New Regulations Mandate Institutional Review Board Registration
The Office for Human Research Protections (OHRP) has added a new subpart
to the HHS protection of human subjects regulations requiring
Institutional Review Boards to register with HHS.
The new regulation applies to IRBs that review human subjects research conducted
or supported by HHS and that are designated under an assurance of compliance
approved for federal-wide use by OHRP (see 74
FR 2399). Information to be registered includes contact information, number of active research protocols, and IRB staffing. A companion regulation was issued by the
Food and Drug Administration requiring registration for IRBs reviewing clinical investigations involving FDA-regulated products (74 FR 2358). A single HHS registration system for
both regulations will be accessible on the OHRP Web site. The two rules become effective July 14, 2009, and initial
registration must be submitted by September 14, 2009. Please contact OHRP directly for additional information.
Return to Table of Contents |