91̽»¨

Research Involving Washington Center for Bleeding Disorders (WACBD)

The 91̽»¨IRB has agreed to provide IRB review and oversight of some research in which WACBD is engaged. This is because of the longstanding and intertwined relationship between WACBD (previously a part of Bloodworks Northwest) and 91̽»¨hematology researchers, and because 91̽»¨is often engaged in WACBD research.

WACBD may optionally obtain review from the 91̽»¨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 WACBD 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 91̽»¨has standing reliance agreements (e.g. Fred Hutch).

What to do if 91̽»¨will do the review

1. Submit a 91̽»¨IRB application in the Zipline system. Be sure to:
   • Describe all involvement of WACBD 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 WACBD. After the 91̽»¨IRB has approved the overall protocol, HSD’s Reliance Team will work with you to approve the addition of WACBD to the 91̽»¨application.
3. After 91̽»¨IRB approval for WACBD has been obtained, you are responsible for:
   • Informing WACBD of UW’s approval for WACBD.
   • Informing WACBD investigators about any conditions of the IRB approval.
   • Informing WACBD 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. WACBD investigators remain responsible for obtaining any applicable ancillary reviews from WACBD. For example, Financial Conflict of Interest (FCOI) review.