• 대한기관윤리심의기구협의회지
• /
• 제5권1호
• /
• pp.21-32
• /
• 2023

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.

• International Journal of Vascular Biomedical Engineering
• /
• 제3권1호
• /
• pp.14-22
• /
• 2005

In the present study, our aim is to investigate whether responses to the head-up tilt (HUT) on nonlinear properties of heart rate variability (HRV) in young and elderly subjects are different or not. Thirteen young-healthy subjects ($24.5{\pm}3.7$ years) and 18 old-aged healthy subjects ($74.5{\pm}7.4$ years) participated in this study. An electrocardiogram (ECG) in the supine posture, at $0^{\circ}$, and in the standing posture, at $70^{\circ}$ of head-up tilt, was recorded. Detrended fluctuation analysis (DFA) and approximate entropy (ApEn), measures of short-/long-term correlation properties and overall complexity of heart rate (HR) respectively, along with spectral components of HR variability (HRV) were analyzed for both the supine and HUT postures. We observed that the short-term fractal exponent ${\alpha}_1$ increased during HUT posture (F(1, 29) = 39.79, P = 0.000), especially, the young subjects showed a significantly higher values compared to the elderly subjects. ApEn significantly decreased (F(1, 29) = 8.61, P = 0.006) during HUT posture. HUT posture decreased the complexity in HR dynamics and increased short-term fractal exponent values in young subjects but not in elderly subjects. These results imply that there are differences of response to HUT on nonlinear properties between young and elderly subjects.

• 대한한의학회지
• /
• 제28권1호통권69호
• /
• pp.42-50
• /
• 2007

Objectives . This study was to assess the Korean Traditional Medicine forecast subjects that had been expected to be accomplished by 2005. The result will help the Korean medical society plan far policies and studies on Korean Traditional Medicine. Methods : Assessed targets were 64 subjects (expected to be studied until 2005) of the total 93 subjects from the 'Mid- to Long-Term Forecast and Plan Study for Korean Traditional Medicine'. The subjects were classified into two types : political subjects and research and development (R&D) subjects. These were determined by the quantity and contents of related political reports, political research projects, thesis, patent, placing products on sale, etc. Results :1) 5 items of a total 12 political subjects were accomplished or partially accomplished (41.7%), and 9 items of a total 46 R&D subjects were accomplished or partially accomplished (9.5%). 2) While the accomplishment percentage (accomplished or partial accomplished) in literature arrangement and D/B construction field was 100%, it was under 10% in product or system development field. Thus, it seems that practical subjects were less accomplished than academic subjects. 3) On 8 subjects of 'Forecast Research on Future of Oriental Medicine' which had been performed in Japan, the Korean expected dates when the subjects would be realized were earlier than the Japanese ones, but no subjects were realized. Conclusion · Political and academic subjects weir accomplished more than R&D and practical subjects.

• 대한기관윤리심의기구협의회지
• /
• 제6권1호
• /
• pp.1-4
• /
• 2024

The strengthening of Institutional Review Board (IRB) and Human Research Protection Program (HRPP) for clinical research on advanced regenerative medicine reflecting the 3 Principles of the Belmont Report (Respect, Beneficence, Justice) is very important. The research institution IRB should naturally be in charge of managing the clinical research process. And it is crucial to reinforce HRPP for the protection of research subjects in institutions conducting advanced regeneration clinical research. So, it is needed to establish a Protection System for Advanced Regenerative Medical Research Subjects composed of clinical research management communication system for advanced regenerative medicine between KAIRB (Korean Association of IRB) of research institutes and National Management Agency for Advanced Regenerative Medical Research. In advanced regenerative medicine clinical research to verify safety and efficacy of the investigational drugs to the subjects with rare and incurable diseases rather than to treat the patients, it is hoped that a management system that guarantees the scientific characteristics of research and the rights of research subjects would be well organized and operated.

• 의료법학
• /
• 제12권1호
• /
• 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.

• Imaging Science in Dentistry
• /
• 제40권1호
• /
• pp.25-32
• /
• 2010

Purpose : This study was designed to evaluate the efficacy and utility of panoramic radiograph for the improvement of the periodic oral examinations. Materials and Methods : Clinical examinations and panoramic examinations were done for the 242 subjects of oral examinations. The results of panoramic radiograph interpretation were compared with the clinical findings. Two questionnaires were created. One was carried out before the panoramic examination and the other done afterwards, to find out the subjects' cognition and satisfaction for the clinical and panoramic examinations. Results : 1. Panoramic findings showed a higher detection rate of 31.9% for periodontal diseases, and 23.1% for dental caries than clinical findings. 2. The additional abnormalities detected through panoramic examinations were impacted tooth in 81 subjects (33.6%), maxillary sinus abnormalities in 28 subjects (11.6%), condylar abnormalities in 5 subjects (2.1%), congenital and acquired dental anormalies in 59 subjects (24.5%), and other miscellaneous abnormalities in 34 subjects (14.1%). 3. 164 subjects (67.8%) were satisfied with the current periodic oral examination, and 75 subjects (31.1%) hoped for better accuracy. 4. In the first and second questionnaire, 154 subjects (67.0%) and 163 subjects (70.6%) responded respectively that panoramic examination was necessary, and 193 subjects (83.2%) responded that it actually helped. Conclusion : The panoramic examination was revealed to improve the effectiveness of the periodic oral examination and to increase the satisfaction of the subjects of examination.

• The Journal of Advanced Prosthodontics
• /
• 제5권2호
• /
• pp.204-208
• /
• 2013

PURPOSE. The purpose of this study was to evaluate the effectiveness of a promotion campaign for subject recruitment and selection, and reasons of withdrawal from a prospective clinical trial of mandibular two-implant supported overdenture. MATERIALS AND METHODS. The subjects of this study were participants in a randomized controlled clinical trial for investigating prognosis of implants and overdentures with attachments. Recruited subjects were classified by gender, age, and participation motives. Withdrawal rate of the participants before and after enrollment were evaluated. RESULTS. 177 patients were recruited and 51 patients were enrolled for the trial. Among them, 40 participants eventually took part in the trial. 116 subjects (65.5%) were recruited by advertisement and 61 (34.5%) were referred by patients of the hospital or local clinics. Regarding recruitment effectiveness, newspaper recruited the largest number of participants. With respect to referral patients, the proportion of our hospital patients was higher (37/61). Subjects in their 70s comprised the largest proportion (22/51). The male to female ratio was similar (25:26). Final withdrawal rate of all subjects were 74.0%. Among the reasons for withdrawal from enrollment (n=126) presence of remaining teeth and lack of motivation were the most common reasons. CONCLUSION. To facilitate recruitment of clinical trial subjects and improve enrollment rate, it is important to obtain a sufficient number of researchers, perform promotion activity with diverse strategies, cooperate with local dentists, increase the research funding, and alleviate subjects' fear against clinical trials by thorough consultation.

• 지역사회간호학회지
• /
• 제21권1호
• /
• pp.53-62
• /
• 2010

Purpose: The purpose of this study was to analyze the contents and trends of smoking and smoking cessation of adolescents in Korea. Methods: The subjects were 315 researches from 1997 to 2008 in Korea. They were examined in terms of subjects, research design, key words, types of intervention, times of intervention, and dependent variables for experimental research, and in terms of subjects, concepts, research questions and research methods for qualitative research. Results: Of the studies 52.4% were master's theses, and 22.9% of the subjects were male high school students. The most common research design was descriptive design. Major concepts studied were related to emotional cognitive variables. Among 80 experimental researches, 70% were about smoking cessation programs. The number of qualitative studies was only 6. Their concepts were smoking experience, motives for smoking cessation, smoking process, and motives for smoking. A major research question was: What does smoking mean to adolescents? Conclusion: More research should be done for the female students' smoking and smoking cessation. Also, research that adapts educational programs for smoking and smoking cessation needs to be performed through at least a 10 times longer period and in regular basis to get desirable results.

• 한국보건간호학회지
• /
• 제22권2호
• /
• pp.255-265
• /
• 2008

Purpose: The principal objective of this study was to assess the topics and research methods of smoking-related research and to suggest future research directions. Methods: The subjects of this study were smoking research articles supported by the National Health Promotion Funds from 1998 to 2007. A total of 41 articles were selected and analyzed from 1999 to 2005 using the frameworks such as topics, subjects contents, subjects, research field, and research design. Results: The most frequent topic of smoking-related research was the development & evaluation of educational programs for smoking prevention and smoking cessation (34.1%). The majority of the research subjects were adults (42.2%) and adolescents (35.9%). 31.7% of the total research researches was conducted at the nationwide population level. The most popular research design was the descriptive study (36.6%) in the non-experimental studies and nonequivalent control group pretest-posttest design(19.5%) in the experimental study studies. Conclusion: The topics of smoking research should be planned under governmental strategies for decreasing to a 30% reduction in of smoking rates, as established in the 2010 Health Plan. With regard to the methodological aspects, longitudinal and nationwide research was first required so that we could plan an evidence-based program for smoking prevention and smoking cessation.

• 대한한의진단학회지
• /
• 제18권1호
• /
• pp.11-24
• /
• 2014

Objectives The aim of this study is to contribute to the establishment of the Traditional Korean Medicine (TKM) policies in future, which is through the assessment to predict the realization by diagnostic subjects. Methods First, we evaluated 8 subjects that were deduced by professionals in 1996 regarding whether or not to be realized in 2013. Second, the governmental and private research projects, reports, articles, domestic patents and products were reviewed and investigated. Third, the Subjects in domestic fields of TKM were investigated on the followings: importance, time of realization, domestic Research and Development level, principal agents and methods for the realization, and hindrance factor on the realization. Results Of the 8 forecasting subjects, one subject was realized, two subjects were partly realized and five subjects were unrealized. Thus, their realization rate was 12.5%. The realized subject is the 'Standard naming of the TKM diagnosis'. Conclusion Continuous researches are necessary to realize the TKM subjects and moreover, professionals should predict new feasible TKM subjects, based on this study.