Federalwide Assurance (FWA) & Registration

Federalwide Assurance (FWA)

HHS human subject protection regulations and policies require that any institution engaged in non-exempt human subjects research conducted or supported by HHS must submit a written assurance of compliance to Office for Human Research Protections (OHRP). The FWA is the only type of assurance of compliance accepted and approved by OHRP. FWAs also are approved by the OHRP for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support.

Information related to the University's FWA, including its current 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.