FDA has issued final guidance on “Considerations When Transferring Clinical Investigation Oversight to Another IRB.”  The guidance is now available on FDA’s website:  https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM398613.pdf

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.  

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.