This post was written by Erin Janssen.

The FDA has published a notice announcing the availability of draft guidance on “Considerations When Transferring Clinical Investigation Oversight to Another IRB.”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’s jurisdiction is transferred from one IRB to another IRB. This guidance also addresses questions previously raised concerning procedures and processes that are required and/or recommended by FDA when such oversight is transferred. Comments are due by August 13, 2012.