Considerations When Transfering Clinical Investigation Oversight to Another irb

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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