Page Updated: 03/05/04

International (and U.S. domestic) institutions engaged in U.S. federally supported research with human subjects must provide an Assurance that they will protect human subjects participating in research.
What is an "Assurance" and when is an assurance needed?

An Assurance is a formalized pledge made by an institution engaged in human subjects research to the U.S. Office for Human Research Protections (OHRP) that it will protect all human research participants. Current U.S. Federal Policy requires that any domestic or international institution engaged in Federally-supported human subject research file or provide an "Assurance." An approved Federalwide Assurance is effective for 3 years after which time an update/renewal must be submitted to the OHRP.

On the Federalwide Assurance application the institution pledges that "all of its research activities related to human subject research, regardless of funding source, will be guided by the ethical principles in The Declaration of Helsinki or The Belmont Report or another such statement." In addition, the institution pledges that "all of its activities related to U.S. federally-conducted or -supported human subject research will comply with...

    (a) the Terms of Assurance for Protection of Human Subjects, and

    (b) procedural standards (one or more of the following: 45 CFR 46 and all of its subparts, 21 CFR 50 and 21 CFR 56, CIOMS International Ethical Guidelines, Canadian Tri-Council Policy, ICH-GCP-E6 Sections 1 through 4, Indian Council of Medical Research Ethical Guidelines for Biomedical Research on Human Subjects)

  • ohrp.osophs.dhhs.gov/humansubjects/assurance/refinfo.htm

    What are the education requirements for International Institutions under the Federalwide Assurance (FWA)?
    "OHRP strongly recommends that the Institution and the designated IRB(s)/IEC(s) establish educational training and oversight mechanisms (appropriate to the nature and volume of its research) to ensure that research investigators, IRB/IEC members and staff, and other appropriate personnel maintain continuing knowledge of, comply with, relevant ethical principles, relevant U.S. regulations; procedural standards under the Assurance; OHRP guidance; other applicable guidance; national, state and local laws; and institutional policies for the protection of human subjects. Furthermore, OHRP recommends that a)IRB/IEC members and staff complete relevant educational training before reviewing human subject research; and b) research investigators complete appropriate institutional educational training before conducting human subject research."

  • ohrp.osophs.dhhs.gov/humansubjects/assurance/filasurt.htm (See part B, no., 13)

    Online Assurance Training
    Note: "The purpose of the modules is to ensure that the three key individuals (The Institutional Signatory Official, the IRB Chair, and the Human Protections Administrator) are aware of the responsibilities that must be fulfilled under an FWA. As such, the modules focus on these responsibilities; general topics such as ethics and the regulations are only given a cursory review… These modules were not designed or intended to serve as general training on human subject protections." [5 March 2001 Newsflash regarding OHRP Assurance Training Modules] (certificate available upon completion)

  • ohrp.osophs.dhhs.gov/educmat.htm

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    Applying for an "Assurance"

    Step I - IRB Registration
    Before an institution can file an Assurance application, it must register the IRB which will review it's investigators' research proposals. Information on how to register an IRB is available at the OHRP.

  • ohrp.osophs.dhhs.gov/humansubjects/assurance/irbs.htm

    An institution may register it's IRB:

    1. by submitting the registration electronically, OR
    2. by mailing in the form found at ohrp.osophs.dhhs.gov/humansubjects/assurance/regirbi.htm
    (1) Electronic submission of a new IRB/IEC is now available (see link below). The electronic form may not be used at this time by institutions that have already submitted IRB Registrations or have been assigned an IORG Number (e.g., all MPA institutions). These institutions must update or renew their IRB/IEC Registrations by faxing or mailing a hard copy. The IRB organization must have an e-mail address to register an IRB electronically. ohrp.cit.nih.gov/efile/

    (2) Mail-in registration of an IRB:

      Why register and IRB or IEC?
    • ohrp.osophs.dhhs.gov/humansubjects/assurance/refinfo.htm#WHY

      Step-by-step instructions for registering an IRB or IEC, including a sample IRB registration document.

    • ohrp.osophs.dhhs.gov/humansubjects/assurance/regirbi.htm

      An institution not having its own IRB may arrange to use the IRB of another institution. - "Under what circumstances can one institution rely on another organization's IRB? Institution A can rely on Organization B's IRB any time Organization B's registered IRB agrees to the arrangement and satisfies the guidelines for knowledge of the local research context (see ohrp.osophs.dhhs.gov/humansubjects/guidance/local.htm). If such reliance reflects an on-going arrangement, Organization B's IRB should be designated in Item 5 of Institution A's FWA. The Head of Organization B or the IRB Chairperson must sign the designation in the FWA Item 5. If the reliance is an unexpected, one-time arrangement, institutions with FWAs can use the sample "IRB Authorization Agreement for an Individual Protocol" on OHRP's website."

      Responsibilities of International IRBs/IECs

    • ohrp.osophs.dhhs.gov/humansubjects/assurance/regirbt.htm

      Update and renewal of an IRB or IEC Registration - IRB/IEC registrations must be renewed each three years. IRB/IEC registration must be updated whenever a change is made to the IRB information on file at the OHRP.

    • ohrp.osophs.dhhs.gov/humansubjects/assurance/renwirb.htm

    Step II - Making an Assurance application
    Visit the OHRP website where the following information is available:

  • ohrp.osophs.dhhs.gov/humansubjects/assurance/fwas.htm

    Does your institution have an FWA on file with the OHRP?
    Search the OHRP database to identify: