Getting or renewing a Federalwide Assurance (FWA) is a filing process, not a lookup. If you already have an institution’s FWA number and just need to check its status or expiration date, use CASRAI’s FWA Lookup guide instead — that covers searching OHRP’s public database. This guide covers the other side: what a research-compliance office actually has to do to obtain a new FWA for the first time, and what’s required to renew one before it lapses.
Obtaining vs. renewing: the two processes at a glance
| Obtaining a new FWA | Renewing an existing FWA | |
|---|---|---|
| Who files | An institution with no active FWA, or a newly formed legal entity (e.g. a spun-off research institute, a newly acquired hospital) | An institution with a currently active FWA approaching its expiration date |
| Prerequisite | At least one IRB already registered with OHRP — internal or external under a written reliance agreement — ready to be designated | An existing FWA on file; designated IRB registration(s) still current or being updated in the same filing |
| Where it’s filed | OHRP’s electronic assurance filing system | Same electronic system, using the renewal option rather than the new-assurance option |
| Who signs | The institution’s Signatory Official | The institution’s Signatory Official (may be a different individual than at initial filing) |
| Typical cycle | One-time, then subject to the renewal cycle below | Every 5 years, regardless of whether anything has changed |
| Also required | N/A | Separate 90-day updates any time the legal name, Signatory Official, or Human Protections Administrator changes — these are not the same as the 5-year renewal |
Before you apply: what has to be true first
OHRP will not approve a new FWA in isolation — an FWA is a promise to comply with the Common Rule (45 CFR 46), and that promise has to name at least one IRB that will actually carry it out. Before starting an FWA application, confirm:
- An IRB of record exists. Either the institution’s own internal IRB is already separately registered with OHRP, or the institution has a written reliance agreement with an external IRB (a commercial IRB such as WCG or Advarra, a partner institution’s IRB, or a single-IRB/sIRB arrangement) that is itself already OHRP-registered. IRB registration and the FWA are two separate, sequential OHRP filings — see CASRAI’s FWA vs. IRB Registration comparison for the full distinction. If the institution has no registered IRB yet, that registration has to happen first or in parallel; OHRP will not designate an unregistered board under a new FWA.
- A Signatory Official is identified. This is the individual authorized to sign the FWA on the institution’s behalf — typically a senior institutional official (vice president for research, general counsel, or equivalent), not the IRB chair or a study investigator.
- A Human Protections Administrator is identified. This is the ongoing point of contact named on the FWA, usually the head of the IRB office or research-compliance office — distinct from the Signatory Official and distinct from an IRB Chair.
- The institution’s exact legal name is confirmed. OHRP files and indexes assurances under the precise legal name of the entity, which may differ from a public-facing brand name. This matters for the lookup step later, and mismatches between an FWA’s legal name and grant paperwork are a common source of subrecipient-monitoring delays.
Step by step: obtaining a new FWA
- Confirm the institution needs its own FWA. Only an institution that is engaged in nonexempt human-subjects research — its own staff obtaining data, biospecimens, or identifiable private information through intervention or interaction with subjects — generally needs one. A component that merely receives pass-through funds without engaging in the research itself typically does not.
- Register or confirm the IRB of record. If relying on an internal board, confirm its OHRP IRB registration is active. If relying on an external board, execute a written reliance agreement and confirm that board’s registration independently — do not assume a partner institution’s IRB registration covers your institution automatically.
- Identify the Signatory Official and Human Protections Administrator who will be named on the filing, per the prerequisites above.
- Complete the FWA application through OHRP’s electronic assurance filing system. The form collects the institution’s legal name and location, any component organizations or alternate names operating under the same assurance, an applicability statement, agreement to the Terms of the Federalwide Assurance, confirmation that only OHRP-registered IRBs will be used, and the designated IRB(s)’ registration numbers.
- The Signatory Official signs and submits. OHRP reviews the submission and, once approved, assigns the institution a unique FWA number.
- Record the FWA number and expiration date in the institution’s own compliance-tracking system, and distribute it to the grants office — it will be requested routinely on federal human-subjects grant applications, Just-In-Time submissions, subaward agreements, and multi-site reliance agreements.
Last verified 2026-08-16: OHRP’s own FWA instruction pages returned an access error to direct automated retrieval during this review; the sequence above is corroborated across multiple institutional human-research-protection-program (HRPP) offices and a CITI Program summary of OHRP’s own form documentation, not a single primary-source page fetch. Confirm current field-by-field form requirements directly against OHRP’s assurance system before filing, since the form itself was revised in March 2026 (see below).
Step by step: renewing an FWA
Renewal uses the same electronic filing system as a new application, but starts from the institution’s existing assurance rather than from nothing.
- Track the expiration date. OHRP requires FWA renewal on a periodic basis — currently every 5 years — even if nothing about the institution, its IRB, or its officials has changed. Build the renewal deadline into the compliance office’s own calendar well before expiration; OHRP does not guarantee same-day turnaround on a late-filed renewal.
- Review and update designated IRBs. Confirm every IRB currently listed on the FWA is still registered and still the institution’s actual IRB of record. Remove boards no longer used; add any new internal or reliance-agreement boards.
- Reconfirm or update the Signatory Official and Human Protections Administrator. If either has changed since the last filing (a common trigger, given typical staff turnover over a 5-year cycle), update the renewal accordingly — this satisfies both the renewal and the separate 90-day update requirement described below in one filing.
- Submit the renewal application with the same institutional information, applicability statement, and Terms-of-Assurance agreement as a new filing.
- Confirm approval and the new expiration date once OHRP processes the renewal, and update internal tracking.
The separate 90-day update requirement
Renewal on a 5-year cycle is not the only time an FWA has to be touched. OHRP separately requires an institution to update its FWA within 90 days of specific triggering changes, most notably:
- A change to the institution’s legal name (e.g. following a merger, acquisition, or corporate restructuring)
- A change of Signatory Official
- A change of Human Protections Administrator
These 90-day updates are filed separately from the 5-year renewal and don’t reset the underlying 5-year expiration clock — treat them as a distinct compliance trigger your office needs to catch in real time (e.g. whenever a Human Protections Administrator role changes hands), not something to bundle into the next scheduled renewal.
What changed on the FWA form in March 2026
OHRP revised the FWA form in March 2026 to reduce filing burden under the 2018 Common Rule requirements at 45 CFR 46.103. The most substantive change for research offices: the option for a U.S. institution to voluntarily extend Common Rule protections to all of its nonexempt human-subjects research, regardless of funding source (commonly called the “unfunded research” extension), was removed from the FWA form itself. An institution can still choose, as internal policy, to apply Common-Rule-equivalent protections to unfunded research — that choice simply no longer falls under OHRP oversight via the FWA. Institutions that checked that option under the older form should confirm with their own Signatory Official or HRPP office how their current assurance is actually scoped, rather than assuming the old default still applies.
Secondary effects of the March 2026 revision reported alongside the substantive change: the estimated time to complete a submission dropped from roughly 30 minutes to roughly 20 minutes, and the ethical-principles-statement and IRB-designation-detail sections of the form were simplified. These process details are corroborated via a CITI Program summary of OHRP’s supporting documentation rather than an independently retrieved primary OHRP page during this review — treat the time estimate and the “unfunded research” removal as the load-bearing facts, both cross-corroborated, and re-verify directly against hhs.gov/ohrp before citing an exact burden-hour figure.
What happens if an FWA lapses
An expired FWA is a live compliance and funding risk, not a paperwork technicality. In practice:
- Federal agencies and collaborating institutions routinely check FWA status before releasing funds, executing a subaward, or finalizing a reliance agreement — a lapsed assurance can stall an active award or block a new one from starting.
- The FWA is institution-wide: a lapse affects every study conducted under that assurance, not just one project, which is why tracking the expiration date is a research-compliance-office responsibility rather than something left to individual study teams.
- There is no grace period built into the assurance system itself — an institution that lets its FWA lapse has to file a new assurance (functionally the “obtaining” process above, not a streamlined renewal) and wait for OHRP approval before human-subjects research covered by that assurance can proceed under federal funding.
Checklist: obtaining a new FWA
- Confirmed the institution is “engaged” in covered human-subjects research and needs its own FWA
- IRB of record identified and its OHRP registration confirmed active (internal board, or external board under a signed reliance agreement)
- Signatory Official identified and available to sign
- Human Protections Administrator identified
- Institution’s exact legal name confirmed against other official filings
- Application completed and submitted through OHRP’s electronic assurance system
- FWA number and expiration date recorded and distributed to the grants/pre-award office
Checklist: renewing an FWA
- Expiration date tracked in the compliance office’s own calendar, with enough lead time to avoid a lapse
- All designated IRBs reviewed for current, active registration
- Signatory Official and Human Protections Administrator reconfirmed or updated
- Renewal submitted through OHRP’s electronic assurance system before the expiration date
- New expiration date confirmed and updated in internal tracking once approved
Frequently asked questions
How long does it take to get an FWA approved?
OHRP does not publish a guaranteed processing timeline, and actual turnaround varies with submission volume and whether the application is complete on first submission (a common source of delay is an IRB designation that doesn’t match an active OHRP IRB registration). Filing well ahead of any funding deadline — not waiting until a Just-In-Time request forces the issue — is the safest practice. Confirm current expected turnaround directly with OHRP ([email protected]) if a deadline is tight.
Does renewing an FWA change the FWA number?
No. The FWA number, once assigned, stays with the institution across renewals. What changes at renewal is the assurance’s expiration date and, where applicable, its associated details — designated IRBs, Signatory Official, Human Protections Administrator.
Do we need a separate FWA for each affiliated hospital or clinic?
Often yes. A parent university’s FWA does not automatically cover an affiliated hospital, clinic, or other component that is its own distinct legal entity — each legal entity engaged in covered human-subjects research generally needs its own FWA, filed and indexed under its own legal name. Large institutions with multiple campuses or affiliated entities frequently hold several separate FWAs rather than one. See CASRAI’s FWA Lookup guide for how to check whether a specific affiliated entity holds its own assurance.
Is there a fee to obtain or renew an FWA?
OHRP’s assurance filing process itself does not charge a government filing fee. An institution’s own indirect costs — compliance-office staff time to prepare the application, and any external IRB reliance fees if using a commercial IRB — are the real cost, not a government fee.
Is an FWA the same as AAHRPP accreditation?
No. An FWA is a mandatory regulatory filing with OHRP required to receive certain federal human-subjects research funding. AAHRPP accreditation is a voluntary, fee-based external review of an institution’s entire Human Research Protection Program against a broader set of quality standards. See CASRAI’s AAHRPP Accreditation vs. FWA Registration comparison for the full distinction.
Who at OHRP handles FWA and IRB registration questions?
OHRP’s contact address for FWA and IRB registration questions is [email protected]. General program information is available through the OHRP pages on hhs.gov.
Related CASRAI resources
- Federalwide Assurance (FWA) — full definition, who needs one, and the FWA/IRB-registration distinction
- FWA Lookup — how to search OHRP’s public database for an existing FWA number
- FWA vs. IRB Registration
- AAHRPP Accreditation vs. FWA Registration
- IRB (Institutional Review Board)
- Common Rule (45 CFR 46)
- Human Research Protection Program (HRPP)
- IRB/REC Approval Process
- OHRP (Office for Human Research Protections)
