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FDA and OHRP IRB Registration Requirements

On January 15, 2009, the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) issued final rules mandating new or expanded registration of institutional review boards (IRBs). The rules are effective July 14, 2009. The FDA and OHRP may also publish additional guidance regarding the process.

Per the FDA final rule, "[a]ll IRBs must comply with the initial registration requirement and, if necessary, make required revisions to their registrations by September 14, 2009." OHRP expands existing registration requirements for IRBs. "Initial registration with all required information must be submitted within 60 days of the effective date of the rule, by September 14, 2009. For any IRB currently registered with OHRP, the institution or organization operating the IRB must submit all information required under this rule by the three year expiration date previously assigned by OHRP or within 90 days of any changes regarding the contact person who provided the IRB registration information or the IRB chairperson."

Quorum Review IRB is in compliance with current IRB registration requirements as it is registered with the United States Department of Health and Human Services (DHHS) Office of Research Protections (OHRP). Quorum’s OHRP number is IRB 00003226. Quorum is also fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Verification of AAHRPP accreditation can be obtained on the AAHRPP Website located at http://www.aahrpp.org/www.aspx.

At this time, a formal registration verification document or certificate is not provided to Quorum by the FDA or OHRP, and there is no indication that such a document will be provided once the new rules are in effect on July 14, 2009. Companies, however, are able to verify Quorum’s current registration on the OHRP website. Quorum also includes a Statement of Compliance on its website located at www.quorumreview.com and approval documents.