Direct comparison
FWA vs. IRB Registration — Key Differences
FWA is an institution's OHRP compliance commitment; IRB registration is each board's own OHRP filing. How they relate, and common renewal/lapse pitfalls.
Side-by-side comparison
| Dimension | Federalwide Assurance (FWA) | IRB Registration |
|---|---|---|
| What it is | An institution's written commitment to OHRP to comply with the Common Rule for covered human subjects research | A specific IRB's own OHRP filing documenting its membership and operating basics |
| Who files it | The institution, signed by its Signatory Official | The institution or organization that operates the IRB |
| Regulatory basis | 45 CFR 46.103 (Common Rule) | 45 CFR 46 Subpart E |
| Scope | Institution-wide — covers all the institution's covered human subjects research | That specific IRB's authority to review research designated under an FWA |
| Term length | Time-limited with periodic renewal, plus updates required within 90 days of a change to legal name, Signatory Official, or Human Protections Administrator | Three-year term, then must be renewed |
| Prerequisite relationship | OHRP will not approve an FWA unless it designates at least one already-registered IRB | Must exist and be active before that IRB can be designated under any institution's FWA |
| Can it be shared across institutions? | No — one FWA per institution (a legal entity may hold more than one FWA for distinct components) | Yes — one registered IRB can be designated under multiple institutions' FWAs (the basis for reliance/sIRB models) |
| Consequence of a lapse | Institution loses authority to conduct or support HHS-covered human subjects research until renewed | That IRB can't continue as, or be newly designated as, an institution's reviewing board until it re-registers |
Common questions
FAQ
Do we need both an FWA and IRB registration?+
Yes, if your institution conducts or supports HHS-covered (or otherwise Common-Rule-covered) human subjects research. You need an active FWA, and every IRB reviewing that research under the FWA needs its own active OHRP registration.
Can one IRB be registered under more than one institution's FWA?+
Yes. Registration attaches to the IRB itself, not to a single institution, which is exactly what makes reliance arrangements and single-IRB (sIRB) review models possible — one registered board can be designated under several institutions' FWAs at once.
What happens if our institution's FWA lapses?+
The institution loses its authorized basis to conduct or support HHS-covered human subjects research until the FWA is renewed. Because the FWA is institution-wide, this can affect the entire portfolio of covered studies, not just one.
What happens if just one designated IRB's registration lapses?+
That IRB can no longer serve as, or be newly designated as, a reviewing board under any institution's FWA until it re-registers with OHRP. The institution's FWA itself and its other designated IRBs aren't automatically affected, but any research relying on the lapsed board is exposed until it's resolved.
