...observations of public behavior when the investigator(s) do not participate in the activities being observed. administered by the Food and Drug Administration)....research project or activity involving human subjects has beer reviewed and approved by an IRB in accordance with an approved assurance. § 16.103 Assuring compliance...

...defined to mean "that the probability and magnitude of harm or discomfort anticipated m the research arc not greater in and of themselves than those ordinarily...physical or psychological examinations or tests." 45 CFR § 46 lt)2(i). Since 1975, research on human fetuses has been subject to restrictions that parallel...

...be carried out without deception, and (dl an appropriate debriefing. Minimal risk is defined to mean that the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests (see US Department of Health and Human Services, 2001, §46.102i and §46.116dl. The definition above...

...interpretation varies, especially in cases that involve some active intervention. According to the Common Rule, "Minimal risk means that the probability and magnitude...routine physical or psychological examinations or tests" (40 CFR 26.102(h)(l)). Even with this definition as a guide, minimal risk is not construed in consistent...

...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...

...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)...

...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...

...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...

...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...

...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...