91̽»¨

The 91̽»¨IRB has agreed to provide IRB review and oversight research led by 91̽»¨investigators in which Public Health Seattle King County (PHSKC) is engaged. This is because of the longstanding and intertwined relationship between PHSKC and 91̽»¨public health researchers, and because PHSKC is often engaged in public health research led by UW. 91̽»¨led research is that which is led by a PI whose primary appointment is UW, for which 91̽»¨is the direct awardee of funding, or in which 91̽»¨has the primary role in designing and/or conducting the research.

The 91̽»¨IRB does not provide IRB review for PHSKC research in which 91̽»¨is not engaged or for PHSKC led research in which 91̽»¨does not have a leadership role. PHSKC researchers should work with the PHSKC Research Administrative Review Committee (RARC) to identify an appropriate IRB for those situations.

What is a part of PHSKC for this agreement:

• This agreement applies to all of PHSKC’s clinical service centers, homeless programs, childcare and early learning services, children’s health services, public health authority services, emergency medical services (King County Medic One), and King County Correctional Facility (KCCF) & Maleng Regional Justice Center (MRJC) health services. For questions about whether an entity is part of PHSKC, contact hsdrely@uw.edu.

What is not a part of PHSKC:

• Washington State Department of Health (DOH) is often confused with PHSKC, however it is a state agency. View HSD’s webpage for Research Involving WA State Agencies.
• Emergency Medical Services other than King County Medic One (such as the Seattle Fire Department’s Medic One).

Additional Information

PHSKC has agreed that the UW/Fred Hutch HIPAA Authorization Form may be used to obtain authorization from study participants for research use of PHSKC held PHI. Researchers do not need to use a separate form.

What to do when 91̽»¨will do the review

1. Submit a 91̽»¨IRB application in the Zipline system. Be sure to:
   • Describe all involvement of PHSKC in your application (the Zipline SmartForms as well as the IRB Protocol form that is uploaded).
   • Follow the instructions for the 91̽»¨Reviewing for Other Institutions pathway.
   • On the Study-Related Documents SmartForm: Upload a completed SUPPLEMENT Multi-site or Collaborative Research to Question 3.
2. The 91̽»¨IRB will review and approve the overall protocol. This is not yet approval for the involvement of PHSKC. After the 91̽»¨IRB has approved the overall protocol, HSD’s Reliance Team will work with you to approve the addition of PHSKC to the 91̽»¨application.
   • You will be asked to complete and return a site application for the involvement of PHSKC. This application must be signed by the PHSKC RARC to document their awareness of the research.
3. After 91̽»¨IRB approval for PHSKC has been obtained, you are responsible for:
   • Informing oversight offices at PHSKC of UW’s approval.
   • Informing PHSKC investigators about any conditions of the IRB approval.
   • Informing PHSKC investigators about their obligation to comply with 91̽»¨IRB reporting requirements about noncompliance, complaints, problems, etc., although such reports must be submitted by you to the 91̽»¨IRB.
4. PHSKC investigators remain responsible for obtaining any applicable ancillary reviews from PHSKC. For example, Financial Conflict of Interest (FCOI) review.