May 2, 2023
For the Record- May 2, 2023: New HSD Requirement for Fred Hutch Led Studies, Zipline Upgrade, Student Office Hours
In this Issue:
New HSD Requirement for Fred Hutch Led Studies Reviewed by the Fred Hutch IRB
Effective July 1, 2023
UW is frequently engaged in research led by a Fred Hutch PI which is reviewed by the Fred Hutch IRB. This is because UW employees or agents are obtaining consent, performing study procedures or administering study intervention, or analyzing identifiable data. HSD does not currently require that researchers obtain authorization from HSD for these studies for review by the Fred Hutch IRB or otherwise obtain any record of their existence and the engagement of UW. This is in contrast to all other research engaging UW that is reviewed by a non-UW IRB and which may be led by a non-UW PI. In all other situations, HSD authorizes the non-UW IRB to review for the engagement of the UW employees or agents and retains a record of the research.
What is changing?
Beginning July 1, 2023, all new studies that are:
- Led by a Fred Hutch PI, and
- Reviewed by the Fred Hutch IRB, and
- Which engage UW in the research activities,
must obtain authorization from HSD for review by submitting a request in Zipline prior to the Fred Hutch IRB issuing its approval for the portion of the research engaging UW.
After HSD has reviewed the request in Zipline, it will issue a letter to the study team to document this authorization. The Fred Hutch IRB will proceed with its review of the overall study, but will hold final approval until it receives a copy of this letter from the study team.
Why is it changing?
Due to the single IRB mandates, there is an increased need for tracking the engagement of UW to ensure UW is complying with federal regulations. Also, UW and Fred Hutch recently renegotiated their longstanding cooperative agreement, and this is a term of the agreement.
What is HSD doing to assist study teams?
HSD is currently identifying a pathway for Fred Hutch employees to gain access to Zipline, and
In consultation with the Fred Hutch IRO and CRS, HSD has developed enhanced webpage guidance along with:
- A two-page worksheet tailored to Fred Hutch led research to assist study teams with identifying UW engagement
- A “cheat sheet” with specific instructions for and FAQs about Zipline submissions for Fred Hutch led studies
More information about the pathway to Zipline access and these guidance materials will be published in the June edition of HSD’s eNews.
For questions about this new requirement, contact hsdrely@uw.edu.
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
Zipline changes. Most of the changes will not be noticeable to researchers, but there is one new required question in the Drugs SmartForm regarding product categories. If the use of an FDA-regulated product is included in your application, Zipline will require you to categorize it as shown:
If you need to make a modification to a study that includes an FDA-regulated product, you will be required to return to the Drugs SmartForm and answer this question.
Contact hsdinfo@uw.edu with any questions.
Spring Office Hours for Student Researchers
Available in 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 conducting a pilot project to offer drop-in Zoom office hours to student researchers in 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