Regulatory Updates from FDA and OHRP

FDA is currently seeking public comments regarding its Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable. The guidance was published in 2006 and is due to expire in 2013. Comments will be accepted until August 13, 2012.

FDA also announced the availability last week of its Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board. This parallels a document simultaneously released by OHRP, titled Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution. Comments on either of these draft guidances should be submitted to the issuing agency on or before August 13, 2012, to allow time for consideration before work begins on the final version.


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