Considerations When Transfering Clinical Investigation Oversight to Another irb

 

 

I. 

INTRODUCTION  

 

This guidance discusses the regulatory responsibilities of institutional review boards (IRBs), 

clinical investigators, and sponsors when oversight of a previously approved, ongoing clinical 

investigation under FDA’s jurisdiction is transferred from one IRB to another IRB.  This 

guidance also addresses questions that have been previously raised concerning procedures and 

processes that are required and/or recommended by FDA when such oversight is transferred.   

FDA encourages individuals to contact the agency directly to discuss any unusual circumstances. 

 

To enhance human subject protections and reduce regulatory burden, FDA and the Office for 

Human Research Protections (OHRP) have been actively working to harmonize the agencies' 

regulatory requirements and guidance for human subjects research. This guidance document was 

developed as a part of these efforts.  For studies subject to 45 CFR part 46 (i.e., studies that are 

funded, conducted, or supported by the Department of Health and Human Services), OHRP 

issued a draft guidance entitled, “Considerations in Transferring a Previously Approved 

Research Project to a New IRB or Research Institution.”

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FDA's guidance documents, including this guidance, do not establish legally enforceable 

responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 

be viewed only as recommendations, unless specific regulatory or statutory requirements are 

cited.  The use of the word should in Agency guidances means that something is suggested or 

recommended, but not required.