January 10, 2023
For the Record- January 10, 2023: Revised Cooperative Agreement with Fred Hutch, More
In this Issue:
Revised Cooperative Agreement with Fred Hutch IRB
No Immediate Changes to Policies or Processes
UW and Fred Hutch have completed negotiations and have reached agreement on a revised cooperative IRB agreement. This cooperative agreement establishes the policies and processes under which the UW and Fred Hutch IRBs review research on behalf of each other. The longstanding cooperative agreement between UW and Fred Hutch was last updated in 2011. Since then, many changes have taken place in the regulatory landscape surrounding multi-institutional oncology research including the NIH single IRB policy, the Common Rule single IRB requirement, and the merger of Fred Hutch and Seattle Cancer Care Alliance.
There will be no changes to the majority of policies and processes affecting researchers. For example, the Fred Hutch IRB will continue to review most greater than minimal risk oncology research led by a UW PI and must obtain authorization from HSD for that review. There will be changes to a few processes which will be implemented over the course of the next year. Details about those changes will be announced in a future eNews.
Fred Hutch IRB Fees for UW Led Research
Now Available Online
The Fred Hutch IRB has recently published a new document which describes their fees for reviewing UW led oncology research. There are no changes to the fee structure. This new document has been published to provide clear information about the Fred Hutch IRB fees for UW research. See the document titled “For UW Investigators: Fred Hutch IRB Fee Schedule – Effective January 4th, 2023” on the Fred Hutch IRB fees webpage.
Launch of the Kaiser Permanente interregional IRB (KPiIRB)
Limited Impact to Cooperative Agreement with UW
On September 6, 2022, Kaiser Permanente launched the Kaiser Permanente interregional IRB (KPiIRB). The KPiIRB will assume all IRB review and oversight of human subjects research taking place in the following Kaiser Permanente regions: Colorado, Northwest (includes Oregon and Southern Washington), Washington, and Georgia.
UW’s longtime cooperative agreement with Kaiser Permanente – Washington will stay in effect. The only change is that the KPiIRB will now perform all IRB reviews and/or requests to rely on the UW IRB on behalf of researchers at Kaiser Permanente of Washington. Kaiser Permanente regions outside of Washington will not be brought into the standing cooperative agreement. Reliance agreements involving UW will be handled for those regions on a study-by-study basis.
For questions about the new KPiIRB, contact KPINTERREGIONALIRB@kp.org.
NIH Pragmatic Clinical Trials Educational Resource for Researchers
New
The NIH Pragmatic Trials Collaboratory recently announced the addition of a new collection in the Living Textbook of Pragmatic Clinical Trials focused on ethical and regulatory aspects of pragmatic trials. The collection launches with four new chapters addressing consent, waiver of consent, and notification; privacy considerations; identifying those engaged in research; and collateral findings that emerge during a study that are unrelated to the primary aims but may have implications for patients, clinicians, or healthcare systems. Each chapter describes the regulatory context, summarizes current academic research on the topic and highlights research subject expectations and preferences. HSD has reviewed the chapters and believes that the textbook is a high-quality resource for researchers working in pragmatic clinical research.