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Federalwide Assurances

    IRB Policy & Guidance
    IRB Authorization Agreements (Reliance Agreements)
    Federalwide Assurances
    Information for Study Participants & the Public
    Clinical Trials at Partners

  • Federalwide Assurances

    ​​Fede​ralwide Ass​urances (FWAs), IRB Registrations and IRB Membersh​​ip

    The Partners IRBs operate in compliance with all applicable regulations and guidelines pertaining to IRBs as listed below, and with the Feder​al Wide Assurance (FWA) and incorporated “Terms of the Federalwide Assurance for Institutions within the United States” held by the Partners entities.

    • Department of Health and Human Services (DHHS) 45 CFR Parts 46 and 164 

    • Food and Drug Administration (FDA) 21 CFR Parts 50 and 56 

    • International Conference on Harmonization (ICH) guideline E6 relating to Good Clinical Practice (GCP), section 3(3.1-3.4), unless ICH guidelines conflict with FDA Regulations 

    The following Partners entity-specific memos provide information for collaborators and sponsors about the entity’s FWA, registered IRBs and membership:

    ​​Terms of Federalwide As​suranc​​e and OHRP Database for Registered IORGs, IRBs, FWAs

    The following links to the OHRP website allow sponsors and collaborators to review terms of the Federalwide Assurance and verify ​the IORG, FWA and IRB Registrations.