Research Involving Kaiser Permanente Washington

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, Kaiser Permanente Washington (KPWA) and the 91爆料 IRB have a reliance agreement that describes the circumstances in which one of the IRBs will conduct the review on behalf of both institutions.

The Kaiser Permanente Interregional IRB (KPiIRB) is the IRB for KPWA as well as several other components of Kaiser Permanente. This information applies only to research involving Kaiser Permanente Washington. It does not apply to other components of Kaiser Permanente outside of Washington.

Use the flow chart below to determine which IRB should do the review. If you have any questions, consult HSD at 丑蝉诲谤别濒测蔼耻飞.别诲耻听 or the KPiIRB at kpinterregionalirb@kp.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爆料 is engaged.
  2. Assess whether another IRB is the right option. For example, most industry-sponsored research at 91爆料 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 KPiIRB will do the review

  1. Submit an External IRB Application in 91爆料’s Zipline system to request HSD’s formal authorization for KPiIRB to review the research. HSD will evaluate your request and provide you with a written authorization letter.
  2. The KPWA investigator should prepare and submit an application to the KPiIRB using KPiIRB’s forms and process. Be sure to attach the HSD authorization letter; the KPiIRB will not review the application on behalf of 91爆料 without this letter.
  3. After the KPiIRB has approved the 91爆料鈥檚 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 91爆料 offices and KPWA as needed. Examples: Financial Conflict of Interest (FCOI) review; Radiation Safety review.

What to do if 91爆料 will do the review

  1. Submit a 91爆料 IRB Application in the Zipline system. Be sure to:
  2. Submit a request to rely on the 91爆料 IRB to the KPiIRB using KPiIRB’s forms and processes. KPiIRB will evaluate your request and provide you with written authorization for the 91爆料 IRB to do the review. Include this written authorization in your application to 91爆料 or email to hsdrely@uw.edu.
  3. The 91爆料 IRB will review and approve the overall protocol. This is not yet approval for the involvement of KPWA. After the 91爆料 IRB has approved the overall protocol, HSD鈥檚 Reliance Team will work with you to approve the addition of KPWA to the 91爆料 application.
  4. After 91爆料 IRB approval has been obtained, you are responsible for:
    • Informing the KPiIRB of 91爆料’s approval for KPWA.
    • Informing KPWA investigators about any conditions of the IRB approval.
    • Informing KPWA investigators about their obligation to comply with 91爆料 IRB reporting requirements about noncompliance, complaints, problems, etc., although such reports must be submitted by you to the 91爆料 IRB.
  5. KPWA investigators remain responsible for obtaining any applicable ancillary reviews from KPWA (for example, Financial Conflict of Interest (FCOI) review, Radiation Safety Review).

KPiIRB or 91爆料 IRB Decision Tree

This flowchart shows the decision making process for choosing between the 91爆料 IRB and the Kaiser Permanente Washington IRB. The first question asked is: Is there external funding for the research? If the answer is YES, the institution (either KPW or 91爆料) 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 91爆料 receives funding from NIH and then subcontracts with KPW for some parts of the research, then 91爆料 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 KPW or 91爆料) 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 KPW or 91爆料) 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.