Nov 20, 2008 Thursday 11:59:28 Human Subjects Research Principles & Declarations Regulations Education Forms & Certification Registration Key Agencies Role of the Institution HSCs: IRBs & IECs Principal Investigators & Researchers BioEthics IACUC, BioSafety & Radiation Safety Search Related Sites: Health Resources Health Topics AIDS Primer Cancer Resources Heart Diseases & Stroke Medical Centers Nutrition & Metabolism Science & Technology The Scientist Reference Desk Treasures of the Internet

Institutional Review Board (IRB) Visit also the Bioethics website and use the health and science-focused Search engines and directories section to find additional information about the topics listed below. 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 Federal Register and use the search section to obtain recent updates of 21.56 & 45.46. ___________ Notes and Footnotes: Click on Literature Sources to access the source of the information database, specified as superscript after each topic link.

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First Written: 19990118 Latest Update: 20060328

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