The final rule specifies the following circumstances that require a revision to the registration
information [see 21 CFR 56.106(e)]:
If an IRB’s contact or chairperson information changes, the IRB must revise its
registration information within 90 days of the change.
If an IRB decides to review new types of FDA-regulated products (e.g., to review device
studies if it only reviewed drug studies previously) or to discontinue reviewing clinical
investigations regulated by FDA, it must report this within 30 days of the change.
If an IRB decides to disband, this must be reported within 30 days of permanent cessation
of the IRB’s review of research.
