A Federalwide Assurance (FWA) is an institution's assurance of compliance filed with the HHS Office for Human Research Protections (OHRP), and IRB registration is the separate OHRP record each IRB reviewing HHS-supported research must keep. This page is for research institutions and independent review organizations registering an IRB, obtaining an FWA, or reconciling the obligations that follow. Integral Healthcare Solutions (IHS) organizes your IRB registration, assurance records and reliance tracking; your IRB and counsel own the review decisions.

Last reviewed: October 2026.

What are the FWA and IRB registration?

The governing texts are OHRP's "Terms of the Federalwide Assurance for the Protection of Human Subjects" and OHRP's IRB registration requirements, under the Common Rule at 45 CFR Part 46. For IRBs reviewing FDA-regulated clinical investigations, FDA's IRB registration rule at 21 CFR 56.106 also applies.

OHRP defines the assurance: "An FWA is an assurance of compliance submitted to the Office for Human Research Protections (OHRP) by an institution that is engaged in nonexempt human subjects research conducted or supported by the Department of Health and Human Services (HHS) or another U.S. Department or Agency that uses OHRP's FWA." It adds: "The Federalwide Assurance or FWA is the only type of assurance accepted and approved by OHRP" (OHRP, Register IRBs and Obtain FWAs).

IRB registration is a separate obligation: "Each institutional review board (IRB) that reviews research involving human subjects conducted or supported by the Department of Health and Human Services (HHS) must be registered with the Office for Human Research Protections (OHRP)" (OHRP, IRB Registration, content last reviewed March 12, 2026).

Neither one certifies compliance. OHRP states that approval of an assurance "does not mean that OHRP has determined that the institution is complying with the requirements of the HHS regulations for the protection of human subjects at 45 CFR part 46" (OHRP), and that registration "does not mean that the IRB has the appropriate competence or expertise to review a particular research project" (OHRP).

Who needs it and what triggers it

The buyer is a research institution or an independent review organization. The triggers:

• The institution becomes engaged in human subjects research supported by a federal agency that has adopted the Common Rule. The FWA terms "apply whenever the institution becomes engaged in human subjects research conducted or supported by any U.S. federal department or agency that has adopted the Common Rule, unless the research is otherwise exempt" (Terms of the FWA).
• A new IRB will review HHS-conducted or supported research and must be registered with OHRP.
• An IRB will review FDA-regulated clinical investigations; under 21 CFR 56.106 initial registration comes before the IRB begins reviewing them (21 CFR 56.106).
• A change in the IRB contact person or chairperson, or in the institution's legal name, Human Protections Administrator or Signatory Official, each of which starts a 90-day update clock; for IRBs reviewing FDA-regulated investigations, a decision to review new types of FDA-regulated products, to stop reviewing FDA-regulated investigations, or to disband starts a 30-day reporting clock (21 CFR 56.106(e)).
• The institution starts relying on another organization's IRB, or another institution starts relying on yours.
• A renewal date is near, or an FWA or registration has lapsed.

How IHS helps

IHS organizes the institution's assurance and registration records through its standard process:

1. A gap assessment of institutional responsibilities against the FWA terms, OHRP registration requirements and, where FDA-regulated research is in scope, 21 CFR 56.106.
2. A crosswalk from each term to an owner and a record.
3. Drafting of institutional procedures, a reliance agreement tracker, renewal and 90-day update controls, and registration records, for your research leadership and counsel to review and approve.
4. A mock review of the assurance file, read the way a reviewer would read it.
5. Drafted registration and update text for your institution to submit.

What you supply: current IRB procedures, rosters, reliance agreements, research leadership and counsel.

The limit: IRB review decisions and questions of regulatory applicability belong to your IRB and counsel. Registration or an approved FWA does not certify compliance, as OHRP itself states. Your institution submits its registrations and assurances through the HHS registration system; IHS does not.

What to have ready

Each item ties to the OHRP pages and FWA terms (read October 2026) or 21 CFR 56.106, as cited.

• A determination of whether the institution is "engaged in nonexempt human subjects research conducted or supported by" HHS or another agency that uses OHRP's FWA (OHRP).
• A list of the federal departments and agencies supporting your research, since the FWA terms reach research supported by "any U.S. federal department or agency that has adopted the Common Rule" (Terms of the FWA).
• The registration record for each IRB that reviews HHS-conducted or supported research (OHRP, IRB Registration).
• An IRB registration calendar: "Update an IRB registration within 90 days after a change in contact person or chairperson, and renew IRB registration every 3 years" (OHRP, IRB Registration). For IRBs reviewing FDA-regulated investigations, 21 CFR 56.106(e) also requires reporting within 30 days a decision to review new types of FDA-regulated products or to stop reviewing FDA-regulated investigations, and within 30 days of permanently ceasing review if the IRB disbands (21 CFR 56.106(e)).
• An FWA calendar. "The FWA is effective for 5 years and must be renewed every 5 years, even if no changes have occurred" (OHRP, Update or Renew an FWA).
• Named holders of the roles the FWA tracks, with a 90-day update control: the institution "must update its FWA within 90 days after changes occur regarding the legal name of the institution, the Human Protections Administrator, or the Signatory Official" (OHRP, Update or Renew an FWA).
• Written reliance documentation. "The institution and the organization operating the IRB must document the reliance and the responsibilities that each entity will undertake to ensure compliance with the requirements of the Common Rule" (Terms of the FWA).
• For IRBs reviewing FDA-regulated investigations, FDA registration records and a renewal date: "Each IRB must renew its registration every 3 years" (21 CFR 56.106(c)).

The introductory call is the place to go through this list against your institution's current records.

How it compares

IHS covers AAHRPP accreditation on its own page: AAHRPP accreditation. Sites running drug or biologic trials may also need a GCP site quality system under ICH E6(R3).

What it costs

The OHRP pages we reviewed state no fee for registering an IRB or obtaining an FWA; confirm current fees with OHRP. IHS scopes each engagement after a free introductory call.

What this is not

• This page is not legal advice, and IHS does not decide whether a project is exempt or whether your institution is engaged in research.
• IHS does not make or review IRB decisions, and an organized assurance file is not a finding of compliance by OHRP or FDA.
• IHS does not submit registrations or assurances, or deal with OHRP or FDA, on your institution's behalf.

Frequently asked questions

What is a Federalwide Assurance (FWA) and does my institution need one?

OHRP describes an FWA as "an assurance of compliance submitted to the Office for Human Research Protections (OHRP) by an institution that is engaged in nonexempt human subjects research conducted or supported by" HHS or another agency that uses OHRP's FWA (OHRP). It is "the only type of assurance accepted and approved by OHRP." Whether your institution is engaged in covered research is a determination for your research leadership and counsel.

What is the difference between registering an IRB and obtaining an FWA?

The FWA is the institution's assurance of compliance. IRB registration is a separate record for each IRB: every IRB that reviews HHS-conducted or supported human subjects research "must be registered with the Office for Human Research Protections (OHRP)." IHS's reading: an institution can hold an FWA and rely on an IRB registered by another organization.

Do we need an FWA if we rely on an external or commercial IRB?

OHRP's definition ties the FWA to an institution "engaged in nonexempt human subjects research" (OHRP). IHS's reading (October 2026) is that this turns on engagement, not on whether the institution operates its own IRB; whether a given institution is engaged is a determination for your research leadership and counsel. When you rely on another organization's IRB, the FWA terms require that "the institution and the organization operating the IRB must document the reliance and the responsibilities that each entity will undertake" (Terms of the FWA).

How do I register an IRB with OHRP, and do FDA-regulated studies need separate registration?

Each IRB reviewing HHS-conducted or supported research registers with OHRP (OHRP). IRBs reviewing FDA-regulated clinical investigations also register under 21 CFR 56.106, and initial registration must occur before the IRB begins reviewing those investigations (eCFR). Section 56.106 imposes its own registration duty on IRBs that review clinical investigations under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act or that support FDA applications, with renewal every 3 years. Section 56.106(a) directs registration "at a site maintained by the Department of Health and Human Services (HHS)," so IHS's reading (October 2026) is that this is not a separate FDA portal; confirm with your counsel whether one HHS-system registration covers both OHRP and FDA purposes. IHS drafts the registration text; your institution submits it.

How often must an FWA and an IRB registration be renewed or updated?

The FWA "is effective for 5 years and must be renewed every 5 years, even if no changes have occurred," and must be updated within 90 days of a change in the institution's legal name, Human Protections Administrator or Signatory Official. OHRP IRB registration is updated within 90 days of a change in contact person or chairperson and renewed every 3 years. FDA IRB registration is also renewed every 3 years (21 CFR 56.106(c)).

What happens if our FWA lapses while research is ongoing?

The FWA terms state: "Failure to renew or update an FWA while continuing to engage in research subject to the Common Rule may constitute noncompliance" (Terms of the FWA). A renewal calendar with named owners is the control for this.

How do we document IRB reliance agreements under the Common Rule?

The FWA terms require that the institution and the organization operating the IRB "document the reliance and the responsibilities that each entity will undertake to ensure compliance with the requirements of the Common Rule." IHS builds a reliance agreement tracker that links each agreement to the responsibilities it assigns.

Does OHRP registration or FWA approval mean our IRB is compliant?

No. OHRP states that approving an assurance "does not mean that OHRP has determined that the institution is complying with the requirements of the HHS regulations for the protection of human subjects at 45 CFR part 46," and that IRB registration "does not mean that the IRB has the appropriate competence or expertise to review a particular research project."