...anticipated in the research are not greater in and of themselves than those ordinarily encountered in dally life or during the performance of routine physical...agency, In accordance with the requirements of this 45 CFR Subtitle A (10-1-98 Edition) policy, that a research project or activity involving human subjects...

...of the Code of Federal Regulations, Section 46.102(i) as 'the probability and magnitude of harm and discomfort anticipated in the research are not greater...physical or psychological examinations or tests." (Office for the Prevention of Research Risk [OPRR], 1991) A. Identify and describe any potential risks...

...principles governing experiments on i 45 CFR 46.208(a). Such research may only pose a "minimal risk,* which means that "the probability and magnitude of harm...physical or psychological examinations or tests." 45 CFR §46.102(0. 45 human subjects — principles reflected as well in the Nuremberg Code, the World...

...meaning that the probability and magnitude of harm or discomfort anticipated in the research are no greater in and of themselves than those ordinarily...routine physical or psychological examinations or tests [40]. The FDA regulations permit the waiver of documentation of informed consent only if the research...

...obtaining the assent of the child and the informed consent of the parent as specified in the regulations. "Minimal risk" means that the "probability and magnitude...routine physical or psychological examinations or tests" (Protection of Human Subjects, 1991, 45 CFR 46.102[i]). Research that poses more than minimal risk...

...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" [Federal Policy § 102(1)] (37). There are strict limitations on research presenting more than minimal...

...other means." Only minimal risk is permitted in the latter category. Minimal risks were defined as "not greater in and of themselves than those ordinarily...routine physical or psychological examinations or tests" (45 CFR 46.102Ì). Application of such a standard to fetuses has never been clarified. Furthermore,...

...institutional review board established in accord with and for the purposes expressed in this policy. (h) IRB approval means the determination of the IRB that the...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...