On June 12, 2012, the Food and Drug Administration (FDA) announced in the Federal Register the availability of a draft guidance document entitled, “Considerations When Transferring Clinical Investigation Oversight to Another IRB.”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’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.
The draft guidance is currently available on FDA’s website at the following web link: www.fda.gov/RegulatoryInformation/Guidances/ucm307757.htm.
Comments are due by August 13, 2012.
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. As a result of these efforts, OHRP has simultaneously published in the same issue of the Federal Register the availability of a draft guidance document entitled, “Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution."
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