 | Administrative law - 1995 - 886 pages
...investigator(s) do not participate in the activities being observed. 38 CFRCh. I (7- 1-95 Edition) ministration). It does not include research activities which are...research project or activity involving human subjects has be«n reviewed and approved by an IRB in accordance with an approved assurance. S 16.103 Assuring compliance... | |
 | Administrative law - 1992 - 464 pages
...Data through intervention or interaction with the individual, or (2) Identifiable private-information, Intervention includes both physical procedures by...requirements of this policy, that a research project or Notional Aeronautics and Space Admin. activity involving human subjects has been reviewed and approved... | |
 | Administrative law - 1994 - 612 pages
...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... | |
 | Administrative law - 2002 - 532 pages
...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... | |
 | Administrative law - 1996 - 460 pages
...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... | |
 | Administrative law - 1993 - 438 pages
...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... | |
 | Administrative law - 1997 - 468 pages
...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... | |
 | Administrative law - 1990 - 460 pages
...of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or...physical or psychological examinations or tests. (j) "Sponsor" means a person or other entity that initiates a clinical investigation, but that does not... | |
 | Administrative law - 1986 - 800 pages
...of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or pyschological examinations or tests. § 512.12 Requirements for research projects and researchers.... | |
 | Administrative law - 1993 - 592 pages
...of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or pyschological examinations or tests. § 512.12 Requirements for research projects and researchers.... | |
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Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological... 
