Research Involving Kaiser Permanente Washington
Note: This information applies only to research involving Kaiser Permanente Washington, formerly known as Group Health. It does not apply to other components of Kaiser Permanente (for example, in California).
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 (KPW) 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.
What to do if KPW will do the review
- Request HSD’s authorization to go to the KPW IRB, by submitting an External IRB Application in the Zipline system. HSD will evaluate your request and provide you with written authorization for the KPW IRB to do the review.
- Your KPW co-investigator should prepare and submit the IRB application to the KPW IRB, using KPW’s forms and process. Be sure to attach the HSD authorization for KPW review; the KPW IRB will not review the application on your behalf without this written authorization.
- Obtain all other applicable ancillary reviews (see the Checklist of Researcher Responsibilities for Externally Reviewed Studies) from the usual UW offices and KPW as needed. Examples: Financial Conflict of Interest (FCOI) review; Radiation Safety review.
- Exception: KPW will provide Genomic Data Sharing (GDS) certification (if necessary) on behalf of both institutions.
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 KPW 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 KPW 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.
- After UW IRB approval has been obtained, you are responsible for:
- Informing your KPW colleague(s) about any conditions of the IRB approval.
- Informing your KPW colleague(s) 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.
- Your KPW colleague(s) remain responsible for obtaining any applicable ancillary review from KPW (for example, Financial Conflict of Interest (FCOI) review, Radiation Safety Review).
- Exception: UW will provide Genomic Data Sharing (GDS) certification (if necessary) on behalf of both institutions.
KPW or UW IRB Decision Tree