• The Journal of KAIRB
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• v.5 no.1
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• pp.21-32
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• 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.

• Progress in Medical Physics
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• v.22 no.2
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• pp.61-66
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• 2011

In this study, we evaluated the effect of grid size on dose calculation accuracy using 2 head & neck and 2 prostate IMRT cases and based on this study's findings, we also evaluated the efficiency of a 2D diode array detector for IMRT quality assurance. Dose distributions of four IMRT plan data were calculated at four calculation grid sizes (1.25, 2.5, 5, and 10 mm) and the calculated dose distributions were compared with measured dose distributions using 2D diode array detector. Although there was no obvious difference in pass rate of gamma analysis with 3 mm/3% acceptance criteria for the others except 10 mm grid size, we found that the pass rates of 2.5, 5 and 10 mm grid size were decreased 5%, 20% and 31.53% respectively according to the application of the fine acceptance criteria, 3 mm/3%, 2 mm/2% and 1 mm/1%. The calculation time were about 11.5 min, 4.77 min, 2.95 min, and 11.5 min at 1.25, 2.5, 5, and 10 mm, respectively and as the grid size increased to double, the calculation time decreased about one-half. The grid size effect was observed more clearly in the high gradient area than the low gradient area. In conclusion, 2.5 mm grid size is considered acceptable for most IMRT plans but at least in the high gradient area, 1.25 mm grid size is required to accurately predict the dose distribution. These results are exactly same as the precious studies' results and theory. So we confirmed that 2D array diode detector was suitable for the IMRT QA.