HHS published a rule January 15, 2009 imposing registration requirements on 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 federal-wide use by the HHS Office for Human Research Protections (OHRP). The registration information will include contact information, numbers of all active protocols and active protocols involving research conducted or supported by HHS, and staffing for the IRB. The rule is effective July 14, 2009. Initial registration must be submitted by September 14, 2009, while IRBs currently registered with OHRP must comply by the three-year expiration date assigned by OHRP or within 90 days of certain IRB personnel changes. The FDA also issued a parallel rule to require IRBs to register through the HHS system and provide contact information and information on the number of active protocols involving FDA-regulated products and types of products reviewed. The rule is effective July 14, 2009, with a September 14, 2009 deadline for compliance with the initial registration requirement. In connection with the rule, the FDA released final guidance entitled “Adverse Event Reporting to IRBs -- Improving Human Subject Protection,” which is intended to help the research community interpret requirements for submitting reports of unanticipated problems, including certain adverse events reports, to IRBs. The document seeks to address concerns raised by the IRB community that increasingly large volumes of individual, unanalyzed adverse event reports are inhibiting the ability of IRBs to adequately protect human subjects.