...within the constraints set forth by the IRB and by other institutional and federal requirements. (i) Minimal risk means that the probability and magnitude...routine physical or psychological examinations or tests. (j) Certification means the official notification by the institution to the supporting department or...

...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...

...participation . " Best Principles for Health Privacy 27 OPRR Guidebook at 5-8 28 Minimal risk is defined as "the probability and magnitude of harm or discomfort...the performance of routine physical or psychological examination or tests." The Common Rule, as written, may not provide adequate privacy protections or...

...Principles for Health Pnvocy •" OPRH Guidebook a 5-8. 28 Minimal risk Is defined as "the probability und magnitude of harm or discomfort anticipated in the...the performance of routine physical or psychological examination or tests." The Common Rule, aa written, may not provide adequate privacy protections or...

...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...

...of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or...routine physical or psychological examinations or tests. (45 Code of Federal Regulations section 46.102, 1999). Category 2: Research involving greater than...

...of harm anticipucd in the proposed research are not greater. considering probability and magnitude, than those ordinarily encountered in daily life or...routine physical or psychological examinations or tesu.*) If the answer is " v« ' explain on continuation pages and anach an explanation of the btBefitt...

...greater, considering the probability and magnitude of physiological or psychological harm or discomfort, than those ordinarily encountered in daily life or...the performance of routine physical or psychological examination or tests such as obtaining blood and urine samples). It would seem therefore that it would...

...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...