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Release of Grant Funds When IRB Review for a Study is Ceded to an External IRB

Version: March 2019

When one institution agrees to use another institution's IRB to review a human subjects protocol, this is known as ceding of IRB review or IRB reliance. Use of IRB reliance is not limited to clinical studies, butstudies, but may be employed for IRB review of any human subjects protocol, so long as the Institutional Official at each institution agrees that IRB reliance is appropriate. OHRP requires the use of an IRB Authorization Agreement (IAA)to document the agreement to cede IRB review from one institution to another.

Award Set-up in RSP When IRB Review Has Been Ceded

No funds for grants which support human subjects research may be released by RSP until RSP has obtained documentation that the human subjects research project has received IRB review and IRB approval. Inherent in this IRB review, is the requirement that the reviewing IRB compare the grant application to the protocol submitted to ensure that the protocol application appropriately aligns with grant objectives.

Procedure for Documenting Ceded Studies and IRB Approvals for Award Set-up

The PI (or designee – typically departmental research administration support) is responsible for providing documentation to RSP that UW-Madison has formally agreed to cede IRB review to another institution's IRB. This may be demonstrated by providing RSP with a copy of the letter issued by UW-Madison’s IRB staff when IRB review for a study has been formally ceded to an external IRB. This letter can be downloaded from ARROW.

The fact that UW-Madison has agreed to cede IRB review does not equate to protocol review and approval. Thus, if a protocol is ceded to another institution for IRB review, it is not enough for the PI to provide evidence that IRB review has been ceded, as this does not demonstrate that the reviewing IRB has reviewed the protocol and issued an approval notice. As a result, for all deferred studies, the PI (or designee) must upload the following documents into WISPER:

  • A copy of the letter from a UW-Madison IRB confirming the IRB reliance decision
  • A copy of the reviewing IRB's approval notice for the initial review application

All copies of the reviewing IRB’s approval notice should include a date and clear indication that the initial review application has been “approved”.

Additionally, on the “Certifications” tab in WISPER, the PI (or designee) should enter the UW-Madison protocol number in the “Assurance Number” field. All ceded studies are now in ARROW and will receive a standard protocol number. RSP staff will investigate appropriately to ensure ato look for evidence of a letter agreeing to cede IRB review and an IRB approval notice from a non UW-Madison IRB has been obtained, as described above.




Keywords:grants, deferral, deferred, IRB of record, cede   Doc ID:26824
Owner:Carol P.Group:Health Sciences IRBs
Created:2012-10-15 07:23 CSTUpdated:2019-04-12 07:58 CST
Sites:Health Sciences IRBs
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