Institutional Review

Consortium members submit new therapeutic oncology and cancer-related protocols to the Fred Hutch Institutional Review Board (IRB), which also serves as the Cancer Consortium IRB (CC-IRB).

 

Submissions to CC-IRB

All cancer-related intervention studies are required to undergo scientific peer review prior to review by the by the Institutional Review Board.  The Fred Hutchinson IRB serves as the Cancer Consortium IRB.  Clinical Research Support (CRS) can help determine if scientific review is required for a particular study and then manages submissions to review committees.  All studies from the Fred Hutchinson Clinical Research Division and from members of the Cancer Consortium should be submitted via Clinical Research Support.

Application forms for CC-IRB

Please use the most current application forms for the CC-IRB.  Questions regarding the application may be directed to either your Protocol Review Coordinator or the FHCRC Institutional Review Office.

University of Washington Significant Financial Interest: Principal Investigators with a primary appointment at the UW must report any significant financial interest.  A completed UW/CC-IRB Coversheet and Review Authorization must be included with all new applications submitted to the Cancer Consortium IRB via Clinical Research Support.

Radiation Safety Committee Review and Institutional Biosafety Committee Review

Radiation Safety review will be done by the University of Washington Radiation Safety Committee (RSC) for radiation that will be performed at the UW patient care sites. Radiation Safety review will be done by the SCCA RSC for radiation that will be performed at the SCCA. If radiation will be performed at both UW and SCCA sites the join HSRAC Committee at UW may review the study. RSC committee review may be simultaneous with IRB review.

The Investigator or study staff for the study is responsible for submitting the appropriate documents to the RSC(s). The UW RSC,SCCA RSC, and HSRAC at UW may forward result letters to the CC-IRB or WIRB once review is complete. The researcher or study staff should submit any result letters from the UW or SCCA Radiation Safety Committees to the appropriate institution performing the Humans Subjects Review.

Institutional Biosafety is generally required for the use of recombinant DNA in humans (gene transfer or recombinant vaccines). IBC review will be done by the UW Institutional Biosafety Committee (IBC) if material will be injected into patients at the UW. Institutional Biosafety review will be done by the SCCA IBC if the material will be injected into patients at the SCCA.

The Investigator or study staff for the study is responsible for submitting the appropriate documents to the IBC(s). Both the UW IBC and SCCA IBC may forward result letters to the CC-IRB or WIRB once review is complete. The researcher or study staff should submit any result letters from the UW or SCCA Institutional Biosafety Committees to the appropriate institution performing the Humans Subjects Review.

Mandatory Training Prior to Obtaining IRB Approval

Good Clinical Practice (GCP) Training: The FHCRC/UW Cancer Consortium requires that all sponsor/investigators, principal investigators and research staff involved in the design, conduct or reporting of therapeutic clinical studies and prevention studies involving drugs, biologics or devices to complete GCP Training. For detailed information about GCP Training and training options including web-based modules through CITI go to the IRB CenterNet or Extranet website:

Human subjects training is required for investigators and staff involved in the design, conduct, or reporting of human subjects research conducted at FHCRC or through the Cancer Consortium. Training must be completed every 3 years. The IRO will track your training and send reminders. For detailed information about Human Subjects Training and training options go to the IRB CenterNet or Extranet website.

Consents and HIPAA

Studies submitted by University of Washington investigators and funded via the UW can use the FHCRC or UW consent templates; however it is preferred and strongly recommended by the CC-IRB that the FHCRC consent template be used. It is required that UW compensation language regarding injury from adverse events be included in the consent forms.

The FHCRC consent template can be found in the forms section of the FHCRC-IRB. The consent template posted includes specific instructions for UW required compensation language.

It is a requirement of the UW HSD that UW consortium studies create a separate document for HIPAA authorization. The template for the UW HSD required HIPAA authorization can be found in HSD documents.

Contacts:

Clinical Research Support:

206-667-4520

Institutional Review Office:

206-667-5900

 

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