 | Administrative law - 2002 - 996 pages
...documentation of informed consent or may waive documentation in accordance with §745.117. §745.103 (3) A list of IRB members identified by name; earned...Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) any unanticipated... | |
 | Administrative law - 2002 - 620 pages
...IRB membership shall be reported to the department or agency head, unless in accord with §97.103(a) of this policy, the existence of an HHS-approved assurance...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 - 502 pages
...7 14 CFR Ch. V (1-1-97 Edition) with §1230.l03(a) of this policy, the existence of an RMS-approved assurance is accepted. In this case, change in IRB...Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) any unanticipated... | |
 | Administrative law - 1999 - 544 pages
...IRB membership shall be reported to the department or agency head, unless in accord with §lc.!03(a) of this policy, the existence of an HHS-approved assurance...without IRB review and approval except when necessary to 7 CFR Subtitle A (1-1-99 Edition; eliminate apparent immediate hazards to the subject. (5) Written... | |
 | Administrative law - 1997 - 604 pages
...of this policy, the existence of an HHS-approved assurance is accepted. In this case, change in IBB membership shall be reported to the Office for Protection...Written procedures for ensuring prompt reporting to the IRB, appropriate Institutional officials, and the department or agency head of (i) any unanticipated... | |
 | Administrative law - 1993 - 748 pages
...HHS-approved assurance is accepted. In this case, change in IRB membership shall be reported § 1028.107 to the Office for Protection from Research Risks,...Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) any unanticipated... | |
 | Administrative law - 1993 - 750 pages
...is accepted. In this case, change in IRB membership shall be reported 16 CFR Ch. II (1-1-93 Edition) to the Office for Protection from Research Risks,...Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) any unanticipated... | |
 | United States. Office of the Federal Register - Business & Economics - 2005 - 648 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 - 2000 - 732 pages
...IRB membership shall be reported to the department or agency head, unless in accord with §11.103(a) of this policy, the existence of an HHS-approved assurance...in approved research, during the period for which IBB approval has already been given, may not be initiated without IBB review and approval except when... | |
 | Administrative law - 1999 - 650 pages
...reported to the Office for Protection from Research Risks, HHS. (4) Written procedures which the IBB will follow (i) for conducting its initial and continuing...Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) any unanticipated... | |
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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... 
