The IRB is governed by federal regulations Title 45, Part 46, Protection of Human Subjects that dictate the scope and purpose of IRB activities. The Office of Human Research Protection (OHRP) is the federal administrative agency that monitors the IRB and its activities. The Food and Drug Administration (FDA) also protects human research subjects through its investigational drug and device regulations. Both the OHRP and the FDA monitor human research subjects protections through educational efforts, site visits, and reporting requirements. Both have the authority to suspend research for failure to adhere to the regulations.
Assurances and IRB Registration
University has a contract with the federal government (called an “assurance” or “assurance of compliance”) that allows investigators to conduct federally conducted or supported research using human subjects. This assurance specifies the University’s responsibilities and must be approved by the federal Office of Human Research Protection (OHRP).
- The UConn-Storrs Federal wide Assurance (FWA) is identified as FWA00007125 and expires on August 9, 2022.
- The UConn-Storrs IRB (IRB00000036) is registered with OHRP and is identified as IRB Organization Number IORG0000027 and expires on August 1, 2020.
In addition, the UConn-Storrs obtained a Department of Defense (DoD)-Navy Addendum to the FWA held by the University.
- UConn-Storrs DoD-Navy Addendum to the FWA is identified as DoD N-A3167 and expires on July 6, 2017.
Multi-site projects that are federally funded (i.e., NIH, DHHS, etc.) must have an appropriate assurance for each research site. Investigators should be aware of the type of assurance held at outside research sites and be prepared to initiate the assurance process, if necessary. This includes research both in and outside of the United States. Investigators should also be aware that federal funding agencies will not make research funds available unless all research sites have an assurance approved by OHRP. The Office of Research Compliance (ORC) can assist investigators and ensure that the appropriate assurances have been obtained for all research sites. See also Research Conducted in a Foreign Country