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

The purpose of this Form is to provide a simplified procedure for institutions engaged in research conducted or supported by the Department of Health and Human Services (HHS) to satisfy the requirements of HHS regulations for the protection of human subjects at 45 CFR 46.103. The respondents for this collection are institutions engaged in research involving human subjects where the research is supported by HHS. Institutional use of the form is also relied upon by other federal departments and agencies that have codified or follow the Federal Policy for the Protection of Human Subjects (Common Rule) which is identical to 45 CFR part 46, subpart A.

The latest form for Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption expires 2021-04-30 and can be found here.