The 91爆料 IRB does not, in most cases, review research that is both industry-sponsored and industry-initiated. HSD currently requires that most industry-sponsored-and-initiated research be reviewed by one of two independent IRBs:<\/p>\n
If the study is cancer-related and the 91爆料 PI is a member of the Cancer Consortium<\/a>, the study may instead be reviewed by the Fred Hutch IRB.<\/p>\n The 91爆料 PI, in consultation with the sponsor and\/or any Contract Research Organization (CRO) managing the study, is responsible for choosing which IRB to submit to for review and for preparing and submitting the application materials.<\/p>\n Advarra and WCG IRB charge fees for most of the IRB review services they provide. HSD will not pay these fees. In most cases, Advarra and WCG IRB will bill the sponsor directly. However, in some cases, the 91爆料 study team will be billed and the sponsor expects to reimburse the costs of the fees. The 91爆料 PI is responsible for understanding how IRB review fees will be paid for.<\/p>\n If you have questions about WCG IRB or Advarra’s fees, contact the client services departments of the IRBs directly and mention that you are affiliated with the 91爆料. For WCG IRB, note that the “Institutional” Fee Schedule is the schedule that applies to industry-sponsored research for which the 91爆料 is one of multiple sites.<\/p>\n The Fred Hutch IRB also charges fees for review of industry-sponsored research. HSD will not pay these fees. The sponsor and\/or study team is responsible for paying any review fees charged by the Fred Hutch IRB<\/a>.<\/p>\n HSD charges a one-time administrative fee to help cover HSD\u2019s costs for fulfilling mandatory regulatory and administrative responsibilities where the indirect cost rate does not cover these activities.<\/p>\n This includes industry-sponsored-and-initiated clinical trials that are reviewed by a non-91爆料 IRB and for which the contract for the study was executed by the 91爆料 Office of Sponsored Programs (OSP).<\/p>\n As of July 1, 2025, the fee is $2117.78. The fee is evaluated annually with any increases applied at the start of each fiscal year (i.e., July 1st).<\/p>\n When requesting authorization from HSD for each study, researchers must provide the worktag they wish the fee to be charged to. This may be any worktag the unit chooses. HSD may begin work on the application without a worktag, however it will not authorize the research for review by the external IRB until a worktag has been provided.<\/p>\n After the study has been authorized, HSD will work with the Office of Research to charge the fee to the worktag in Workday. The Office of Research does not send paper or electronic invoices.<\/p>\n In rare circumstances, HSD may waive the fee. Note that not successfully getting funded is not a valid reason for a fee waiver. Researchers must request a fee waiver by sending a written request to hsdrely@uw.edu<\/a>. The request must be made prior<\/strong> to applying for authorization in Zipline. Waivers are not granted after HSD’s review has begun. The request should include:<\/p>\n HSD considers the following factors when evaluating the waiver request:<\/p>\n HSD will communicate its determination to the PI.<\/p>\n Before you submit for review to Advarra, WCG IRB, or the Fred Hutch IRB, follow the instructions under How to ask for Non-91爆料 IRB review<\/a> to obtain authorization. Although HSD has established reliance agreements with those IRBs, it must authorize the use of any external IRB for each study. Advarra, WCG IRB, and the Fred Hutch IRB will not review applications without documentation of this authorization.<\/p>\n On the WCG IRB application form, under this question:<\/p>\n Will this research be conducted through an organization that has a contract or Master Services Agreement (MSA) to use WCG IRB for IRB services?<\/em><\/p>\n Applications may be submitted to the IRB by the 91爆料 study team or by the sponsor\/CRO. When applications relevant to the 91爆料 are submitted by the sponsor or CRO, WCG IRB will hold the submission for 5 days and notify the 91爆料 study team so that they may confirm that the submission is correct and reflects the 91爆料 sites activities.<\/p>\n New to submitting applications to WCG IRB? Work with WCG IRB’s representative to the 91爆料 to understand the application and approval process.<\/p>\n Andy Parkhurst (Institutions Partnership Manager) When registering for an account in CIRBI<\/a>, Advarra’s online system, make sure to list your institutional affiliation as “91爆料.”<\/p>\n New to submitting applications to Advarra? Work with Advarra’s representatives to the 91爆料 to understand the application and approval process.<\/p>\n Celeste Duran or Andrew Saunders 91爆料 PIs are responsible for following the policies of the external IRB. This includes submitting to the reviewing IRB using their forms and processes (or assisting the sponsor or CRO with that process), following their reporting requirements for unanticipated problems and new information about the study, and complying with the stipulations of the IRB’s approval.<\/p>\n 91爆料 PIs are also responsible for:<\/p>\nContents<\/h3>\n
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IRB review fees<\/h2>\n
HSD administrative fee<\/h2>\n
Process<\/h3>\n
Fee Waiver<\/h3>\n
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Requesting authorization<\/h2>\n
WCG IRB specific instructions<\/h2>\n
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\naparkhurst@wcgclinical.com<\/a><\/p>\nAdvarra specific instructions<\/h2>\n
\ninstitutions@advarra.com<\/a><\/p>\n91爆料 researcher responsibilities<\/h2>\n
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