Research Involving Fred Hutch (not cancer-related)
This page is about research that is not cancer-related. For cancer-related research, refer to HSD’s other webpage.
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, Fred Hutch and the UW IRB have a reliance agreement that describes the circumstances in which one of the IRBs will conduct the review on behalf of both institutions. This applies regardless of whether or not the study is funded.
Fred Hutch and UW have agreed that that institution that is the Primary Appointment of the PI should conduct the review when Fred Hutch and UW are the only institutions engaged in the research. The Primary Appointment of the PI is the institution that is listed in the Cancer Consortium membership directory for the investigator regardless of whether or not the research is cancer-related.
If the PI is not listed in the Cancer Consortium membership directory, consult with HSD at email@example.com for instructions.
Before you begin
- Assess whether both institutions are engaged in the research. If only one institution is engaged, you should submit to that institution’s IRB.
- Use the engagement decision tool to identify whether UW is engaged in the research.
- Consult with the Fred Hutch IRB to identify whether Fred Hutch is engaged in the research.
- Assess whether another IRB is the right option. For example, most industry-sponsored research at UW should be reviewed by an independent IRB (for example, WCG IRB), and research that involves institutions other than Fred Hutch and UW may require review by another IRB. Review the information about identifying the correct IRB if you are unsure.
What to do if Fred Hutch will do the review
- Submit an External IRB Application in UW’s Zipline system to request HSD’s formal authorization for Fred Hutch to review the research. HSD will evaluate your request and provide you with a written authorization letter.
- The Fred Hutch investigator should submit an application to the Fred Hutch IRB using Fred Hutch’s forms and process. Be sure to attach the HSD authorization letter; the Fred Hutch IRB will not review the application on behalf of UW without this letter.
- After the Fred Hutch IRB has approved the UW’s participation, send the approval letter to firstname.lastname@example.org.
- Obtain all other applicable ancillary reviews (see the Checklist of Researcher Responsibilities for Externally Reviewed Studies) from the usual UW offices and Fred Hutch as needed. Examples: Financial Conflict of Interest (FCOI) review; Radiation Safety review.
What to do if UW will do the review
- Submit a UW IRB Application in the Zipline system. Be sure to:
- Describe all involvement of Fred Hutch in your application (the Zipline SmartForms as well as the IRB Protocol form that is uploaded).
- Follow the instructions for the UW Reviewing for Other Institutions pathway.
- On the Study-Related Documents SmartForm: Upload a completed SUPPLEMENT: Multi-site or Collaborative Research to Question 3.
- Request Fred Hutch’s authorization to rely on the UW IRB by following their instructions. Fred Hutch will evaluate your request and provide you with written authorization for the UW IRB to do the review. Deliver this letter to email@example.com.
- The UW IRB will review and approve the overall protocol. This is not yet approval for the involvement of Fred Hutch. After the UW IRB has approved the overall protocol, the HSD Reliance Team will work with you to approve the addition of Fred Hutch to the overall application.
- After UW IRB approval for Fred Hutch has been obtained, you are responsible for:
- Informing the Fred Hutch IRB of UW’s approval for Fred Hutch.
- Informing Fred Hutch investigators about any conditions of the IRB approval.
- Informing Fred Hutch investigators about their obligation to comply with UW IRB reporting requirements about noncompliance, complaints, problems, etc., although such reports must be submitted by you to the UW IRB.
- Fred Hutch investigators remain responsible for obtaining any applicable ancillary review from Fred Hutch (for example, Financial Conflict of Interest (FCOI) review, Radiation Safety Review).