The protocol fee is a one-time fee for services to industry-sponsored studies rendered in the Fred Hutchinson Cancer Research Center IRO (which administers the Fred Hutch and Cancer Consortium IRBs), Cancer Consortium Clinical Research Support, and UW Human Subjects Division.
Protocol fees have been collected for Fred Hutch-based studies since the late 1980s. With the creation of the Cancer Consortium, that policy was extended to cover studies where the PI has their primary appointment at the UW and the funding for the study was processed through the UW.
Fee Criteria and Information
Fees are charged for all industry-sponsored studies. The only studies exempt from these fees are investigator-initiated clinical studies that do not receive financial support from a commercial company.
It is important to note that:
- These fees are separate and distinct from the fee WIRB charges for their review.
- This fee is separate and distinct from the fee UW HSD charges for oversight and recordkeeping. However, for studies reviewed by the CC-IRB, the UW HSD will waive their fee (this is reflected in the fee chart below).
For contracts that began negotiations on or after October 1, 2010, the CC-IRB began assessing a one-time fee for new industry-initiated and sponsored studies. That fee is collected along with the protocol fee.
For contracts that began negotiations on or after September 1, 2012, there were several changes:
- The Fred Hutch IRB/Cancer Consortium IRB instituted a fee for multi-site trials where they serve as the IRB of record for a site outside the Consortium.
- Fred Hutch trials managed by the SCCA Phase 1 Team eligible for WIRB review will be charged by the Fred Hutch IRB for management of the file.
- The fee for WIRB reviewed studies was increased and the level of service offered to those studies expanded to include posting on Clinical FYI of protocol documents.
- Investigator-initiated studies that receive industry funding will be charged fees per the schedule below.
For new industry-sponsored studies that entered contract negotiations on or after July 1, 2014, the IRB review fee increased from $2500 to $3000.