Contains Nonbinding Recommendations
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(8) Updating IRB registration information.
The IRB registration rule at 21 CFR 56.106(e) requires that any IRB that decides to review FDA-
regulated research involving new types of FDA-regulated products, or decides to discontinue
reviewing FDA-regulated research, must revise its registration within 30 days of the change in
product type review or permanent cessation of the IRB’s review of research. A receiving IRB
may therefore need to revise its registration if it previously did not review clinical investigations
of FDA-regulated products or if it will assume the review for a new type of FDA-regulated
product upon the acceptance of clinical investigations from an original IRB (e.g., the receiving
IRB will now review clinical investigations of medical devices, whereas the IRB previously
reviewed only clinical investigations of drugs). Similarly, the original IRB may need to update
its registration information if it will no longer be reviewing a certain type of FDA-regulated
product, will no longer be reviewing FDA-regulated research, or plans to disband. IRBs must
revise their registration within 30 days of any such changes and may do so electronically through
http://ohrp.cit.nih.gov/efile
.
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