Archive: General Page

  • HIPAA Regulations

    In the research context, HIPAA establishes the conditions under which PHI may be created, obtained, used or disclosed by covered entities for research purposes. As defined by HIPAA, the term “cov

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  • IRB of Record Forms

    OHRP Guidance: Assurance Process HHS human subject protection regulations and policies require that any institution engaged in non-exempt human subjects research conducted or supported by HHS must

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  • Study Specific Disclosure Forms

    Study Specific Disclosure Form -GUMC Study Specific Disclosure Form -Medstar/GU Each “investigator“ must submit a Georgetown University Study Specific Disclosure Form as part of each protocol applicat

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  • Templates and Forms

    Translation Service: Chris Elznic, Client Success Manager, chris@ad-astrainc.com, Office number: +1 301.408.4242 Ext. 106, Ad Astra Inc., 8701 Georgia Ave Suite 808, Silver Spring, MD 20910, www.ad-a

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  • Templates & Forms

    The Georgetown IRB does not accept paper submissions. Please attach the documents in the Georgetown-MedStar IRB System. Templates and Forms (Protocol Templates, Informed Consent Templates, Externa

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  • GHUCCTS IRB Committee E

    The Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) Institutional Review Board is the IRB for the GHUCCTS consortium; its purpose is to review c

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  • Student-conducted Research

      Investigator Responsibilities The HHS regulations at 45 CFR (Code of Federal Regulations) part 46 use the term “investigator” to refer to an individual performing various tasks related to the condu

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  • Social and Behavioral Sciences IRB (IRB-C)

    The Institutional Review Board for social and behavioral science research involving human subjects (IRB-C) has the responsibility of reviewing proposed research projects to ensure that the priv

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  • CIRB

    The National Cancer Institute Central Institutional Review Board Initiative provides a centralized, independent model review of NCI-sponsored clinical trials. The CIRB Initiative is a partnership bet

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