May 4, 2021
For the Record – May 4, 2021: COVID, Zipline Updates, and New Guidance
- COVID News
- ZIPLINE News
- Minor Changes to Zipline e-IRB System
- Administratively Discarding Non-Responsive Applications
- Zipline Email Inbox is not Monitored
- Regulatory News
No changes have been made to the type of human subjects research that is allowable under current COVID-19 pandemic conditions. However, please contact HSD Director Karen Moe firstname.lastname@example.org if you think that your not-allowed research can be done safely with appropriate controls. She can work with you and UW Environmental Health & Safety to identify the requirements and circumstances that could allow your research to begin or resume.
Minor Changes to Zipline e-IRB System
Implemented April 29, 2021
The Zipline e-IRB system was revised during the evening of April 29th. Most of the changes are visible only to HSD staff. However, researchers will notice a few differences.
New SmartForm question. A new question about UW School of Medicine employed faculty practicing their licensed healthcare profession at a non-UW Medicine approved site of practice has been added to the Study Scope SmartForm. You will be prompted to complete this new question when you prepare a new application, respond to a clarification request for an ongoing application, or submit a modification to a currently approved study.
Other SmartForm improvements. Information on where to upload a curriculum vitae and what modification scope to choose has been added to the SmartForms.
Notifications. Small additions were made to two of the automatic notifications sent by Zipline.
Application forms. Documents linked in Zipline have been updated to the most current versions.
In-Review tab. This tab on the Submissions Workspace will now show relying sites and site modifications that are under review, so all initial applications and modifications being reviewed by the UW IRB can be found in one place. Applications to use an External IRB are still found on the External IRB tab.
List of all changes. The Release Notes describing the changes to Zipline in more detail have been posted on the Zipline Release Notes page.
Administratively Discarding Non-Responsive Applications
Implemented April 29, 2021
In these circumstances, HSD may administratively discard applications in Zipline due to non-response:
- The item is clearly not needed or not able to be processed, and it has been sitting for 60 days without researcher response to a request that it be discarded
- For all other applications, the item has been sitting for 6 months without researcher response
The PI, PI proxy, and primary contact of the item will be contacted by email two weeks before the item is administratively discarded. If the application is still needed, respond to the email or in Zipline so that it is not discarded.
Reminder: Zipline Email Inbox is not Monitored
Zipline will automatically send email notifications when certain actions occur, such as approval of an application or a request for clarification. The email address from which these notifications are sent is not monitored. Responses to requests for clarifications should be submitted in Zipline using the Submit Response activity. For questions about an item under review, please contact the IRB Coordinator assigned to your submission. For all other questions, email email@example.com.
HSD has developed detailed guidance about prisoners and research. The guidance was developed with significant input and advice from a UW IRB member and faculty member who is also a prisoner advocate and who has held leadership roles in the Washington State Department of Corrections. HSD is grateful for his willingness to actively lead us through the development and accuracy of the information and policies.
Prisoners include individuals who are prisoners at the time of research enrollment as well as individuals who become prisoners after they are enrolled. They are one of the federally protected populations of research participants. The guidance leads researchers through the significant complexity of conducting research involving prisoners. It includes:
- A multi-faceted definition of “prisoner” that addresses the numerous circumstances in which an individual can be considered a prisoner
- How to navigate the considerable variability in applicable regulations and requirements across different external research funding sources
- HSD policies about prisoner research
The regulatory complexity of this area tends to discourage researchers from doing prisoner research. However, HSD and many bioethicists encourage researchers to include prisoners in their research when appropriate. This is essential for developing evidence-based understanding, services, care, and interventions (psychological, social, educational, biomedical) for this often-overlooked vulnerable population with its unique needs and characteristics. HSD hopes that this guidance will significantly assist researchers interested in this area.
NIH Fetal Tissue Policy change
A recent notice from the National Institutes of Health was published to inform the research community that the federal Health and Human Services Department has reversed its 2019 decision that all research applications for NIH grants and contracts that propose the use of human fetal tissue from elective abortions will be reviewed by a federal-level Ethics Advisory Board. All other requirements for the collection and use of the tissue remain unchanged. NIH reminds researchers of the expectations to obtain informed consent from donors and of continued obligations to conduct the research only in accord with any applicable federal, state, or local laws and regulations, including prohibitions on payment for the tissue.