Office of Public Health and Science; Institutional Review Boards: Registration Requirements

The Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS), is adding a new subpart E to the HHS protection of human subjects regulations, which requires institutional review boards (IRB) that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federalwide use by OHRP to register with HHS. The registration information includes contact information, approximate numbers of all active protocols and active protocols involving research conducted or supported by HHS, and staffing for the IRB. The registration requirements will make it easier for OHRP to convey information to IRBs and will support the current IRB registration system operated by OHRP. Under this final rule, the IRB registration system is compatible with the IRB registration requirements of the Food and Drug Administration (FDA), which are simultaneously published as a final rule in this issue of the Federal Register, allowing the operation of a single HHS IRB registration system.