UW Research

August 6, 2024

For the Record- August 6, 2024: DCTI Resources, Conversion of Paper External Reliance Records

In this Issue:

Diversity in Clinical Trials: Building a Community-Based Research Collaboratory

Resources

The UW Office of Healthcare Equity (OHCE) is leading the University’s efforts to establish the necessary infrastructure to support implementation of the community engagement aspects of WA State’s new Diversity in Clinical Trials law (RCW 69.78). One component of their efforts is the development of a Community-Based Research Collaboratory (CBRC). This innovative approach will empower community members to actively participate in shaping research agendas and priorities for the University.

CBRC Vision:

  • Center community voices: By involving community members from the outset, the CBRC aims to create a truly patient-centered research process.
  • Address health disparities: The CBRC will focus on chronic diseases disproportionately affecting marginalized communities.
  • Build partnerships: Collaborating with community organizations is essential to building trust and driving meaningful change.
  • Enhance researcher access: By streamlining community engagement resources and processes, researchers gain best practices across the research lifecycle.

Building the Foundation: OHCE has initiated discussions with community-based organizations to foster strong partnerships. These collaborations are crucial for understanding community needs and co-creating research projects that address their priorities.

To support this critical work, OHCE is expanding their team and hiring a Community Engagement Specialist and a Director by the end of the year. These dedicated roles will strengthen the University’s capacity to build relationships, support community-led initiatives, and advance CBRC goals.

More information about the CBRC and other OHCE initiatives to facilitate researcher engagement with underrepresented communities will be presented at the September 20th virtual town hall meeting.

Diversity in Clinical Trials Town Halls

Update

Registration for the September 4, 2024 (9:00-10:30am Pacific Time), virtual town hall meeting regarding the UW’s Diversity in Clinical Trials Initiative is now open. This event is intended to provide researchers and other interested parties with the opportunity to ask questions and provide feedback on the soon to be published draft diversity plan and associated guidance. A special mid-August HSD e-newsletter will announce when these documents are available.

The event will begin with a 30-minute overview presentation, followed by a 60-minute Q&A. Attendees are encouraged to submit in advance any questions they would like addressed using the Contact Us form on the UW DCTI website. For those unable to attend, a post-session recording will be available.

There will be another town hall meeting on Friday, September 20, 2024, 2:00-3:30pm Pacific Time, which will focus on the UW’s plans for providing translation and interpreter services as well as supporting community engagement. More information regarding this event will be published in our September e-newsletter.

Conversion of Paper External Reliance Records to Zipline

Notice and Request for Review

HSD’s Reliance Team continues to manage approximately 150 paper applications for reliance on a non-UW IRB. HSD now plans to convert these applications into Zipline over the next 6 months. In contrast to previous waves of study conversions, this process will require little to no involvement of study teams.

To convert these applications, HSD’s Reliance Team will:

  • Create a shell application in Zipline with the information that HSD already has available, and
  • Upload all documentation that it has for the application to the shell application, and
  • Send a Zipline notification to the PI of the application that it has been converted along with instructions for how to manage the application.

HSD may contact individual study teams if additional information is required to complete the conversion process.

Because HSD has extremely limited information about these applications, only the PI will be listed on the application.

What should PIs do?
When the PI receives a notification, they should review the Zipline content for accuracy and contact HSD immediately if any of the following apply:

  • There is a change in UW PI, or
  • There is a change to the reviewing IRB, or
  • There is a proposal to use eConsent.

Otherwise, no action is needed.

Because these applications are created with the limited information that HSD has, most of the SmartForm questions will be blank and typically required documentation will not be present. Initiating a modification or study update will trigger system requirements to answer all Smartform questions, even if those questions are not relevant to the modification. Because of this, HSD does not require that these applications be “brought into line” with current documentation requirements and strongly discourages study teams from modifying the application except for the reasons noted above.

PIs will receive annual notifications about the status of the application, as they would for any external reliance applications, and should close the application when it is closed by the non-UW IRB.

For questions about the conversion plan or how to manage these applications, contact hsdrely@uw.edu.