An institution’s Federalwide Assurance (FWA) number is the identifier the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP) assigns once it approves that institution’s commitment to comply with the Common Rule for human-subjects research. Research administrators, grants staff, and IRB offices need to look this number up constantly — for subrecipient monitoring, multi-site reliance agreements, grant application forms, and verifying a collaborating institution’s compliance status is current. This guide covers how to search OHRP’s public FWA database, how to read what it returns, and what to do when a search comes back empty.
Where the FWA lookup tool actually lives
OHRP maintains a free, public search tool at ohrp.cit.nih.gov/search. It is a separate system from OHRP’s general website and is not indexed the way an ordinary web page is, which is part of why searchers often land on a mix of university compliance-office pages, blog summaries, and outdated screenshots instead of the tool itself. The search interface offers a basic search (institution name or FWA number) and an advanced search with more filters (state, expiration-date range, Signatory Official name). A related but separate search on the same domain covers registered IRBs/IORGs, and a “Documents Received in Last 60 Days” listing shows very recent filings that may not yet be fully processed into the main database. If you have trouble locating or using the tool, OHRP’s own contact address for FWA and IRB registration questions is [email protected].
Step by step: searching by institution name
- Open the basic FWA search and enter the institution’s name. Search broadly first — try just the core name (e.g. “State University” rather than the full legal name with campus/branch qualifiers) since institutions are indexed under the exact legal name on file with OHRP, which does not always match the name they use publicly.
- Scan the results for multiple entries. Large institutions — a university with an affiliated hospital system, a health system with several member hospitals, a multi-campus system — frequently hold separate FWAs for separate legal entities. A parent institution’s FWA does not automatically cover an affiliated hospital, clinic, or component that is its own legal entity; each needs to be checked individually.
- Open the matching record and confirm the FWA number, expiration date, and the institution’s exact legal name as filed. This is the version to cite on a grant application, subaward agreement, or reliance agreement — not a name typed from memory.
Step by step: searching by FWA number
If you already have an FWA number — from a collaborator’s grant paperwork, a prior agreement, or a signed assurance document — searching directly by number is faster and avoids the name-matching ambiguity above. FWA numbers are assigned sequentially by OHRP and formatted as “FWA” followed by a string of digits; entering the number exactly as provided, without extra spaces or punctuation, returns the single matching record if it’s current.
Reading the results
A returned FWA record typically shows the institution’s legal name and address, the FWA number itself, its approval and expiration dates, the designated Signatory Official and Human Protections Administrator, and the IRB(s) currently designated under that assurance (each with its own separate IRB registration number). Two things are worth checking every time, not just the FWA number itself:
- Expiration date. An FWA is time-limited and must be renewed periodically (OHRP currently requires renewal roughly every five years) even when nothing about the institution has changed. A funding agency or partner institution relying on a lapsed FWA is relying on nothing — an expired assurance is a real compliance gap, not a paperwork technicality, and can stall an active award or reliance agreement.
- Which IRB is designated. The FWA is the institution’s own compliance promise; the IRB registration is a separate filing for the specific review board doing the actual protocol review. A single FWA can list several designated IRBs (the institution’s own board plus one or more external boards under written reliance agreements), and one IRB can be designated under many different institutions’ FWAs at once — the arrangement that makes single-IRB (sIRB) and commercial-IRB reliance models work for multi-site studies. If you need to confirm a specific board’s own registration status rather than the institution’s assurance, use OHRP’s separate IRB/IORG search rather than the FWA search.
Why this lookup matters in practice
A few concrete situations where confirming an FWA number and status is a routine part of the job, not an occasional edge case:
- Grant applications and Just-In-Time submissions. Federal funding agencies that route human-subjects research through OHRP’s assurance system routinely require the performance site’s or subrecipient’s current FWA number as part of the application or pre-award package.
- Subrecipient monitoring. A prime awardee institution is generally expected to confirm that any subrecipient engaged in the human-subjects research — not merely receiving pass-through funds — holds an active FWA before funds flow, and to re-check periodically over the life of the award.
- Multi-site reliance and sIRB agreements. Reliance agreements name both the relying institution’s FWA and the reviewing IRB’s registration number; verifying both are current and correctly matched avoids delays when a sponsor or coordinating center audits the paperwork.
- Due diligence on a new collaborator. Before finalizing a subaward or data-sharing agreement involving human subjects, confirming the partner institution actually holds an active FWA (rather than trusting a self-reported number) is a basic, fast check.
If the institution isn’t found
A blank search result does not always mean the institution has never held an FWA. Before concluding that, check the following:
- Try the legal name, not the marketing name. Institutions are indexed under the exact name filed with OHRP, which can differ from a rebranded public-facing name, especially after a merger, acquisition, or name change.
- Check for a separate entity. A hospital, medical school, research institute, or affiliated foundation that operates under a larger university or health-system brand may hold its own distinct FWA, filed and searchable under its own legal name.
- Consider whether it lapsed rather than never existed. An institution that once held an FWA but let it expire without renewing will not show up as an active, current assurance — contact the institution’s research compliance or IRB office directly to confirm status and, if needed, prompt renewal.
- Confirm the institution actually needs one. Not every organization touching a study needs its own FWA — only those engaged in the nonexempt human-subjects research itself (obtaining data, biospecimens, or identifiable private information through intervention or interaction with subjects). A vendor providing purely administrative services, for example, typically would not need one. See CASRAI’s Federalwide Assurance (FWA) dictionary entry for the full definition of who is required to hold one.
FWA search vs. IRB registration search
These are two different OHRP filings, searched in two different (though adjacent) tools, and confusing them is a common source of delay in compliance offices:
| FWA search | IRB/IORG registration search | |
|---|---|---|
| What it answers | Which institution has promised to comply with the Common Rule | Which specific review board is registered to review covered research |
| Who holds the number | The institution (legal entity) as a whole | The individual IRB or IORG |
| Typical use | Grant applications, subrecipient monitoring, reliance agreements | Confirming a specific board’s registration when relying on its review |
Frequently asked questions
Is the OHRP FWA database free to search?
Yes. It is a free, publicly accessible tool maintained by OHRP; no account or fee is required to search it.
How current is the database?
New and renewal FWA submissions are filed electronically through OHRP’s online assurance system, and the database reflects processed filings. OHRP also publishes a separate “Documents Received in Last 60 Days” listing for very recent submissions that may not yet be fully reflected in the main searchable record — check that listing if a very recent filing doesn’t yet appear in the standard search.
Can an FWA number change?
The number itself, once assigned, generally stays with the institution across renewals. What changes over time is the assurance’s status (active vs. expired) and its associated details — designated IRBs, Signatory Official, Human Protections Administrator — which OHRP requires institutions to update within 90 days of specific triggering changes, most notably a change to the institution’s legal name, Signatory Official, or Human Protections Administrator.
Does a current FWA mean every study at that institution is automatically covered?
No. The FWA is an institutional-level compliance commitment, not a blanket clearance for any specific study. Individual studies still require review and approval by an IRB properly designated under that FWA before they proceed — see CASRAI’s IRB/REC Approval Process guide for what that review covers.
