FDA Issues Draft Guidance to IRBs Regarding Their Responsibilities to Evaluate Clinical Investigators and Research Sites and the Determination of the Need for INDs/IDEs

    November 2012

    The American Health Lawyers Association (AHLA) recently distributed to their Life Sciences and Teaching Hospitals and Academic Medical Centers Practice Group Members the Alert "FDA Issues Draft Guidance to IRBs Regarding Their Responsibilities to Evaluate Clinical Investigators and Research Sites and the Determination of the Need for INDs/IDEs," authored by Squire Sanders lawyers Maureen Bennett and Karl M. Nobert. It relates to the November 20 publication by the US Food and Drug Administration (FDA) of a Draft Guidance for institutional review boards (IRBs) regarding their responsibilities to evaluate the qualifications of clinical investigators and the adequacy of research sites used in connection with clinical research.

    Please note that the FDA is accepting comments until January 22, 2013, on the Draft Guidance referenced in the AHLA Alert. That document is titled, "IRB Responsibilities for Reviewing Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed" (PDF). 

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