July 9, 2024
For the Record- July 9, 2024: Zipline Website Redesign, DCTI Town Halls
In this Issue:
Zipline Website Redesign
Launched June 25, 2024
The Human Subjects Division launched a new design for our Zipline landing page and associated help materials on June 25. The goal of this project was to improve site navigation by providing clear pathways to the most needed information for all types of researchers, from students working with the IRB for the first time to experienced study staff.
Changes include:
- Streamlined Zipline landing page featuring quick access to the most used resources
- Updated process overview pages designed to give new and infrequent users a high level overview of common actions such as applying for review
- Flattened structure in the Zipline Help Library with curated information to make it easier to find step by step instructions for common tasks such as updating the study team in Zipline
- Updated Zipline FAQs to address the most common questions about using Zipline
Thank you to UW researchers who participated in interviews and provided in-depth feedback about our draft designs. Your insights helped to ensure that our final design is better suited to the needs of the UW research community.
Contact hsdinfo@uw.edu if you have any feedback or questions about where support materials have moved.
Diversity in Clinical Trials Town Halls
Coming September 2024
In our special June 18, 2024 newsletter, we mentioned a planned series of virtual town halls to provide researchers and other interested parties the opportunity to ask questions and provide feedback on the UW’s Diversity in Clinical Trials Initiative (DCTI). The first two session dates have been set and will occur:
- Tuesday, September 4, 2024, 9:00-10:30am Pacific Time
- Friday, September 20, 2024, 2:00-3:30pm Pacific Time
A registration link for both events will be provided in our August newsletter. HSD intends to publish our draft diversity plan template and associated guidance in advance of the September 4th town hall for public comment. Information about these events, including post-session recordings will also be posted on the UW DCTI website.
ClinicalTrials.gov Results Reporting
Reminder
UW clinical trials that are funded by the National Institutes of Health (NIH) and/or are considered to be an applicable clinical trial under the 2007 FDA Amendments Act are required to be registered and the results reported on ClinicalTrials.gov. Late results reporting comes with the potential for financial penalties levied against the Principal Investigator and/or the withholding of NIH funding.
A recent Chronicle of Higher Education article described an incident in which the NIH withheld funding for the entire University of California at San Diego because one scientist, who had retired from the University, had failed to turn in final reports for two of his grants. While this is not specific to ClinicalTrials.gov results reporting, the parallel and potential for similar enforcement action to occur is there.
HSD, working with School of Medicine, School of Public Health, School or Nursing and other schools/colleges has been making efforts to improve our institutional compliance with clinical trial results reporting. Since 2019, the UW compliance rate has gone from 64% to 94.8%! We appreciate our research community’s efforts to report results in a timely manner.
More information regarding reporting requirements can be found on the HSD website. Please contact HSD at hsdreprt@uw.edu for assistance.
HSD Administrative Fee Increase for Industry Clinical Trials
Reminder
Effective July 1, 2024, HSD’s administrative fee increased from $1933.70 to $2060.06. 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.