91±¬ÁÏ

Research Involving Bloodworks Northwest

The 91±¬ÁÏ IRB has agreed to provide IRB review and oversight of some research in which Bloodworks Northwest is engaged. This is because of the longstanding and intertwined relationship between Bloodworks Northwest and 91±¬ÁÏ hematology researchers, and because 91±¬ÁÏ is often engaged in Bloodworks Northwest research.

Bloodworks Northwest may optionally obtain review from the 91±¬ÁÏ IRB for all research in which it is engaged, except research that:

• Is industry sponsored, or
• Requires the use of the Exception to Informed Consent mechanism, or
• Is cancer-related and involves more than minimal risk, or
• Involves Bloodworks Northwest as the lead institution for multi-institutional research for which Single IRB review is required except when all institutions are other local institutions with which 91±¬ÁÏ has standing reliance agreements (e.g. Fred Hutch).

What to do if 91±¬ÁÏ will do the review

1. Submit a 91±¬ÁÏ IRB application in the Zipline system. Be sure to:
   • Describe all involvement of Bloodworks Northwest in your application (the Zipline SmartForms as well as the IRB Protocol form that is uploaded).
   • Follow the instructions for the 91±¬ÁÏ 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 91±¬ÁÏ IRB will review and approve the overall protocol. This is not yet approval for the involvement of Bloodworks Northwest. After the 91±¬ÁÏ IRB has approved the overall protocol, HSD’s Reliance Team will work with you to approve the addition of Bloodworks Northwest to the 91±¬ÁÏ application.
3. After 91±¬ÁÏ IRB approval for Bloodworks Northwest has been obtained, you are responsible for:
   • Informing Bloodworks Northwest of 91±¬ÁÏ’s approval.
   • Informing Bloodworks Northwest investigators about any conditions of the IRB approval.
   • Informing Bloodworks Northwest investigators about their obligation to comply with 91±¬ÁÏ IRB reporting requirements about noncompliance, complaints, problems, etc., although such reports must be submitted by you to the 91±¬ÁÏ IRB.
4. Bloodworks Northwest investigators remain responsible for obtaining any applicable ancillary reviews from Bloodworks Northwest. For example, Financial Conflict of Interest (FCOI) review.