October 5, 2020
For the Record – October 5, 2020
Non-Zipline Studies More than Four Years Old
REMINDER: By June 1, 2021, researchers must either close all studies that have paper-based IRB applications (if they have been completed) OR convert the old paper-based IRB applications into Zipline Applications.
All active non-exempt studies that were approved by the UW IRB prior to Zipline implementation and that have not yet converted their IRB application into a Zipline application. This does not apply to studies reviewed by other IRBs, such as WIRB or the Fred Hutch IRB.
The database that supports these older studies uses a 20-year-old software program that is prone to problems and that cannot be updated.
We are grateful to the many researchers and study teams who have closed or converted their IRB applications in response to the multiple campus reminders about this deadline in the past two years. With the deadline now only 9 months away, we are switching to communications to individual researchers and taking the steps described below to ensure that all of these studies will be closed or converted by the deadline.
- Research for which all procedures except data analysis have been completed.
A significant number of studies indicated in the most recent Status Report that all data collection and subject contact had been completed, and that the IRB application remained open only because there was ongoing analysis of identifiable data. HSD staff will create a conversion application for each of these studies, using information from the paper IRB application. This process will require very minimal involvement of the researcher or study team.
- Research that will be completed prior to June 1, 2021.
Current IRB approval expires prior to June 1, 2021: The paper Status Report process may be used to renew IRB approval but the renewed approval will end on May 31, 2021. Subsequent IRB approval will be granted only if the IRB application has been converted into Zipline prior to June 1, 2021.
Current IRB approval expires on or after June 1, 2021: The current IRB approval period is being shortened; researchers will receive an email notification with their new expiration date. Subsequent IRB approval will be granted only if the IRB application has been converted into Zipline prior to June 1, 2021.
- Research that will continue study procedures and/or subject contact on or after June 1, 2021.
Current IRB approval expires prior to June 1, 2021: The study must be converted into Zipline (or closed) before the expiration date. The paper Status Report process for renewal will not be allowed except in specifically-approved circumstances. IRB approval will not be renewed unless conversion has occurred.
Current IRB approval expires on or after June 1, 2021: The current IRB approval period is being shortened; researchers will receive an email notification with their new expiration date. The study must be converted into Zipline prior to the end of the revised approval expiration date. If the study is not converted by that date, it will no longer have IRB approval and subsequent IRB approval can be obtained only by submitting a new IRB application in Zipline.
Questions and Answers
What will happen if a study is not closed or converted by June 1, 2021?
The IRB approval will lapse. At that point, it can be renewed only by submitting a new application in Zipline. No conversion applications will be accepted after May 31, 2021.
How do I know whether my research can be closed?
Doing data analysis does not necessarily mean your IRB approval needs to be maintained – it depends on the type of analysis. Contact the HSD Team that manages your IRB application or Dolly Morse (206.616.8042).
Are there instructions for doing a conversion?
Yes. See the materials and information at the Zipline Conversion webpage.
Who can I contact for help or more information?
Contact Dolly Morse (206.616.8042).
What if there are extenuating circumstances?
No exceptions to the June 1, 2021 deadline will be allowed. When Zipline was implemented four years ago in 2016, researchers were asked to begin converting their IRB applications into Zipline and were informed that paper-based processes would continue for a limited time. Multiple reminders have been communicated in the past two years to campus (in this eNewsletter) and to all affected individual researchers (in individual email reminders near the end of IRB approval periods).
News about WIRB
Many industry-funded clinical trials are reviewed by the independent IRB called WIRB instead of the UW IRB.
The electronic system used by WIRB has been completely rebuilt. This system, called WCG Connexus, has been re-designed to improve efficiency, ease-of-use, and transparency. The full launch of this important change is still ongoing.
The Human Subjects Division has coordinated with WIRB to host a web-based training for the new WCG Connexus system. This training is being held specifically for anyone in the broader UW community who might use Connexus. Because the interface has significantly changed, this 1.5 hour session will involve a thorough demonstration of the new platform, including how to navigate, make a submission, find outcome documents, and access tutorials for future reference. WCG Connexus experts will be available to answer your questions about the new platform.
Date: Wednesday, October 28
Time: 11:30 – 1:00 Pacific Time
Should you have any questions about the training or the new WCG Connexus platform, please feel free to reach out to Carmen Thompson.