The new rule will provide FDA, as well as other interested parties (e.g., the IRB community,
sponsors, and clinical investigators), with a comprehensive listing of all U.S. IRBs that review
FDA-regulated research. It will also provide information about non-U.S. IRBs/IECs/RECs that
review FDA-regulated research and choose to voluntarily register. This more complete
knowledge of IRBs that actively review FDA-regulated studies will:
Facilitate our sharing of educational and other information with IRBs. We believe
that the lack of an accurate, complete, and regularly updated listing of IRBs involved
with the review of FDA-regulated studies limits our outreach and educational efforts;
Assist us in scheduling and conducting IRB inspections under our bioresearch
monitoring (BIMO) inspection program, by assuring up-to-date contact information;
and
Help us to prioritize IRB inspections.
