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Human Subjects Research - Assurances
Last Revised: February 11, 2010

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  1. What is an “Assurance”?
  2. When does my institution need an Institutional Assurance?
  3. When is my institution “engaged” in research involving human subjects?
  4. What is the process for institutions to obtain an Assurance from OHRP?
  5. How can my institution register an IRB?

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  1. What is an “Assurance”?

    An “Assurance” is a documented commitment by an institution to comply with the requirements in 45 CFR 46. All institutions “engaged” in research covered by the HHS regulations (45 CFR 46) that is conducted or supported by a Federal Department or Agency must either apply to OHRP for an Assurance or provide their Assurance number to NIH.

    The HHS regulations state the requirement for an Assurance and define what it must contain at 46.103. The OHRP Federalwide Assurance page describes Assurances in greater detail and provides the documents and instructions necessary for obtaining an Assurance.

  2. When does my institution need an Institutional Assurance?

    An institution needs an Institutional Assurance whenever that institution is engaged in non-exempt human subjects research. OHRP provides Guidance on Engagement of Institutions in Human Subjects Research.
    http://www.hhs.gov/ohrp/policy/engage08.html

  3. When is my institution “engaged” in research involving human subjects?

    An institution is automatically considered to be “engaged” in human subjects research whenever it receives a direct HHS award to support human subjects research. The awardee institution bears ultimate responsibility for protecting human subjects under an HHS award.

    An institution becomes “engaged” in human subjects research when its employees or agents:

    Intervene or interact with living individuals for research purposes; or

    Obtain individually identifiable private information for research purposes.

    Pharmaceutical companies may also become “engaged” in human subjects research without receiving a direct HHS award if they:

    Provide test articles regulated by the FDA for use in HHS-supported research;

    Supply other materials or support for HHS-supported research; or

    Otherwise collaborate in HHS-supported research

    Engagement is defined on OHRP Guidance on Engagement of Institutions in Human Subjects Research
    http://www.hhs.gov/ohrp/policy/engage08.html

  4. What is the process for institutions to obtain an Assurance from OHRP?

    Institutions can apply for a Federalwide Assurance (FWA) from OHRP (not from NIH). Applying for an FWA involves filling out an electronic application and registering an Institutional Review Board that has agreed to review the human subjects research of that institution or for that research study.

    Instructions, including application forms, can be found at the OHRP Federalwide Assurance page.

  5. How can my institution register an IRB?

    Institutions can apply for a Federalwide Assurance (FWA) from OHRP (not from NIH). Applying for an FWA involves filling out an electronic application and registering an Institutional Review Board that has agreed to review the human subjects research of that institution or for that research study.

    Instructions, including application forms, can be found at the OHRP Federalwide Assurance page.

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This page last updated on February 11, 2010
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