October 7, 2025
For the Record- October 7, 2025: SMART IRB 3.0, Status Inquiries for Student Research
In this Issue:
SMART IRB 3.0 Agreement
Now a Participating Institution
HSD has completed its review of version 3.0 of the SMART IRB Reliance Agreement and is now a participating institution under the agreement. Beginning immediately, HSD can enter into reliance arrangements based on the SMART Agreement.
The SMART IRB Agreement is a National Center for Advancing Translational Sciences (NCATS) funded umbrella agreement that pre-negotiates many common terms required for IRB reliance with the aim of reducing the amount of time needed to reach an agreement. SMART leadership has confirmed that reliance arrangements completed under versions 1.0 and 2.0 of SMART do not need to be transitioned to version 3.0. HSD does not plan to initiate any transitions for existing research.
HSD will continue to employ a range of reliance agreement options. Institutions relying on the UW IRB do not have to be SMART signatories, and HSD can make use of non-SMART based reliance agreements when relying on a non-UW IRB.
For questions, contact hsdrely@uw.edu.
New Status Inquiry Process for Student Research
New
HSD will be implementing a new status inquiry process for IRB approved student-led studies that have no expiration date and remain open after three years. The purpose of this process is to ensure closure of the Zipline application once the research has been completed.
HSD will contact student Principal Investigators to inquire if the research is ongoing and if no response is received within 30 days, HSD will administratively close the submission for inactivity. See section 8.4 of SOP IRB Review for more information regarding this policy.
As a reminder, please close your IRB approved submission when complete. This helps us identify active submissions in our portfolio and meet our records retention requirements. If you have questions about closing your study, email us as hsdinfo@uw.edu.