Federalwide Assurance (FWA) & Registration

Federalwide Assurance (FWA)

Any institution conducting or supporting non-exempt human subjects research funded by HHS must submit a written assurance of compliance to the Office for Human Research Protections (OHRP). The Federalwide Assurance (FWA) is the only form of assurance OHRP accepts.

The FWA is also recognized by other federal agencies that have adopted the Federal Policy for the Protection of Human Subjects (the Common Rule), allowing them to rely on a single assurance across agencies.

Information related to the university's FWA, including its expiration date, is available on OHRP's website. Once you are on OHRP's website, click the FWA tab. Next, under Institution/Organization Name, type "U of Tennessee Hlth Science Ctr" or type the FWA number.

OHRP/FDA Registration Numbers

The HHS regulations at 45 CFR part 46, subpart E, require all IRBs to register with HHS if they will review human subjects research conducted or supported by HHS and are to be designated under an assurance of compliance approved for federalwide use (i.e., an FWA) by OHRP.

Information related to the University's Registration is available on OHRP's website. Once you are on OHRP's website, click the IORG or IRBs tab. Next, under Institution/Organization Name, type "U of Tennessee Hlth Science Ctr" or the IORG or Registration number.

The Statement of Compliance can be used as documentation of institutional compliance standards for the UTHSC IRB.