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.
The Signatory Official listed on UTHSC’s FWA is the UTHSC Chancellor. As of January 20, 2017, the UTHSC Vice Chancellor for Research may sign as the Designee for the UTHSC Signatory Official on Institutional Review Board (IRB) Authorization Agreements. Download a copy of the Designee notice.
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 registration numbers for each section of the UTHSC IRB are as follows:
|Registration #||Section #|
|IRB00000070||UTHSC IRB #1|
|IRB00000071||UTHSC IRB #2|
|IRB00000072||UTHSC IRB #3|
|IRB00000073||UTHSC IRB #4|