April 4, 2023
For the Record- April 4, 2023: HSD Fee for Industry Clinical Trials, Student Office Hours, COVID Changes, More
In this Issue:
Changes to HSD Fee for Industry Clinical Trials
Effective July 1, 2023
HSD currently charges a one-time $1500 administrative fee for fulfilling mandatory regulatory and administrative responsibilities for industry-sponsored-and-initiated clinical trials reviewed by a non-UW IRB where the contract has been 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 these activities. It is common for universities and research institutes to charge these fees for industry research.
The billing of the fee to the study budget is currently handled by Grant & Contract Accounting (GCA). This charge appears as “UW HSD Fee” on study budgets.
Effective July 1, 2023, HSD is making the following changes:
- Fee Increase: All new authorization requests to use a non-UW IRB will be charged $1933.70. HSD anticipates that this fee will increase on an annual basis commensurate with HSD’s costs.
- Why? HSD has not reassessed its costs since 2010. HSD completed a recent assessment through UW Management Accounting & Analysis (MAA) to establish the current cost rate for performing these activities.
- Change in Billing Process: GCA will no longer be involved in billing the fee. Instead, HSD will work with the Office of Research to charge the fee using a researcher-provided budget number. This budget number must be provided as part of the authorization request in Zipline before HSD will authorize the study for review.
- Why? UW’s transition to Workday as part of UW’s Finance Transformation is necessitating this change.
More information about the process for fee collection will be published in our June newsletter. For questions about these changes, contact hsdrely@uw.edu.
Spring Office Hours for Student Researchers
Available in April and May
The Human Subjects Division receives many applications from a wide variety of UW students, and we often find that students of all levels would benefit from additional support in navigating the IRB process from the beginning.
HSD is launching a pilot project to offer drop-in Zoom office hours to student researchers and new researchers in April and May 2023. Depending on the results of the pilot, we may offer additional office hours in the future.
See our HSD Office Hours webpage for the schedule and Zoom information.
At office hours, students will:
- Meet team representatives from HSD
- Get guidance on:
- If they need to submit an IRB application, and if so, what they need to do next
- How to fill out the IRB protocol and other forms
- Using Zipline, the eIRB system
At office hours, students won’t:
- Receive IRB approval or an official determination for their project
- Get answers to questions about:
- Compliance issues, such as data breaches
- Working with another IRB or relying on the UW’s IRB for review if you’re affiliated with another institution
Changes to HSD COVID Related Requirements
Effective April 3, 2023
Effective April 3, 2023, the WA State Department of Health ended the Secretary of Health Mask Order which required universal masking in healthcare, long-term care, and correctional facilities in WA State. On May 11, 2023, the Federal Public Health Emergency expires. Considering these changes, the Human Subjects Division will no longer:
- Maintain a COVID Related Requirements for Human Subjects Research web page.
- Require the COVID-specific researcher attestation in our applications.
- Include a COVID-specific statement in the approval letter.
Researchers and study participants must still abide by any requirements imposed where the in-person research activities will occur (e.g., institutional or facility requirements, local government, or public health agency). This includes research conducted in international settings. For example, facemasks will continue to be required in UW Medicine medical facilities and other University healthcare settings, such as Hall Health Center, the School of Dentistry, clinical research settings, and on UW Shuttles serving healthcare facilities (Refer to the UW Face Covering Policy for details).
We recognize this as a major milestone and thank our entire research community, healthcare, University, and public health partners who have worked tirelessly over the past 3 years to bring us to this point. We would not be here without the important scientific and public policy contributions you have made.
Zipline Upgrade
Effective June 5, 2023
On Monday, June 5, Zipline will be down for an upgrade. Please plan for a system downtime of up to 48 hours.
During this downtime, researchers will not be able to:
- Submit applications of any kind (new, modification, RNI, continuing review)
- Respond to any requests from HSD or the IRB
- Access and print approved consent forms or other documents
If there is an emergency need for copies of any of your documents in Zipline or some other action during the downtime: Contact hsdinfo@uw.edu.
Fred Hutch Launches New Electronic IRB System
Effective March 29, 2023
The Fred Hutch Institutional Review Office launched a new electronic IRB system (“Hutch IRB”) on March 29. Hutch IRB is an end-to-end, web-based, electronic system that will support the Fred Hutch/Cancer Consortium IRB’s oversight of research. This system uses the same software as University of Washington’s Zipline system but a separate log-in is required for each and the two systems do not currently communicate or share data with each other. This rollout impacts all study teams who submit to the Fred Hutch IRB.
The latest information on Hutch IRB can be found on Extranet, including training resources, and instructions for requesting access.