NIH Federalwide Assurance
The NIH Federalwide Assurance (FWA) is NIH's written commitment to protect human subjects and comply with federal human subjects regulations. This page explains what the NIH FWA is, whether it applies to you, and what to do if you are not covered.
The NIH Federalwide Assurance (FWA) is NIH's written commitment to protect human subjects and comply with federal human subjects regulations. This page explains what the NIH FWA is, whether it applies to you, and what to do if you are not covered.
What is the NIH Federalwide Assurance?
A Federalwide Assurance (FWA) is a written commitment by an institution to comply with the federal regulations for protecting human subjects (45 CFR 46). It applies to all research activities conducted or supported by the U.S. Department of Health and Human Services (HHS) where the institution is engaged in human subjects research (HSR). Since NIH is a part of HHS, all NIH human subjects research falls within the scope of the NIH FWA.
NIH FWA at a Glance
| FWA# | FWA00005897 |
| Expires | August 22, 2028 |
| IRB Registrations |
NIH Intramural IRB IRB00012078 – National Institutes of Health IRB #9 |
|
Research Compliance Review Committee (RCRC) IRB00011862 – National Institutes of Health IRB #10 |
Am I Covered by the NIH FWA?
You are generally “covered” under the NIH FWA if you conduct HSR on behalf of the NIH and fall into one of the categories below. The NIH Enterprise Directory (NED) identifies these categories.
- NIH Employee
- Special Volunteer* (Only individuals classified as Special Volunteers in NED are automatically covered under the NIH FWA.)
- Intergovernmental Personnel Act (IPA) appointee (distinct from IPA detailee)
- Visiting Fellow (VFs)
- Intramural Research Training Awardee (IRTA)
- Cancer Research Training Awardee (CRTA)
- NIH Contractors if:
- they work at an NIH site with an NIH employee; or
- the OHSRP Director/designee determines that the NIH FWA covers their activities.
* Other volunteer classifications are not covered by the NIH FWA and may require a written agreement before participating in human subjects research.
What If I Am Not Covered by the NIH FWA?
If you are not automatically covered under the NIH FWA, you may still participate in NIH human subjects research. However, NIH may need to establish a written agreement before you can begin research activities.
- External collaborators
- Guest Researchers
- Rotating fellows
- Rotating students
- Volunteers who are not Special Volunteers
Depending on the circumstances, NIH may establish a written agreement that extends NIH FWA coverage to an individual investigator or executes a Reliance Agreement. A Reliance Agreement changes which IRB reviews the research. It does not determine whether an investigator is covered under the NIH FWA.
Key Takeaway
Before beginning research, determine whether you are covered under the NIH Federalwide Assurance. If you are not automatically covered, contact OHSRP to determine whether a written agreement is needed before you participate in the study.
Need Help?
Contact OHSRP if you have questions about NIH FWA coverage, Reliance Agreements, Individual Investigator Agreements, Special Volunteer status, or multi-site research.