HS IRBs News July 2020

Phase 2 Research Reboot Update

With the rollout of phase 2 of research reboot on campus, the IRB offices are receiving many questions from study teams about how to restart their studies as well as what needs to be reported to the IRB regarding things like Covid-19 screening procedures. This newsletter focuses on addressing the key questions study teams have as well as providing links to important resources as study teams plan how to move forward with their studies.

The pandemic has created a complicated and ever-evolving landscape for human subjects researchers. We strongly encourage study teams to review our Covid page FAQs and then contact us with any questions they may have (608.263.2362 or asktheirb@hsirb.wisc.edu). We are here to help.

What NOT to Report to the IRB

Nearly all information regarding institutionally required Covid-19 precautionary measures and approvals does NOT require IRB review and approval. This includes, but is not limited to:

• Institutional approvals to restart a study
• Copies of documents that describe Covid-19 precautionary measures, such as EHS’s guidance on precautionary measures for study visits occurring outside UWHC facilities
• Information sheets for subjects describing the precautionary measures that will be in place for their face-to-face visits (see template information sheet on the bottom of this page)
• Covid-19 screening scripts or tools that will be used with study subjects or staff (see template screening script on the bottom of this page)
• Information about any Covid-19 testing subjects may be required to undergo

What Should be Reported to the IRB

• Changes to move study activities remote, including consent processes (see the Remote Study Activities Guidance guidance for details on moving study activities remote)
• Changes to address scientific design or subject population concerns relating to Covid-19, such as adjustments to study procedures to reduce the Covid-19 exposure for higher risk subjects populations (see the What is required from an IRB standpoint before restarting face-to-face research activities? FAQ for details)

Useful Links for Study Teams

In addition to those provided above, the following links may be useful:

• OVCRGE’s face-to-face interactions page
• SMPH restart information
• Office of Clinical Trials operations status page
• IRB Covid-19 updates page
• Remote consenting guidance