May 5, 2026

For the Record- May 5 ,2026: Expedited Study Expiration Dates, Fee for Single IRB Review

In this Issue:

Expiration Dates for Expedited Research

Beginning June 2026

In anticipation of future changes that will impact HSD’s IRB review system (Zipline) HSD is discontinuing the practice of approving new expedited applications with no expiration dates and will be implementing a status inquiry process for existing approved expedited applications to confirm if the study is still active or should be closed. Studies that are still active will be required to submit for continuing review in Zipline and assigned an expiration date.

Status Inquiry Process
For studies that have already been approved by expedited procedures and have no expiration dates, researchers will receive automated notifications from Zipline requesting submission of a Continuing Review application to confirm the study is still active and avoid study closure. These email notifications will be sent through Zipline at 60 days and 30 days prior to the administrative closure of the study.

If no response is received by the deadline in the notice, HSD will presume that the study is inactive and administratively close the study.

Due to the high number of studies in the Zipline system that have no expiration dates, the notification process will be staggered over approximately 12-18 months to help HSD manage the potential volume of continuing review applications.

Expiration Dates for Expedited Applications
All studies will be assigned an expiration date with a three year approval period, unless a shorter approval period is otherwise required by regulations or justified by the IRB.

This change will help ensure regular review of ongoing research activity and support accurate tracking of active studies.

Questions. Contact us at hsdinfo@uw.edu

 

 

HSD to Begin Charging Fees for Single IRB Review

Effective July 1, 2026

Beginning July 1st, 2026, HSD will begin charging fees when the UW IRB reviews on behalf of non-UW organizations for non-exempt research. There is no fee for the UW site(s).

Rationale
UW’s negotiated indirect rates do not cover the additional UW IRB review effort for non-UW relying sites. In acknowledgement of this, funding agencies, such as NIH, typically allow these costs to be charged as direct costs to an award. Many peer institutions already charge for single IRB review services. HSD is now implementing a similar fee and fee structure.

The fees
For the review of each non-UW relying institution, HSD will charge:

Fee type Amount Services included
Initial Review
Charged at the time the non-UW site is first reviewed by HSD		 $1,902.40
  • Negotiating and establishing reliance agreements
  • Reviewing applications and materials
  • Site-specific modifications for the first year
Annual Maintenance
Charged at each yearly anniversary		 $748.05
  • Ongoing site-specific modifications
  • Reliance agreement updates as needed

HSD will not charge a fee for the review of the overall study protocol and the involvement of UW in the research, including modifications, continuing review, and reports of new information for the overall study protocol. The costs for these activities are already typically covered by UW’s indirect rates.

In line with the expectations of federal funding agencies, HSD will charge the same fee regardless of funding (e.g., federal, industry, foundation).

Exceptions

  • Studies submitted in Zipline prior to July 1st, 2026, unless a significant number of non-UW relying sites is added as part of a modification (e.g., new funding means that new sites will be added to an existing application instead of a new application being submitted). HSD will assess these on a case-by-case basis.
  • Studies for which the PI has consulted with HSD and HSD has already issued a letter of support indicating that fees will not be charged. Researchers are reminded that HSD’s policy is that it cannot commit to serving as the single IRB for research for which it has not been consulted.
  • Review of non-UW sites who are existing cooperative agreement partners (i.e., Fred Hutch and Seattle Children’s). Due to the pre-established terms of these agreements, the UW IRBs additional effort is much more limited than for other organizations.

Letter of Support Process and Additional Resources
To assist with budget preparation prior to submission of proposals to sponsors, HSD will provide an estimate of fees as part of its letter of support process. HSD strongly suggests that research teams seek HSD’s letter of support early in the proposal preparation process.

Associated Policy Changes
HSD will no longer limit single IRB services to federally funded or supported research. All investigator-initiated research, regardless of funding, may seek out single IRB services from the UW IRB. All studies receiving single IRB services will be charged the same fees, regardless of funding.

No other changes to the circumstances under which UW will serve as the single IRB are being made at this time. Studies must be investigator-initiated, non-exempt, within UW’s expertise and capacity, and UW must be engaged in the research. HSD leadership will assess over the course of the next year whether this fee structure will allow additional capacity and expertise.

HSD will publish additional guidance on this topic in the near future. For questions, contact hsdrely@uw.edu.

 

Advarra and WCG Move to New Online Submission Platforms

No Major Impact to HSD Processes

Both WCG and Advarra are in the process of switching to new online submission platforms. UW relies on WCG and Advarra for most industry-initiated studies and a small number of other studies. HSD is currently working with Advarra and WCG to understand the transition. At this time, there should be no impact to HSD’s processes as a result of the transition.

WCG
All applications will be migrated by WCG from Connexus to their new system, eReview Manager, on a rolling basis until the full transition is complete on approximately June 30th. Study teams will receive notification from WCG as each study is selected to migrate. After migration, study teams should manage the application in eReview Manager. For studies that have not yet been migrated, study teams should continue to use Connexus.

WCG is offering several live online training sessions for the new system. For questions, contact WCG at clientcare@wcgclinical.com.

Advarra
All submissions for active protocols will be migrated by Advarra to their next generation of CIRBI platform. A small number of UW site submissions are part of the early adopter phase and are currently being migrated. All other UW site submissions will migrate during general adoption which is anticipated to take place sometime this summer or fall. Study teams associated with early adopter studies will receive an email from Advarra with registration information and additional resources. For studies that have not yet been migrated, study teams should continue to use the current CIRBI system.

Advarra will provide additional updates to study teams via email with more defined timelines for general adoption before it begins. Advarra plans to offer several resources to study teams including webinar demonstrations, and automatic registration for eLearning modules for the new platform. Study teams currently using Advarra services will receive an email from Advarra (notifications@learnupon.com) when they are automatically enrolled in the trainings.

A self-directed click-through demo of the new system is available for all users now. For questions, contact Advarra at support-CIRBI@advarra.com.