...has been reviewed and may be conducted at an institution within the constraints set forth by the EBB and by other institutional and federal requirements....project or activity involving human subjects has been 45 CFR Subtitle A (10-1-94 Edition) reviewed and approved by an IRB in accordance with an approved...

...within the constraints set forth by the IRB and by other Institutional and federal requirements. (1) Minimal risk means that the probability and magnitude...human subjects has been reviewed and approved by an ГОВ in accordance with an approved assurance. § 16.103 Assuring compliance with this policy —...

...within the constraints set forth by the IRB and by other institutional and federal requirements. (1) Minimal risk means that the probability and magnitude...human subjects has been reviewed and approved by an TUB in accordance with an approved assurance. § 1230.103 Assuring compliance with this policy —...

...event of an investigation conducted by a team of individuals, is the responsible leader of that team. (i) Minimal risk means that the probability and magnitude...physical or psychological examinations or tests. (j) Sponsor means a person or other entity that initiates a clinical investigation, but that does not actually...

...of an investigation conducted by a team of individuals, is the responsible leader of that team. (1) Minimal risk means that the probability and magnitude...physical or psychological examinations or tests. (J) Sponsor means a person or other entity that initiates a clinical investigation, but that does not actually...

...act or under sections 351 and 354-360F of the Public Health Service Act (42 USC 262 and 263b-263n). (i) Minimal risk means that the probability and magnitude...routine physical or psychological examinations or tests. (m) Legally authorized representative means an individual or judicial or other body authorized under...

...or under sections 351 and 354-360F of the Public Health Service Act (42 USC 262 and 263b-263n). (l) Minimal risk means that the probability and magnitude...routine physical or psychological examinations or tests. (m) Legally authorized representative means an individual or judicial or other body authorized under...

...approved research. In terms of the American regulations, research involves no more than minimal risk when the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests. (US Federal Policy, 1991: Section 102(i)) Adoption of expedited review (in these terms) could gready...

...the following circumstances pertain: the research involves no more than minimal risk to the subjects; ("Minimal risk" means that the probability and magnitude...routine physical or psychological examinations or tests (45 CFR 46.102(i)).) g] the waiver, or alteration, of consent will not adversely affect the rights...

...benefits to which the subject is otherwise entitled." 4 The regulations define minimal risk as meaning "that the probability and magnitude of harm or discomfort...physical or psychological examinations or tests." IRBs may alter or exclude some or all consent elements—as well as expedite review of a protocol—if...