Thursday, June 21, 2012

New Draft FDA and OHRP Guidance: Comment Period Open

On June 12, 2012, the Food and Drug Administration (FDA) announced in the Federal Register the availability of a draft guidance document entitled “Considerations When Transferring Clinical Investigation Oversight to Another IRB.”

This guidance discusses the regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved clinical investigation under FDA jurisdiction is transferred from one IRB to another. The draft guidance also addresses questions that have been previously raised concerning procedures and processes that the FDA requires or recommends when oversight is transferred.

The Office for Human Research Protections (OHRP) has published “Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution” in the same issue of the Federal Register. OHRP and the FDA actively worked to harmonize the two documents.

The draft guidance is available on the FDA’s website at the following link:

The OHRP draft guidance document and instructions for how to submit comments can be accessed on the OHRP website at

Comments are due by August 13, 2012.

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