Cancer Consortium IRB
Cancer Consortium IRB
- Submissions to the CC-IRB
- Application forms for CC-IRB
- Consents and HIPAA
- Radiation Safety Committee Review and Institutional Biosafety Committee Review
- Application forms for WIRB
- Communication Letters regarding Cancer Consortium IRB
- FAQS
- Cancer Consortium Protocol Office and Cancer Consortium (FHCRC) IRB Contacts
As of September 1, 2005, Cancer Consortium members have submitted new therapeutic oncology and cancer-related protocols to the Cancer Consortium IRB at FHCRC. The duties of the Cancer Consortium IRB (CC-IRB) are being performed by the FHCRC-IRB. In addition, renewals of Cancer Consortium studies currently approved by the University of Washington as of January 1, 2003, are being submitted to the CC-IRB, beginning with approvals that expired after December 31, 2005.
Industry-sponsored studies funded through the University of Washington may be submitted to Western IRB or to the CC-IRB.
Grants and contracts will continue to be negotiated by the institution receiving the award. *At this time, no changes are being made to the submission process for Seattle Children's studies.
Submissions to the CC-IRB
Studies that are eligible to be submitted to the CC-IRB for review are studies where the PI is a Cancer Consortium member and the study is cancer related. Submissions to the CC-IRB for FHCRC CRD and UW Consortium studies must be submitted via the Cancer Consortium Protocol Office. Please go to www.cancerconsortium.org/shared_resources/rto/protocol_office/ for submission procedures relating to the Cancer Consortium Protocol Office.
The Cancer Consortium as a Comprehensive Cancer Center is required to execute scientific peer review for all intervention studies prior to submission for IRB review. To find out if scientific review is required for your study, please go to www.cancerconsortium.org/shared_resources/rto/protocol_office/forms/checklist.pdf. The Cancer Consortium Protocol Office will assist with submissions to the scientific review committees.
Application forms for CC-IRB
Application forms for the CC-IRB can be found at http://extranet.fhcrc.org/EN/sections/iro/irb/forms/index.html. The forms currently posted on the site have undergone revisions to make them additionally user friendly to non-FHCRC Cancer Consortium members in addition to other required changes. Please use the forms currently posted on the website. Address questions to the CC-PO or the FHCRC-IRO.
University of Washington Significant Financial Interest: For all UW Cancer Consortium studies that will be submitted to the Cancer Consortium IRB a form reporting any significant financial interest by study investigators must be completed. Studies submitted to the Cancer Consortium IRB must complete the UW/CC-IRB Coversheet and Review Authorization. This form must be included with all new applications submitted via the Cancer Consortium Protocol Office to the Cancer Consortium IRB.
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 website at http://extranet.fhcrc.org/EN/sections/iro/irb/forms/index.html. 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 at http://www.washington.edu/research/hsd/formRetrieve.php?ver=accreditation&id=134.
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 both must 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). Both the UW RSC and SCCA RSC 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.
Application forms for WIRB
Communication Letters regarding Cancer Consortium IRB
FAQs
Cancer Consortium Protocol Office and Cancer Consortium (FHCRC) IRB Contacts
Protocol Office
(206) 667-4520
ProtocolOffice@cancerconsortium.org
Mailstop LM-230
Contact for submissions to the Cancer Consortium IRB.
Basic questions regarding the submission process can also be answered.
Karen Hansen
(206) 667-4867
khansen@fhcrc.org
Mailstop J6-110
FHCRC IRO Director
Contact for submission questions related to IRB procedures and forms.
