Jan 17, 2019 Thursday 20:17:34 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

Regulations & Enforcement 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. Protection of Human Subjects The two statutes (21.56 & 45.46), cited below, are required readings for all investigators doing research involving human beings. Public Welfare -- Subtitle A -- DHHS -- Part 46 -- Protection of Human Subjects29 Review detailed sections of Protection of Human Subjects 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 Visit the Federal Register and use the search section to obtain recent updates of 21.56 & 45.46. "Mirror" 45 CFR 46 - Protection of Human Subjects28 Statutory Basis for 45 CFR 4628 Presidential Memorandum on Protection of Human Subjects (2/17/94)28 Human Subject Regulations Decision Charts (9/98)28 Research that may be Reviewed Through an Expedited Procedure28 Public Law 103-43, Sec. 498A Fetal Tissue Transplantation Research28 Enforcement Information for Health Professionals FDA Disqualified Investigator List FDA Debarred Persons List PHS List of Investigators Subject to Administrative Action Warning letters ___________ 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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