Office of Research Oversight
Institutional Review Board (IRB) Registration Instructions
Per VHA Directive 1200.05, IRBs operated by VA medical facilities must be registered with the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP). Information on registering an IRB is available at: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-registration/index.html. NOTE: VA medical facilities planning to initiate a new research program must obtain prior approval from the VHA Office of Research & Development pursuant to VHA Directives 1200.02 and 1200.05. Further, VA medical facilities planning to change any of the IRBs that they rely upon, including planning to rely on an additional IRB not previously approved for specific use by the facility, must obtain prior approval for such a change from the VHA Office of Research & Development pursuant to VHA Directive 1200.05.
With the issuance of VHA Directive 1058, dated November 8, 2024, there is no longer a requirement for VA medical facilities to prospectively provide the VHA Office of Research Oversight (ORO) with a copy of the IRB Registration or local IRB membership rosters for IRBs required to be designated on their approved Federalwide Assurances (FWAs) on file with HHS OHRP. However, a copy of such rosters must be provided to ORO promptly upon request.
Questions regarding the process for seeking approval to change an IRB relied upon to review, approve, and oversee VA research should be directed to the VHA Office of Research & Development.
