Considerations When Transfering Clinical Investigation Oversight to Another irb

Contains Nonbinding Recommendations 

 

 

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When a large number of clinical investigations are being transferred, it may be preferable to 

phase-in the transfer over a period of weeks or months to facilitate a smooth transition.   

 

If oversight is being transferred because of the closure of an IRB, the original IRB is expected to 

inform all clinical investigators and/or sponsors, as appropriate, of the pending closure date.  If 

oversight by a new IRB cannot be obtained by the closure date, approval for the research would 

be considered suspended or terminated with no further subject enrollment.

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  The original 

IRB must follow its written procedures for ensuring prompt reporting to its institutional officials 

and FDA of the suspension or termination, as required under 21 CFR 56.108(b)(3).

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  In 

addition, sponsors of device studies must report to FDA and all reviewing IRBs and participating 

investigators any instances of IRB withdrawal of approval of an investigation or a part of an 

investigation within 5 working days after receipt of the withdrawal of approval.

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 Sponsors of 

drug/biologic studies must report to FDA the discontinuance of a clinical investigation.

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(4) Conducting a review by the receiving IRB, where appropriate, before it accepts