Nov 20, 2008 Thursday 03:13:07 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 Statutes Defining the Scope and Functions of IRBs The two statutes (21.56 & 45.46), cited below, are required readings for all investigators doing research involving human beings. 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 Review detailed sections of Institutional Review Boards Title 45 Public Welfare -- Subtitle A -- DHHS -- Part 46 -- Protection of Human Subjects29 Review detailed sections of Protection of Human Subjects Visit the Federal Register and use the search section to obtain recent updates of 21.56 & 45.46. Further Clarifications of the Above Statutes by Regulatory Agencies Institutional Review Board (IRB), Approval Periods and Continuing Review of Research (1/00) 28   Institutional Review Board (IRB), Designation of an Independent IRB (2/97) 28 Institutional Review Board (IRB) Knowledge of Local Research Context (10/98)28 Institutional Review Board (IRB), Reliance on Another Institution's IRB (7/91)28 IRB Meetings Convened via Telephone Conference Call28  IRB Review of Applications for HHS Support28 ___________ 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: [an error occurred while processing this directive]

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