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KMID : 0986720070150020007
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Korean Journal of Medicine and Law
2007 Volume.15 No. 2 p.7 ~ p.26
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Criteria of ’Minimal Risk’ in the Review of Clinical Research
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Lim In-Ae
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Abstract
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This study was performed for the purpose of recognizing problems about judging minimal risk and of suggesting the direction of application. Based on understanding several relevant concepts necessary for understanding the concept of minimal risk, the issues of discussion related to minimal risk were examined Also, by arranging issues related to minimal risk, which are reflected in main regulations and guidelines at home and abroad, parts in the current domestic regulations were pointed out. When the Institutional Review Boards/Ethics Committees make judgments on the existence of minimal risk, several methods of analysis may beapplied. However, following absolute interpretation, which judges based on the daily life or routine test in a manner we all experience, one is presented with the most consistent risk criteria, thereby being able to prevent some people from being exposed to unfair risk. The concept of ’Minor Increase over Minimal Risk’ is desirable to be decided upon according to a level that can be accepted socially. And also, it is reasonable to compare and judge the risk and potential benefit by considering each of several procedures that are included in each research. Most regulations and guidelines at home and abroad suggest only the principal issue on evaluation of risk and benefit. Also, even the standard operating procedures for main domestic institutions are in an insufficient state for consideration and application on this. The specific application to the review process of the actual clinical research is required by specifically defining the concept related to minimal risk and by deciding on which method of analysis will be the most reasonable to be conformed to.
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KEYWORD
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clinical research, institutional review boards, risk/benefit analysis, minimal risk
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