Research Involving Benaroya/Virginia Mason

Research involving two institutions normally requires review by each institution’s IRB. To avoid this “dual review” and the extra work it requires from researchers, Benaroya Research Institute (BRI) and the 91探花IRB have a reliance agreement that describes the circumstances in which one of the IRBs will conduct the review on behalf of both institutions.

Use the flow chart below to determine which IRB should do the review. If you have any questions, consult HSD at hsdrely@uw.edu or BRI at CRP@Benaroyaresearch.org.

Before you begin

  1. Assess whether both institutions are engaged in the research. If only one institution is engaged, you should submit to that institution’s IRB. Consult with HSD at hsdrely@uw.edu to identify whether 91探花is engaged.
  2. Assess whether another IRB is the right option. For example, most industry-sponsored research at 91探花should be reviewed by an independent IRB (for example, Advarra) and some cancer-related research should be reviewed by the Fred Hutch IRB or the NCI IRB. Review the information about identifying the correct IRB if you are unsure.

What to do if Benaroya will do the review

  1. Submit an External IRB Application in UW’s Zipline system to request HSD’s formal authorization for BRI to review the research. HSD will evaluate your request and provide you with a written authorization letter.
  2. The BRI investigator should prepare and submit an application to the BRI IRB, using BRI’s forms and process. Be sure to attach the HSD authorization letter; the BRI IRB will not review the application on behalf of 91探花without this letter.
  3. After the BRI IRB has approved UW’s participation, send the approval letter to hsdrely@uw.edu.
  4. Obtain all other applicable ancillary reviews (consult the Checklist of Researcher Responsibilities for Externally Reviewed Studies) from the usual IRB offices and BRI, as needed. Examples: Financial Conflict of Interest (FCOI) review; Radiation Safety review.
    • Exception: BRI will provide Genomic Data Sharing (GDS) certification (if necessary) on behalf of both institutions.

What to do if 91探花will do the review

  1. Submit a 91探花IRB application in the Zipline system. Be sure to:
  2. Submit a request to rely on the 91探花IRB to the BRI IRB using BRI’s forms and processes. Contact CRP@Benaroyaresearch.org for assistance or instructions. BRI will evaluate your request and provide you with written authorization for the 91探花IRB to do the review. Include this written authorization in your application to 91探花or email to hsdrely@uw.edu.
  3. The 91探花IRB will review and approve the overall protocol. This is not yet approval for the involvement of BRI. After the 91探花IRB has approved the overall protocol, HSD鈥檚 Reliance Team will work with you to approve the addition of BRI to the 91探花application.
  4. After 91探花IRB approval for BRI has been obtained, you are responsible for:
    • Informing the BRI IRB of UW’s approval for BRI.
    • Informing BRI investigators about any conditions of the IRB approval.
    • Informing BRI investigators about their obligation to comply with 91探花IRB reporting requirements about noncompliance, complaints, problems, etc., although such reports must be submitted by you to the 91探花IRB.
  6. BRI investigators remain responsible for obtaining any applicable ancillary reviews from BRI. Examples: Financial Conflict of Interest (FCOI) review, Radiation Safety review.
    • Exception: 91探花will provide Genomic Data Sharing (GDS) certification (if necessary) on behalf of both institutions.

BRI or 91探花IRB Decision Tree

This flowchart shows the decision making process for choosing between the 91探花IRB and the Benaroya/Virginia Mason Research Institute IRB. The first question is: Is there external funding for the research. If the answer to this is NO: consult with HSD by emailing hsdrely@uw.edu. Usually the institution doing most of the subject contact and research procedures will conduct the review. If the answer to this is YES: then the next question to ask is which of the institutions is receiving funding for the research? There are three possible scenarios in response to this question. The simplest scenario is that only one institution is receiving any money. If this is the case, then the institution that is the recipient of the funding (Benaroya or UW) is the institution that will do the review. The next two scenarios are more complex. One is that one institution is receiving money directly from the research sponsor or from a third institution and then subcontracting to the other institution. The other scenario is that both institutions are receiving money directly from the research sponsor or from a third institution. In either of these cases, the solution is to consult with HSD by emailing hsdrely@uw.edu. Usually the institution doing most of the subject contact and research procedures will conduct the review.