Funding Source Document (FSD) Review

Funding source review allows the IRB to ensure that there are adequate resources to conduct the research activity and to confirm that the activity described in the funding proposal matches the activity proposed in the protocol. IRO also facilitates review by the Office of General Counsel, with the aim of ensuring consent language accurately conveys any study payments and any compensation in the case of a study-related injury/illness.

Studies reviewed by the Fred Hutch IRB: One of the responsibilities of the IRB under the Pre-2018 Requirements of the Common Rule is to review federal grant applications and the human subjects research activities to be supported by them. Fred Hutch extends this requirement to all types and sources of external funding, including to research approved under the 2018 Common Rule (e.g., non-federal grants, industry contracts, private foundation funding, restricted gifts, and other funds).

Studies reviewed by an External IRB:  If Fred Hutch is the recipient of a federal award or a signatory on a funding agreement, the funding source document requires administrative review by IRO, as part of the External IRB submission.

Funding Sources that Require Review

Both internal and external support must be listed for the IRB's review. A funding source document (FSD) must be attached for all external support.

Support includes both monetary and non-monetary support, such as provision of study drug, equipment, facilities, or other non-monetary research support.

When to Submit

New studies: Within the Hutch IRB SmartForm, the study team must identify at initial submission each organization that will fund or support the study (including monetary and non-monetary support).  If a new study is submitted without a referenced funding source document, the application is determined to be incomplete, and final approval cannot be issued until the finalized FSD has been submitted.

Modifications: When adding a new funding source, or removing an expired funding source, a modification must be submitted in Hutch IRB.  A modification is also necessary to reflect a no-cost extension of an existing grant. (The only exception to the modification requirement is interim or bridge funding tied to an existing grant on the IRB file, unless the interim or bridge is for a scope of work beyond that of the original grant.)

Continuing Reviews:  When preparing to create a continuing review submission, the study team should review all funding listed in Hutch IRB to ensure it is current and accurate. If any updates are needed, including any no-cost extensions, prepare a combined Modification/Continuing Review submission to address the funding updates at the same time.

Annual Status Reports:  For studies not subject to the continuing review requirement, an annual status report email reminder is sent out directly from Hutch IRB.  Upon receipt, the study team should review all funding listed in Hutch IRB to ensure it is current and accurate. If any updates are needed, including any no-cost extensions, prepare a Modification submission to address the funding updates at that time so the file remains accurate and complete in Hutch IRB.

What to Submit

1. Federal grants and other sponsored funding: 
   
   • A full copy of most recent competing application must be submitted when it is first added to the IRB file. "Full" is everything but appendices. "Full" means the face page, personnel, budget, facilities pages as well as scientific and human subjects sections; just the "specific aims" section is not sufficient, nor is a progress report from a non-competing continuation. Individual salaries may be blacked out, but the overall budget information must be provided. 
   • For program project grants, the relevant project(s) from the most recent competing application may be submitted in lieu of the entire grant. 
   • Grants may be submitted for IRB review at anytime during the grant application and funding cycle, that is, the grant does not need to be awarded prior to submission the IRB. However, if the grant scope of work changes between time of review by the IRB and the notice of grant award, the awarded grant with an updated scope of work must be submitted to the IRB as an updated funding source.
   • When a grant completes a competing renewal cycle, it is considered a "new" funding source. The competing grant application must be submitted to the IRB as if it was a new grant.
2. Funding from a foundation:
   • A funding source document is required, but it will vary depending on the application process and what the foundation provides as documentation. For example, normally you had to submit a scope of work to obtain the funding, so you should provide that scope of work as your funding source document. If no scope of work was submitted, provide a letter or other documentation from the foundation indicating the award.
3. Industry Contracts or other "agreements": 
   • A copy of the contract or agreement, including a scope of work and budget, must be submitted.
     
   • Unsigned contracts may be submitted for review. When the final contract is signed, a copy of the finalized contract must be submitted to the IRB for review. The final contract and most currently proposed consent document(s) are reviewed by the General Counsel prior to release of IRB approval documents.
     
4. Internal Funds such as discretionary or departmental funds, gifts or donations, endowment support, royalties, etc.: 
   • List the funding in Hutch IRB. No funding source document is required to be attached.
5. Interim or bridge funding tied to a specific grant: 
   • If the interim funding is for a scope of work beyond that of the original grant, or if the grant was not approved under a particular IRB file(s), then the interim funding must be submitted as a new funding source as outlined above.
     
6. Exceptions:
   • Copies of the Cancer Center Support Grant (CCSG) are not required to be submitted because it undergoes a comprehensive separate review.
   • Cooperative Oncology Group studies (i.e., NSABP, GOG) do not require individual FSD's since the FSD is reviewed with the "master" coordinating center.