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.
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.
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.