| Trudy R. Turner - Social Science - 2005 - 342 pages
...do with children rarely involves much risk of physical or emotional harm. Minimal risk is defined as "the probability and magnitude of harm or discomfort...physical or psychological examinations or tests." (45 CFR 46.102). This is a definition that certainly leaves room for interpretation, especially as... | |
| Christoph Brochhausen - Children - 2005 - 222 pages
...without a disorder or condition may be exposed during the course of research. Minimal risk is defined as "the probability and magnitude of harm or discomfort...physical or psychological examinations or tests." Is this in the actual daily life of the particular research subject? The daily life of all similar... | |
| Evan DeRenzo, Joel Moss - Medical - 2005 - 320 pages
...is minimal risk (45 CFR 46; Appendix, No. 15). Minimal risk, according to DHHS regulations (46.102), means that the probability and magnitude of harm or...the performance of routine physical or psychological tests. This definition has been consistently interpreted to refer to risk that is inherent in the daily... | |
| Eric Kodish M.D. - Philosophy - 2005 - 376 pages
...alleviate a serious problem affecting the health or welfare of children. "Minimal risk" is defined as "the probability and magnitude of harm or discomfort...of routine physical or psychological examinations" (45 CFR 46.102(i)). While the regulations do not explicitly distinguish between children of different... | |
| Daniel Farb, Bruce Gordon - Medical - 2005 - 337 pages
...wherever you want to go!" Michele groaned. "All right, all right!" The car displayed: Ooh, yeah! CARMATE: "Minimal risk means that the probability and magnitude...than those ordinarily encountered in daily life." True or false? Answer: True. This also includes the chance and level of harm or discomfort during the... | |
| James C. Harris M.D. - Medical - 2005 - 448 pages
...The common rule for protection of human subjects includes the following definition of minimal risk: Minimal risk means that the probability and magnitude...themselves than those ordinarily encountered in daily life during the performance of routine physical and psychological examinations or tests. (Field and Behrman,... | |
| Martin Charron - Medical - 2006 - 616 pages
...in Figure 7.1. In subsection 46.102 (i), the CFR suggests the following definition for minimal risk: Minimal risk means that the probability and magnitude...routine physical or psychological examinations or tests. Given that the study's risk classification determines its approval, this definition is a paramount... | |
| Jerry Menikoff, Edward P. Richards - Philosophy - 2006 - 336 pages
...minimal risk on children is permissible. Minimal risk is defined in the federal regulations as meaning that "the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests."10 This definition leaves a number of issues open to interpretation. For example, different... | |
| Gillian H. Ice, Gary D. James - Science - 2006 - 263 pages
...expedited review as long or longer than a full-board review, from the viewpoint of the researcher. probability and magnitude of harm or discomfort anticipated...physical or psychological examinations or tests." (Title 45 CFR Part 46, 2001, 102 (i)). In 1998, guidelines defining these procedures and to whom they... | |
| Elizabeth A. Bankert, Robert J. Amdur - Institutional review boards (Medicine) - 2006 - 568 pages
...the course of research that does not offer the prospect of direct benefit. Minimal risk is defined as "the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests."1'5'5"'1021'" The National Commission initially stipulated that this standard should be indexed... | |
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