UW Research

June 3, 2025

For the Record- June 3, 2025: Translated HIPAA Forms, New Requirements for Industry Initiated Studies, Fee Changes

In this Issue:

Translated HIPAA Authorization Forms

Published May 29, 2025

In our May 6, 2025 newsletter we announced the updated joint UW-Fred Hutchinson Cancer Center HIPAA Authorization Form for research. In partnership with Fred Hutch and the UW Office for Healthcare Equity, we have translated this form into 24 languages to facilitate and support the inclusion of study participants with a non-English language preference. These documents may be found on the HSD website and Fred Hutch website.

If the language you need is not posted, contact hsdinfo@uw.edu.

 

Industry Initiated Studies and Studies Reviewed by Advarra and WCG

New Requirements

During the past year, HSD, the Office of Sponsored Programs (OSP), the UW Clinical Trials Office (CTO), and UW Medicine have been collectively making changes to the requirements for compensation for injury in industry-initiated research with the intention to:

  • Better protect study participants,
  • Better protect the University of Washington,
  • Improve clarity of policy and process for all, and
  • Reduce potential for inaccurate consent materials.

What has already changed?

On July 8, 2024, UW Medicine’s Comp 202 policy was revised to prohibit the billing to study participants and/or their insurer’s first with the sponsor to pay the balance. This universal policy provides greater protection to study participants and the UW.

On January 1, 2025, OSP began using stock contract terms that align with the updated Comp 202 policy when negotiating study-specific Clinical Trial Agreements (CTA) with industry sponsors. OSP is currently assessing whether already established Master Clinical Trial Agreements (MCTA) align with Comp 202, and developing a plan for renegotiating these agreements.

On May 6, 2025, HSD announced new, stock consent form language that aligns with Comp 202 and the contract terms negotiated by OSP and CTO. The language can be found in HSD’s GUIDANCE Consent Elements for Externally Reviewed Studies.

What is changing now?
Change #1: Effective July 1, 2025, all new industry initiated clinical trials authorized for non-UW IRB review will require the use of HSD’s stock consent form language for studies:

  1. Under a single study CTA (in other words, not under an existing MCTA or consortium agreement), or
  2. Under any of the following MCTAs:
Alkermes Hoffman-LaRoche
Amgen Janssen R&D
AstraZeneca Medtronic
Bayer Corporation Merck
Biogen Novartis
Boehringer Ingelheim Pfizer
Bristol Myers Squib Sanofi
Cochlear Americas SC Liver Research Consortium
Edwards Lifesciences

Rationale for change:

  • Ensures that consent language accurately reflects the terms of CTAs and applicable MCTAs and compliance with Comp 202.
    • In a review of consent forms for a large number of studies, HSD found that 16% of studies’ compensation for injury language in the IRB approved consent form was inconsistent with the final CTA/MCTA.
  • Stock language improves the confidence of study teams that they are using the right language from the beginning.
  • Streamlines HSD’s required review of consent materials. Reduces potential for consent form(s) to require revision and re-review by the IRB.
  • Use of institutional stock language has been implemented successfully at peer institutions.

Change #2: HSD will continue to review consent forms for initial study submission after the non-UW IRB has reviewed the submission, but will now implement the following procedures beginning July 1, 2025:

Reviewing IRB HSD Consent Review Process
WCG IRB or Advarra IRB (all studies) These IRBs will not release approval documents to study teams until HSD has verified that the consent forms meet UW requirements. This process happens automatically after the IRB has reviewed the study. Study teams will be alerted by HSD if consent materials do not meet requirements or when the review is concluded. HSD will complete its initial review within five business days or less for most studies. After this review is complete and any required changes are made to consent forms, approved documents will be released to study teams by WCG or Advarra
Other IRBs (only industry-initiated clinical trials where the contract is negotiated by OSP or CTO) In limited circumstances, HSD may allow other IRBs to review industry research. In these cases, the UW study team is responsible for delivering the IRB approved consent forms to HSD immediately after approval by the IRB and prior to use with study participants. HSD will complete its review within 5 business days. Researchers who fail to deliver copies of IRB-approved consent materials to HSD prior to use may be subject to findings of non-compliance and participants may need to be re-consented if there are errors.
Fred Hutch (all studies) None. Under the UW/Fred Hutch cooperative agreement, Fred Hutch IRB will apply any UW consent requirements. Consent forms may be used with study participants immediately after Fred Hutch IRB approval.

Detailed information about the above requirements will be added to the authorization letter that HSD provides for each study.

Rationale for change:

Under the current process, HSD has struggled to audit these consent forms in a timely manner because of when the consent form(s) and the CTA are provided to HSD. This audit sometimes occurs months after the study has opened to enrollment, meaning participants may be enrolled with inaccurate consent materials. Any requested revisions require resubmission to the non-UW IRB for approval (cost) and reconsent of affected participants (burden). This new process means that study teams who receive approved documents from WCG or Advarra may use them with study participants immediately.

For questions about the changes, contact hsdrely@uw.edu.

Fred Hutch IRB Fees

Effective July 1, 2025

As a result of budget cuts, effective July 1, 2025, the Office of Research will no longer cover the $2500 Fred Hutch IRB review fee for non-industry sponsored studies. This fee applies to oncology-related research or expanded access treatment protocols where the Primary Appointment of the Principal Investigator or treating physician as listed in the Cancer Consortium membership directory, is the UW.

Studies that have not received Fred Hutch IRB approval before July 1, 2025, will be charged. A UW worktag will be collected as part of your application process to Fred Hutch and your study billed directly.

There are no changes to the Fred Hutch industry sponsored fees, which will continue to be billed directly to the study team at the current rate of $5,000 per study. Review the Fred Hutch IRB Fee Schedule webpage and navigate to the Federally and Non-Federally Sponsored Studies fee schedule for UW Faculty for more details.

Contact hsdinfo@uw.edu if you have any questions.

HSD Administrative Fee Increase for Industry Clinical Trials

Update

Effective July 1, 2025, HSD’s administrative fee will be increasing from $2060.06 to $2117.78. This one-time fee only applies to industry-sponsored-and-initiated clinical trials reviewed by a non-UW IRB where the contract was negotiated by UW’s Office of Sponsored Programs (OSP). This fee is charged because this type of research has an indirect cost rate that does not cover HSD’s costs for performing necessary administrative and regulatory oversight activities. The rate increase reflects updated costs for HSD to perform these activities. It is common for universities and research institutes to charge these fees for industry research.

Applicable external authorization requests submitted in Zipline on or after the effective date will have the new rate applied.

Contact hsdrely@uw.edu if you have any questions.

 

Zipline Downtime

June 26, 2025

Zipline will be unavailable while we make some minor updates to the e-IRB system the evening of June 26, 2025, from 6 pm until 8 pm Pacific Time. Please remember to save your work and log off before this time.

All updates are internal to HSD staff.

If you have any questions, please contact hsdinfo@uw.edu.

 

Zipline Tidbits

You CAN close that application 

As the end of the quarter approaches, it is a good time to think about a little bit of Zipline housekeeping. Do you have a study that is complete, and is just sitting? Are you tired of getting email reminders? Think about closing that study!

Visit the Close Your Application webpage for more information on whether you’re required to close your study, the criteria for study closure, and steps to close.

Email hsdinfo@uw.edu if you have any questions, and happy housekeeping!