Compliance Statements

Federalwide Assurance Letter

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 OHRP. The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP. FWAs also are approved by the Office for Human Research Protections (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.

UTHSC's Federalwide Assurance (FWA) number is 00002301.

IRB Registration Letter

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.

UTHSC's Registration number is IORG0000051.

The sections of the UTHSC IRB are as follows:

Registration # Section # City
IRB00000070 UTHSC IRB #1 Memphis
IRB00000071 UTHSC IRB #2 Memphis
IRB00000072 UTHSC IRB #3 Memphis
IRB00000073 UTHSC IRB #4 Memphis

The Office for Human Research Protections (OHRP)’s Database for Registered IORGs and IRBs, Approved FWAs, and Documents Received in the Last 60 Days is located at

21 CFR 11

This document explains how iMedRIS addresses the requirements of FDA regulation 21 CFR 11. This federal regulation pertains to electronic records/electronic signatures and sets forth criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. People using electronic signatures must certify to the agency that the electronic signature in their system is intended to be the legally binding equivalent of traditional handwritten signatures.