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Frequently Asked Questions From Applicants
Assurances
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.
When does my institution need an Institutional Assurance?
An institution needs an Institutional Assurance whenever that institution is engaged in human subjects research. The OHRP memos, "Engagement of Institutions in Research" and "Engagement of Pharmaceutical Companies in HHS-Supported Research" provide guidance and examples of when institutions are and are not engaged in human subjects research. In short:
- 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 the award.
- An institution becomes engaged in human subjects research when its employees or agents:
(i) Intervene or interact with living individuals for research purposes; or
(ii) 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:
(i) Provide test articles regulated by the FDA for use in HHS-supported research;
(ii) Supply other materials or support for HHS-supported research; or
(iii) Otherwise collaborate in HHS-supported research
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 in the OHRP memos “Engagement of Institutions in Research” and “Engagement of Pharmaceutical Companies in HHS-Supported Research
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.
How can my institution register an IRB?
Institutions can register an IRB with OHRP. Registration of an Institutional Review Board (IRB) with OHRP is voluntary, however in order to obtain a Federalwide Assurance (FWA), an institution must first register an IRB that will be linked to the FWA. IRB registration is not currently required by the Food and Drug Administration. The requirements and procedures can be found at the OHRP Institutional Review Board Registration page.
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