Register IRBs & Obtain FWAs

Instructions for registering institutional review boards (IRB) and obtaining Federalwide Assurances (FWA) are provided in the links below.

Federalwide Assurances (FWAs):

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.

The fact that OHRP has approved an institution’s 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. It means that an institution has submitted all 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 nonexempt human subjects research conducted or supported by HHS or otherwise covered by the assurance. The Federalwide Assurance or FWA is the only type of assurance accepted and approved by OHRP.

IRB Registration:

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).

The fact that an IRB is registered with OHRP does not mean that OHRP has determined that the IRB reviews research in accordance with the requirements of the HHS regulations for the protection of human subjects at 45 CFR part 46, and does not mean that the IRB has the appropriate competence or expertise to review a particular research project. It means that the IRB-operating institution or organization has provided all the required elements of the IRB registration application to OHRP.

The public Search database (https://ohrp.cit.nih.gov/search/search.aspx?styp=bsc) of registered IRB-operating institutions or organizations (IORGs) and IRBs includes information on IRBs that are registered with OHRP only, both OHRP and the Food and Drug Administration (FDA) , and FDA only.