OHRP provides instructions for registering institutional review boards (IRB) and obtaining Federalwide Assurances (FWA) through the links on this page.
An institution must have an FWA in order to receive HHS support for research involving human subjects. Each FWA must designate at least one IRB registered with OHRP. Before obtaining an FWA, an institution must either register its own IRB (an “internal” IRB) or designate an already registered IRB operated by another organization.
On Federalwide Assurances (FWAs), please note:
The fact that the Office for Human Research Protections (OHRP) has approved an institution’s assurance does not mean that OHRP has determined that the institution is complying with the requirements of the Department of Health and Human Services (HHS) Protection of Human Subjects regulations, 45 CFR part 46. It means that an institution has submitted all of the documentation OHRP requires to constitute a commitment by the institution to comply with the requirements of 45 CFR part 46 when its employees or agents engage in non-exempt human subjects research conducted or supported by HHS or other research covered by the assurance. The Federalwide Assurance is the only type of assurance accepted and approved by OHRP.
On IRB registration with OHRP, please note:
The fact that an Institutional Review Board (IRB) is registered with the Office for Human Research Protections (OHRP) does not mean that OHRP has determined that the IRB reviews research in accordance with the requirements of the Department of Health and Human Services (HHS) Protection of Human Subjects regulations, 45 CFR part 46, and does not mean that the IRB has the appropriate competence or expertise to review a particular research project. However, all IRBs that review human subjects research conducted or supported by HHS, and that are designated under assurances of compliance approved for federalwide use by OHRP under 45 CFR 46.103(a), must be registered with OHRP. The Database of registered IORGs and IRBs includes information on IRBs that are regulated by OHRP only, OHRP and FDA , and FDA only.
IRB Registration
Find information on registering an IRB (a separate process from obtaining a FWA).
FWAs
Find information on obtaining a FWA (a separate process from registering an IRB).
IRB & FWAs Status
Learn the status of an IRB registration or a FWA submission.
Forms
Find a variety of forms (e.g., sample IRB authorization, individual investigator agreements, IRB registration and FWA instructions, and terms of assurances).
Contact Us
Contact OHRP with questions about FWAs or IRB registration.
