Institutional Review Board Registration Form

The purpose of the Institutional Review Board (IRB) Registration Form is to provide a simplified procedure for: (1) IRBs to satisfy the requirements for IRB registration at 45 CFR part 46, subpart E; and (2) IRBs in the United States (US) to satisfy the FDA requirements for IRB registration at 21 CFR 56.106. The respondents for this information collection are institutions or organizations operating IRBs that review human subjects research conducted or supported by HHS; or, in the case of FDA’s requirements, each IRB in the United States that reviews clinical investigations regulated by FDA under sections 505(i) or 520(g) of the Federal Food, Drug and Cosmetic Act; and each IRB in the United States that reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products. Many of the IRBs also review research conducted or supported by other Federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (the Common Rule).

The latest form for Institutional Review Board Registration Form expires 2029-10-31 and is listed under ICR 202505-0990-003.

View the official OMB control history on Reginfo.gov.

Institutional Review Board (IRB) Registration Form_ Registration Updates or Renewals

Federal Enterprise Architecture: Health - Health Care Services

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.