| 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... | |
| Dorothea Magnus - Children - 2006 - 356 pages
...institutional and federal requirements. (i) Minimal risk means that the probability and magnitude of härm or discomfort anticipated in the research are not...requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved... | |
| 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... | |
| 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,... | |
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