Institutional Review Board Registration Form

The respondents for this collection are institutions or organizations operating IRBs designated by an institution under an assurance of compliance approved for federalwide use by OHRP under 45 CFR 46.103(a) and that review human subjects research conducted or supported by HHS, or, in the case of FDA's regulation, 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.

The latest form for Institutional Review Board Registration Form expires 2022-02-28 and can be found here.

Institutional Review Board (IRB) Registration form

Federal Enterprise Architecture: Health - Health Care Services