FWA & IRB Registration
The Federalwide Assurance (FWA) is an assurance of CMU's compliance with the U.S. federal regulations for the protection of human subjects in research. It is approved by the Office for Human Research Protections (OHRP) for all human subjects research conducted or supported by the U.S. Department of Health and Human Services (HHS). The FWA is also approved by OHRP for federalwide use, which means that other U.S. federal departments and agencies that have adopted the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely upon the FWA for the research they conduct or support.
All Institutional Review Boards (IRBs) designated in an FWA or that review FDA regulated research, must be registered with the US Health and Human Services (HHS).
This letter provides documentation of CMU's Federal Wide Assurance (FWA) filed with the Office of Human Research Protection (OHRP), along with Institutional Review Board (IRB) registration as required by federal regulations. In addition, this letter serves as evidence of compliance with all applicable regulations for the protection of research participants and is provided in lieu of a request for IRB member names.