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Focus on Regulation

Tag Archives: IRB

HHS Seeks Comments on Transfer of IRB Oversight Draft Guidances

HHS’ Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) have simultaneously released notices seeking comments on draft guidance documents regarding the transfer of previously approved research projects to another Institutional Review Board (IRB) or research institution.  These guidances were released as part of a joint effort between the FDA and… Continue Reading