 | United States. Congress. House. Committee on Science - Political Science - 2004 - 162 pages
...reasonable risk as participants in biomedicalAnological experiments. The definition of Minimal Risk is "the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests" (from 45 CFR 46.102(i)). The definition of Reasonable Risk is "the probability and magnitude of harm... | |
 | Lori A. Nesbitt - Health & Fitness - 2004 - 300 pages
...risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than...routine physical or psychological examinations or tests.vi • Risk — the probability of harm or injury (physical, psychological, social, or economic)... | |
 | United States. Congress. House. Committee on Science - Political Science - 2004 - 158 pages
...Reasonable Risk is "the probability and magnitude of harm or discomfort anticipated in the research are greater in and of themselves than those ordinarily...routine physical or psychological examinations or tests, but the risks of harm or discomfort are considered acceptable when weighed against the anticipated... | |
 | Daniel Farb, Bruce Gordon - Medical - 2005 - 337 pages
...or under sections 351 and 354-360F of the Public Health Service Act (42 USC 262 and 263b-263n). (k) Minimal risk means that the probability and magnitude...routine physical or psychological examinations or tests. (1) Legally authorized representative means an individual or judicial or other body authorized under... | |
 | John E. Steiner - Clinical trials - 2006 - 498 pages
...used as long as the research involves no more than "minimal risk." As defined in the DHHS regulations, "minimal risk" means "that the probability and magnitude...routine physical or psychological examinations or tests."27 The most recent listing was published in the Federal Register28 in 1998 and includes research... | |
 | Eric Kodish M.D. - Philosophy - 2005 - 376 pages
...minor increase. In the Code of Federal Regulations (45 CFR 46.102), minimal risk is defined as meaning "that the probability and magnitude of harm or discomfort...physical or psychological examinations or tests." Minimal risk studies may be approved by IRBs under 45 CFR 46.404 regardless of whether the research... | |
 | 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... | |
 | Kenneth Rockwood, Serge Gauthier - Medical - 2005 - 324 pages
...research although it has been described in various ways.25 Typically, this refers to the requirement that 'the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests'.26 Such is rarely the case in clinical trials of new treatments for Alzheimer's disease, however.... | |
 | 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... | |
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Minimal risk means that 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... 
