January 25, 2021
For the Record – January 25, 2021: Updated COVID-19 Web Pages and New Zipline Resources
- HSD’s COVID-19 Webpages and Risk Tool
- IRB Protocol Form: Minor Revisions
- Minor Changes to Zipline e-IRB System
- Zipline Modifications- New Resources
- Department Administrator Access to Zipline
- New Instructions: Managing Multi-site Studies in Zipline
- New Zipline FAQ: Zipline comments
- Reminder: Zipline Help Text
HSD’s COVID-19 Webpages and Risk Tool
There have been no changes to the criteria for what type of research is currently allowed. The information was reviewed and revised to ensure that links are still active and information is up-to-date. Minor revisions to shorten the content or improve clarity were made.
Webpage COVID-19 and Human Subjects Research. No new information has been added but items have been removed because they are out-of-date or no longer necessary. It is now much easier to find the criteria for which research is currently allowed.
Webpage Human Subjects Research Allowed During the COVID-19 Pandemic. There are no changes to the categories of allowed research. Some out-of-date introductory information has been removed. Minor clarifications have been made to the Infection Control Requirements section.
HSD COVID-19 Relative Risk Tool. This tool is used by researchers to self-determine whether their research is allowed under current COVID-19 pandemic conditions and restrictions.
- Important Assumptions section. Minor clarifications were added.
- Risk Factor 2: Participant Age. The age range – 85 has been revised to 75 and above.
- Risk Factor 3: Medical conditions. The four options have been reduced to three options and the description in the footnotes has been significantly revised. This reflects revised guidance from the Centers for Disease Control and Prevention (CDC).
IRB Protocol Form: Minor Revisions
Implemented January 21, 2021
A few minor revisions to the IRB Protocol from were implemented to improve clarity. No questions have been added or deleted.
- Prisoners. Re-ordering of questions 2.3 and 2.4 about prisoners, to ensure that the issue of “incidental” prisoners was not overlooked.
- MRI procedures. Add the new Arts & Sciences MRI scanner to the list of UW MRI facilities. Move some questions about the use of contrast agents from the Procedures section to the Risks section.
- Electronic consent. Minor changes for clarity, in response to campus questions.
The remaining news items describe several improvements, short new instructional videos, and reminders related to the use of our Zipline e-IRB application system. Many of these are in response to requests from you – thank you!
Minor Changes to Zipline e-IRB System
The Zipline e-IRB system was revised the evening of January 21st. Most of the changes are visible only to HSD staff. However, researchers will notice a few refinements.
- More help text has been added to assist in answering questions in the Zipline SmartForms
- Small changes were made to the Study Scope SmartForm, but no new questions have been added
- Application forms linked in Zipline have been updated to the most current versions
- Minor revisions were made to the modification approval and determination letter templates
List of all changes. The Release Notes describing all changes to Zipline have been posted on the Zipline Release Notes page.
Zipline Modifications – New Resources
Modifying your approved study in Zipline is not as straightforward as it may seem, especially if you need to update the study team or make changes to study roles. Some new resources are now available to help:
- New Video: Modifications Overview– Watch this short video to learn best practices and reduce the amount of back and forth needed with HSD staff to review your modification.
- New Video: Study Team Modifications– Watch this video to learn best practices for study team modifications, including how to avoid unnecessary modifications.
- New webpage: Study Team Modifications– Get a quick overview of modifications to change study access and/or study roles.
- New FAQ questions– Find answers to some of the most frequent questions that HSD staff receive about modifications.
Department Administrator Access to Zipline
Did you know that department administrators can be given access to all Zipline studies for their department? Requests for department-level access in Zipline must come from the overall department administrator or department-wide manager (such as the department’s Research Manager). See our Department Access webpage in the Zipline Online Help Library to learn more, including how to submit a request for access.
New Instructions: Managing Multi-site Studies in Zipline
Over the past year, the UW IRB has been serving as the single IRB for an increasing number of studies. In Zipline, these multi-site studies are documented through a STUDY record that provides the overall description of the research and a separate SITE record to manage each institution (“site”) involved in the research. See this short video for a quick overview of Single IRB and collaborative/multi-site research in Zipline.
When a change is needed to a multi-site study, it can be challenging to determine what action is needed in Zipline. A new webpage on Managing Multi-site Studies is now available in the Zipline Online Help Library to help you submit continuing review reports, modifications, and requests for site closures. Contact email@example.com with any questions.
New Zipline FAQ: Should I use Zipline comments to contact HSD staff with questions?
Have you ever wondered about the best way to contact HSD staff with a question or request? While we frequently receive comments on Zipline applications, they aren’t the best means of getting a prompt response. Instead, we recommend contacting the group email for the team that reviews for your department. See our new FAQ for more information.
Reminder: Zipline Help Text
Zipline has help text embedded in the SmartForms to provide guidance on how to answer questions. If you are completing a Zipline application for the first time, or are unsure of how to answer a question, click the help bubble next to the question. If you are still uncertain of how to answer a question, contact the HSD team assigned to your application.