UW Research

Research Involving Seattle Children’s

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, Seattle Children’s (SC) 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.

Use the flow chart below to determine which IRB should do the review. If you have any questions, consult HSD by sending an email to hsdrely@uw.edu.

Before you begin

Assess whether both institutions are engaged in the research. Use the engagement decision tool to identify whether UW is engaged in the research. See the Seattle Children’s IRB webpage to request a consultation to identify whether SC is engaged in the research. If only one institution is engaged, you should submit to that institution’s IRB.

Assess whether another IRB is the right option. For example, industry-initiated research at UW should be reviewed by an independent IRB (for example, WIRB) and some oncology studies should be reviewed by the Cancer Consortium IRB or the NCI IRB. Review the information about external IRB review of UW research if you are unsure.

What to do if SC will do the review

  1. Request HSD’s authorization to go to the SC IRB, by submitting an External IRB Application in the Zipline system. HSD will evaluate your request and provide you with written authorization for the SC IRB to do the review.
  2. The SC investigator should prepare and submit the IRB application to the SC IRB, using SC’s forms and process. Be sure to attach the HSD authorization for SC review; the SC IRB will not review the application on your behalf without this written authorization.
  3. Obtain all other applicable ancillary reviews (see the Checklist of Researcher Responsibilities for Externally Reviewed Studies) from the usual UW offices and SC as needed. Examples: Financial Conflict of Interest (FCOI) review; Radiation Safety review.
    • Exception: SC will provide Genomic Data Sharing (GDS) certification (if necessary) on behalf of both institutions.

What to do if UW will do the review

  1. Request SC’s authorization to go to the UW IRB by submitting an External IRB Application in the SC Click IRB system. SC will evaluate your request and provide you with written authorization for the UW IRB to do the review.
  2. Submit a UW IRB Application in the Zipline system. Be sure to:
    • Describe all involvement of SC in your application (the Zipline SmartForms as well as the IRB Protocol form that is uploaded). This should include any funding that is received by SC for the study.
    • On the Study Scope SmartForm: Answer YES to Question 1 (“Are there any non-UW institutions, organizations, or individuals who will…”)
    • On the External Sites SmartForm: Answer YES to Question 1 (“Do any of the non-UW institutions, organizations, or individuals involved in the activities wish to rely upon the UW IRB for review?”)
    • Attach the completed SUPPLEMENT: Rely on the UW IRB and the written authorization from the SC IRB.
  3. After UW IRB approval has been obtained, you are responsible for:
    • Informing SC investigators about any conditions of the IRB approval.
    • Informing SC investigators about their obligation to comply with UW IRB reporting requirements about non-compliance, complaints, problems, etc., although such reports must be submitted by you to the UW IRB.
  4. SC investigators remain responsible for obtaining any applicable ancillary review from SC (for example, Financial Conflict of Interest (FCOI) review, Radiation Safety Review).
    • Exception: UW will generally provide Genomic Data Sharing (GDS) certification (if necessary) on behalf of both institutions.

SC or UW IRB Decision Tree

This flowchart shows the decision making process for choosing between the UW IRB and the Seattle Children's IRB. The first question asked is: Is there external funding for the research? If the answer is YES, the institution (either SC or UW) that is the direct* recipient of the funding from the external sponsor does the review. *Direct recipient means the institution that is closest to the source of the external funding. For example: if UW receives funding from NIH and then subcontracts with SC for some parts of the research, then UW is the direct recipient. If the answer to the question is NO, then the next question to ask is: Does the research involve interaction with the subjects (in person, internet, social media, phone, email, etc.)? If the answer to this question is YES, the institution (either SC or UW) where the majority of the interactions will occur does the review. If the answer to this question is NO, then the next question to ask is: Were or are all of the identifiable data and or specimens being used for this research collected from the subjects for some other purpose or study? If the answer to this question is YES, then the institution (either SC or UW) from which the majority of the specimens or data are being obtained does the review. If the answer to this question is NO, then you should email the Human Subjects Division at hsdrely@uw.edu and request a consultation.