Purpose: The traditional ethical study only suggests a blurred insight on the research using medical big data, especially in this rapid-changing and demanding environment which is called "4th Industry Revolution." Current institutional/ethical issues in big data research need to approach with the thoughtful insight of past ethical study reflecting the understanding of present conditions of this study. This study aims to examine the ethical issues that are emerging in recent health care big data research. So, this study aims to survey the public perceptions on of health care big data as part of the process of public discourse and the acceptance of the utility and provision of big data research as a subject of health care information. In addition, the emerging ethical challenges and how to comply with ethical principles in accordance with principles of the Belmont report will be discussed. Methods: Survey was conducted from June 3th August to 6th September 2020. The online survey was conducted through voluntary participation through Internet users. A total of 319 people who completed the survey (±5.49%P [95% confidence level] were analyzed. Results: In the area of the public's perspective, the survey showed that the medical information is useful for new medical development, but it is also necessary to obtain consents from subjects in order to use that medical information for various research purposes. In addition, many people were more concerned about the possibility of re-identifying personal information in medical big data. Therefore, they mentioned the necessity of transparency and privacy protection in the use of medical information. Conclusion: Big data on medical care is a core resource for the development of medicine directly related to human life, and it is necessary to open up medical data in order to realize the public good. But the ethical principles should not be overlooked. The right to self-determination must be guaranteed by means of clear, diverse consent or withdrawal of subjects, and processed in a lawful, fair and transparent manner in the processing of personal information. In addition, scientific and ethical validity of medical big data research is indispensable. Such ethical healthcare data is the only key that will lead to innovation in the future.
Purspose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among advanced general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans. Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 clinical trial institutions, including 11 AAHRPP-accreditated general hospitals in Korea, as well as the operation of the IRB deliberation. Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why individuals are vulnerable, and for what reasons. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 14 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 15 institutions classified sujects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 8 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 6 classified foreigners as vulnerable. Conclution: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs' classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/benefit, and a review using checklists and spokeperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.
Go-Eun Lee;Sanghee Kim;Sue Kim;Sang Hui Chu;Jeong-Ho Seok;So Yoon Kim
The Journal of KAIRB
/
v.6
no.1
/
pp.17-31
/
2024
Purpose: This study aims to develop preliminary items for measuring the perceived service quality of clinical trials among participants and to verify content validity. Methods: This study was designed as a methodological study. A conceptual framework was established based on Brady and Cronin's hierarchical model, and preliminary items were prepared through translation-back-translation, a review of existing instruments, and in-depth interviews with clinical trial participants and clinical research coordinators. The final items were completed through content validity testing by experts and a review of items by clinical trial participants for the prepared preliminary items. Results: Through this study, a set of 58 items across four domains (quality of interaction with researchers, the physical environment, performance procedures, and performance results) and 9 components (information·education·communication, trust, respect for participant preferences, securing facilities and space, accessibility, comfortability, informed consent, coordination of care, subjective understanding of clinical trials) on the service quality of clinical trials were completed. The scale content validity index of all preliminary items was 0.96, meeting the recommended standards. The individual-item content validity index also meets the recommended criteria for most items, excluding four items. Conclusion: This study holds significance in developing items to measure the quality of clinical trial execution from the perspective of participants. By verifying the reliability and validity of these items through subsequent research, it is expected that they can be utilized as a valuable instrument to devise strategies for improving the quality of clinical trials.
Jae Hwi Park;Dong Hyun Kim;Jee Won Chai;Hyo Jin Kim;Jiwoon Seo;Jin Young Son
Journal of the Korean Society of Radiology
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v.85
no.1
/
pp.36-53
/
2024
As the number of spinal surgeries being performed expands, the number of medical imaging procedures such as radiography, CT, and MRI is also increasing, and the importance of their interpretation is becoming more significant. Herein, we present the radiological findings of a variety of complications that can occur after spinal surgery and discuss how effectively and accurately they can be diagnosed through imaging. In particular, this study details the characteristic imaging findings specific to the early and long-term postoperative periods. Early complications of spinal surgery include improper placement of surgical instruments (instrument malpositioning), seromas, hematomas, pseudomeningoceles, and infections in the region surrounding the surgical site. Conversely, long-term complications may include osteolysis around surgical instruments, failure of fusion, adjacent segment disease, and the formation of epidural fibrosis or scar tissue. A precise understanding of the imaging assessments related to complications arising after spinal surgery is crucial to ensure timely and accurate diagnosis, which is necessary to achieve effective treatment.
The generation amount of radioactive waste has been rapidly increased by increase of the usage of radioisotope source in medical field. Especially, the use of the radioactive source of I-131 with short half-life of 8.02 days used in treatment of thyroid has been increased, and all of the wastes concerned have been disposed by means of the self-disposal method. IAEA proposed criteria for clearance level of waste which depends on the individual (10 ${\mu}Sv/y$) and collective dose (1 man-Sv/y), and concentration of each nuclide (IAEA Safety Series No 111-P-1.1, 1992 and IAEA RS-G-1.7, 2004). In this study, various radioactive wastes in medical fields are collected and measured for establishing the disposal methods and procedures of radioactive wastes. In addition, comparison evaluation of decay storage period between the half-life which was calculated by attenuation curve based on real measurement and analytical half-life is considered. With comparing the theoretical half-life and the effective half life(7.72 days) which was based on the decay equation of measured data, it is resulted in the theoretical half-life is longer than effective half-life. The storage period of radioactive waste for self-disposal may be curtailed. The result of this study will be proposed as ISO standard.
The propagation of Infectious Diseases is very dreadful. It is not easy to detect through whom and where Infectious diseases start. Due to traffic development, these days, viral infectious diseases that weren't known in Korea in the past sometimes emerge in Korea, that is, probability to be propagated by certain viral infectious disease is getting bigger and bigger. The prevention of infectious diseases should be thoroughly blocked before they are introduced, nevertheless, when introduced, the government has a duty and responsibility to prevent them from spreading as soon as possible. There may be a terrible case that a certain infectious disease is spreading all over the world. Of course, in this case, cooperation between countries becomes more and more important than ever. But even in this situation, the nation's role should not decrease. Quarantine Law in Korea says that the government can take a quarantine measures to minimize the risk of infection. So the government can isolated questionable people with the risk of infection as well as people with the risk of infection. Quarantine or Isolation is a quite effective measures to prevent the viral infectious disease, however, it allows all subjects' right of freedom to be restricted. So, in any case that a infectious disease is spreading quickly, the probability for subjects to be isolated unreasonably or preposterously can probably happen. In this paper, I'll consider and discuss about the harmony between Public Health and Human Rights through quarantine or isolation.
The Joint Photographic Experts Group (JPEG) standard was proposed by the International Standardization Organization (ISO/SC 29/WG 10) and the CCITT SG VIII as an international standard for digital continuous-tone still image compression. The JPEG standard has been widely accepted in electronic imaging, computer graphics, and multi-media applications, however, due to the lossy character of the JPEG compression its application in the field of medical imaging has been limited. In this paper, the JPEG standard was applied to a series of head sections of magnetic resonance (MR) images (256 gray levels, $256{\times}256$ size) and its performance was investigated. For this purpose, DCT-based sequential mode of the JPEG standard was implemented using the CL550 compression chip and progressive and lossless coding was implemented by software without additional hardware. From the experiment, it appears that the compression ratio of about 10 to 20 was obtained for the MR images without noticeable distortion. It is also noted that the error signal between the reconstructed image by the JPEG and the original image was nearly random noise without causing any special-pattern-related artifact. Although the coding efficiency of the progressive and hierarchical coding is identical to that of the sequential coding in compression ratio and SNR, it has useful features In fast search of patient Image from huge image data base and in remote diagnosis through slow public communication channel.
This research aims to adapt and evaluate the validity and reliability of the Korean version of the Interdisciplinary Education Perception Scale (K-IEPS). The original IEPS was translated into Korean according to the World Health Organization's guidelines. A total of 302 questionnaires were collected from healthcare professional students at 4 universities in South Korea. The validity and reliability of the scale were measured using Exploratory Factor Analysis (EFA), Confirmatory Factor Analysis (CFA), Cronbach's alpha, and Intraclass Correlation Coefficient (ICC). As a result of the factor analysis, a ten-item scale with two factors (Competency & Autonomy and Perception of Actual Cooperation) was achieved. Additionally, the Cronbach's alpha coefficient was found to be .87, and test-retest reliability was .83. Our study results show that the Korean version of the IEPS is a valid and reliable instrument. Therefore, the K-IEPS can be used in measuring interdisciplinary perceptions of healthcare professional students between different occupational groups.
The purpose of this study was to investigate the factors affecting infection control practice by dental hygienist students in Jeju during clinical training amidst the COVID-19 pandemic. Online survey was conducted on 112 students and the results were statistically analyzed with frequency analysis, Student's T-test, one-way ANOVA, and regression analysis using SPSS 20.0. In the 'awareness and practice of infection control by year in college' section, 2nd year students scored significantly higher in 'cleaning and surface disinfection,' 'medical waste disposal,' and 'COVID-19 preventive measure' compared to 3rd year students. In the 'type of training institution' section, hospital setting scored significantly higher in 'cleaning and surface disinfection,' 'instrument disinfection and sterilization,' 'personal and patient protection,' and 'COVID-19 preventive measure' compared to dental clinic setting. In the 'location of institution' section, Seoul metropolitan region scored higher in 'medical waste disposal' compared to Jeju region. According to regression analysis, year in college (2nd year), type of training institution (hospital setting), location of training institution (Seoul metropolitan region), and difficulty using protective gear (no difficulty) were associated with better COVID-19 preventive measure This first study in Jeju provides an insight on the awareness and practice of infection control measures by dental hygienist students in Jeju during clinical training. Further investigation for improvement of clinical training manual is warranted.
Targeting the radiological technologists working in Gyoungsangnam province, this study was performed to obtain the fundamental data to improve the competency and right awareness of the hospital infection management, and to educate infection management of radiological technologists by analyzing the status, awareness, and performance of the hospital infection management. During April 1, 2018 to April 31, 2015, after we sent out a total of 400 questionnaires for the survey to radiological technologists working at the clinic located in Gyoungsangnam province, 320 questionnaires suitable for research were analysis by using SPSS 18.0 statistical analysis software. As the hospital infection management factors, 5 items for hospital infection and 60 items of the awareness and performance for the hospital infection management were used. 60 items of the awareness and performance for the hospital infection management were consisted hand hygiene, personal hygiene and clothing, medical equipment and supplies, cleaning and waste, examination and environment. And as the sociodemographic characteristics, the gender, marriage, age, level of education, working organization, working period, and working department were used. Consequentially, the awareness for the hospital infection management($4.19{\pm}.60$) and the performance($4.22{\pm}.52$) were confirmed as high level. Using these results, the hospital infection management level of the radiological technologists working in Gyoungsangnam province was found to be high in arareness and performance of hospital infection management. There was a significant correlation between the degree of awareness and performance of radiological technologists for hospital infection management. Furthermore, in the multiple regression analysis of cognitive factors on performance, it was found that 66.1% explanatory power had a significant positive influence. In order to improve the awareness of hospital infection management of radiological technologist working in various departments, the infection management education and improvement of hospital work environment are necessary. And also, It is important to participate actively in hospital infection management and preventive education and to play a pivotal role in securing expertise in hospital infection management.
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