UW Research

March 1, 2021

For the Record – March 1, 2021: Advarra, Return of Results, ITHS COVID Review Process

In this Issue:

Training for Staff and PIs who use the Advarra IRB

For the broader UW community

UW allows industry-sponsored research to be reviewed by an independent IRB instead of the UW IRB. Additionally, some large multi-site federally-funded research studies are required by funding agencies to use an independent IRB. One of these independent IRBs is Advarra.

The Human Subjects Division has coordinated with the Advarra IRB to host a web-based orientation to working with Advarra, which includes a demonstration of their online application system called CIRBI. This training is being held specifically for anyone in the broader UW community who currently has studies reviewed by Advarra or who might use Advarra as an IRB in the future. Advarra experts will be available to answer your questions about working with Advarra and using the CIRBI system.

Date: Tuesday, March 9th
Time: 11:00 am – 12:00 noon Pacific Time
Webinar Access: Join from PC, Mac, Linux, iOS or Android
For the best audio experience, please use computer audio.

Should you have any questions about the webinar or the CIRBI platform, please feel free to reach out to Susanna Keilman.

Return of Results Guidance Update

Updated CLIA information

The UW Return of Results Guidance has been revised to update the information about CLIA certification of laboratories. This has implications for researchers about what individual information they can, and cannot, share with research participants.

Washington State regulators have clarified that that CLIA certification (or the state equivalent) is required for a research lab to return any individual level results that “will be or could be” used for health care purposes. In other words, if a research lab intends to report individual-level results to the tested individual or their clinician, the lab must first obtain CLIA certification, or establish a process to obtain confirmatory testing in a CLIA-certified lab. IRB approval for returning results may be withheld in the absence of CLIA certifications.

ITHS COVID Review Process

Discontinued February 23, 2021

The ITHS COVID Review Working Group and its web research portal were established in March 2020 at a time of great need and uncertainty. Its function was to coordinate, prioritize, and streamline research involving UW Medicine patients with COVID-19 and/or their healthcare records, ensuring that patients and their records were enrolled only in rigorous, high quality research. The Working Group’s review and approval was required before the research could be fullyapproved by the UW IRB.

The number of applications has dropped steadily, indicating that there is no longer a need for the group and its functions. Therefore, the ITHS COVID Review Working Group and its associated research portal have been discontinued.

HSD is grateful for the partnership with this group. Among other things, the group’s review assured the IRB that UW Medicine COVID-19 patients were not overwhelmed with requests to participate in numerous studies.

Since its formation, the Working Group received 220 applications via the ITHS / UW Research Portal. This is consistent with HSD’s observation that a large number of UW researchers, in a wide variety of disciplines, have been vigorously involved in research about the COVID-19 pandemic and the SARS-CoV-2 virus. It ranges from biomedical research on testing, treatment, and vaccine development to public health surveillance to understanding and mitigating social, behavioral, and educational impacts. Thank you to our outstanding researchers and their commitment, creativity, and contributions!

Save Time by Copying Existing Zipline Applications

Helpful Zipline tip

Do you need to start a new Zipline application that is similar to an existing one?

If the study you are creating is very similar to another study you already have in Zipline, you may be able to save time by copying the original application and making revisions to the copy. Just make sure that you make any needed edits to the forms and that you upload a new IRB protocol form and other study documents before submitting to HSD.