IRB Guidance: Research and Sponsored Programs (RSP) Release of Grant Funds When Studies Are Ceded to Another Institution's IRB for Review and Approval
This page addresses what needs to be done when studies are ceded to another institution and grant funds need to be released.
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 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) or written agreement to document the agreement to cede IRB review from one institution to another.
The Office for Human Research Protections (OHRP) has recognized benefits in using a single IRB to review protocols on behalf of two or more institutions engaged in the same multisite research. In an April 30, 2010 letter, OHRP stated that it hopes that sponsors, institutions, institutional review boards (IRB), and clinical investigators involved in multicenter clinical research will consider the use of a single central IRB... especially if using centralized review could improve the efficacy of IRB review. Also, as of January 25th, 2018, multi-site studies funded by NIH will require single IRB review. Additionally, the New Common Rule, which is supposed to go into effect in January 2018, indicates that as of January 2020, single IRB review will be required for multi-site studies conducting the same research protocol.
Award Set-up in RSP When a Deferral Has Been Made
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 Deferrals and IRB Approvals for Award Set-up
It is the responsibility of the PI to provide 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 IAA (the IAA is uploaded into Arrow when it is fully executed) or other written agreement. Alternatively, the PI may provide RSP with documentation from a UW-Madison IRB confirming that IRB review has been ceded; this may take the form of an email or letter to the PI confirming the ceding of IRB review to another institution.
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 ceded studies, the PI must upload the following documents into WISPER:
- A copy of the fully executed IAA or other documentation from a UW-Madison IRB confirming the IRB reliance decision
- A copy of the reviewing IRB's approval notice for the initial review application
- On an annual basis, a copy of the reviewing IRB's approval notice for the continuing review application
- A copy of the reviewing IRB’s approval notice for any change of protocol when the change affects the grant (e.g. change in funding, addition of a new funding source, etc.)
- All copies of the reviewing IRB’s approval notice should include a date and clear indication that the initial review application, continuing review application or change has been “approved”.
Additionally, on the “Certifications” tab in WISPER, the PI should enter the word “deferred” in the box labeled “Assurance Number”. The PI should not list a UW-Madison IRB protocol number in this box when IRB review has been ceded to another IRB. This will alert RSP staff to look for evidence of a ceded approval (e.g. an IAA or other letter from a UW-Madison IRB) and an IRB approval notice from a non UW-Madison IRB as described above.