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Untitled Oct 22, 2018

Human Subjects Research Untitled
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Untitled Institutional Review Board (IRB)
    Visit also the Bioethics website and use the health and science-focused Untitled Search engines and directories section to find additional information about the topics listed below.
  • Untitled Federal Register -- Title 21 Food and Drugs Revised April 1, 2000 -- Chapter I: P 1 to 99 -- FDA, DHHS -- Part 56 -- Institutional Review Boards 29
    This statute defines the the scope and functioning of IRBs and its relation to the FDA, the main regulatory agency involved in regulating clinical research.
    • Text PDF 21.56.101 Scope.29
    • Text PDF 21.56.102 Definitions.29
    • Text PDF 21.56.103 Circumstances in which IRB review is required.29
    • Text PDF 21.56.104 Exemptions from IRB requirement.29
    • Text PDF 21.56.105 Waiver of IRB requirement.29
    • Text PDF 21.56.107 IRB membership.29
    • Text PDF 21.56.108 IRB functions and operations.29
    • Text PDF 21.56.109 IRB review of research.29
    • Text PDF 21.56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.29
    • Text PDF 21.56.111 Criteria for IRB approval of research.29
    • Text PDF 21.56.112 Review by institution.29
    • Text PDF 21.56.113 Suspension or termination of IRB approval of research.29
    • Text PDF 21.56.114 Cooperative research.29
    • Text PDF 21.56.115 IRB records.29
    • Text PDF 21.56.120 Lesser administrative actions.29
    • Text PDF 21.56.121 Disqualification of an IRB or an institution.29
    • Text PDF 21.56.122 Public disclosure of information regarding revocation.29
    • Text PDF 21.56.123 Reinstatement of an IRB or an institution.29
    • Text PDF 21.56.124 Actions alternative or additional to disqualification.
  • see also Protection of Human Subjects
    The latter statute not only defines the scope and functioning of IRBs, but further clarifies issues regarding protection of human subjects.
  • Visit the Untitled Federal Register and use the search section to obtain recent updates of 21.56 & 45.46.

Notes and Footnotes:
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Untitled First Written: 19990118 Latest Update: 20060328
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