Funding source review assures at a minimum, 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 application form.
The NIH requires that federal grant applications, and the human subjects research activities to be supported by them, be reviewed by the IRB. Fred Hutch extends the NIH requirement to all types and sources of funding, including non-federal grants, industry contracts, private foundation funding, Center pilot funds, restricted gifts, discretionary funds, and other funds requiring a Fred Hutch Attachment A or Attachment B review. Review of the funding source document (FSD) is a necessary and integral part of IRB review.
All parts of the FSD that might directly or indirectly affect the conduct of human research must be reviewed-including but not limited to sections on specific aims, methods, human subjects, budget, personnel, and facilities.
When to Submit
- At initial review, funding that might directly or indirectly affect the conduct of human research must be reviewed - including but not limited to FSD sections on specific aims, methods, human subjects, budget, personnel, facilities. If a new application is submitted without a referenced funding source, the application is determined to be incomplete and review will not take place until the FSD has been submitted.
- When adding a new funding source and/or deleting a funding source to/from an existing IR file, submit a Research Modification Form and a Funding Source Supplement Form with the exception of interim or bridge funding tied to an existing grant. See IRB 2.5 Policy Modifications to Ongoing Activities. If adding and/or deleting a funding source is in addition to other modifications, a separate Protocol Modification Form is not required. However, the protocol modification form must clearly mention the FSD addition or deletion.
- At the time of Continuing Review, a Funding Source Supplement Form is submitted to disclose all active funding associated with the ongoing research.
What to Submit
- Federal Grants and other sponsored funding: A full copy of most recent competing application must be submitted along with the Funding Source Supplement Form. "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, submit 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, the grant does not need to be awarded prior to submission the IRB. If the grant scope of work changes between time of review by the IRB and notice 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.
- Industry Contracts or other "agreements": A copy of the contract or agreement including a scope of work and budget must be submitted along with the Funding Source Supplement Form. If the new funding source involves an industry sponsored agreement, a Research Trials Office (RTO) Industry Sponsored Form and Final Contract memo must be completed and submitted along with the Application for Review or Research Modification Form (to an existing IR File) to the IRB.
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.
- Non Sponsored Funding Requiring an Attachment B, other than interim or bridge funding tied to a specific grant: A scope of work, description of the type of funds (e.g., royalty account, divisional funds, PI discretionary funds), and budget must be submitted along with the Funding Source Supplement Form.
- Interim or bridge funding tied to a specific grant: For interim non-sponsored funding tied to a specific grant which has already been approved by the IRB, only the Attachment B form needs to be submitted. The grant associated with the interim funding must be identified on the Attachment B. IRO staff will conduct as administrative review to confirm the grant has already been approved by the IRB and will update the IRB records to indicate the grant scope of work has been extended through interim funding.
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 non-sponsored funding source as outlined above.
- Copies of the Core grant are not required 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.
- Cooperative review and IRB Authorization Agreement files do not need FSD review, since the IRB of record reviews the FSD.
- PI's submitting research for review by Fred Hutch IRB who have their primary appointment at another institution (e.g., University of Washington) are not required to submit non-sponsored funding sources for review.