Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption

The purpose of the form is to provide institutions engaged in research conducted or supported by the Department of Health and Human Services (HHS) and other Common Rule signatory departments and agencies a simplified method of collecting information for IRB certification to satisfy the requirements of the Common Rule provisions at section 103, pursuant to 42 U.S.C. 289. The form also allows institutions engaged in human subjects research supported or conducted by a Common Rule department or agency to provide identification of their assurance status, and if applicable, declaration of exempt status. The respondents for this collection are institutions engaged in research involving human subjects where the research is supported or conducted by HHS; the form can also be used by institutions engaged in research supported or conducted by other Common Rule departments or agencies. That is, other federal departments and agencies that have codified or follow the Federal Policy for the Protection of Human Subjects (the Common Rule), which is codified for HHS at 45 CFR part 46, subpart A, can also rely on use of this form if they choose to adopt this process.

The latest form for Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption expires 2027-09-30 and can be found here.