the actual intracranial aneurysm structure of the corresponding patients. The use of the 3D model was associated with a higher understanding and satisfaction of preoperative patient education and consultation. On a 5-point Likert scale, the average level of understanding was scored as 4.7 (range, 3.0-5.0) in group I. In group II, the average response was 2.5 (range, 2.0-3.0). Conclusion : The 3D printed models were accurate and useful for understanding the intracranial aneurysm structure. In this study, 3D printed intracranial aneurysm models were proven to be helpful in preoperative patient consultation.

• The Korean Society of Law and Medicine
• /
• v.12 no.1
• /
• pp.99-131
• /
• 2011

To strengthen the protection of human research subjects and human materials, the Korean Ministry of Health and welfare proposed the amendment bill of Bioethics and Safety Law(2010) to the Congress. It includes so many meaningful clauses. According to the bill, the scope that this act shall apply will be expended to the research involving human subjects and human materials. In the bill, there are the principles of this act; the protection of the life, health, and dignity of the human subjects, the obtaining of the adequate informed consent, the protection of the human subject's information confidentiality and the human subject's privacy, the assessment and minimizing of the risks involved and the guarantee of the safety for the human subjects, the preparation of the special protection program for the vulnerable human subjects, and so on. According to the bill, Institutional Bioethics Review Board(the same as Institutional Review Board) will be responsible for the auditing and monitoring on the research that was approved by IBRB, conducting the education program for the researchers, IBRB members and administrative staffs, preparing of the special protection program for the vulnerable human subjects, and forming the guidelines for the researchers as well as the review of the research protocols. And the State and local governments shall take necessary measures to support the expending of the social infrastructure. In addition to, IBRB will have to be assessed and to be gained the accreditation by the Korean Ministry of Health and welfare. So, if Bioethics and Safety Law is amended, it will contribute enormously to enhance the level of the human research subjects protection. Also, if this Law is amended, IBRB will play a major role for the conduct of the ethically, scientifically, and legally proper research. But now, as a matter of fact, the capability of IBRB members and IBRB office members is not enough to charge of this role because some people and some organizations does not know the importance of IBRB exactly. In spite of, IBRB shall be able to this role to protect the human subjects and to develop the level of the research On the international level. Therefore, the State, local governments and the Organization shall back up the administrative and financial terms of the IRB and IRB Office.

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