Health Law Alert: OHRP Publishes New Registration Requirements for IRBs

On January 15, 2009, the Office for Human Research Protections (OHRP) published new registration requirements for institutional review boards (IRBs)1 and expanded the amount of information to be collected from registering IRBs. The requirements apply to IRBs designated under an assurance of compliance for federal-wide use by OHRP and engaged in human subjects research conducted or supported by the U.S. Department of Health and Human Services (HHS). Under the new rules, registration will be effective for three years. This final rule comes after OHRP’s Notice of Proposed Rulemaking, which was published on July 6, 2004.2

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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