Considerations When Transferring Clinical Investigation Oversight to Another IRB Guidance for IRBs, Clinical Investigators, and Sponsors May 2014

GUIDANCE DOCUMENT

• Docket Number: FDA-2011-D-0835
• Issued by: Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice; Center for Drug Evaluation and Research; Center for Devices and Radiological Health; Center for Biologics Evaluation and Research

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(i.e., studies that are funded, conducted, or supported by the Department of Health and Human Services), OHRP issued a draft guidance entitled, “Considerations in Transferring a Previously Approved Research Project to a New IRB or Research Institution.”

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