Considerations When Transfering Clinical Investigation Oversight to Another irb

Contains Nonbinding Recommendations 

 

 

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from the informed consent requirements under 21 CFR 50.24, unapproved therapies with 

a high risk of morbidity and/or mortality, novel therapies including new cellular or gene 

therapies, and those flagged by the original IRB for more frequent review.  The receiving 

IRB may also decide to conduct an initial review if, for example, the IRB believes that 

there may be local issues that would warrant its review.  Initial review should also be 

considered where the receiving IRB has no familiarity with the original IRB, such that it 

may not be comfortable wholly relying on the original IRB’s review and approval.  The 

IRB should consider whether to conduct an initial review of device studies to make an 

independent determination of significant or non-significant device risk, particularly when 

the transfer occurs because of noncompliance by the original IRB.

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