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• W2088513054 abstract "Some studies necessary for improving pediatric care cannot directly benefit the children involved. For example, pharmacokinetic studies and studies into pathophysiological mechanisms often do not directly benefit their subjects. From an ethical point of view, involving children in such studies is complex: when considering the assumption that children cannot give informed consent, it is not easy to justify research risks that are faced solely for research purposes. Yet a total ban on such studies would seriously harm future sick children. As a compromise, the drafters of the US Federal Regulations and those of many other rules and regulations have chosen to allow review boards to approve research that does not directly benefit the children involved only when the risks are minimal or, under certain conditions, constitute a minor increase over minimal risk. 1 The concept of ‘‘minimal risk’’ was not drawn from common language. Thus, it is not clear how pediatric researchers, when designing studies, and review boards, when reviewing them, should understand and use this concept. How should one judge whether, for instance, a lumbar puncture, an anorectal manometry, or a bronchial provocation test can be considered minimal risk? An adequate definition of the concept seems vital, not only to support those involved in designing and reviewing pediatric studies but also to appropriately protect children from research risks and to let research that involves acceptable risk levels be approved. The approach in the United States was to define minimal risk in relation to other situations with risks that one may regard as minimal. The definition reads as follows: ‘‘the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.’’ 2 Thus, to determine whether certain research risks are minimal, researchers and review boards are supposed to comparethemwiththerisksofdailylifeandofroutineexaminations." @default.
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• W2088513054 date "2011-09-01" @default.
• W2088513054 modified "2023-09-28" @default.
• W2088513054 title "How Best to Define the Concept of Minimal Risk" @default.
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• W2088513054 doi "https://doi.org/10.1016/j.jpeds.2011.05.034" @default.
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