Industry Sponsored Studies
When Fred Hutch is the IRB of Record
A one-time fee is charged for new Industry funded studies submitted to the Cancer Consortium/Fred Hutch IRB which covers review of research activities involving human subjects, to ensure that ethical standards for the care and protection of human subjects have been established, and that research activities are in compliance with all pertinent regulations (federal, state and local) and with Fred Hutch policy.
When Fred Hutch is Not the IRB of Record
A one-time fee is charged for new Industry funded studies where Fred Hutch is “engaged” in the research and relies on an external (non-Fred Hutch) IRB. The fee helps cover the IRO’s costs for fulfilling mandatory regulatory and administrative responsibilities.
If you are conducting an industry sponsored research study, please build the one-time IRB fees into your study start-up budget. For those researchers whose budget is developed by Clinical Research Support or Division Administration please verify with them that the fee has been included.
These IRB fees are separate from the Cancer Consortium Protocol fee which may apply to research overseen by Fred Hutch Clinical Research Support. Fees will automatically be billed to your study budget.
Industry Sponsored Study = a study that has financial support from a commercial company. This includes studies that have been written by the commercial company or investigator.
Federally and Non-Federally Sponsored Studies
Effective January 25, 2018, IRB Fees will be charged to Performance Sites (outside the Cancer Consortium) that rely on Fred Hutch as the IRB of record. The fees apply to new or competing grants or contracts submitted on or after January 25, 2018.
Please build these fees into your budget when conducting multi-site trials where Fred Hutch will be the IRB of record.
For more information, please contact the IRO department.
Direct Cost Example Scenario
sIRB Fees and Grant Planning
A Fred Hutch PI prepares an NIH grant application out of which two protocols are planned—the first a study to be conducted at Fred Hutch and the University of Washington; the second a two-year, multi-site study in which Fred Hutch, Dana Farber, and Johns Hopkins will collaborate. The grant will be submitted to the NIH in February 2018.
The Fred Hutch PI will need to contact the Dana Farber and Johns Hopkins investigators to see if they want to participate, and discuss which institution’s IRB will be the IRB of record. The Fred Hutch PI would like the Fred Hutch IRB to the IRB of record, and the other investigators agree. The Fred Hutch PI and the investigators at Dana Farber and Johns Hopkins should each contact their IRB offices to see if this arrangement is agreeable. All agree, and the Fred Hutch PI will let the Fred Hutch Institutional Review Office know that IRB reliance agreements will be needed with Dana Farber and Johns Hopkins for this protocol.
In the NIH grant application, the Fred Hutch PI outlines the plan for Fred Hutch IRB to be the sIRB, and that Dana Farber and Johns Hopkins will rely on Fred Hutch IRB. In this scenario, Fred Hutch is the primary awardee and the sIRB, so primary activities are charged as Fred Hutch’s indirect costs, while the secondary activities at Dana Farber and Johns Hopkins may be charged as Fred Hutch’s direct costs.
Protocol #1 – Fred Hutch and University of Washington (UW)
No Charge for Fred Hutch PI and all activities occurring at consortium locations
Protocol #2: Fred Hutch, UW, Dana Farber, and Johns Hopkins
Initial Review
No charge for Fred Hutch PI and all activities occurring at consortium locations.
$3300 for review of Dana Farber investigator.
$3300 for review of Johns Hopkins investigator.
Continuing Review
No charge for Fred Hutch and all activities occurring at consortium locations.
$600 for review of Dana Farber investigator.
$600 for review of Johns Hopkins investigator.
Only one CRR is planned for the two-year study (end of Year 1). Therefore, when writing the grant, the Fred Hutch PI should plan for a total of $7800 in direct costs for IRB review.