Considerations When Transfering Clinical Investigation Oversight to Another irb

Contains Nonbinding Recommendations 

 

 

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The complexity and duration of the IRB transfer process itself is expected to vary, depending on 

the reasons for the transfer, the parties involved, and the number and risk of the studies being 

transferred.  For example, transfer of IRB oversight due to purely administrative reasons such as 

consolidating IRB workload may be relatively quick and straight-forward, whereas a transfer of 

oversight due to the original IRB’s non-compliance might be lengthier and involve more 

complicated legal, regulatory, administrative, and logistical considerations.  In general, the type 

of IRBs involved (e.g., academic, hospital-based, independent) would not affect the steps to 

consider when transferring oversight.

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Section III of this guidance document provides recommendations concerning the transfer of IRB 

oversight from one IRB to another IRB that is not part of the same institution (including 

independent IRBs).  Section IV of this document addresses several special situations:  the 

transfer of oversight from one IRB to another IRB operating within the same institution, the 

temporary transfer of clinical investigation oversight to another IRB that occurs as a result of a 

natural disaster or for other reasons, and the transfer of a clinical investigation to a new research 

site requiring IRB review.