Federalwide Assurance (FWA)

A Federalwide Assurance (FWA) is a written, time-limited agreement that a research institution files with the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP), committing the institution itself — not any single study or investigator — to comply with the Common Rule (45 CFR 46) for the nonexempt human-subjects research it conducts or supports. Holding a current, active FWA number is a precondition for federal funding to flow to human-subjects research at that institution from HHS or from any other U.S. federal department or agency that has adopted the Common Rule and relies on OHRP’s assurance system. An FWA is filed and signed by an institutional official (the Signatory Official) and must name a Human Protections Administrator as the ongoing point of contact; OHRP assigns the institution a unique FWA number once the assurance is approved.

Who needs one

Any institution — a university, hospital, health system, independent research institute, or other organization — that is engaged in nonexempt human-subjects research conducted or supported by HHS, or by another federal department or agency that has adopted the Common Rule and uses OHRP’s FWA system, is generally required to hold one. “Engaged” is doing real work in that sentence: an institution can be engaged in a federally supported study — and so need an FWA — even when it is a subrecipient or collaborating site rather than the direct grantee, if its own staff obtain data or biospecimens through intervention or interaction with subjects, or obtain identifiable private information. Determining whether a specific collaborating site is actually “engaged,” versus merely receiving pass-through funds, is its own analysis with a defined federal framework — see CASRAI’s Human Subjects Research Determination Process guide for how institutions work through that question.

Before OHRP will approve a new FWA, the institution must first put an IRB of record in place — either its own internal IRB (already separately registered with OHRP) or an external IRB operated by another organization, under a written reliance agreement. An FWA cannot exist without at least one registered IRB designated under it; the FWA is the institutional promise, the IRB is the body that actually carries it out study by study.

A notable, and frequently misunderstood, historical feature of the FWA was a checkbox letting a U.S. institution voluntarily extend Common Rule protections to all of its nonexempt human-subjects research, not just the portion that happened to be federally funded — commonly discussed as the “unfunded research” extension. As part of a March 2026 OHRP revision to the FWA form (implementing burden-reducing provisions tied to the 2018 Common Rule requirements at 45 CFR 46.103), that voluntary extension option was removed from the FWA itself: an institution can no longer use its FWA to place its own unfunded human-subjects research under OHRP oversight. An institution may still choose, as a matter of internal policy, to apply Common-Rule-equivalent protections to research that has no federal funding or FDA nexus — but that choice now sits outside the FWA and outside OHRP’s regulatory oversight, rather than being part of what OHRP itself formally assures. Institutions and IRB offices that still describe the FWA as covering “all human-subjects research regardless of funding source” by default should confirm against their own current FWA filing, since that used to be an available option and, for institutions that checked it before the form changed, may still describe an assurance filed under the older terms.

Federalwide Assurance vs. IRB registration vs. IRB Authorization Agreement

Research-compliance offices routinely handle three related but legally distinct OHRP-adjacent instruments, and conflating them is a common source of confusion:

	Federalwide Assurance (FWA)	IRB registration	IRB Authorization Agreement (IAA)
What it is	An institution’s own promise to OHRP to comply with the Common Rule	The specific review board’s own filing with OHRP	A written agreement designating which IRB reviews a study for a relying institution
Who holds it	The institution (a legal entity), as a whole	The individual IRB or IORG	Two (or more) specific institutions, for a defined scope of research
Filed with	OHRP, by the institution’s Signatory Official	OHRP, by the organization operating the IRB	Between the institutions themselves — not filed with OHRP as a standalone document
What it establishes	That the institution will follow the Common Rule for covered research	That a specific board is eligible to review HHS-covered or FDA-regulated research	That a named IRB, already registered and already designated under a relying institution’s FWA, will serve as IRB of record for specified studies
Term	Renewed roughly every 5 years	Registered for a 3-year term	Varies by agreement; commonly ongoing (e.g. SMART IRB) or per-study
Typical example	A university’s single institution-wide FWA	A hospital’s own IRB registering itself with OHRP	A subrecipient site relying on the coordinating center’s IRB for a multi-site trial

An FWA has to designate at least one already-registered IRB before OHRP will approve it, and a single FWA can designate multiple IRBs (an institution’s own internal board plus one or more external boards under reliance agreements). Conversely, one registered IRB can be designated under several different institutions’ FWAs at once — this is exactly the arrangement independent commercial IRBs and single-IRB (sIRB) reliance models depend on for multi-site studies, and it is the IRB Authorization Agreement that documents each specific relying relationship. See CASRAI’s Central IRB / Single IRB (sIRB) entry for how the IAA mechanism works in practice, including the SMART IRB reliance model. The FWA number and the IRB registration number are always separate identifiers, both issued by OHRP, and both are commonly requested together on federal grant applications, ethics-approval statements, and multi-site reliance agreements — but they answer different questions: the FWA answers “which institution promised to comply,” the IRB registration answers “which committee actually reviewed this,” and the IAA answers “which specific agreement lets that committee review it for this particular relying institution.” See CASRAI’s FWA vs. IRB Registration comparison for a fuller side-by-side.

How to look up an institution’s FWA number

OHRP maintains a free, public search tool at ohrp.cit.nih.gov/search, separate from OHRP’s general website. In brief:

1. Search by institution name (try the core legal name, not a marketing name) or, if already known, directly by FWA number.
2. Check for multiple records — a parent university’s FWA does not automatically cover an affiliated hospital, clinic, or other separately incorporated component.
3. Open the matching record and confirm the FWA number, expiration date, and the designated IRB(s) — not just the institution name.
4. If nothing comes back, try the exact legal name, check whether the entity you need is actually a separate legal entity, and consider whether an assurance existed but lapsed rather than never having been filed.

See CASRAI’s FWA Lookup guide for the full walkthrough, including how to read a returned record and what a blank result does and doesn’t mean.

Filing, renewal, and what happens if an FWA lapses

FWAs are not permanent once approved. OHRP requires an institution to renew its FWA on a periodic basis (currently five years) even when nothing about the institution has changed, and to update the FWA within 90 days of specific triggering changes — most notably a change to the institution’s legal name, its Signatory Official, or its Human Protections Administrator. New and renewal FWA submissions are filed electronically through OHRP’s online assurance system rather than on paper.

An expired or lapsed FWA is an active compliance risk for a research office, not a paperwork formality. Federal funding agencies and collaborating institutions routinely check FWA status before releasing funds or executing a reliance agreement, and a lapsed assurance can stall an active award. Because the FWA is institution-wide, a lapse affects every study conducted under that assurance, not just one project. There is no grace period built into the assurance system itself: an institution that lets its FWA lapse generally has to file a new assurance and wait for OHRP approval before human-subjects research covered by that assurance can proceed under federal funding. See CASRAI’s Federalwide Assurance: Obtaining and Renewing guide for the full step-by-step filing and renewal procedure, including a checklist for each process and what changed on the FWA form in March 2026.

Related CASRAI resources

• Federalwide Assurance: Obtaining and Renewing — step-by-step filing and renewal procedure
• FWA Lookup — how to search OHRP’s public database
• FWA vs. IRB Registration
• AAHRPP Accreditation vs. FWA Registration
• IRB (Institutional Review Board)
• Central IRB / Single IRB (sIRB)
• Human Research Protection Program (HRPP)
• Common Rule (45 CFR 46)
• Human Subjects Research Determination Process
• IRB/REC Approval Process

References

• OHRP, Federalwide Assurances (FWAs) — hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas
• OHRP, Terms of the Federalwide Assurance for the Protection of Human Subjects — hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjects
• OHRP, FWA public search tool — ohrp.cit.nih.gov/search
• Common Rule, 45 CFR 46.103 (assurance requirements) and Subpart A generally
• OHRP, Assurance Process FAQs — hhs.gov/ohrp/regulations-and-policy/guidance/faq/assurance-process