Considerations When Transfering Clinical Investigation Oversight to Another irb

Contains Nonbinding Recommendations 

 

 

5 

(7)

 

Notifying the key parties; and 

(8)

 

Updating IRB registration information. 

 

(1) Identifying those studies for which IRB oversight is being transferred. 

 

One of the first steps in the transfer process is determining for which studies IRB oversight is 

being transferred.  FDA recommends that the original and receiving IRBs have a clear 

understanding of this as it will help to bring certainty and continuity to the process and allow for 

effective planning, particularly when a large number of studies is being transferred.  The number 

of studies, the risk posed by them, and the circumstances leading to the transfer, as discussed 

below, will influence subsequent steps in the transfer process (e.g., whether records are obtained 

from the original IRB or the clinical investigator/sponsor, how the transfer date is established, 

and whether the receiving IRB decides to conduct a review before accepting responsibility for 

the research).