 | Administrative law - 1994 - 456 pages
...membership shall be reported to the department or agency head, unless in accord with §1230.103(a) of this policy, the existence of an HHS-approved assurance...has already been given, may not be initiated without ГОВ review and approval except when necessary to eliminate apparent immediate hazards to the subject.... | |
 | Kenneth Getz - Bioethics - 2007 - 377 pages
...membership shall be reported to the Office for Human Research Protections, HHS, or any successor office. (4) Written procedures which the IRB will follow (i)...Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) any unanticipated... | |
 | Administrative law - 1997 - 944 pages
...than the investigators that no material changes have occurred since previous ГОВ review; and (ill) for ensuring prompt reporting to the IRB of proposed...institutional officials, and the department or agency head of (1) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompllance... | |
 | Administrative law - 2007 - 584 pages
...changes have occurred since previous IRB review; and (iii) for ensuring prompt reporting to 211-047 D-7 the IRB of proposed changes in a research activity,...Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (1) any unanticipated... | |
 | Administrative law - 1991 - 1046 pages
...since previous IRB review; and (Hi) for ensuring prompt reporting to the IRB of proposed changes hi a research activity, and for ensuring that such changes...Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (1) any unanticipated... | |
 | Administrative law - 1995 - 1088 pages
...from sources other than the investigators that no material changes have occurred since previous 1KB review; and (iii) for ensuring prompt reporting to...In approved research, during the period for which 1KB approval has already been given, may not be initiated without IRB review and approval except when... | |
 | Administrative law - 1999 - 492 pages
...than the investigators that no material changes have occurred since previous 1KB review; and (ili) for ensuring prompt reporting to the IRB of proposed...in approved research, during the period for which 1KB approval has already been given, may not be initiated without IRB review and approval except when... | |
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IRB review; and (iii) for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without... 
