An IRB that fails to register could be considered noncompliant with these regulations. As part of
our inspectional activities, FDA may conduct an inspection of an IRB to verify compliance with
regulatory requirements, including the requirement for an IRB to register under 21 CFR
56.106(a).
Sponsors and clinical investigators are required by FDA regulations governing the conduct of
clinical studies (21 CFR Part 312 for drugs and biologics and 21 CFR Part 812 for devices) to
use IRBs that comply with 21 CFR Part 56. Therefore, if a sponsor and/or clinical investigator
submits a study for review to an unregistered IRB, that sponsor and/or clinical investigator could
be considered noncompliant with FDA regulations.
In addition, we plan to use the information accrued through the IRB registration system to
distribute educational materials to IRBs that review FDA-regulated studies (see #2 above).
Therefore, sponsors and/or clinical investigators who use IRBs that are not registered run the risk
that the IRB may not be familiar with our current policies.
