It can be challenging for 91爆料 researchers to identify which IRB should review cancer-related research. This is because:<\/p>\n
<\/a><\/p>\n 91爆料 is a member of the Fred Hutch\/91爆料\/Seattle Children\u2019s Cancer Consortium<\/a>, a regional effort funded by the National Cancer Institute (NCI) to coordinate cancer-related research across 91爆料, Fred Hutch, and Seattle Children\u2019s. Cancer Consortium leadership defines what research conducted by those institutions is considered cancer-related.<\/p>\n Cancer-related research is research that meets any of the following criteria:<\/p>\n If the research meets any of the criteria above, it is considered cancer-related regardless of the departmental affiliation or academic discipline of the Principal Investigator (PI).<\/p>\n <\/a><\/p>\n The 91爆料 IRB does not have sufficient oncology expertise to review most interventional cancer research. In addition, there may be standing agreements by which another IRB should review the research. See below to identify the IRB that should review 91爆料 led, non-exempt cancer-related research. For exempt research, each institution involved in the research makes its own exemption determination.<\/p>\n Single Patient Expanded Access (Drug, Biologic, Device) or Compassionate Use (Device)<\/strong> Expanded Access Treatment (non-emergency) or HUD Protocols<\/strong> Industry-initiated-and-sponsored research<\/strong> Investigator-initiated, industry-funded research<\/strong> If the research is greater than minimal risk and\/or the 91爆料 IRB does not have appropriate membership expertise to review the research, and 91爆料 is the Primary Appointment of the PI as listed in the Cancer Consortium membership directory<\/a>, the 91爆料 activities must be reviewed by Fred Hutch or another IRB that has agreed to be the single IRB. Review is at the expense of the funding sponsor or study team.<\/p>\n If the research is minimal risk, and 91爆料 is the Primary Appointment of the PI as listed in the Cancer Consortium membership directory<\/a> the 91爆料 IRB will review the 91爆料 and Fred Hutch activities, but will not review for sites outside the consortium (e.g. Memorial Sloan Kettering Cancer Center (MSKCC)).<\/p>\n CITN studies<\/strong> NMDP and CIBMTR studies<\/strong> NCTN and cooperative intervention studies<\/strong> Pediatric cancer-related trials<\/strong> Participating site in a federally funded multi-site study not listed above<\/strong> Lead site in a federally funded multi-site study not listed above<\/strong> If the research is greater than minimal risk, and 91爆料 is the Primary Appointment of the PI as listed in the Cancer Consortium membership directory<\/a>, Fred Hutch may agree to be the single IRB if most of the sites are within the Cancer Consortium. Researchers should consult with the Fred Hutch IRO when preparing funding proposals in order to confirm this and to obtain information about Fred Hutch review fees<\/a>.<\/p>\n If the research is minimal risk, and 91爆料 is the Primary Appointment of the PI as listed in the Cancer Consortium membership directory<\/a>, 91爆料 IRB may agree to be the IRB according to its policy on serving as the single IRB<\/a>. Researchers must consult with HSD when preparing funding proposals in order to obtain confirmation.<\/p>\n For some research, for example large clinical trials, neither Fred Hutch nor 91爆料 may be able to serve as the single IRB. Researchers may need to obtain review from a commercial IRB for this research. The costs of this review will be the responsibility of the study team.<\/p>\n All other 91爆料-led cancer-related studies not described above<\/strong> If the research is more than minimal risk, and 91爆料 is the Primary Appointment of the PI as listed in the Cancer Consortium membership directory<\/a>, the Fred Hutch IRB does the review for the 91爆料 and any institutions within the Cancer Consortium, even if Fred Hutch is not otherwise involved in the research. The costs of the review will be the responsibility of the study team.<\/p>\n If the research is minimal risk, and 91爆料 is the Primary Appointment of the PI as listed in the Cancer Consortium membership directory<\/a>, the 91爆料 IRB will review for the 91爆料 activities and for Fred Hutch but not for sites outside of the Cancer Consortium (e.g. MSKCC).<\/p>\n <\/a><\/p>\n Follow the instructions for How to Ask for a Non-91爆料 IRB<\/a>. Be sure to identify all institutions (regional or otherwise) that are working with the 91爆料 researcher. HSD will issue an authorization letter for the study to be reviewed by the non-91爆料 IRB. For studies led by a 91爆料 PI, the Fred Hutch IRB will not begin its review until it has received this letter from the study team.<\/p>\n <\/a><\/p>\n Submit an application in the 91爆料\u2019s Zipline e-IRB system. If there are any other institutions engaged in the research who will be relying on the 91爆料 IRB\u2019s review (including Fred Hutch or Seattle Children\u2019s), make sure to follow the 91爆料 Reviewing for Other Institution(s)<\/a> pathway in Zipline.<\/p>\n If Fred Hutch is engaged in the research, request authorization for Fred Hutch to rely on 91爆料\u2019s review by completing the External IRB Cover Sheet<\/a> and submitting in Hutch IRB<\/a>. Once its review is complete, the Fred Hutch Institutional Review Office (IRO) will send an endorsement letter to proceed with external IRB review. This letter must be delivered to HSD for 91爆料 to complete the review on behalf of Fred Hutch.<\/p>\n <\/a><\/p>\n When Fred Hutch IRB reviews the research<\/strong> HSD does not charge an administrative fee to rely on the Fred Hutch IRB unless the research is industry-sponsored-and-initiated. Visit the page Industry Sponsored Research<\/a> for more information.<\/p>\n When 91爆料 IRB reviews the research<\/strong> Other institutions may or may not charge administrative fees to rely on the 91爆料 IRB. Study teams are responsible for identifying these fees and budgeting appropriately.<\/p>\n When another IRB reviews the research<\/strong> HSD does not charge an administrative fee to rely on other IRBs unless the research is an industry-sponsored-and-initiated clinical trial. Visit the page Industry Sponsored Research<\/a> for more information.<\/p>\n <\/a><\/p>\n Research led by another institution can often engage<\/a> the 91爆料. This usually happens when 91爆料 employees do things such as obtain consent, perform protocol required procedures or collect study data under the direction of a non-91爆料 PI. This most frequently happens when research is led by a Fred Hutch PI and takes place in 91爆料 facilities, but there can be other situations as well.<\/p>\n Cancer-related research led by a non-91爆料 institution such as Fred Hutch is almost always reviewed by that institution\u2019s IRB, or another IRB such as Advarra, WCG IRB, or the NCI cIRB. 91爆料\u2019s engagement must be accounted for in these circumstances, even if the Fred Hutch IRO has authorized review of the research by another IRB. This accounting for engagement is almost always accomplished by 91爆料 relying on the reviewing IRB rather than conducting its own review.<\/p>\n For the purpose of its relationship with Fred Hutch, 91爆料 considers the research to be Fred Hutch led when Fred Hutch is the Primary Appointment of the PI as listed in the Cancer Consortium membership directory<\/a>.<\/p>\n Use the brief WORKSHEET 91爆料 Engagement for Fred Hutch-led Research<\/a> to determine if 91爆料 is engaged in research led by Fred Hutch. For research led by other institutions, contact hsdrely@uw.edu<\/a> for a consultation.<\/p>\n If 91爆料 is engaged, follow the instructions for How to Ask for a Non-91爆料 IRB<\/a>. Be sure to identify all institutions (regional or otherwise) that are working with the non-91爆料 institution. Use the Quick Reference Guide<\/a> for additional support when preparing submissions.<\/p>\n <\/a><\/p>\n Due to 91爆料\u2019s membership in the Cancer Consortium<\/a>, there are additional requirements that may apply to cancer-related research, for example obtaining scientific review from the Cancer Consortium Scientific Review Committee<\/a> before the external IRB reviews the research and registration in the OnCore Clinical Trial Management System (CTMS)<\/a>. Researchers are responsible for identifying whether these requirements apply to their research.<\/p>\nWhat is Cancer-Related Research?<\/h2>\n
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Which IRB should do the review for 91爆料 led cancer-related research?<\/h2>\n
\nThese activities are not considered research; however an IRB must be involved in this process due to FDA requirements. 91爆料 physicians may use this process<\/a> to report these uses to the 91爆料 IRB. Fred Hutch physicians may use the same process, but only for emergency use.<\/p>\n
\nThese activities are not considered research, however an IRB must review the activity due to FDA requirements. These protocols should be reviewed by the IRB that would review the activities if they were research. This is usually either Advarra, WCG IRB, or Fred Hutch IRB. Investigators\/physicians and\/or their departments are responsible for any IRB review fees. Visit the page Expanded Access Guidance<\/a> for more information.<\/p>\n
\nThese studies are not required to have a single IRB of record. The 91爆料 portion of the research must be reviewed by Advarra, Fred Hutch, or WCG IRB at the sponsor\u2019s expense. HSD charges a one-time administrative fee for this research. Visit the page Industry Sponsored Research <\/a> for more information.<\/p>\n
\nThese studies are not required to have a single IRB of record.<\/p>\n
\nCancer Immunotherapy Network (CITN) studies must be reviewed by the National Cancer Institute\u2019s Central IRB.<\/p>\n
\nBone marrow donation or transplantation research involving the National Marrow Donor Program (NMDP) or the Center for International Blood and Marrow Transplant Research (CIBMTR) must be reviewed by the NMDP IRB.<\/p>\n
\nNational Clinical Trials Network and cooperative group intervention studies must be reviewed by the National Cancer Institute’s Central IRB. Researchers must work with the Cancer Consortium’s Clinical Research Support office<\/a> to obtain the IRB review.<\/p>\n
\nThese studies may or may not be required to have a single IRB of record depending on funding. These must be reviewed by the Seattle Children’s IRB<\/a> (if Seattle Children\u2019s is involved) or the Fred Hutch IRB unless another IRB has agreed to be the single IRB.<\/p>\n
\nThese studies are required to have a single IRB of record. The IRB is typically chosen by the lead site or coordinating center and should not be the 91爆料 IRB. Visit the page 91爆料 is a Participating Site<\/a>\u00a0for more information.<\/p>\n
\nThese studies are required to have a single IRB of record. The IRB is typically chosen by the 91爆料 investigators in consultation with HSD. The IRB that will do the review depends on (1) the level of risk to research participants; and (2) which other institutions are involved in the research. For example:<\/p>\n
\nThe IRB that does the review depends on (1) the nature of the 91爆料\u2019s participation; (2) which other institutions are involved in the research; and (3) the level of risk to the research participants. Consult with HSD at hsdrely@uw.edu<\/a> if you are not sure which IRB is appropriate.<\/p>\nWhat to do if Fred Hutch or another IRB will do the review<\/h2>\n
What to do if 91爆料 will do the review<\/h2>\n
What about fees?<\/h2>\n
\nFred Hutch IRB charges fees for IRB review of 91爆料-led cancer-related research. For all research approved after July 1st, 2025, these fees are the responsibility of the 91爆料 study team. Visit the Fred Hutch IRB fee webpage<\/a> for more information.<\/p>\n
\nExcept in rare circumstances, 91爆料 IRB does not charge fees for IRB review of 91爆料-led cancer-related research, including review on behalf of non-91爆料 institutions.<\/p>\n
\nOther IRBs vary significantly regarding whether or not they charge fees and how this fee is structured. HSD will not cover the cost of these fees. The fees must be paid for out of the study budget or other resources.<\/p>\nWhat about research led by a non-91爆料 institution?<\/h2>\n
Other Considerations for Cancer-Related Research<\/h2>\n