IRBs and Assurances

Registering an institutional review board (IRB) and obtaining a Federalwide Assurance (FWA) are related but separate processes.

• 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, (an “external” IRB), after establishing a written agreement with that other organization.

• An IRB is a committee that performs ethical review of proposed research.

• A graphic summarizing the decision sequence can be seen and printed in PDF format here, and is available in text form here.

• Other federal departments and agencies that conduct or support human subjects research permit use of the FWA as the assurance required by their regulations.
  • Some require use of their own assurance for research not appropriate for an FWA

The Web page for electronic submission of new IRB registrations and FWAs, or update/renewal of existing IORGs/IRBs and FWAs is at http://ohrp.cit.nih.gov/efile/Default.aspx.