For HHS/OASH Consultation Process, Institutional Review Board (IRB) Records

The Office for Human Research Protections (OHRP) is requesting reinstatement of the Office of Management and Budget (OMB) information collection request, OMB No. 0990-0481, For HHS/OASH Consultation Process, Institutional Review Board (IRB) Records, with no changes, for a three-year period. The previous information collection was approved by OMB on February 14, 2022, and expired on February 28, 2025. The purpose of the collection is for OHRP to receive IRB records when an IRB or an institution requests an HHS consultation process, for proposed research that is not otherwise approvable by an IRB involving, respectively: (1) pregnant women, human fetuses or neonates; (2) prisoners; or, (3) children, as subjects. OHRP uses this information to determine whether or not an HHS consultation process should be performed.

The latest form for For HHS/OASH Consultation Process, Institutional Review Board (IRB) Records expires 2029-01-31 and is listed under ICR 202503-0990-001.