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Institutional Review Board (IRB)
Approval Information

Updates & Announcements


Records Retention Change - Effective immediately

The Washington State retention period for human subjects research records has been changed from 30 years after the close of the study to six years after the close of the study. The change applies to new, active, and already-closed studies.

  • This will have a significantly positive effect on budgets, space, and administrative oversight for researchers and their departments.
  • FDA, industry, and funding sponsor retention requirements continue unchanged, as applicable to specific studies.

The websites of UW Records Management and UW Medicine Records Management have been updated to reflect this major change.

Source: For the Record Monthly HSD Newsletter 4/6/15

Posted: 04/09/15

Federal Research Support - New Guidance

A new GUIDANCE: Federal Support document is now available. It describes the types of federal support (direct, indirect, and federal engagement) and gives examples. The presence or absence of federal support is one fundamental factor in determining:

  • Which human subjects regulations apply to a study
  • Whether many of the UW IRB flexibility policies (such as a 3-year approval period) can be applied to a study

Some minor changes to the funding section of each application form have also been made, to assist in the identification of federal support.

Source: For the Record Monthly HSD Newsletter 4/6/15

Posted: 04/09/15

Research Devices: National Medicare Approval

Medicare (CMS) has decided to adopt a national review and approval for billing IDEs (investigational devices) in clinical trials with FDA approval letters issued in 2015 and forward.  CRBB will continue to notify studies that they need prior permission to bill Medicare.
UW Medicine Compliance will:

  • Continue to provide IDE coverage and billing guidance for study teams
  • Continue to help studies with the IDE local Medicare application to Noridian
  • Help studies with national approval for IDE complete the required local notification process
  • Assist UW investigator-initiated studies obtain national approval for IDE billing

CMS national site:

UW Medicine Compliance site:

Source: School of Medicine Announcement 3/30/15

Posted: 04/09/15

IRB Performance Metrics

Median turn-around times:

  • Full IRB review:67 days (n=61 applications)
    • Outcomes for 1st Full Review of Initial Applications: 70% Deferred, 28% Conditional Approval, 2% Approved
  • Minimal risk review: 26 days (n=365 applications)
    • Use of Identifiable Specimens/Data: 15 days (n=135 applications)
  • Exempt Status: 9 days (n=280 applications)

Source: HSD Metrics Report #21 (reporting period 7/1/14 – 12/31/14)

Posted: 04/09/15

Archived News

eIRB System: Zipline

HSD expects to deploy the new electronic application system (Zipline) in the 1st quarter of 2016.  Widespread beta testing and training will begin in autumn quarter.  The switch from a paper-based application system to an electronic system created the need and opportunity for a series of related and coordinated changes that will also occur during the next fourteen months:

  1. Forms and processes:  Application process will be simplified, primarily by reducing the number of forms and supplements.  Researchers will not need to make preliminary regulatory decisions, for example, whether an initial application qualifies for Minimal Risk review or must instead go to the full committee.
  2. Staff reorganization: The Full Board and Minimal Risk teams will be combined together.  The current 13 small teams will become 6 larger teams, each associated with one of the IRBs, and a new supervisory structure will be established.  Departments will still be assigned to specific teams, but this change will result in more flexible and consistent operations, staff with greater breadth and depth of expertise, and reduced integration and training time for new staff.

Posted: 1/14/15

Boost the Visibility of Research Studies withRESEARCH PARTICPANT LINK

In collaboration with the UW School of Medicine, ITHS has developed a new site that offers researchers a centralized, coordinated resource to connect with potential study participants.

The registration process to post new research studies is free, open to any researcher with a UW NetID, and takes less than 10 minutes to complete.  You will be asked to enter:

  • Study information
  • Study team contacts
  • Institutional Review Board approval dates
  • Enrollment projections
  • Basic demographics

Once a study is approved to post, which usually occurs within one business day, the research team will be contacted directly by potential participants who visit Research Participant Link.

Please visit to learn more or to post a study.

Source:  ITHS e-mail 12/3/14

Posted: 12/10/14

Longer IRB Approval Periods

The new default IRB approval period will be 3 years instead of 1 year for studies that are:

  • Minimal risk
  • Not federally supported
  • Not regulated by the FDA

This new policy will be applied to all eligible new applications and Status Reports that are approved after 12/1/2014.

Resulting impact on researchers:

  • Estimated ~60% of minimal risk studies will be eligible for the longer approval periods

Source: For the Record Monthly HSD Newsletter 12/2/14

Posted: 12/9/14

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